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EPIX Pharmaceuticals Initiates Phase 1 Multiple Ascending Dose Clinical Trial of PRX-07034 in Obesity

Posted on: Tuesday, 24 October 2006, 09:00 CDT

EPIX Pharmaceuticals, Inc. (NASDAQ:EPIX) today announced the initiation of a Phase 1 multiple ascending dose clinical trial to study the safety, tolerability, pharmacokinetics, and pharmacodynamics of PRX-07034 administered once-daily for 28 days in a population of otherwise healthy obese adults with body mass indices between 30 and 42 kg/m2. PRX-07034 is a novel, highly selective 5-HT6 receptor antagonist being developed for the treatment of obesity, as well as for cognitive impairment associated with Alzheimer's Disease and schizophrenia.

"We are pleased to announce the initiation of this multiple dose trial of PRX-07034 in obese adults," said Michael G. Kauffman, M.D., Ph.D., chief executive officer of EPIX Pharmaceuticals. "PRX-07034 is the fourth novel drug candidate internally discovered at EPIX. We recently completed a single dose study of PRX-07034 and results from that trial demonstrated that PRX-07034 was well tolerated and supported once-daily oral dosing."

Results from the Phase 1 Single Ascending Dose Trial

PRX-07034 is a novel, highly selective, small-molecule antagonist of a specific G-protein coupled receptor (GPCR) known as 5-HT6. Preliminary safety and tolerability data from a recently completed single ascending dose Phase 1 trial in healthy adult male and female volunteers indicated that single doses of PRX-07034 were well-tolerated up to 2500 mg, the highest dose tested. In addition, PRX-07034 demonstrated adequate absorption, with drug exposures increasing with increasing doses and a half-life of 14 to 24 hours, making it suitable for once-daily dosing.

PRX-07034 has also shown cognitive-enhancing properties in preclinical animal models of memory impairment, as well as reductions of both food intake and body weight in several preclinical animal models of obesity. Indications are that the human 5-HT6 receptor is found mainly in the central nervous system with little or no expression in peripheral tissues, which may result in greater drug selectivity with fewer side effects.

About EPIX

EPIX Pharmaceuticals is a biopharmaceutical company focused on discovering, developing and commercializing novel pharmaceutical products through the use of proprietary technology to better diagnose, treat and manage patients. The company has a blood-pool imaging agent approved and marketed in Europe (Vasovist™), and five internally-discovered therapeutic and imaging drug candidates currently in clinical trials targeting conditions such as depression, Alzheimer's disease, cardiovascular disease and obesity. These drug candidates include EP-2104R, a novel thrombus imaging agent which has completed a Phase 2a trial, PRX-08066 in Phase 2 clinical development for pulmonary hypertension associated with chronic obstructive pulmonary disease, and PRX-03140, which has completed a Phase 1b clinical trial in Alzheimer's patients. EPIX also has collaborations with leading organizations, including Amgen, Cystic Fibrosis Foundation Therapeutics, and Schering AG (Germany). For more information about EPIX, please visit the company's website at www.epixpharma.com.

Source: Business Wire

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