EPIX Pharmaceuticals Announces Updated Results From Phase 2a Clinical Trial Of PRX-03140 In Alzheimer's Disease

Main Category: Alzheimer's / Dementia
Also Included In: Clinical Trials / Drug Trials
Article Date: 18 Jan 2008 - 14:00 PDT

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EPIX Pharmaceuticals, Inc. (NASDAQ:EPIX), a biopharmaceutical company focused on discovering and developing novel therapeutics through the use of its proprietary and highly efficient in silico drug discovery platform, today announced revised results from its Phase 2a clinical trial of PRX-03140, its novel 5-HT4 agonist, in Alzheimer's disease. The trial was designed to assess the effects of PRX-03140 following two weeks of treatment as monotherapy and separately in combination with donepezil (Aricept®) in patients with mild Alzheimer's disease and the company announced initial findings on December 18, 2007. The updated results described below reflect the correction of previously undetected errors that were included in the trial results as provided to the company from a third party contract research organization (CRO) and as reported by the company in a recent press release, as well as newly available data on other measures of cognition.

As a result of errors made in the transcription of data and calculation of the Alzheimer's Disease Assessment Scale cognitive subscale (ADAS-cog) score, an independent re-analysis of the data has been conducted. The corrected results show that patients receiving 150 mg of PRX-03140 orally once daily as monotherapy achieved a mean 3.6 point improvement on the ADAS-cog versus a 0.9 point worsening in patients on placebo, which continues to be statistically significant (p= 0.021). Data for the patients on a 50 mg dose of PRX-03140 showed a 1.0 point improvement on the ADAS-cog. The monotherapy dose response (150 mg versus 50 mg versus placebo) continues to be statistically significant with p=0.026. There were no substantive changes in the results from the combination arms of the study.

The previously reported safety results from the trial are unchanged. In the Phase 2a clinical trial, PRX-03140 appeared to be well tolerated, both alone and in combination with donepezil (Aricept®). No serious drug-related adverse events occurred during the trial.

The two-week study also utilized other cognitive tests including Mindstreams, an automated battery of computerized cognitive function tests. Patients on monotherapy demonstrated significant (p<0.04) improvements in memory and visual-spatial indices as measured using Mindstreams when compared with placebo.

Based upon the compelling improvements in cognition demonstrated over such a short duration of time, EPIX has received requests from certain patients, caregivers and clinical trial investigators for continued access to PRX-03140. EPIX has been able to accommodate such requests on a case-by-case basis by extending the study to allow these patients to continue on PRX-03140. To date, one patient has completed 11 additional weeks of study treatment, and additional patients have initiated extended dosing.

"We are very excited by the measurable impact on memory and cognition achieved with PRX-03140 in a two-week study that was designed primarily to assess tolerability and safety. While we were disappointed that these errors were not detected during the CRO clinical monitoring or data verification processes, EPIX moved as quickly and efficiently as possible to reassess these data, reanalyze the findings and release the updated results of the trial to the public," stated Michael G. Kauffman, M.D., Ph.D., chief executive officer of EPIX. "With our partner, GlaxoSmithKline, we are continuing with our plans to initiate a Phase 2b clinical trial program in Alzheimer's patients in the first half of this year."

About EPIX

EPIX Pharmaceuticals is a biopharmaceutical company focused on discovering and developing novel therapeutics through the use of its proprietary and highly efficient in silico drug discovery platform. The company has a pipeline of internally-discovered drug candidates currently in clinical development to treat diseases of the central nervous system and lung conditions. EPIX also has collaborations with leading organizations, including GlaxoSmithKline, Amgen, Cystic Fibrosis Foundation Therapeutics and Bayer Schering Pharma.

http://www.epixpharma.com

Forward Looking Statements

This news release contains express or implied forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 that are based on current expectations of management. These statements relate to, among other things, our expectations regarding the timing and results of future clinical development of PRX-03140 and its potential efficacy, safety and tolerability. These statements are neither promises nor guarantees, but are subject to a variety of risks and uncertainties, many of which are beyond our control, and which could cause actual results to differ materially from those contemplated in these forward-looking statements. In particular, the risks and uncertainties include, among other things: risks that product candidates may fail in the clinic or may not be successfully marketed or manufactured; risks relating to our ability to advance the development of product candidates currently in the pipeline or in clinical trials; failure to obtain the financial resources to complete development of product candidates; our inability to further identify, develop and achieve commercial success for new products and technologies; our inability to achieve commercial success for our products and technologies; our failure to comply with regulations relating to our products and product candidates, including FDA requirements; the risk that the FDA may interpret the results of our studies differently than we have; and risks of new, changing and competitive technologies and regulations in the U.S. and internationally.

Existing and prospective investors are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof. We undertake no obligation to update or revise the information contained in this press release, whether as a result of new information, future events or circumstances or otherwise. For additional information regarding these and other risks that we face, see the disclosure contained in our filings with the Securities and Exchange Commission, including our most recent Annual Report on Form 10-K and subsequent Quarterly Reports on Form 10-Q.

EPIX Pharmaceuticals

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