EPIX Pharmaceuticals Announces Updated Results from Phase 2a Clinical Trial of PRX-03140...

Wed Jan 16, 2008 7:30am EST

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EPIX Pharmaceuticals Announces Updated Results from Phase 2a Clinical Trial of PRX-03140 in Alzheimer's Disease

    Data Continue to Show Statistically Significant Improvements in
            Cognitive Function and Favorable Safety Profile
LEXINGTON, Mass.--(Business Wire)--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(R)) 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

   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(R)). 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 (pless
than0.04) 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. For more
information, please visit the company's website at 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.

Kim C. Drapkin, 781-761-7602
Chief Financial Officer
Pure Communications
Keri Mattox, 215-791-0105

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