CAMBRIDGE, Mass., Aug. 9 /PRNewswire/ -- 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.
About Peptimmune
Peptimmune, Inc. is a privately held clinical stage biotechnology company
focused on utilizing both novel and proven technologies to improve the
therapeutic management of chronic autoimmune and metabolic disorders. The
company is developing second generation therapeutics that are expected to
result in safer and more effective products for obesity, multiple sclerosis,
rheumatoid arthritis and pemphigus vulgaris. Founded by a team of world class
scientists and led by an experienced management team, Peptimmune's mission is
to reduce the burden these diseases place on the individuals, their families
and the healthcare system.
For information, access our website at http://www.peptimmune.com.
SOURCE Peptimmune, Inc.
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Related links:
http://www.peptimmune.com
CONTACT:
Thomas Mathers, President of Peptimmune,
Inc., +1-617-715-8040, Tom.Mathers@peptimmune.com
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