Clifton Brown (Sporting News) grades the Patriots: A+

No pass rusher, but a slew of talented players led by Nate Solder, Ras-I Dowling, Shane Vereen and Ryan Mallett. Plus they have two picks next year in both the first and second rounds.

NBC Sports Grades the Draft. New England Patriots: B+

Another predictably unpredictable Patriots draft. They took players other teams were afraid to: Ryan Mallett fell to round three because of off-field concerns, while Marcus Cannon fell to round five because of a non-Hodgkin’s Lymphoma diagnosis. Both were arguably first-round talents. A pair of mid-round running backs (Shane Vereen and Stevan Ridley) should help right away, but passing on front seven help was curious. Nate Solder was perhaps the most talented tackle in this class and could replace Matt Light immediately. Line coach Dante Scarnecchia will know what to do with Solder. Oh, and by the way: The Patriots picked up an extra first- and second-round pick in next year’s draft.

Nate Davis (USA Today) Patriots are winners in the 2011 Draft.

Yet again they worked the board to their advantage and already have two first-rounders and two second-rounders for the 2012 draft ... potentially even more advantageous if the expected rookie wage scale doesn't go into effect for another year. For 2011, they come away with Nate Solder, likely QB Tom Brady's new blindside bodyguard; a deeper talent pool in their offensive and defensive backfields; and two value picks -- QB Ryan Mallett (third round) and OL Marcus Cannon (fifth round) -- potential Round 1 choices who plummeted due to perceived off-field concerns in Mallett's case and medical ones for Cannon. Assuming Mallett never displaces fairly young Brady (34 this season), he could be a valuable trading chip in future years while Cannon, if healthy, could earn a spot on a line in transition.

Andrew Perloff (SI) The Patriots are one of the teams that still have holes to fill following the draft.

The Patriots didn't have a player with more than 5.5 sacks last season and struggled to get teams off the field on third down. But even though they entered the draft with six picks in the first three rounds and this was supposed to be one of the best defensive end drafts ever, they didn't take any pass rushers in the early rounds. Now they'll have to find someone who can get after the quarterback in free agency.

Adam Caplan (Fox Sports) New England Patriots are losers after the Draft.

The Patriots had a major need for pass rushers, but Bill Belichick ignored the outside linebacker position. They could have selected outside linebacker Akeem Ayers, but chose to go with a cornerback instead in the second round. The Patriots were already in decent shape at cornerback, but all the good cover guys in the world won’t matter if you can’t consistently get to the quarterback.

WEEKEND LINKS

• Patriots Links from Saturday - 4/30/11
  
• Patriots Links from Sunday - 5/01/11
  

LOCAL LINKS

• Jeff Howe assesses the Patriots' risk-taking in the draft and notes now it's all about enduring the waiting game.
• Greg A. Bedard looks at whether the new draftees will cause a shift in the rankings of the AFC East next season.
• Mike Reiss analyzes the 2011 Patriots roster as it looks right now.
• Karen Guregian grades the AFC East.
• Chris Gasper thinks the Patriots should have gone all out to trade up for the best player while Brady is still in his prime.
• Mike Reiss tells us how ESPN draft analyst Mel Kiper assessed the Patriots' draft: C+
• Christopher Price gives us ten undrafted free agents to keep an eye on once the lockout ends.
• Karen Guregian notes that Patriots 6th-round pick DE Markell Carter sounds comfortable making the switch to outside linebacker.
• Ian Rapoport posts his video of Patriots RB Shane Vereen talking about his draft experience at Gillette. (4.53 min. video)
• Ian Rapoport posts a video of new Patriots CB Ras-I Dowling from the UVA Athletic Department. (3.37 min. video)

NATIONAL NEWS

• Tim Graham (ESPN) Mel Kiper grades the AFC East.
• Andrew Perloff (SI) Ten teams that still have holes to fill following the draft.
• Clifton Brown (Sporting News) NFL Draft grades: Lions, Patriots ace their tests; Jets swing and miss.
• Michael Silver (Yahoo! Sports) 32 Post-Draft Assessments.
• Pat Kirwan (NFL.com) Mallett-to-Patriots is best fit among rookie QBs.
• Armando Salguero (Miami Herald) What to do with Henne, and why not Ryan Mallett.
• Sean Leahy (USA Today) With Ryan Mallett in tow, Tom Brady says he'll play 10 more years.
• Adam Caplan (Fox Sports) Draft's best and worst.
• Nate Davis (USA Today) Winners and losers from the 2011 NFL Draft.
• Greg Gabriel (Nat'l Football Post) Draft winners.
• Rick Gosselin (Dallas Morning News) As usual, draft turns into Patriot days.
• Rob Rang (CBS Sports) Final draft grades. Patriots: B.
  
• NBC Sports Grades the Draft. New England Patriots: B+
• Kerry J. Byrne (SI) Cold Hard Football Facts Draft grades: Patriots: C-
  
• Lisa Olson (Sporting News) NFL Draft delivers great stories in spite of arduous labor pains.
• Peter King (SI) News of NFL Draft takes a backseat to news of bin Laden's death.
• Dan Pompei (Nat'l Football Post) Sunday Blitz: Examining the Falcons' bold move, best value picks and lots of draft scoop.
• Vic Carucci (NFL.com) Which picks will have a sudden impact on the depth chart?
• Gil Brandt (NFL.com) Devlin tops list of best available undrafted players.
• Chad Reuter (CBS Sports) When lockout ends, these undrafted players will get calls.
• PFW Staff (Pro Football Weekly) Highest-ranked players who went undrafted.
• Richard Deitsch (SI) ESPN, NFL Network tally more hits than misses during draft weekend.
• Sean Leahy (USA Today) NFL draft TV viewership down 16% from 2010.

LABOR LUNACY

• Albert Breer (NFL.com) Five need-to-knows about the 8th Circuit's pending ruling.
• Judy Battista<</span>!> (NY Times) Court ruling puts lockout back in place temporarily.
• Barry Wilner, AP (NBC Sports) Monday could be critical day for NFL labor.

BEAUMONT: Basketball tournament to benefit Muscular Dystrophy Association InlandSoCal.com The city of Beaumont will host a basketball tournament Thursday to benefit the Muscular Dystrophy Association. Tip-off will be at 6 pm at the Albert A. Chatigny Sr. Community Recreation Center, 1310 Oak Valley Parkway. Competing teams are the city of ...

F. Scott Fitzgerald supposedly told Ernest Hemingway, “The rich are different from you and me.” And Hemingway supposedly replied, “Yes, they have more money.”

Engineers are different from the rest of us. Sometime around the middle of the 20th century, they assumed the poetic mantle that writers had once worn.

In today's world engineers can dream, embrace the future, and comfort us with the notion that everything can be fixed. Well, almost everything; except, perhaps, the human condition.

One could measure easily the difference between engineers and the rest of us in the aftermath of the Fukushima nuclear disaster. While we feared for the Japanese and other populations, engineers — and I have canvassed dozens — were full of praise for how the reactors had performed during the earthquake.

Marc Goldsmith, an MIT-trained engineer from Newton, Mass., said, “Everything worked as designed in the earthquake. At 9 on the Richter scale, the reactors shut down as planned; emergency systems went into operation and engineering triumphed.”

What?

Yes, Goldsmith is adamant. The reactors, he said, survived an extraordinary earthquake like shock-resistant watches. It was the tsunami that did them in, destroying all fall-back power systems, including the diesel generators. Yet the 40-year-old reactors did what they were designed to do: They shut down.

The spirit of engineering as the poetic best hope for the creative, competitive future is to be found in engineering pure plays like PaR Systems, Inc., the bespoke engineering company based in Shoreview, Minn., near Saint Paul-Minneapolis. This company, relatively small with a few hundred employees and a blue-chip client list, epitomizes the idea of engineering with a poetic dimension and a mission to overcome failure, as in the work they are doing to help secure the Chernobyl nuclear disaster site in Ukraine; overcome complex and difficult crane installations; or simply to overcome the labor intensity and boredom of putting cans of food into cartons for delivery.

Overcoming is their ethos; clever robots, their pride. PaR chief technology officer, Albert A. Sturm, accepts the idea of poet-in-chief but believes that unlike poets of old, writing alone, the engineer-poet needs a team of engineering and related disciplines, and what he calls “a culture of creativity.”

Mostly, PaR is called in when nothing short of towering imagination and superb design and implementation will do; so they are less fettered by the need to “do it cheaply.”

President Mark A. Wrightsman says that since PaR went private some years ago, they have been saved from the tyranny of quarterly results. “If we were to go public again, I would not issue market predictions,” he says.

Two shadows pass across the countenance of engineering as mankind's friend and benefactor, disturbing the serenity of the world of logarithms, CADS (computer-aided designs) and micro-tolerances: design error and human error. If a bridge fails, blame the engineers for its faulty design or substandard materials. More often, the deadly foe of good systems is to blame: human error.

That was the case with the Deepwater Horizon catastrophe in the Gulf of Mexico: people cutting corners and hoping for the best. Humans failing engineering. It also was human error that led to the meltdown at Three Mile Island; and human error that caused a miracle of engineering, the Airbus A380 superjumbo jet, to clip a small Bombardier aircraft at Kennedy Airport in New York.

As Douglas Adams wrote, “A common mistake people make when trying to design something completely foolproof is to underestimate the ingenuity of complete fools”

Yet engineers remain more hopeful than most people. They peer into the future, and where we see chaos and shortage, they see wonderful systems and plenty. Vive la difference.

By Llewellyn King for WHChronicle.com

Andy Hart gives his initial reaction to the newly-released Patriots 2011 schedule, and how he thinks they"ll do.

The meat of the Patriots 2011 schedule is in truly the meat of the season &ndash; the eight game stretch from Oct. 9 through Dec. 4 that kicks off hosting the Jets, concludes with a Sunday night game at Gillette against the Colts and in between has the team taking on the Cowboys, Steelers, Giants, Jets again, Chiefs and Eagles. That’s two games against their top AFC East competition, tough trips to Pittsburgh and Philly, home contests with the Giants and Chiefs as well as what should be resurgent Dallas squad. Of the eight games, six are against 2010 playoff teams, while the Giants were a 10-win team a year ago.

If New England successfully navigates the tough middle of the season, things theoretically lighten up down the stretch. The final four games are trips two Washington and Denver followed by hosting division foes Miami and Buffalo.  If the postseason is still on the line at that point, a four-game winning streak to end the year certainly wouldn’t be out of the question.

Mike Reiss offers his initial reaction to the Patriots 2011 schedule.  Here are a few of them:

Cowboys lone opponent coming off a bye. The Cowboys will be coming off a bye before traveling to face the Patriots, which means they should be fresh for that Week 6 matchup. The Cowboys are the only team coming off a bye to face the Patriots this season.

Weather test in Miami. The Patriots open the season on Monday night (Sept. 12) at the Dolphins. Temperatures in South Florida at that time of year can be challenging, even at night. This brings back memories of the 2004 season when the Patriots played at Arizona in Week 2 of the season and Bill Belichick made constant references to conditioning in the weeks leading up to the game.

First Jets game a good spot. The Jets will be coming off road games at Oakland and Baltimore when they visit the Patriots in Week 5. That's a good spot for New England.

Ian Rapoport gives us a few of his thoughts on the Patriots schedule for this season.

&ndash; I thought last year’s schedule was extremely tough, and the Pats ended up 14-2. This time, I’d characterize the slate as very fair. Opponents have a combined record of 129-127, which is 16th toughest. Not bad.

&ndash; For those who like holidays, you should be thrilled. There is no road game at Buffalo on Christmas and no Thanksgiving game in Detroit. There are no Thursday games at all. On Christmas Eve, the Pats are home against Dolphins at 1 p.m., which could have you home for presents (if that’s when you do them). Still, the Jan. 1 home game against the Bills at 1 p.m. means hangover hell for a bunch of you.

TEAM TALK

• Patriots 2011 Schedule announced: Team notes and trends.
• Ask PFW: Picking the prospects.
• Andy Hart highlights Bill Belichick's appearance on "Movin' the Chains", talking about the Draft with Pat Kirwan and Jim Miller.
• Patriots Today - 2011 Regular season schedule. (3.09 min. video)
• Patriots Today - 2011 Draft Preview: LB (6.29 min. video)
• PFW in Progress (4/19/11): This edition includes discussion of various mock drafts as well as a wide variety of offseason topics.
• Vote here for the 2011 Patriots Hall of Fame Enshrinee: Fans now have through May 15 to vote.

LOCAL LINKS

• Shalise Manza Young reports the Patriots open their season at Miami on a Monday night, and gives her thoughts on the schedule.
• Greg A. Bedard offers some quickie thoughts on the 2011 schedule: On paper the Patriots have a chance to start and finish the season strong.
• Ian Rapoport notes that if the Patriots want to continue the dominance they displayed during last year’s regular season, they must begin by doing so on the road.
• Christopher Price takes a closer look at the Patriots 2011 schedule.
• Mike Reiss posts his first reaction to the Patriots 2011 schedule.
• Ian Rapoport looks at how much it would cost the Patriots to move up to a top ten spot in the Draft.
• Mike Reiss profiles possible Patriots: CB Brandon Harris (Miami).
• Tom E. Curran previews potential Patriots: DT Nick Fairley (Auburn)
• Mike Reiss analyzes Peter King's first-round mock draft that has the Patriots selecting C/G Mike Pouncey (Florida) and trading the 28th pick to the Titans.
• AP reports the NFL and locked-out players are set for Day 4 of mediated talks today.

NATIONAL NEWS

• Tim Graham (ESPN) New England Patriots schedule analysis.
• NFL.com 2011 NFL Schedule: See who's playing who, sorted by Team or Week.
• Tim Graham (ESPN) Worst officiating call in AFC East history?
• Gregg Rosenthal (ProFootballTalk) Pioli explains needs over value, and Jeff Marriott over Tom Brady.
• Richard Deitsch (SI) March media power list. Includes a story behind "The Brady 6" from James Weiner, NFL Films, senior producer.
• Peter King (SI) MMQB Mail: Why teams set at QB are kicking tires on Dalton, others.
• Mike Florio (ProFootballTalk) Schedule contains no hint that the league plans to miss games.
• Alex Marvez (Fox Sports) Schedule release spoiled by lockout.
• Mike Florio (ProFootballTalk) Sunday Night Football is loaded with great games.
• Don Banks (SI) Seventeen NFL games to watch for.
• Joe Fortenbaugh (Nat'l Football Post) 10 must-see matchups on the 2011 NFL schedule.
• Adam Caplan (Fox Sports) NFL regular season most intriguing matchups.
• Vinnie Iyer (Sporting News) NFL schedule: Top 10 games of 2011.
• Jason Cole (Yahoo! Sports) Ten best/worst games of '11 schedule.
• Paul Kuharsky (ESPN) Power Rankings: Top 10 NFL cornerbacks. Guess who made the list?
• Brian Billick (Fox Sports) Good scouts not enough for draft success.
• Gregg Rosenthal (ProFootballTalk) ESPN expects draft ratings to be higher.

LABOR LUNACY

• Albert Breer (NFL.com) 'Some progress' in labor talks on day NFL schedule released.
• Mike Florio (ProFootballTalk) "Some progress" made Tuesday in mediation.
• Mike Florio (ProFootballTalk) Jeffrey Kessler absent from mediation, too.
• Mike Florio (ProFootballTalk) Goodell, Ryan Clark have different views about schedule release.

 Today on the blog Conatus' drug CTS-1027 will be highlighted, with media updates, EASL 24-week interim results, which consisted of Conatus' drug CTS-1027 in combination with Pegasys® and ribavirin (Copegus®) in HCV genotype 1 null-responder patient population. It's unusual for an early phase trial to be composed around null responders. A possible bonus is the anti-inflammatory and anti-fibrotic effects the company claims that CTS-1027 has, which is exciting. Right now there are a number of companies involved in hepatitis C drug development , you can view them here.

 Included in this entry is a link to the companies Phase 2b trial, which as you may know is currently recruiting approximately 260 patients, at up to fifty medical centers in the U.S. (locations are listed below). Also included is additional information on the drug from Conatus' web site.

On this blogs web site is a&nbsp;Summary of  investigational Hepatitis C drugs presented at this months EASL and a comprehensive list of Hepatitis Clinical Trials.

Conatus Pharmaceuticals recently announced funding is in place to advance the development of CTS-1027.
.
See Link;
Conatus Adds $7.5M, Closes Series B Round
April 14
San Diego’s Conatus Pharmaceuticals says it has closed the Series B round of funding that began in February with a $7.5 million investment by MPM Capital of South San Francisco, CA. In a statement yesterday, the company says it has raised a total of $32.5 million in this round. Conatus plans to use the proceeds to advance development of CTS-1027, a new drug candidate for treating hepatitis C that the company licensed from F. Hoffman-La Roche, and to evaluate compounds acquired from Idun Pharmaceuticals last year. The hepatitis C compound is currently in multiple mid-stage clinical trials.

CTS-1027 for Liver Disease

CTS-1027 is a novel and proprietary oral small molecule that inhibits the activity of key members of a class of proteases, the matrix metalloproteases or MMPs. Excessive MMP activity has been demonstrated to occur in the liver in response to HCV infection. Data from our laboratory taken together with data in the literature suggest that MMP activity in HCV-infected patients could play multiple roles in shifting the balance toward sustained virus replication and away from host-mediated viral clearance. Conatus believes that HCV regulates MMP levels and activity in order to efficiently infect hepatocytes and to interfere with the host interferon response. MMP inhibitors can be effective counter-measures against HCV directly, by inhibiting new infections, and indirectly, by amplifying the antiviral effects of interferon. This intervention would impact both the clearance of HCV-infected cells and the appearance of newly infected cells that over time could lead to reduction or elimination of circulating virus and ultimately all virus-infected cells. CTS-1027 has unique potential to impact HCV survival strategies and provide significant benefit to the HCV-infected patient population.

CTS-1027 Preclinical Summary
CTS-1027 is a potent small molecule inhibitor of MMPs. It inhibits individual members of the MMP family that are believed to be important in inflammation and tissue damage. CTS-1027 was specifically designed, however, not to inhibit MMP 1, as inhibition of MMP 1 was believed to be associated with musculoskeletal side effects.

Results of studies conducted in preclinical models of hepatitis and fibrogenesis provide support for the potential usefulness of CTS-1027 in patients with chronic hepatitis C virus infection. Although there are no non-primate comprehensive models of HCV infection, various aspects of the pathogenesis in man can be studied preclinically, and CTS-1027 has effects that could lead to benefit in patients. CTS-1027 inhibits HCV infection in primary human hepatocytes when added before or after HCV infection.

In the murine bile-duct ligation model of liver fibrosis, CTS-1027 significantly reduced collagen deposition, number of bile infarcts, apoptotic hepatocytes, and hepatocytes positive for activated caspases 3/7. Biomarkers of fibrogenesis and activation of stellate cells were also reduced. CTS-1027 also prevented elevations of plasma alanine aminotransferase (ALT) levels in acute hepatitis induced by tumor necrosis factor alpha (TNF-α)/D-galactosamine (Gln), activating Fas antibody, Concanavalin A (Con A), or lipopolysaccharride (LPS)/Gln.

Overall, the results of these different preclinical models of hepatitis suggest that CTS-1027 is hepatoprotective, blocks HCV replication, reduces inflammatory and fibrogenic responses associated with a variety of hepatic injuries, and may provide benefit to patients with chronic hepatitis C virus infection. The table below summarizes the preclinical experiments that have been conducted with CTS-1027 in liver disease.

CTS-1027 Clinical Summary

More than 700 subjects (including healthy volunteers, patients with osteoarthritis and HCV patients) have been exposed to one or more doses of CTS-1027. Single dose exposures were as high as 700 mg, while multiple dose exposures have included up to 315 mg once a day for 28 days, and 150 mg once a day for 24 weeks in osteoarthritis patients.

A number of investigational trials have been conducted to test the tolerability of CTS-1027 in the hepatitis C patient population and to explore potential efficacy. Initial efficacy measures were surrogate markers presuming an anti-inflammatory and anti-fibrogenic mechanism of action. Based on additional preclinical data, antiviral endpoints are now also being explored. The therapeutic trials are summarized briefly in the table below and described in more detail in the paragraphs that follow.

	CTS-1027-01 (completed)	CTS-1027-03 (completed)	CTS-1027-04 (in progress)	CTS-1027-05 (in progress)
Drug(s)	CTS-1027 monotherapy	CTS-1027 +/- Ribavirin	IFN/Ribavirin + CTS-1027	IFN/Ribavirin + CTS-1027 or Placebo
Duration	Variable	24 Weeks	Up to 48 Weeks	Up to 48 Weeks
Patient Population	HCV infected patients	IFN treatment naïve	IFN/Ribavirin null responders	IFN/Ribavirin null responders
Population Mix	Heterogeneous, but enriched for poor IFN responders	Broadest patient group	Purest IFN refractory population	Purest IFN refractory population
(Expected) Outcome	Identify dose for future trials, observed some evidence of antiviral response	Significant viral load decrease coupled with decrease in ALT/AST	≥ 2 log reduction @ week 24, viral clearance @ wk 48, SVR @ wk 72	SVR @ wk 72, viral clearance @ wk 48

CTS 1027 as Monotherapy (Trials CTS-1027-01 and CTS-1027-03)

CTS-1027 has been studied in patients with chronic hepatitis C infection, both in treatment naïve patients for whom interferon is not appropriate, and in those who previously failed to respond to SOC (treatment failures). Various doses and dosing regimens were tested initially to confirm the tolerability of twice daily dosing. It was determined that 15 mg BID (twice a day) is a well-tolerated dose for chronic administration in HCV patients. A subset of patients experienced a transient elevation in aminotransferases, followed by a transient fall in HCV-RNA. This was not a safety signal as ALT levels declined with continued exposure to drug. While these observations are anecdotal, they are consistent with CTS-1027 playing a role in overcoming immune tolerance in chronically-infected patients. Sentinel aminotransferase spikes have been reported in acutely infected HCV human patients who clear the virus spontaneously. It is also a phenomenon that precedes viral clearance in human hepatitis B infection (see figure below).

Pattern of ALT flares and HCV-RNA reductions: spontaneous clearance (adapted from Hoofnagle, Hepatology; 2002, 35, S21).





CTS-1027 with Ribavirin (Clinical Trial CTS-1027-03)

This study began in June 2009. Patients were randomized to receive 15 mg CTS-1027 BID + placebo, or 15 mg CTS-1027 BID + ribavirin for 24 weeks (30 patients per arm). While the primary endpoint was measurement of serum HCV RNA (viral load), CTS-1027, alone or in combination with ribavirin, was also evaluated for its potential anti-fibrogenic effects (normalization of aminotransferase enzymes).
Collective clinical experience in the treatment of patients with chronic HCV has demonstrated that patients who fail to achieve a 2 log reduction at 12 weeks have an especially low likelihood of achieving an SVR. A significant subset of treatment failure patients fall into this category. These patients, classified as "null" responders in the figure below, have few treatment options.

The preclinical experiments in the replicon assay showing a synergistic effect of CTS-1027 with interferon, taken together with patient data from Trials CTS-1027-01 and -03, suggest that CTS-1027 might enhance the response to endogenous or exogenous interferon.

 In Trial CTS-1027-04, initiated in January 2010, Conatus is studying the effects of CTS-1027 in combination with SOC in patients who are null responders (patients who fail to achieve a 2 log reduction at 12 weeks) to SOC.

 It is a single-arm pilot study in 60 patients, using historical controls (described in the table below), and is designed to explore the interferon amplifying activity of CTS-1027. Viral load after 4, 12 and 24 weeks of dosing CTS-1027 (15 mg BID) combined with SOC will be compared to historical response to repeat SOC therapy. Patients with reductions in HCV RNA of at least 2 log units at week 24 will continue treatment for an additional 24 weeks with additional follow-up to determine SVR. IL-28B screening data will be obtained at week 24, which will allow determination of potential differences in responses to CTS-1027 + SOC due to polymorphisms at this locus.

SOC null responder retreatment (data adapted from Rustgi et al. Hepatology 2009; 50: 1719).

	4 Weeks (RVR)	12 Weeks (cEVR) (EVR)	24 Weeks (CVR)	48 Weeks (EOT)	72 Weeks (SVR)
SOC Historical Responses	0%	5% 15%	≤15%	15%	5%

Given it is likely that one or more protease or polymerase inhibitors (DAA) will become part of SOC in the near future, it is possible that Phase 3 trials in combination with this new SOC may be necessary. It is important to note that null responder patients are not necessarily good candidates for DAA therapy, as recent data from trials with telaprevir have shown that a significant proportion of these patients have viral breakthrough or relapse during triple therapy.

If the CTS-1027-04 data show a significant antiviral effect of SOC plus CTS-1027 in the null responder population, CTS-1027 may be a useful addition to the soon to be approved triple therapies of SOC plus DAAs.

The Data&nbsp; CTS-1027-04/ The 24-week interim results

Published: Thursday, Mar. 31, 2011 - 12:08 pm

Full Press Release
CTS-1027 Plus Pegasys/Riba geno 1 null-responder 24-week interim results in hepatitis C patients

CTS 1027 in combination with Peginterferon Alpha-2a (Pegasys®) and ribavirin (Copegus®)-
.
Trial CTS-1027-04

CTS 1027 in combination with Peginterferon Alpha-2a (Pegasys®) and ribavirin (Copegus®) in a treatment experienced, hepatitis C virus (HCV) null-responder patient population. Null-responder patients are the most difficult to treat patient population and are clinically defined as those patients failing to achieve an early virologic response (EVR) when undergoing treatment with the current standard of care (SOC; pegylated interferon and ribavirin). EVR is defined as at least a 2 log decline in HCV-RNA by week 12 of SOC treatment.

The CTS-1027-04 clinical trial enrolled 67 HCV genotype 1 null-responder patients.

The clinical trial is a single arm and open label design with sustained viral response (SVR; no detectable virus 24 weeks after the end of treatment) as its primary end point.

At week 12, 51% (31/61) of patients receiving 15 mg twice a day of CTS-1027 in addition to standard doses of Pegasys® and Copegus® achieved an EVR on a per protocol (PP) basis. HCV-RNA was below quantifiable limit (BQL) in 5 patients (8.2%, PP) at week 12 and increased to 17 patients (34%, 17/50, PP) at week 24.

This clinical trial is ongoing and final SVR results are expected in 2011.

Data from the CTS-1027-04 clinical trial were presented at the 46th annual meeting of the European Association for the Study of the Liver (EASL) held in Berlin, Germany.

Posters Presented at EASL 2011:

24-Week Treatment With CTS-1027 in Combination With Ribavirin Reduces HCV-RNA in Treatment Naive Genotype-1 Patients. M. Chojkier, G. Everson, A. Muir, B. Bacon, M. Rodriguez-Torres, M. Bennett, M. Fried, S. Gordon, J. Gross, D. Nelson, L. Balart11, M. Jonas, G. Szabo, J. Bloomer, A. McCullough, L. Nyberg, C. Smith, O. Boehm, E. Castelloe, M. Huyghe, S. Mento, P. Contreras, A. Fox, R. Cross, A. Spada<</span>!>


Unique Pattern of Virologic Response in Patients With Genotype-1 HCV: A Phase II Study of CTS-1027 in Combination With Peginteferon Alpha-2A and Ribavirin in Null Responders. M. Rodriguez-Torres, B. Bacon, S. Gordon, R. Rubin, T. Box, M. Kugelmas, J. Vierling, B. Yoffe, P. Pockros, G. Everson, M. Jonas, L. Balart, O. Boehm, E. Castelloe, M. Huyghe, S. Mento, A. Spada, AW. Fox, M. Chojkier

From
Clinical Trials.gov

(CTS-1027-05) Trial Recruiting Participants
CTS-1027 is an oral, small molecule compound that inhibits the activity of key members of a class of protease enzymes, the matrix metalloproteinases (MMPs).

The trial will evaluate the safety, tolerability, and antiviral activity of the triple combination after up to 48 weeks of therapy.

The Phase 2b clinical trial (CTS-1027-05) will test CTS-1027 at higher doses in combination with Pegasys® and Copegus® in the null-responder genotype 1 patient population

The placebo-controlled, multicentre, double-blind, randomised trial will enroll approximately 260 patients who will receive Peginterferon Alfa-2a (Pegasys) and ribavirin (Copegus) with or without CTS-1027.

See Link For Full Information;

Standard of Care (SOC) With or Without CTS-1027 in Hepatitis C (HCV) Null-Responders
This study is currently
recruiting participants.
Verified on April 2011 by Conatus Pharmaceuticals Inc.


Locations
United States, Alabama

University of Alabama at Birmingham Recruiting

Birmingham, Alabama, United States, 35294

Contact: Olivia Hogue, RN, BSN 205-934-1224
ohogue@uab.edu
Principal Investigator: Omar Massoud, MD

United States, California

Southern California Liver Centers Recruiting

Coronado, California, United States, 92118

Contact: Ileana Rubio 619-522-0330
irubio@livercenters.com
Principal Investigator: Tarek Hassanein, MD

Scripps Clinic Recruiting

La Jolla, California, United States, 92037

Contact: Shari Gilbert, RN, BSN, MA 858-652-5421
gilbert.shari@scrippshealth.org
Principal Investigator: Paul Pockros, MD

Loma Linda University MC Recruiting

Loma Linda, California, United States, 92354

Contact: Delia Lujan, LVN, CCRP 909-558-3656

Principal Investigator: Mohamd El Kabany, MD

Huntington Medical Research Institute Recruiting

Pasadena, California, United States, 91105

Contact: Roberta Fitzgerald 626-397-5820
robertaf@hmri.org
Principal Investigator: Myron Tong, MD

UCSD Recruiting

San Diego, California, United States, 92161

Contact: Monique Gagnon 858-552-8585 ext 7216
Monique.Gagnon@va.gov
Principal Investigator: Mario Chojkier, MD

Medical Associates Research Group Recruiting

San Diego, California, United States, 92123

Contact: Dianne Tuohy 858-277-5678
dianne.tuohy@marginc.com
Principal Investigator: Michael Bennett, MD

United States, Colorado

University of Colorado Denver Recruiting

Aurora, Colorado, United States, 80045

Contact: Jennifer DeSanto, RN 303-724-1861
Jennifer.DeSanto@ucdenver.edu
Principal Investigator: Greg Everson, MD

United States, Connecticut

Yale University School of Medicine Recruiting

New Haven, Connecticut, United States, 06520

Contact: Danielle Jacques 203-785-7031
danielle.lettieri@yale.edu
Principal Investigator: Michael Schilsky, MD

United States, Florida

University of Miami Not yet recruiting

Miami, Florida, United States, 33136

Contact: Dimitri Duvilaire 305-243-6939
dduvilaire@med.miami.edu
Principal Investigator: Eugene R. Schiff, MD

United States, Georgia

Atlanta Medical Center, Inc. Recruiting

Atlanta, Georgia, United States, 30309

Contact: Alona Waldrop-Kelly 404-428-2970
waldrop-kelly@comcast.net
Principal Investigator: Brian Pearlman, MD

Liver Center of Atlanta Recruiting

Atlanta, Georgia, United States, 30309

Contact: Julie Costello, CCRP 404-355-3200 ext 166
julie.costello2@piedmont.org
Principal Investigator: Raymond Rubin, MD

United States, Illinois

Rush University Medical Center Recruiting

Chicago, Illinois, United States, 60612

Contact: Bridget Galetti, RN, BSN, CCRC 312-563-3919
Bridget_Galetti@rush.edu
Principal Investigator: Nikunj Shah, MD

Loyola University Recruiting

Maywood, Illinois, United States, 60153

Contact: Cathy Kalnicky, RN, BSN, CCRP 708-216-2027
ckalnic@lumc.edu
Principal Investigator: Marty Cohen, MD

United States, Indiana

Indiana University School of Medicine Recruiting

Indianapolis, Indiana, United States, 46201

Contact: Virginia Blevins 317-278-1872
vblevins@iupui.edu
Principal Investigator: Paul Y. Kwo, MD

United States, Kansas

University of Kansas Medical Center Recruiting

Kansas City, Kansas, United States, 66160

Contact: Scott Stanley 913-588-0296
sstanley@kumc.edu
Principal Investigator: Richard Gilroy, MD

United States, Kentucky

University of Louisville Not yet recruiting

Louisville, Kentucky, United States, 40202

Contact: Mary R Salem, MA, RN 502-852-5547
mary.salem@louisville.edu
Principal Investigator: Luis Marsano, MD

United States, Louisiana

Ochsner Clinic Foundation Not yet recruiting

New Orleans, Louisiana, United States, 70121

Contact: Christine Maier, BA, CCRC 504-842-2709
cmaier@ochsner.org
Principal Investigator: Shobha Joshi, MD

Tulane University Health Sciences Center Recruiting

New Orleans, Louisiana, United States, 70112

Contact: Melissa Spedale 504-988-1346
mspedale@tulane.edu
Principal Investigator: Luis Balart, MD

United States, Massachusetts

Beth Israel Deaconess Medical Center Recruiting

Boston, Massachusetts, United States, 02215

Contact: Sheila A Wilson 617-632-1086
sawilson@bidmc.harvard.edu
Principal Investigator: Nezam H. Afdhal, MD

University of Massachusetts Memorial Medical Center Recruiting

Worcester, Massachusetts, United States, 01655

Contact: Donna Giansiracusa, RN, CCRC 774-441-7648
giansd01@ummhc.org
Principal Investigator: Nadeem Anwar, MD

United States, Michigan

Henry Ford Hospital Recruiting

Detroit, Michigan, United States, 48202-2689

Contact: Diana Thornbury, RN, BSN 248-344-2355 dthornb1@hfhs.org

Principal Investigator: Stuart C. Gordon, MD

United States, Minnesota

Mayo Clinic Recruiting

Rochester, Minnesota, United States, 55905

Contact: Linda M. Stadheim, RN 507-284-0141
stadheim.linda@mayo.edu
Principal Investigator: John B. Gross Jr., MD

United States, Missouri

St. Louis University Recruiting

St. Louis, Missouri, United States, 63104

Contact: Doreen Garabedian, RN, CCRC 314-977-9394
dgarabed@slu.edu
Principal Investigator: Bruce Bacon, MD

United States, New York

Einstein College of Medicine (Jacobi Medical Center) Recruiting

Bronx, New York, United States, 10461

Contact: Claudia Calderon, RN 718-918-3577

Principal Investigator: Douglas Simon, MD

Columbia Presbyterian Medical Center Recruiting

New York, New York, United States, 10032

Contact: Sumerah Bakhsh 212-304-5684

Principal Investigator: Robert Brown, MD

Weill Medical College of Cornell Recruiting

New York, New York, United States, 10021

Contact: Christine Cervini 212-746-9822
cmc9003@med.cornell.edu
Principal Investigator: Maya Gambarin-Gelwan, MD

New York University Recruiting

New York, New York, United States, 10016

Contact: Tom Hahambis 212-263-3643
sagapao04@gmail.com
Principal Investigator: Samuel Sigal, MD

Concorde Medical Group Recruiting

New York, New York, United States, 10016

Contact: Maureen Haskins 212-889-5544 ext 152
mhaskins@concordmed.com
Principal Investigator: Hillel Tobias, MD

New York Medical College Recruiting

Valhalla, New York, United States, 10595

Contact: Ana R. Casellas, RN 914-594-3439
ana_casellas@nymc.edu  
Principal Investigator: Edward Lebovics, MD

United States, North Carolina

Duke University Medical Center Recruiting

Durham, North Carolina, United States, 27710

Contact: April Seward, RN 919-681-8852
april.seward@duke.edu
Principal Investigator: Andrew J. Muir, MD

United States, Ohio

Consultants for Clinical Research Recruiting

Cincinnati, Ohio, United States, 45219

Contact: Andrea Neff, RN 513-872-4549
aneff@ccrstudy.com
Principal Investigator: Mark Jonas, MD

Cleveland Clinic Not yet recruiting

Cleveland, Ohio, United States, 44195

Contact: Ruth Sargent, RN 216-444-3126
sargenr@ccf.org
Principal Investigator: Arthur J. McCullough, MD

United States, Pennsylvania

Albert Einstein Medical Center Recruiting

Philadelphia, Pennsylvania, United States, 19141

Contact: Stacey Carmody, CCRP 215-456-7534
carmodys@einstein.edu
Principal Investigator: Victor Araya, MD

United States, Texas

Baylor All Saints Medical Center Recruiting

Fort Worth, Texas, United States, 76104

Contact: Erin Fassett, RN, MSN, MBA 817-922-7667
erinf@baylorhealth.edu
Principal Investigator: Stevan Gonzalez, MD

University of Texas Medical Branch at Galveston Recruiting

Galveston, Texas, United States, 77555

Contact: Betty Shipp, RN 409-772-4896
bjshipp@utmb.edu
Principal Investigator: Andrea Duchini, MD

University of Texas HSC at Houston Recruiting

Houston, Texas, United States, 77030

Contact: Stacy Burk 713-500-5232
Stacy.Burk@uth.tmc.edu
Principal Investigator: Michael B. Fallon, MD

Research Specialists of Texas Recruiting

Houston, Texas, United States, 77030

Contact: Herman Ortiz, LVN, CCRC 713-634-5114
hortiz@texasliver.com
Principal Investigator: Joseph Galati, MD

St. Luke's Episcopal Hospital Recruiting

Houston, Texas, United States, 77030

Contact: Jessica Wilson, MA 832-355-8966

Principal Investigator: John Vierling, MD

VAMC Houston Recruiting

Houston, Texas, United States, 77030

Contact: Kethy Garza-Gasitashvili 713-791-1414 ext 561
garzagas@bcm.tmc.edu
Principal Investigator: Boris Yoffe, MD

United States, Utah

University of Utah Recruiting

Salt Lake City, Utah, United States, 84132

Contact: Lindsey Waddoups 801-587-9050
lindsey.waddoups@hsc.utah.edu
Principal Investigator: Terry Box, MD

United States, Virginia

Metropolitan Research Group Washington DC Recruiting

Fairfax, Virginia, United States, 22031

Contact: Becky Dawson, BS 703-698-9254 ext 20
bdawson@metrohepgi.com
Principal Investigator: Vinod K. Rustgi, MD

INOVA Health Care Services Washington DC Recruiting

Falls Church, Virginia, United States, 22042

Contact: Mir Heshaam, MD 703-776-4171
heshaam.mir@inova.org
Principal Investigator: Zobair Younossi, MD

Liver Institute of Virginia Recruiting

Newport News, Virginia, United States, 23602

Contact: Diane M Hutson 757-947-3190
Diane_Hutson@bshsi.org
Principal Investigator: Mitchell L. Shiffman, MD

Virginia Commonwealth University (VCU) Recruiting

Richmond, Virginia, United States, 23298

Contact: Kimberly Williams 804-675-6848
kimberly.williams1@va.gov
Principal Investigator: Velimir Luketic, MD

United States, Washington

Benaroya Research Institute at Virginia Mason Recruiting

Seattle, Washington, United States, 98101

Contact: Cheryl Shaw, MPH, CCRC 206-341-1786
cheryl.shaw@vmmc.org
Principal Investigator: Kris Kowdley, MD


Criteria<</span>!>
Inclusion Criteria:
Male or female patients of minimum adult legal age (according to local laws for signing the informed consent document), able to provide written informed consent, and understand and comply with the requirements of the study

HCV genotype 1 infected null responders to prior therapy comprised of pegylated interferon and ribavirin (standard of care, SOC) defined as:

Failure to achieve an early virologic response (< 2 log decline in HCV-RNA by Week 12), or

If Week 12 HCV-RNA was not obtained, post Week 12 HCV-RNA response was < 2 log decline

Screening HCV-RNA viral load of > 5.0 log (i.e., >100,000 IU/mL)

alpha-fetoprotein (AFP) less than or equal to 100 ng/mL

Hemoglobin greater than or equal to 12 g/dL for women and greater than or equal to 13 g/dL for men, hemoglobin A1c less than or equal to 7.5 %, platelet count greater than or equal to 90 x 109/L, and white blood cell count greater than or equal to 1.5 x 109/L

Thyroid Stimulating Hormone (TSH) within normal limits

In the opinion of the Principal Investigator, the patient met the 80%/80%/80% rule during the previous pegylated interferon and ribavirin therapy (i.e., received at least 80% of the pegylated interferon and ribavirin doses, at least 80% of the dose size, for at least 80% of the treatment duration)

Willingness to utilize two reliable forms of contraception (for both males and females of childbearing potential) from screening to at least six months after the completion of the study.


Exclusion Criteria:
< 2 log decline in HCV-RNA at Week 12 but > 2 log decline at any time from Week 12 to Week 24 during prior therapy with pegylated interferon and ribavirin (prior standard of care therapy)

Decompensated or severe liver disease defined by one or more of the following criteria:

Prothrombin time 4 seconds > control or INR > 1.2

Total bilirubin ≥ 1.5 mg/dL or direct bilirubin ≥ 1 mg/dL

Serum albumin below normal limits

AST or ALT > 5 x ULN at screening

Presence of ascites

Hepatic encephalopathy

Hepatocellular carcinoma (HCC) or suspicion of HCC clinically or on ultrasound (or other imaging techniques)

Clinically significant ocular findings such as retinopathy, cotton wool spots, optic nerve disorder, retinal hemorrhage, or other abnormality

Known history or presence of human immunodeficiency virus (HIV) infection

Co-infection with hepatitis B virus (HBV)

If female: pregnant, lactating, or positive serum or urine pregnancy test

Male partners of women who are currently pregnant 10 Renal impairment (creatinine > 1.2 x ULN), serum creatinine clearance < 50 mL/min, or hepatorenal syndrome with ascites

Hospitalization for liver disease within 60 days of screening

History of alcohol abuse (> 50 g per day) within the past year

History of severe psychiatric disease, especially depression, characterized by:

Suicide attempt

Hospitalization for psychiatric disease

Period of disability as a result of psychiatric disease

Prior exposure to CTS-1027

Patients who qualify as a null-responder based on treatment(s) other than pegylated interferon and ribavirin

History or presence of clinically concerning cardiac arrhythmias or prolongation of pre-dose QTc interval of > 450 milliseconds

History of or current autoimmune disease

Diagnosis of or symptoms suggestive of fibromyalgia

Currently on liver transplantation waiting list or recipient of any organ transplant

Other concomitant disease or condition likely to significantly decrease life expectancy (e.g., moderate to severe congestive heart failure) or any malignancy other than curatively treated skin cancer (basal cell or squamous cell carcinomas), unless adequately treated or in complete remission for five or more years

Exposure to any other investigational treatment for any aspect of disease associated with HCV during the past 6 months

Exposure to any investigational drug or device within 30 days of dosing, or scheduled receipt of another investigational drug or device during the course of this study.



http://www.clinicaltrials.gov/ct2/show/NCT01273064?term=cts-1027&amp;rank=3


http://www.conatuspharma.com/products/cts-1027-for-liver-disease.htm

Christopher Price highlights what the Patriots Director of Player Personnel Nick Caserio had to say about the Pre-Draft process.

•On draft day, Caserio described things in the draft room as being "pretty tame" for most of the time. "When you’re not picking, things are pretty quiet," he said. As for trades, most of them occur on draft night, with most discussions usually picking up between five and eight picks out: "There are [trade] possibilities examined the week before, but things don’t really manifest themselves until the draft," he said.

•Where are things right now? Caserio said that most of the Pro Days have been completed to this point, with most of the players who will be drafted having worked out. He added that the time frame for the 30 allotted visits expires next Wednesday, April 20. However, you can work a player out until the day before the draft &mdash; he recalled an instance a few years ago where he flew out to work out a player a day or two before the draft.

•The private workouts are important for getting a handle on a prospect, but they can be invaluable for trying to figure out if a small school prospect, an injured player or a non-combine invitee might fit into your system. Caserio used wide receiver Julian Edelman and offensive lineman Sebastian Vollmer as examples of two guys the Patriots were able to get a much clearer picture of as a result of private workouts, as both were not invited to the combine. When it comes to private workouts, "We’re just trying to make sure we have the most accurate picture of the player possible." (Caserio added that when they were working out Edelman prior to the 2010 draft, they had multiple private workouts with him, including as a wide receiver, running back and return man.) "In the end, the goal is to have it right. Is it perfect? No. There are players where it hasn’t worked out," Caserio said. "[But] it’s a projection element. You are talking about the unknown."

•When asked about the preconceived ideas some people have when it comes to the Patriots and the outside linebacker spot &mdash; and if they have adjusted them somewhat &mdash; Caserio replied: "I think you’re always looking at different things. In terms of the players and the types of players and the standards … the most important thing is finding good football players that can help our football team, whatever shape and form they come in. Danny Woodhead is the perfect example. I’d say he falls short in some of the ‘standards,’ but … that’s something we’re always evaluating across the positions, the different standards and where we are relative to the rest of the league. That position, there’s more teams that are looking for similar-type players, and in college, maybe the pool of players isn’t that big to begin with, so everybody’s looking at the same players and ultimately, you just have to make the decision on who you feel like is best for your team."

TEAM TALK

• Nick Caserio Pre-Draft Press Conference: Transcript of Q&A; plus 35 min. video.
• Erik Scalavino catches up with special teams coach Scott O'Brien, who offers his unique insight as the Patriots prepare for this month's NFL Draft.
• Erik Scalavino notes Scott O'Brien says kicker Stephen Gostkowski was rehabbing and feeling pretty good the last time he saw him before the lockout.
• Erik Scalavino updates the Patriots prospect list as of 4/14.
• Patriots Today - Caserio gives unique glance at the draft. (2.44 min. video)
• Patriots Today - 2011 Draft Preview: Safeties. (4.27 min. video)
• The New England Patriots 2011 Hall of Fame finalists are announced. Drew Bledsoe and Bill Parcells join Houston Antwine as this year's class of nominees. Vote here.
• Watch video clips for QB Drew Bledsoe (1.40 min.), HC Bill Parcells (1.32 min.) and DT Houston Antwine (1 min.)

LOCAL LINKS

• Karen Guregian notes QB Drew Bledsoe, HC Bill Parcells and DT Houstin Antwine are the three finalists for the Patriots Hall of Fame. Fans have one month to vote.
• Mike Reiss believes Drew Bledsoe is the right call for the Hall.
• Shalise Manza Young reports the Patriots are locking in on draft prospects.
• Tom E. Curran says that with workouts nearly done, the Pats enter the grading process.
• Mike Reiss reports how Nick Caserio, in a media tutorial on the draft process, detailed the elements of a fictional draft card.
• Mark Farinella<</span>!> gives his take on the seminar delivered by Nick Caserio yesterday.
• Paul Kenyon writes about Nick Caserio's pre-draft primer for the media yesterday.
• Jeff Howe notes that the Patriots won't change their draft strategy because of the labor uncertainty.
• Karen Guregian reports DE Da'quan Bowers (Clemson) was spotted making a visit to Foxboro yesterday.
• Mike Reiss focuses on the draft picks available at the wide receiver position for the Patriots, beyond the first round.
• Greg A. Bedard breaks down where the 2010 opening day starters on each NFL team came from in the draft: Inside Linebackers.
• Mike Reiss offers the transcript of his weekly online chat.

NATIONAL NEWS

• Tim Graham (ESPN) Draft Watch: AFC East.
• Tim Graham (ESPN) Power Rankings show AFC East is terrible.
• Tim Graham (ESPN) Kiper: Window closing for Pats, Tom Brady.
• Gregg Rosenthal (ProFootballTalk) Report: Mayock will replace Theismann and Millen; Gus Johnson in mix for role too.
• Steve Wyche (NFL.com) First round gets hype, but second-round crop offers value.
• Wes Bunting (Nat'l Football Post) Mr. safe pick: they might not be the sexiest of selections, but these prospects will make NFL rosters better.
• Clifton Brown (Sporting News) Moving down in the NFL Draft is sometimes the best way to move forward.
• Dan Pompei (Nat'l Football Post) Players as consultants.
• Russ Lande (Sporting News) NFL draft analysis: Defensive tackles.

LABOR LUNACY

• Albert Breer (NFL.com) Round 2 of NFL-player mediation begins with 'fence-mending'.
• Josh Katzowitz (CBS Sports) NFL, NFLPA will continue mediation Friday.
• Minneapolis, AP (SI)) Mediation resumes in labor dispute.
• Mike Florio (ProFootballTalk) Only two of the 10 named plaintiffs attending mediation.
• Vic Carucci (NFL.com) If lockout persists, UFL ready to pounce on undrafted rookies.
• Mike Florio (ProFootballTalk) Goodell holding lockout conference calls with season-ticket holders.
• Gregg Rosenthal (ProFootballTalk) Goodell discusses contingency plans for Super Bowl.

They travel hundreds of miles on creaky buses wearing hot, scratchy wool uniforms, all in the name of entertainment. Marching band members are the unsung heroes of college sporting events, and they remember every bottle (or curse word) you've thrown at them.

The unsung heroes of the college sporting world are the members of your friendly local marching band, a collection of students too slow to play football and too smart to try. Every weekend in the sporting fall they suit up for your entertainment in musty wool uniforms, travel hundreds of miles in creaky buses to strange environs like East Lansing and Starkville, and then play the same five songs over and over again while enduring heat, cold, rain, snow, abuse and the punishing effects of their own self-inflicted hangovers.

Why do they do it? The $30 per diem? The glory of taking a battery in the face from a Georgia fan? The single credit hour being in marching band offers for the academic transcript at many universities? The opportunity to urinate next to a broadcasting legend who saw you come out of the women's bathroom? All of these in part, yes. But the simple truth is that being in marching band is just like football or any other sport: It's a silly business taken very seriously, i.e. the best kind of business there is.

Theirs is a rough and untold story -- until now. We asked readers to share their tales of marching band greatness and depravity, and they responded with an outpouring of histories lost on the highways and charter buses of our nation. From bowl games to bathrooms, kegs of beer smuggled in with the tuba section to multiple instances of the Clemson mascot being assaulted, these are their stories in their own words. This is the oral history of the college marching band.

THE BEST INTRO LINE WE GOT FROM A RESPONSE

Hi.  I was a member of the Rice Marching Owl Band from 2003-2007. I had a rubber duck on my fedora. -- Adam, Rice.

THEY ARE COWBOYS, ON BRASS HORSE THEY RIDE: THE ROAD

2008 Fiesta Bowl versus Texas. We were playing a very powerful classical halftime show, with the closer being the 1812 Overture, instead of the traditional cannon for the final push our directors got clearance from the stadium crew to use fireworks. So on the final company front push during the ending fireworks with a loud report are being set off on each goal line. Well, less than 20 yards away from the one pyrotechnic station was the University of Texas mascot "Bevo". The live bull did not take too well to the fireworks and started bucking around wildly and eventually defecating all through his cage. Making it clear that the Ohio State University Marching Band will make your mascot shit itself... -- Scott, Ohio State.

My "favorite" road story comes from the University of Georgia, which I've had the misfortune of visiting twice. Neither time has convinced me that Dawg fans aren't a lower form of life than the rest of humanity. In 2008 I had a bottle thrown at me -- thankfully, it was only a plastic bottle, but this past year someone else had a glass bottle thrown at them. Back in 2006 a friend of mine had a lighter thrown at their face  -- Carter, Georgia Tech.

Whenever we traveled to Death Valley or Neyland Stadium, we had to enact road protection rules. This meant that, as a lady, I had to be positioned on the inside of my line as we marched into the stadium. Only guys could be on the outside of the lines, because, like rabid hyenas pulling down an antelope, UT and LSU fans would attempt to snatch band members away into the crowd. They would also attempt to steal our mouthpieces as shiny souvenirs. -- Pam, Alabama.

Florida/Georgia 2003. We had to walk through the UGA tailgating area back to the band buses. Tired of being harassed and barked at, our director formed a marching block with the drumline in front and sousaphones lining the outer edge, protecting the wee woodwind players on the inside. Our band director was literally throwing drunk bulldog fans aside while the drummers rammed others. The entire marching band had to march OVER a few of the victims. -- Jordan, Florida.

Williams-Brice stadium in Columbia is one of the weirdest places in the SEC. I have a harrowing tale of the men's room under the visiting band seats. After halftime the Gamecocks gave us each a water and an apple in 2006. It was a Thursday night game, and everyone had to drink quickly to mimic a Saturday atmosphere, so what happened when I went to the restroom during the 15 minutes Auburn held the ball in the 3rd quarter ... and found a guy and his girlfriend behind the partition separating the urinals from the entrance and the regular stalls.

She had no qualms about making sure even though Auburn won, he would be the happiest Cock on earth. He high-fived guys who finished their business at the urinals and only after CSC Event staff showed up and took cell phone pictures did the guy and the girl leave the restroom in shame.. .and probably went to the Cockabooses to finish. -- Darren, Auburn.

First was my trip to South Carolina in 1992. The game was right after the almost team revolt against the head coach (Sparky Woods???, I know he later became our OC and sucked donkey balls). Steve Tanneyhill was the quarterback. Anyway, we are sitting in the stands probably 2 hours before the game.  All of the sudden, over the PA system we hear this announcement:

"Don't forget Gamecock fans, next week is Cock Fest 92!"

I nearly peed myself laughing so hard. -- Andrew, South Carolina.

Another memorable moment was marching into Death Valley while being followed by a particularly inbred looking cajun gnawing on fried alligator yelling "TIGAH BAIT TIGAH BAIT TIGAH BAIT" -- Jordan, Florida.

2003. We roll into Baton Rouge with probably 45% of the regular State Troopers of Louisiana all the way from the Lousiana border to Baton Rouge. The one finger salutes begin promptly. When the buses turn the corner to park near Tiger Stadium, tailgating LSU fans begin throwing ziploc bags of urine at our bus windows. -- Darren, Auburn.

A friend of mine, JDH, was leaving the field after our halftime performance in 2003 in Sanford Stadium to the GEORGIA-labeled end-zone, which is directly in front of the Fans with Disabilities Section. At any rate, one proud UGA fan shout at JDH "Stop playing your gay songs. Look at the SCORE!" JDH replied, "Look at your legs."  The guy was a dwarf who replied simply with silence and then a shout of "GO DAWGS!" -- Darren, Auburn

THE ONE WHERE THE BOISE STATE BAND DIRECTOR HAS A HEART ATTACK ON THE FIELD AND MISSES A FEW HOURS OF WORK.

In the closing moments of the 2007 Fiesta Bowl between Boise State and Oklahoma<</span>!>, as Ian Johnson sealed the Broncos' win with "Statue Left", the entirety of Bronco Nation in attendance was in a state of bedlam. The majority of young fans in the area near the Boise State University Blue Thunder Marching Band rushed to the front of the stands hoping for an opportunity to rush the field. In the madness the director of the BSUBTMB, David A. Wells (RIP), a 60-something former chain smoking wildman, was crushed against the barrier and suffered a heart attack.

There was confusion all around as the people trying to get the director to an ambulance struggled to clear a path through those celebrating the victory. Once he was out and en route to the hospital the band went about its business of packing up and exiting University of Phoenix Stadium with a potpourri of mixed emotions. We were all concerned for Dave's health, elated by the glorious triumph of our football team, and angry with Dave for not letting us enjoy the victory.After our buses were packed we drove to the hospital where, after a short wait, Dave emerged to accompany us on our flight back to Boise. When we reached the band hall in Boise at approximately 4 a.m. we spent 2 hours checking in our equipment and uniforms, all the while Dave marched around barking orders as if nothing out of the ordinary had occurred.He would never admit to the heart attack, saying only that he was slightly stunned by the stampeding fans. Those close to him knew what really happened. He died 2 years later, but David A. Wells will always be an inspiration to me for being a tough SOB.

-- David, Boise State.

FURTHER TALES OF THE GLORIOUS ROAD

2002 Bedlam Game. Game ends and everyone rushes the field and proceeds to tear down the goal posts. We had to stay in our seats for "our safety" and it was here that I witnessed the three best representations of OSU. 1 - The dude with his 4 or 5 year old on his shoulders with both of them flipping us off. 2 - The OSU student with a shirt that read: "You can't spell C_cks_cker without OU" without realizing that you couldn't spell it without OSU. 3 - The people who had one of the uprights tried to launch it into the band. -- Matt, Oklahoma<</span>!>

Fall 2001. My freshman year. The University of South Carolina @ Mississippi State

was the Thursday night ESPN Game, and the first televised football game after 9/11. So there's this moment of silence before the game, and this being my first away trip out of the box I was really impressed that everyone in the stadium was actually silent. It really was, which is why you could hear one guy from the crowd yell with a fine Mississippi accent "You go to hell Bin Laden." -- Jason, South Carolina.

New Orleans 2007 - Witnessed Albert the Alligator

(not in costume) get arrested for drunk and disorderly (quite a feat on Bourbon St). The cheer squad coach asked the tallest band member to fill in at the bball game because we hadn't bailed him out yet. -- Jordan, Florida<</span>!> The 2007 Sugar Bowl. Notre Dame played LSU that year

in what was the first Sugar Bowl to be played in the Superdome after Hurricane Katrina. The New Year's celebration on Bourbon Street was epic; at least half the band probably slept curled up next to the toilet afterwards, trying to keep down that last hand grenade. 

But the highlight (lowlight?) of the trip happened when we visited a flood-ravaged Catholic school in the Lower Ninth Ward for a public rehearsal and photo op. The fine parent volunteers of the school were nice enough to prepare several hundred pounds of jambalaya for our post-rehearsal dinner, as well as procure several dozen cases of PBR for our refreshment. However, our image-conscious director became worried that someone might snap a photo of a band member with beer in hand, so none of us were allowed to have any at all. As the PBR was carted away, the attitude of the band quickly turned to this:

Sure, they didn't destroy the beer, and it probably found a good home in the end.  But you don't know frustration until you see 400 college students denied several free beers apiece.  Daggers.

-- Greg, Notre Dame.

My bus always did the Gator chomp

as we got close to road stadiums to count how many middle fingers we could get. While Tennessee fans made a valiant attempt, Miami fans far and away won the title.--David, Florida.

GO BACK TO CUBA<</span>!>

In 2007, Miami played FSU in Tally.

Instead of being dropped off next to the stadium, our bus dropped us off into a parking lot a quarter mile away, with the path to Doak Campbell lying straight through one of the tailgating zones. Our promised police escort was nowhere to be found.

As we lined up and got ready, a band of rednecks addressed us with a bullhorn from the back of a pickup truck. " No speaky spanish" "We no serve rice and beans" "Go back to Cuba". We moved the sousas into a position to surround the dancers so as to avoid groping, and marched straight through. At least a half dozen Seminoles tried to break the ranks. Somehow, most of them ended up getting hit by large pieces of metal. Once we got to the stadium, the staff couldn't unlock the gate to let us in. As we waited en masse, from the upper levels of the stadium, full cups of coke rained down on us.Kirby Freeman led Miami to a comeback victory. In our next game, against a horrid NC State team, he went 1-14. With 3 interceptions.

-- Daniel, Miami.

Rice vs. Texas A&amp;M, 1973. Rice had only changed to the scatter band format a few years prior, and the Aggies are of course not known for having a sense of humor. So, when the band performed a show that involved goose-stepping, parodying the A&amp;M fight song, and making a joke about Reveille while in the form of a fire hydrant, the reaction was unpleasant.  When Rice ended up winning the game, irate A&amp;M fans barricaded the band inside the tunnel of the stadium until Rice food service trucks were called in to smuggle the band away from the angry Aggies.

-- Adam, Baylor.

1996 Alabama at Tennessee which was my first road trip with the band and my first time to Neyland Stadium. My best friend, Steve, who was also in the band had gotten food poisoning that morning and was barfing in a garbage bag all the way there on the bus. Once we arrived to the stadium it was clear Steve was not going to make it into the stadium to march. However, his hatred for the Vols ran deep and he wouldn't be denied the opportunity to at least deface the stadium. 

So we helped him off the bus to the closest structure connected to Neyland and he commenced to throwing up all over it with Vol fans watching in horror. He was in full uniform by the way.  The rest of us started a big Rolllllll Tide Roll cheer as Steve continued to administer the Technicolor yawn to that God forsaken place. Alabama lost a close game to the Vols 20-13. As I was leaving the stadium in a very depressed state, a group of Vol fans saw me and said "You guys did a great job" and one of the guys held out his hand to shake mine. As I went for the shake he pulled away and said "F-- YOU, GO VAAAWWWLS!" 

I still feel like Steve got the last laugh though.

-- Brad, Alabama<</span>!>SECRET TRADITIONS AND OCCULT KNOWLEDGE.

At South Carolina there is a tradition, recently in jeopardy, to sing a song when the game is won or a victory is certain and only time is a factor. It is a game entirely of double entendre where a chant is met by an act. Examples: "Let me see you show your nuts" = you raise your hands and scream, "let me see you jack it off" = open and close band jackets in rhythm, "let me see you roll a joint" = hold elbow and circle forearm in the air, etc. -- Andy, South Carolina.

One thing people don't know is that before running out of the tunnel for pregame, the entire Michigan Marching Band sings "Eye of the Tiger" at the top of our lungs. -- Joe, Michigan

Standing on the sidelines before halftime meant that we had prime viewing conditions for the backsides of lots and lots of incredibly toned men wearing white pants, which by the second quarter had become transparent due to sweat. -- Pam, Alabama.

People may not realize that the UAA gives cash per diem to band members on road trips. (At least when I was there.) And that as a work-study employee of the band office I was sent to retrieve said cash prior to a full band road trip. Which means I then walked across campus with approximately $10,000 in cash in a backpack. At the time that would've paid for a brand new car ... or a linebacker. -- Beth, Florida.

This might no longer be the case but at certain booster events, especially the Beat Texas Party, where we would play you might get a few twenty-dollar handshakes.--Matthew, Oklahoma.

Marching Band people are foul-mouthed and inventive when it comes to just about anything.  For example, the University of Nebraska alternate lyrics to "Boomer Sooner":

Barry Switzer likes his ass torn / by a raging Texas Longhorn

Every Sunday to his leisure / beats his grandma to a seizure.Roamin' 'cross the prairies / all the mothers come from dairiesAnd the fathers rape the cattle / and the offspring join the Band.

Rape little piggies / Rape little chickies / Rape little puppies / S--- off ducks

Eat my butt out with a fork / F----in' assholes - Y'ALL SUCK!


-- Anonymous Nebraska guy.

The band is the best way to smuggle ANYTHING into a football stadium.  Our bari-sax player routinely carried between a 6- and 12-pack of beer in the bell of his horn. Our tuba/bass drum cases could (and did) hide a keg quite easily. The other secret is that band people will steal anything not nailed down. Once at women's ACC tournament in Charlotte we stole a 15 foot tall inflatable something-or-other from in front of a liquor store even though we had no use for it and no good place to stash it on the bus. -- Todd, Georgia Tech.

Every marching band has a dealer. At noon games in the Florida sun in wool uniforms, sometimes the dealer doesn't make it through the halftime show and needs to be resuscitated by paramedics. -- Daniel, Miami.

SAVAGE VIOLENCE! (AND PEOPLE ATTACKING THE CLEMSON TIGER)

This one isn't mine,

it's just a legend that has been passed down the Georgia Tech band for more than a decade. Tech at Clemson, sometime in mid-90s.

8-ball the Clemson Tiger

and our mascot Buzz got into a mascot fight. Then Clemson's other mascot got into it and the two tigers started ganging up on Buzz. This was too much for one of the RATs, who charged out of the band section, onto the field, and tackled one of the tigers, before climbing back into the stadium seats. Somehow, his RAT cap managed to stay on ... right until he climbed back into the seats, causing him to jump back onto the field before returning to the band. And when security inevitably came .... the directors disavowed any knowledge of him or his location. They ALWAYS protect the band .... even when we're the ones doing something stupid.

-- Carter, Georgia Tech. The best story I can come up with is from the 1996 game between Ga Tech and Climpsun (@ Climpsun).  The tiger mascot was antagonizing the band so one of my fraternity brothers offhandedly mentioned to a freshman tuba player that he should go kick that tiger's ass. It would seem that said freshman was both more amped up and more inebriated that was immediately apparent because he did exactly as had been suggested. 

He ran down the bleachers, jumped the wall and tackled the tiger. He followed this up by pummeling the tiger MMA-style until a props person pulled him off and spirited him away before either the Climpsun cheerleaders or the police could find him.  He got away with it completely even though 50 thousand people saw it happen. The fact that he was the only black tuba player and extremely easy to find just makes it funnier.

-- Todd, Georgia Tech.

FAMOUS PEOPLE!

When I was in the band we were on probation

so we didn't get to be on television and my last year was the only bowl game we went to (All American Bowl in Birmingham...WOO HOO!). However, as consolation the band did get selected to play at halftime of a Tampa Bay Buccaneers game when they were playing the Chicago Bears. We went down to the field before halftime and stood on the Chicago sideline where I made it a point to stand right behind Walter Payton and Neal Anderson as they were sitting on the bench. After the halftime show we were leaving the field through the tunnel that the Bears were using to re-enter the field and MIKE DITKA was standing right there shaking hands with the band members and telling them "good job". So I shook hands with Ditka ...I SHOOK HANDS WITH DITKA. And when I did I noticed he was wearing suspenders...with teddy bears on them.

-- Beth, Florida<</span>!>

Beth also took these amazing pictures of famous person Emmitt Smith and former Florida coach/current Penn State offensive co-coordinator Galen Hall at the Swamp, because remember no one besides the refs gets closer to the game than marching band members. Look at all that marvelous artificial turf! 

 

This is technically a basketball band story, but during halftime of the 2009 Big Ten Tournament opening round game (Michigan v. Iowa) I gleefully skipped into the bathroom, excited about a halftime lead. It was only when I had gotten all the way into the bathroom that I realized it was in fact the women's bathroom. I hurriedly turned around hoping no one had noticed, and none had, but one person: Brent Musberger. He was standing at the entrance, chuckling in a way only Brent Musberger can. He said, "Well that could have been quite embarrassing (chuckle chuckle chuckle)" I smiled, greeted Brent, then proceeded to pee next to him while talking about Morton's Steakhouse. -- Brian, Michigan

MUSICIANSHIP IS A KEY HALLMARK OF THE COMMITTED COLLEGE MARCHING BAND MEMBERI once got a beater bass trombone from a local high school that didn't want it any more. In terrible shape, I had it repaired to playable (although ugly-looking) shape and marched with it for a few years. I used to freak out the freshman by scraping the bell on the asphalt before parades. At warmups for the Gator Bowl game against Michigan State (Vince Dooley's last game), we ended with the Krypton Fanfare (which was still new to the group at the time, having been introduced only two years prior), which begins with a huge Bb blast.

We played the beginning note, then, as the fanfare progressed, I noticed I was having some difficulty staying on pitch.  When the piece ended, I discovered that the initial blast had blown off my tuningslide; I'd been playing the whole piece without it. God, I miss that horn.

-- Michael, Georgia<</span>!>

We thank all those who responded and shared their stories, and hope they never have to wear wool in subtropical heat again.

Karen Guregian reports Ty Warren has added mixed martial arts-style training to his workout regimen.

"I was just looking for something different," Warren told the Herald last week. "I don’t wake up in the morning, and get all geeked up about going and squatting hundreds and thousands of pounds and benching crazy weight and stuff like that. With my war wounds, at this point in my career ... I was looking for something different so I could maintain my strength and at the same time focus more on my cardio strength and quickness."

"I’m excited to wake up. I look forward to it every day. I get up and can’t wait to do that deal," Warren said of his MMA regimen. "All my emphasis isn’t solely on MMA, but I’m implementing that along with stuff I’ve done in the past. It’s more for helping with longevity. So I’ve been running and doing all kinds of stuff."

"You start easy on the joints, but at the same time, I feel like I’m getting my workload in," he said. "It’s been good. I’ll be in excellent shape when I get back."

Karen Guregian gets Mel Kiper's thoughts on the success of the Patriots' draft strategy.

"Because (the Patriots) have traded around, they cost themselves (a shot at) Clay Matthews twice a few years ago," Kiper said. "So as good as they are, (would you say) that’s a terrible philosophy because New England could have had Matthews and they got too cute by trading down twice? No, because it’s worked for them. They’ve been right there. They’ve won Super Bowls. They’re in the mix to go to the Super Bowl.

"They’ll be in the mix the next three to four to five years because of what they’ve done. They made a mistake there, but nobody is infallible. No philosophy is perfect. You’re going to look bad sometimes. Same thing with the Colts. they’ve made some picks in the first round who haven’t necessarily gotten the job done ... but they have a philosophy and a formula that’s worked. Do they maybe have to alter that (philosophy) this year? Possibly. But they still may feel they can mold an offensive line that (doesn’t include) first-round picks)."

TEAM TALK

• The New England Patriots 2011 Draft Release.
• Andy Hart, Erik Scalavino and Paul Perillo debate what the Patriots will do in the first round of the Draft.
• Patriots Today - 2011 Draft Preview: G/C. (6.04 min. video)
• Sarah Leong Oliver reports Patrick Pass visited students at Pleasant View Elementary School in Providence, RI to announce the NFL PLAY 60 contest winners.

LOCAL LINKS

• Greg A. Bedard reports Judge Nelson will be informed on every part of the NFL-player mediation and could weigh in if either side drags its feet.
• Karen Guregian wonders if Ty Warren could be on the roster bubble.
• Mike Reiss takes a look at the Patriots' roster by draft round (not including FAs), as a reminder that the importance of the Draft stretches beyond round one.
• Mike Reiss mentions a trickle-down effect of the NFL's lockout being the impact it has on players entering their second season.
• Shalise Manza Young scouts the Draft: WR Leonard Hankerson (Miami), RB Ryan Williams (Virginia Tech) and DE/OLB Robert Quinn (North Carolina).
• The Providence Journal tells us why the patriots may spend a draft pick on an offensive tackle.
• Shalise Manza Young posts the clip from an emotional Tom Brady as he recalls his fall to the sixth round of the 2000 draft.
• Ian Rapoport previews ESPN's documentary, "The Brady 6" and says "Don't miss it." The film makes you appreciate how hard it is to be successful.
• Mike Reiss shares some additional recollections from one of Tom Brady's Michigan teammates that didn't make it into "The Brady 6" documentary.
• Christopher Price looks at who was the best fifth-round pick and best fourth round pick in Patriots history.
• Mike Reiss notes NFL Network's Path to the Draft show focused on the Patriots this week, and is worth a watch.
• The Boston Herald warns Patriots fans they might not want to vote for Danny Woodhead as cover man for EA Sport’s Madden ’12 because of the curse.

NATIONAL NEWS

• Mike Florio (ProFootballTalk) Eleven years later, Tom Brady still gets emotional about draft snub.
• Tim Graham (ESPN) Tom Brady cries when recalling 2000 draft.
• Peter King (SI) MMQB: Panthers do homework on Newton, plus 10 draft things I've learned.
• Andy Morales (Tucson Sun) NFL All-Pro wide receiver Wes Wellker to honor Jacob Arzouman.
• Dan Pompei (Nat'l Football Post) Sunday Blitz: Which positions are heating up and why, projecting impact rookies and all the latest on the Draft.
• Albert Breer (NFL.com) Teams face slim pickings, difficult task drafting this year.
• Mike Florio (ProFootballTalk) Rookie wage scale uncertainty could limit trades at top of draft.
• Gil Brandt (NFL.com) Hot 100: Pro days results tweak latest top-prospects list.
• The Sporting News 2011 NFL Draft risers and fallers.
• Pat Kirwan (NFL.com) Draft Do-overs: Rivers great, but Big Ben would best serve Chargers.
• Matt Bowen (Nat'l Football Post) Would Randy fit with Rex Ryan and the Jets?

LABOR LUNACY

• Mike Florio (ProFootballTalk) NFL, players have no choice but to zip it.
• Mike Florio (ProFootballTalk) When mediation resumes, both sides should rely on professional negotiators.

The word "franchise" is derived from the Anglo-French word meaning “liberty.” In Middle French, it is “franchir”&ndash; to free. In Old French, it is “franc,” signifying free. The French term “francis” means granting rights or power to a peasant or serf. The English term “enfranchise” is defined as empowering those who have no rights. The term “Royal Tithes” is the predecessor of royalties, and originated as the practice of certain English men (referred to as “freemen”) receiving a percentage of the land fees paid by serfs to nobility. Throughout history, franchising has promoted economic liberation, synergy, and opportunity, and has been true to its etymological roots &ndash; “freeing” commerce from many of the traditional chains that had bound it. Naisbitt’s famous comment in Megatrends is no exaggeration &ndash; “Franchising is the single most successful marketing concept ever.”

This article provides a brief timeline on the seminal developments in franchising since the Middle Ages, followed by a more detailed description of the flourishing history of McDonald’s and KFC, the historical intersection between franchising and antitrust law, and finally, a brief overview of the regulatory framework that has emerged over the past thirty-five years.

I. THE HISTORY OF FRANCHISING

A. Kings, Courts and Lord &ndash; Franchising Pre-1800

-- During the Middle Ages, local governments granted high church officials and other personages a license to maintain civil order and to assess taxes. Medieval courts or lords granted others the right to operate ferries, hold markets, and perform professional business activities. The licensee paid a royalty to the powers that be in exchange for, among other things, “protection.” This was equivalent to a monopoly on commercial ventures. The practice was perpetuated throughout the Middle Ages, and eventually became part of European common law.

-- During the Colonial Period, European monarchs bestowed franchises on daring entrepreneurs who agreed to establish colonies and gain the protection of the “Crown” in exchange for taxes or royalties.

B. Drinks, Cars and Sewing Machines -- Franchising From 1800 to 1900

-- In 19th Century England and Germany, pub proprietors with financial difficulties became exclusive distributors of beer purchased from specific brewers. The breweries did not exercise any day-to-day control over the pubs.

-- The first franchise in Australia under "royal privilege" was granted by Governor Macquarie in 1809. The franchisee was granted the right to import 45,000 gallons of rum over three years in exchange for building the Sydney Hospital (the so-called "rum hospital"). -- In the United States during the mid-1800's, trademark/product franchising developed when the Singer sewing machine company formed a franchise in 1851. Due to the lack of necessary capital and the incipient stage of the sewing industry, Singer had difficulty in marketing sewing machines, and turned to franchising. Singer commissioned agents to sell and repair its line of machines. However, once the machines were accepted by the public, Singer changed its marketing strategy and commenced selling the machines through its company-owned outlets in the 1860's.

-- In the 1880's, U.S. cities granted monopoly “franchises” to utility companies for water, sewage, gas, and later electricity. -- In 1898, William E. Metzger of Detroit, Michigan became the first official dealer/franchisee of General Motors Corporation (GM). Under GM’s system, dealers purchased the land and built the buildings for the dealership. In return, the dealers were allowed to buy GM’s vehicles at a discount. -- In 1899, Coca Cola sold its first franchise.

C. A Period of Steady Growth &ndash; Franchising From 1901 to 1950

-- In the early 1900's, Henry Ford franchised dealers for his Model T. The oil companies followed suit, franchising gas stations. -- In 1902, Rexall Drugstores began franchising. -- In 1909, Western Auto established dealership programs. -- In 1920, the “Ben Franklin” store systems appeared with general merchandise stores. -- In 1925, A&amp;W established “walk up” root beer stands, and Howard Johnson offered his three flavors of "superior" ice cream from his Wollaston, Massachusetts drugstore. Howard Johnson’s franchised ice cream business expanded to a group of East Coast restaurants, and in 1940, appeared on a state turnpike. -- Between 1938 and 1955, the following companies commenced franchise activities: Arthur Murray Dance Studios, Baskin-Robbins ice cream stores, Duraclean carpet cleaning services, McDonald’s, Howard Johnson Motor Lodge, and Harlan Sanders’s Kentucky Fried Chicken. -- In 1948, Dairy Queen established its 2500th unit.

D. Build Along the Highway &ndash; Growth In Franchising from 1951-1969

-- Franchising in the U.S. exploded in the 1950s. In 1950, less than 100 companies had employed franchising in their marketing operations. By 1960, more than 900 companies had franchise operations involving an estimated 200,000 franchised outlets. -- In 1955, Tastee Freeze established its 1500th unit. -- In the 1950's and 1960's, the development of business format franchising escalated, due in large part to the expansion of the service economy and President Eisenhower’s decision to build the Interstate Highway System (with its concomitant increase in automobile travel). Holiday Inn, Roto-Rooter, Dunkin Donuts, McDonald’s, Burger King, H&amp;R Block, Lee Myles, Midas, 7-Eleven, Dunhill Personnel, Wendy's, Pearle Vision Center, Dairy Queen, Orange Julius, Tastee Freeze, and Sheraton all began to franchise. -- By the late 1960's, McDonald’s, Holiday Inn, and KFC were all approaching or had surpassed the one-thousand unit mark. -- Between 1964 and 1969, fueled by an ever expanding economy, an estimated 100,000 new franchise businesses commenced.

E. New Regulation and an Oil Embargo &ndash; Franchising 1970 to 1985

-- In 1970, annual retail sales for franchises were estimated at over $95 billion. -- In 1970, the U.S.’s 181,000 franchised gasoline stations accounted for 82% of product/trade name franchises and nearly 55% of all franchises. -- Also in 1970, California became the first state to regulate the sale of franchises when it enacted the California Franchise Investment Law (CFIL). -- In 1971, annual retail sales of franchised businesses were estimated at over $114 billion. -- Between 1969 and 1973, an additional 50,000 franchised units took form, and by 1973, franchised businesses exceeded 374,000 units.

-- Between 1973 and 1976, due to the Arab oil embargo, national shortages of gasoline precipitated the closure of nearly 32,000 franchised gasoline service stations. -- In 1975, retail sales of franchises exceeded $161 billion. -- By 1976, gasoline’s share of total franchising fell to 41%, and, by 1980, to 36%. -- Between 1976 and 1980, more than 19,000 new franchises were established; however, the increase did not offset the loss of gasoline franchises during the decade. -- In 1978, the Federal Trade Commission (FTC) adopted the FTC Rule involving pre-sale disclosures, which became effective in 1979. -- In 1979, retail sales of franchises exceeded $274 billion, an increase of 140% from 1971. -- By 1980, there were more than 356,000 franchised businesses, 18,000 less than the peak level achieved in 1973. Product/trade name franchise sales reached $231 billion, an increase of 129% from 1971. Sales by business format franchises tripled from $16 billion in 1971 to $48 billion in 1979. -- In 1985, retail sales of franchises exceeded $474 billion.

F. Big Overall Growth Returns &ndash; 1986 to 1995

-- In 1986, the U.S. Department of Commerce estimated that retail sales by franchised establishments represented 34% of all retail sales. Sales of products and services by all franchises grew by $198 billion during the period of 1980-1986. -- During 1987 and 1988, an additional 50,000 new business format franchises were established, nearly double the number added during 1985-1986.

-- In 1988, there were more than 416,000 franchise businesses, employing approximately 7 million workers, with estimated sales of $543 billion. The mix was approximately 70% business format, and 30% product franchise. The estimated 27,273 new franchise units that opened in 1988 represented the addition of one new franchise unit every twenty minutes throughout the year.

-- Between 1987 and 1989, franchises added over 400,000 new jobs to the United States economy, while the Fortune 500 companies added only 10,000 (i.e., franchising accounted for 40 times as many new jobs). -- In 1990, retail sales of franchises exceeded $607 billion, with more than 460,000 units in existence. -- In 1993, NASAA unanimously adopted the UFOC Guidelines as the recommended format for franchise disclosure documents at the state level. The FTC approved the use of the UFOC as an alternative to the FTC’s disclosure requirements later that year. -- By 1995, the new UFOC Guidelines were adopted by each of the state franchise regulatory authorities that require registration of franchise offerings.

F. The Current Status and Reasons for New Growth &ndash; 1996 to the Present

Advances in technology, orientation towards a service economy, a relative decrease in the importance of product franchising, an expansive interstate road system, active baby boom retirees looking to “be their own boss,” and women in the work force, have all contributed to the burgeoning rise in business format franchising. According to a survey conducted for the International Franchise Association’s Educational Foundation, as of 2001, there were more than 767,483 franchise-related businesses (including franchisor owned), generating 9,797,117 jobs (equivalent employment of all manufacturers of durable goods, such as computers, cars, trucks, planes, communications equipment, primary metals, wood products, and instruments), meeting a $229.1 billion payroll, and producing $624.6 billion of output. The same survey found that franchised businesses in 2001 accounted for 7.4 percent of all private-sector jobs, 5.0 percent of all private sector payrolls, and 3.9 percent of all private sector output. Business format franchising accounted for 4.3 times as many business establishments as product franchising, and four times as many jobs, and operated more establishments, met a greater payroll, and generated more output in business services than in any other single line of business. The quick service restaurants hired more people than any other business format segment, and automotive and truck dealers employed more workers and had the greatest payroll of any other product distribution franchise. Jobs and payrolls in franchised businesses were greatest in California, Texas, Florida, and Illinois in 2001. Relative to the size of the statewide economy, franchising had the greatest impact on jobs and payrolls in Nevada, Arizona, New Mexico, Florida, and Mississippi.

Studies indicate that a new franchise business opens approximately every five to eight minutes of each business day, and that franchises are, on average, more profitable than company owned locations. This holds especially true for franchisors in the fast food industry. 50% of all franchise companies in existence started in the last 25 years, 70% of them in the last 45 years, and 97% of them in the last 55 years.

II. Two Short Case Studies &ndash; the Beginnings of McDonald’s and KFC

A. McDonald’s

Raymond Albert Kroc (“Kroc”), born in Chicago, Illinois, became a volunteer ambulance driver in World War I, a dance-band musician, a salesman, a representative for Lily-Tulip paper cups and plates, and, later in his career, a promoter of a milk shake mixing machine. Never completing high school, Kroc espoused a conservative, anti-regulatory philosophy, and fought for a modification of the minimum wage law to allow entrepreneurs to employ teenage and student workers.

In 1954, Kroc visited the McDonald brothers' small San Bernardino, California, hamburger stand, because he was curious why the brothers needed so many of Kroc’s milk shake mixers. What Kroc found was a specialized labor system that produced quality sandwiches at an affordable price. Kroc obtained the exclusive license to market the McDonald name and methods, and founded McDonald's Corporation. Kroc also opened a drive-in location in Des Plaines, Illinois, to demonstrate the business format's profitability.

Along with his associate, Harry Sonnenborn, Kroc purchased the land to build franchise locations, and then rented the real estate to franchisees on long-term leases. This action increased access to capital funds. In 1957, there were 37 McDonald’s locations, by 1959 there were 100 locations, and by 1961, there were 228 locations. McDonald’s meteoric rise continued. In 1977, Kroc assumed the title of Senior Chairman. By 1980, there were 5,000 McDonald’s locations, and by 1987, there were 10,000. At that point, McDonald's estimated that it had sold 65 billion hamburgers to the eagerly consuming public. It has been estimated that McDonald’s purchases 7.5% of the total potato crop production in the United States.

B. KFC The story of Harlan Sanders is equally intriguing. In the Great Depression era of the 1930's, Sanders operated a gas station in Corbin, Kentucky, feeding weary travelers a unique fried chicken that earned Sanders accolades from the governor of Kentucky. From gas station owner to restaurateur, Sanders’ business flourished until 1955, when the new interstate road system left him impecunious, as his chicken restaurant was not sufficiently close to the interstate. In 1956, Sanders took to the road and convinced restaurateurs in Kentucky, Ohio, and Indiana to pay him a five cent royalty for using his proprietary recipe.

By 1960, there were 200 KFC franchised outlets, by 1963, 600 outlets, and by the end of the decade, approximately 1,000. Sanders managed the burgeoning company from his home in Shelbyville, Kentucky, with a relatively modest staff. KFC continued to grow, reaching the 6,000 mark in the 1980's, and eventually 10,000 outlets.

III. Franchising’s Collision With Antitrust Law &ndash; 1949 to 1980

Following the Supreme Court ruling in 1949 in Standard Oil v. United States, franchisors operated in a legal quicksand, unsure of whether their actions constituted violations of the federal antitrust laws. Standard Oil involved the issue of whether a required purchase agreement between a franchisor and franchisee could constitute a Clayton Act prohibition against tying or exclusive dealing. Two years later, the Court in United States v. Richfield Oil Corp, further complicated the issue by stating that Richfield’s relationship with its franchisees both: (1) constituted an unreasonable restraint of trade in violation of the Section One of the Sherman Act, and (2) resulted in a substantial lessening of competition in violation of Section Three of the Clayton Act. This led to decades of legal and academic debate on the antitrust implications of franchising. Leading the charge in the 1960's were the Antitrust Division of the Department of Justice (which also took an aggressive stand on mergers and acquisitions during this period), as well as the FTC. Both held the view that economic imbalances in the franchisor/franchisee relationship needed to be rectified through taking a hard line on tying arrangements.

The conundrum was resolved in the Carvel cases in the mid-1960's, and led to a resurgence in franchise activity. The Federal Court of Appeals and the FTC separately ruled that the Carvel trademark licenses set a critical element in the franchise arrangement, and were not anti-competitive illegal ties, but rather, a necessary component in preserving the franchisor’s goodwill. However, the pendulum swung back against franchising in Siegel v. Chicken Delight during 1970-1973. The Federal Court held that the trademark could not shield an illegal tying arrangement. The FTC followed suit in 1973, ruling that the franchisor could not force feed a franchisee product as part and parcel of the franchise arrangement. This resulted in numerous class action lawsuits against franchisors.

This heavy-handed federal regulatory approach lasted until 1977, when the Supreme Court decided the landmark GTE Sylvania case. In GTE Sylvania, the Supreme Court distinguished vertical restraints intended to hinder competition from those that may have “redeeming virtues” in promoting inter-brand competition, by permitting a manufacturer to compete more efficiently, or by assuring the safety and quality of products to consumers. Since franchise agreements generally have such “redeeming virtues,” the decision was considered a victory by franchise proponents and entrepreneurs. Gone were the Standard/Richfield days of excessive scrutiny and overbearing antitrust regulation over independent businessman who benefited industry and commerce. Instead of being judged illegal tying arrangements per se, the rule of reason (competitive analysis of the relevant market) carried the day and judged the franchise bundle of goods and services as an integrated format for doing business. GTE Sylvania also had the practical effect of dramatically increasing franchise activity post-1980, and of refocusing the FTC’s concerns away from anti-competitive ties, and towards earnings claims and pre-purchase disclosure. The FTC’s disclosure investigation culminated in the Franchise Rule of 1979.

IV. The History of Franchising’s Regulatory Environment

Concomitant with the enormous growth of the franchise industry came the growth of franchise abuse, and with the abuse, industry regulation. The notion of “fairness” began to pervade the regulatory scene by the 1950's, and franchise fairness provisions began to appear in federal legislation in the Automobile Dealer Franchise Act of 1956, the various franchise bills introduced in Congress in the 1960s, and the Federal Petroleum Marketing Practice Act of 1968.

In the mid-1970's, due in part to the failure of Congress to enact any franchise fairness legislation, as well as the perceived bargaining inequality between franchisors and franchises, many states adopted franchise relationship laws to prevent abuses involving encroachment, renewal, performance standards, assignment, free association, discrimination, and wrongful termination. Although there were brief attempts to regulate franchises by treating them as a type of security (an “investment contract”) to provide federal statutory protection for consumers, the notion that a franchise was akin to a security never gained solid legal footing, in part due to the fact that a security is a passive investment while a franchise requires active involvement by a franchisee.

In 1985 and 1986, legislation was introduced in twenty-two states impacting franchise sales or relationships, including amendments to existing franchise disclosure statutes, fairness statutes, dealer relationship, and business opportunities laws. During 1987, the number of franchise or dealer-related legislative proposals increased substantially, with a record forty-nine new statutes or amendments enacted into law. The pace persisted. In 1989, forty-three franchise or dealer-related statutes were enacted by twenty-five state legislatures, including regulatory changes to the franchise statutes in Michigan, Minnesota, New York, and North Dakota.

Many states have enacted some form of a “little FTC Act,” prohibiting unfair methods and deceptive acts in trade or commerce, as well as industry relationship laws regulating automobile dealerships, gasoline franchises, farm equipment dealers or alcoholic beverage distributorships. Nearly 75% of the states have business opportunity statutes prohibiting fraud and misrepresentation in the sale of certain types of franchises and business opportunities. Business opportunity scams have been a major focus of FTC enforcement over the years. Since 1995, the FTC has organized at least six coordinated sweeps with various state agencies focused on fraudulent business opportunities, with a recent sweep dubbed “Project Busted Opportunity.” The FTC has brought over two hundred law enforcement actions against 640 respondents under Section 5 of the FTC Act and the Franchise Rule.

There are fifteen states which have enacted statutes specifically regulating franchise solicitations and sales (California, Hawaii, Illinois, Indiana, Maryland, Michigan, Minnesota, New York, North Dakota, Oregon, Rhode Island, South Dakota, Virginia, Washington, and Wisconsin). These states account for one-third of the nation’s population, more than a third of all the franchises, and the overwhelming majority of all franchise enforcement actions. Although there were great similarities, there were many differences as well among the statutory enactments. For example, disclosure requirements in Illinois, North Dakota, South Dakota, New York, and Washington required specific language referencing franchise renewal, arbitration, and termination. Virginia required estimating annual costs of operation, while Wisconsin prohibited substantive changes to renewal agreements. Minnesota required acknowledging a franchisee’s right to use the franchisor’s trademarks, while California required reference to the policy prohibiting non-competition covenants.

Following the United States’ model, Australia, Canada, China, France, Indonesia, Korea, Malaysia, Mexico, Romania, and Spain, among other countries, have enacted disclosure laws, many of which have Rule 436's requirement of disclosure to prospective franchisees ten days prior to the execution of the franchise agreement.

As regulation became more pervasive, it also grew more complex. In response, in August 1987, the National Conference of Commissioners on Uniform State Laws (NCCUSL) recommended a Uniform Franchise Act for greater uniformity and coordination by state legislatures. An alternative Model Franchise Investment Act was circulated in draft form in mid-1989 by the North American Securities Administrators Association (NASAA), which embodied a more stringent regulatory approach, including a strongly-worded good faith standard, and rigorous restrictions relating to franchise termination, renewal, and transfer. To counter the claims of abuse in franchising, the International Franchise Association (IFA) instituted self-policing mechanisms including a Code of Ethics, and organizations such as the American Association for Franchisees and Dealers (AAFD), and the American Franchise Association (AFA) began to flourish. The stated goal of these entities was to educate regulators, franchisors, and franchisees on a “win-win” approach, and “level the playing field” for all concerned.

Although federal legislation has never been adopted, over the last decade the Congress repeatedly introduced a version of the Federal Fair Franchising Practices Act ("FFFPA&quot;), initially introduced by Congressman John LaFalce (D-NY) in the early 1990’s. The bill would allow a private right of actions for damages, recovery of attorneys' fees, as well as actions by state attorneys general. The bill would regulate both disclosure and the franchise relationship, and addresses fraud, discrimination in the sale of franchises, termination and cancellation, purchasing requirements, non-competition clauses, fiduciary, good faith, and due care duties, encroachment, and mandatory arbitration. After Chairman LaFalce lost the Chair of the Small Business Committee in 1995, the prospects for successful passage of the bill became remote, although efforts are ongoing.

V. Conclusion

Given that franchising over the last century has been true to its roots in “freeing” commerce, the goal is to encourage the indomitable entrepreneurial spirit that has led to so many success stories, while simultaneously restraining the cupidity that has led to abuse in the past. It is the right balance of legislation, regulation, enforcement, oversight, self-policing, and education that will pave the way for franchising in this new millennium.