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  #1  
Old 08/09/2004, 08:57 PM
Randy Holmes-Farley Randy Holmes-Farley is offline
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OT: Anti-Obesity Drug that I've been working on enters clinic

The anti-obesity drug that I've been working on for a number of years has just entered human clinical trials. Here are the press releases:

http://www.peptimmune.com/pep080904.htm

"Peptimmune Announces Start of Phase I Trial for Obesity

August 9, 2004

CAMBRIDGE, Mass. - Peptimmune, Inc. a privately held biotechnology company, announced that physicians have treated the first participant in a clinical trial to evaluate the safety, tolerability and pharmacokinetics of GT389-255, a lipase inhibitor conjugated to a fat binding polymer for the treatment of obesity.

The Phase I single ascending dose (SAD) double blind placebo controlled randomized study will involve 48 healthy male volunteers who will receive the drug in six escalating dose cohorts. Later in 2004, the SAD study will be followed by a multiple ascending dose Phase I study (MAD). If Phase I development is successful, Peptimmune anticipates launching a Phase II trial in patients with obesity in 2005.

GT389-255 is a novel conjugate of a pancreatic lipase inhibitor and a fat binding hydrogel polymer. It acts within the gastro-intestinal tract to prevent fat digestion and is expected to have fewer side-effects than currently marketed therapies. The reduction in caloric intake and lowering of fat absorption may lead to weight loss, with potential concomitant improvement in both diabetic and cardiovascular risk profiles. GT389-255 has been evaluated in a number of preclinical studies, including investigational new drug-enabling toxicology studies. Peptimmune licensed GT389-255 from Genzyme Corporation earlier this year.

"The commencement of this clinical trial is an important milestone for the development of GT389-255 and for the company," stated Thomas Mathers, President of Peptimmune. "The goal for GT389-255 is the development of a lipase inhibitor/fat binder that provides inhibition of fat absorption and associated weight loss, but mitigates the gastrointestinal side effects associated with undigested trigylerides in the colon".

Obesity is nearing epidemic proportions in the developed world. The prevalence of obesity is increasing worldwide, with 2003 World Health Organization estimates that over 300 million people are affected. Since 1980, the number of adults in the US has doubled and the number of obese teens has tripled. Obesity is associated with an increased risk of serious metabolic diseases, including cardiovascular disease, Type 2 diabetes, hypertension, stroke, dyslipidemia, and osteoarthritis. Approximately 300,000 deaths per year are attributed to being overweight or obese. Obesity exerts a significant burden on the health care system.

Diet and exercise alone have failed to treat this growing epidemic. Currently approved pharmacological therapies for weight loss have had limited success due to insufficient efficacy and burdensome, unpleasant side effects and safety concerns. New therapies with improved tolerability and fewer side effects are needed not only to treat obesity, but also to prevent the significant co-morbidities associated with it, such as diabetes, hypertension and cardiovascular disease. "

and

http://www.peptimmune.com/pep051004.htm

"Peptimmune is Granted Exclusive License from Genzyme to Develop and Commercialize Treatment for Metabolic Diseases including Obesity

May 10, 2004

CAMBRIDGE, Mass. - Genzyme Corporation and Peptimmune, Inc. today announced that Genzyme has granted an exclusive worldwide license to Peptimmune to develop and market a Genzyme investigational drug candidate for the treatment of obesity and other metabolic disease indications. Peptimmune plans to file an IND with the U.S. Food and Drug Administration to begin clinical trials of the drug later this year.

Under the agreement, Genzyme grants Peptimmune exclusive rights to develop, manufacture and commercialize GT389-255, in exchange for royalties, in addition to shared milestones and payments if the program is partnered further. Financial details were not disclosed.

"The acquisition of a product in the metabolic disease field that could enter the clinic in 2004 broadens and diversifies Peptimmune's pipeline," stated Tom Mathers, president of Peptimmune. "It accelerates our evolution from a research and discovery stage company, to a fully integrated biopharmaceutical company. The prospect of a new treatment for obesity offers hope for the millions of people suffering from this worldwide epidemic."

The investigational drug candidate, GT389-255, has a dual mechanism of action, serving as a pancreatic lipase inhibitor and a fat-binder. It acts within the gastro-intestinal tract to prevent fat digestion and is expected to have fewer side-effects than currently marketed therapies. GT389-255 has been evaluated in a number of preclinical studies, including investigational new drug-enabling toxicology studies.

"We have discovered a very innovative treatment for obesity that has the potential to address a very serious and growing worldwide public health problem," stated Ted Sybertz, Ph.D., senior vice president and general manager of Genzyme Drug Discovery and Development. "However, because of its broad physician call-point, obesity is not a strategic fit for Genzyme. Given Peptimmune's experienced management team, clinical development expertise in both autoimmune and metabolic disease, and their commitment to moving this program forward, we think they are an excellent partner."

The Genzyme drug discovery effort that developed the anti-obesity program has drawn upon the company's extensive expertise in developing compounds to treat metabolic disease and its world-renowned reputation in polymer chemistry. Two polymer products have been brought to market, Renagel® (sevelamer hydrochloride), a calcium-free, metal-free phosphate binder for patients with end-stage renal disease, and WelChol® (colesevelum hydrocholoride), a cholesterol-lowering agent. A third polymer, tolevamer, has recently completed Phase 2 clinical trials for the treatment of C. difficile associated diarrhea. These polymer therapies are not absorbed and all act within the GI tract.

Obesity - An Expanding Epidemic

Obesity is a global healthcare issue that is associated with an increased risk of serious metabolic diseases, including cardiovascular disease, Type 2 diabetes, hypertension, stroke, dyslipidemia, and osteoarthritis. Published prevalence rates indicate that more than 180 million people in the United States and Europe are obese, and the number of obese individuals continues to increase dramatically worldwide. A 1999 article published in the Journal of the American Medical Association estimates that there are some 300,000 deaths per year in the United States that are attributed to overweight and obesity. According to data released by the U.S. Department of Health and Human Services, the direct medical costs to the U.S. population that were attributed to obesity totaled $117 billion in 2000.

About Genzyme

Genzyme Corporation is a global biotechnology company dedicated to making a major positive impact on the lives of people with serious diseases. The company's broad product portfolio is focused on rare genetic disorders, renal disease, osteoarthritis and immune-mediated diseases, and includes an industry-leading array of diagnostic products and services. Genzyme's commitment to innovation continues today with research into novel approaches to cancer, heart disease, and other areas of unmet medical need. More than 6,300 Genzyme employees in offices around the globe serve patients in over 80 countries.

About Peptimmune

Peptimmune, Inc. is a privately held biotechnology company focused on development of therapeutics for the treatment of autoimmune and metabolic diseases. The company is led by an experienced management team with a track record of building commercial biotechnology companies. Peptimmune has one product in clinical trials for the treatment of pemphigus vulgaris, and a pipeline of late stage preclinical products for the treatment of autoimmune and metabolic diseases including, multiple sclerosis, rheumatoid arthritis and obesity. For information, access our website at http://www.peptimmune.com. "
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  #2  
Old 08/09/2004, 10:12 PM
bertoni bertoni is offline
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Congratulations! Now, does this work for fat between the ears? I'm looking for a solution...
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  #3  
Old 08/10/2004, 12:21 AM
inwall75 inwall75 is offline
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Congratulations!!! I hope the trials are successful.
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  #4  
Old 08/10/2004, 12:26 AM
Abominable Reefer Abominable Reefer is offline
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My company is making a drug that fattens you up. We've got it all covered now.
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  #5  
Old 08/10/2004, 07:57 AM
Habib Habib is offline
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Cool.

study will involve 48 healthy male volunteers

Any particular reasons to use only males?
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  #6  
Old 08/10/2004, 08:25 AM
Randy Holmes-Farley Randy Holmes-Farley is offline
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I'm not permitted to make any public comments on our clinical trials (and don't know the precise answer in our case anyway), but often companies run the early phases of clinical trials on men only to avoid any concerns about possible harm to fetuses of women that may be pregnant. Additionally, lots of pregnancies go bad for unknown reasons. If that happens in a small clinical trial, the drug may get blamed even if it had nothing to do with it.
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  #7  
Old 08/10/2004, 08:28 AM
Habib Habib is offline
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That makes sense.

Thanks, learned something new today.
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  #8  
Old 08/10/2004, 08:34 AM
Boomer Boomer is offline
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Hmm, I don't remeber you asking us for permisson to use our military codes

SAD = Strategic Air Defense

MAD = Mutually Assured Destruction

Hmm, on second thought maybe that is what you guys really mean

Congrats Randy


Hab

Any particular reasons to use only males?

I think Randy is pregedous or the wife has something to a say about it or Randy is trying to tell us something about himself in the near future.

Edit

Ok, now I see why good idea
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  #9  
Old 08/10/2004, 08:58 AM
wasp wasp is offline
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You work too !
With the fast replies and the sheer volume of stuff you do on RC I thought you must be retired or something
You must be one busy guy.
  #10  
Old 08/10/2004, 10:35 AM
Hobster Hobster is offline
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Looks like a very promising new development. I am forwarding the info to my brother in law who is a research Endocrine Doc. Should be right up his alley.
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  #11  
Old 08/11/2004, 07:41 AM
Cearbhaill Cearbhaill is offline
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Quote:
but often companies run the early phases of clinical trials on men only to avoid any concerns about possible harm to fetuses of women that may be pregnant. Additionally, lots of pregnancies go bad for unknown reasons. If that happens in a small clinical trial, the drug may get blamed even if it had nothing to do with it.
Isn't our "hormonal instability" sometimes used as a reason to avoid using women in trials such as this? It would add just one more set of variables to contend with in interpreting the results.

Not that I agree with the whole line of reasoning- most all research in any number of health related issues is conducted solely on men. I could open up the whole "men run the companies that fund the research that is controlled by men" can of worms but that would be grossly unfair to Randy who is but a player in the game.

Sorry to rant- guess I'm "hormonally unstable". That's what 5+ years of hot flashes can do to a person.

Hey- the title said OT!!
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  #12  
Old 08/11/2004, 08:46 AM
Boomer Boomer is offline
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You work too !

I can answer that, very little, he is always on vacation, like right now again He has more threads on I'm going on vacation than I have posts here


Hey- the title said OT!!

OT =Over-Time @ work, a word Randy has never heard of, except when he sends me my pay check, he always wants to know what it stands for
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  #13  
Old 08/11/2004, 09:23 AM
Randy Holmes-Farley Randy Holmes-Farley is offline
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FWIW, the early planning and design of our clinical trial of our obesity drug was carried out by a woman MD.

Later stage clinical trials for all drugs not aimed exclusively for men certainly include large numbers of women.
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  #14  
Old 08/11/2004, 09:24 AM
Randy Holmes-Farley Randy Holmes-Farley is offline
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I can answer that, very little, he is always on vacation, like right now again

Yes, a couple more days of vacation......
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  #15  
Old 10/05/2004, 07:02 AM
Habib Habib is offline
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Hmmmmm, knowing that you are a reefer it would not surprise me if it is just some form of dried corals:

FOOD CONTAINING CORAL

Patent number: JP10276722
Publication date: 1998-10-20
Inventor: HIROTA YUJI
Applicant: M P G KK
Classification:
- international: A23L1/304
- european:
Application number: JP19970102796 19970404
Priority number(s):


Abstract of JP10276722

PROBLEM TO BE SOLVED: To obtain a food having not only activities for inhibiting generation of cancer cells but also activities for neutralizing and degrading fat and for excreting wastes in a body.
SOLUTION: This food containing coral is obtained by adding the coral dried and formed into the powdery one to a food (including a drink) to provide the objective food having not only activities for inhibiting generation of cancer cells but also activities for neutralizing and degrading fat and for excreting wastes in a body.
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  #16  
Old 10/05/2004, 07:34 AM
Randy Holmes-Farley Randy Holmes-Farley is offline
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If ground up corals were in my food, I think I would loose weight.
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  #17  
Old 10/05/2004, 07:43 AM
wasp wasp is offline
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Yeah !
All those coral toxins might be just the ticket.
You eat it, you spend the next day barfing and with diarrhea, you lose an incredible amount of weight in a short time
  #18  
Old 10/05/2004, 11:28 AM
drtango drtango is offline
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Sounds like an improved Xenical! If it works, and doesn't cause nasty diarrhea, could be a breakthrough drug.

John
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  #19  
Old 10/05/2004, 11:43 AM
Randy Holmes-Farley Randy Holmes-Farley is offline
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Sounds like an improved Xenical! If it works, and doesn't cause nasty diarrhea,

Yes, exactly.
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  #20  
Old 10/07/2004, 11:18 AM
Greg Hiller Greg Hiller is offline
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So...Randy, is THAT how you lost the weight!
  #21  
Old 10/07/2004, 01:03 PM
Randy Holmes-Farley Randy Holmes-Farley is offline
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I wish it were, because then I probably wouldn't be gaining it back as I am now.
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  #22  
Old 10/11/2004, 08:55 PM
radiata radiata is offline
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Re: OT: Anti-Obesity Drug that I've been working on enters clinic

Quote:
Originally posted by Randy Holmes-Farley
The anti-obesity drug that I've been working on for a number of years has just entered human clinical trials.
Randy,

I hope that you're a principal in the company - so you can retire and devote even more time to this forum!

Congratulatons!
Bob D.
  #23  
Old 10/11/2004, 08:59 PM
rspar rspar is offline
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I always thought someone could do something like this with my wife's cooking. Hmmm...Randys been very busy since we had him over for dinner......
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  #24  
Old 10/11/2004, 09:13 PM
Randy Holmes-Farley Randy Holmes-Farley is offline
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I hope that you're a principal in the company - so you can retire and devote even more time to this forum!

I was the second employee of GelTex, but Genzyme bought us a few years back for $1.25 billion. I'm now VP of Chemical Research at Genzyme doing drug discovery chemistry. Genzyme is a fairly large company (thousands of employees and more than a billion dollars in sales each year), so I am nothing that would be called a "principle" in the company, nor do I have much ongoing financial interest in the drug itself since we licensed it out. Mostly just hope, and hopefully, satisfaction if it works.


I always thought someone could do something like this with my wife's cooking. Hmmm...Randys been very busy since we had him over for dinner......

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Old 10/14/2004, 04:03 PM
wasp9166 wasp9166 is offline
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that drug has been on the market for years randy , its called cocaine i think
 

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