EPIX
Press Release Source: EPIX Pharmaceuticals, Inc.
EPIX Pharmaceuticals Issued Composition of Matter Patent on Novel 5-HT4 Receptor Agonists
Tuesday March 17, 6:30 am ET
Company’s 5-HT4 Agonist Compound, PRX-03140, Receives Patent Protection
LEXINGTON, Mass.--(BUSINESS WIRE)--EPIX Pharmaceuticals, Inc. (NASDAQ: EPIX - News) 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 that the United States Patent and Trademark Office has issued U.S. Patent No. 7,488,736 entitled “Thienopyridinone Compounds and Methods of Treatment” to EPIX. The granted claims of this patent are directed to the highly selective 5-HT4 small molecule agonist, PRX-03140, and to compositions that include PRX-03140 as one of the active ingredients. EPIX also has pending patent applications relating to compositions and methods of using PRX-03140.
“We believe this patent will be a valuable asset as we continue to develop PRX-03140 for the treatment of Alzheimer’s disease,” said Elkan Gamzu, Ph.D., president and chief executive officer of EPIX. “In 2008, we announced compelling results of our Phase 2a clinical trial of PRX-03140 as a single agent and in combination with Aricept®, which demonstrated, among other characteristics, that PRX-03140 was well tolerated with no serious drug-related adverse events. As we continue to make progress in the development of PRX-03140, we believe this milestone may prove to be a significant benefit in the eventual commercialization of the compound, which we believe may have the potential to improve cognition and memory and to slow the progression of Alzheimer’s disease.”
PRX-03140 is being developed under EPIX’s worldwide multi-target strategic collaboration with GlaxoSmithKline to discover, develop and market novel medicines targeting four G-Protein Coupled Receptors (GPCR) for the treatment of a variety of diseases. EPIX has three drug candidates currently in the clinical stage of development that were discovered utilizing its proprietary computer-based GPCR platform and optimized with integrated computational-medicinal chemistry. In May 2008, EPIX announced the initiation of its PRX-03140 Phase 2b program in Alzheimer's disease. The Phase 2b proof-of-concept program consists of two clinical trials - a six-month trial evaluating PRX-03140 in combination with donepezil and a three-month trial studying PRX-03140 as monotherapy. The combination trial began in early May 2008 and the monotherapy trial was initiated in late May 2008. For information about these two ongoing clinical trials, please visit www.trialforAD.com or www.ClinicalTrials.gov and (for the latter) use the search terms EPIX and/or PRX-03140.
PRX-03140 – Summary of Clinical Data
EPIX believes that its drug candidate PRX-03140 may have the potential to improve cognition and memory, and to slow the progression of Alzheimer's disease, with fewer and less-severe side effects than drugs currently on the market to treat this condition. It is selective for the 5-HT4 receptor in the brain and is believed to stimulate both acetylcholine production and release - which enables symptomatic improvement in Alzheimer's patients - and the alpha-secretase pathway - which may slow Alzheimer's disease progression. Phase 2a results indicated that patients receiving daily oral 150 mg doses of PRX-03140 as monotherapy for two weeks achieved a mean 3.6 point improvement on the Alzheimer's Disease Assessment Scale cognitive subscale (ADAS-cog) versus a 0.9 point worsening in patients on placebo (p= 0.021).
In three Phase 1 trials and the Phase 2a trial, with more than 180 patients and healthy subjects, PRX-03140 has been well-tolerated. In a 14-day Phase 1b clinical trial, treatment with PRX-03140 resulted in changes in brain wave activity in Alzheimer's patients that are consistent with those seen in clinical trials with currently approved drugs for Alzheimer's disease. In preclinical studies, PRX-03140 was shown to improve cognitive function through increasing levels of acetylcholine, and led to increased levels of soluble amyloid precursor protein (sAPP) and brain-derived neurotrophic factor (BDNF) in regions of the brain known to be important for memory.
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 and Cystic Fibrosis Foundation Therapeutics.
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 our strategic collaborations, the progress, timing and results of our clinical development program for PRX-03140, and the potential effects of PRX-03140. 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, including PRX-03140, may fail in the clinic or may not be successfully marketed or manufactured; risks relating to the our ability to advance the development of product candidates currently in the pipeline or in clinical trials, any failure to comply with regulations relating to our products and product candidates, including FDA requirements; failure to obtain the financial resources to complete development of product candidates; the risk that the FDA may interpret the results of our studies differently than we have; competing products may be more successful; our inability to interest potential partners in our technologies and products; our inability to achieve commercial success for our products and technologies; the possibility of delays in the research and development necessary to select drug development candidates; the risk that we may be unable to successfully secure regulatory approval of and market our drug candidates; 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.
Contact:
EPIX
Kim C. Drapkin, 781-761-7602
Chief Financial Officer
or
Pure Communications
Jennifer Beugelmans, 646-596-7473
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