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EPIX Pharma Reveals Discontinuation Of PRX-00023 Clinical Program On Lack Of Efficacy In Phase 2a Trial; Shares Plunge

By RTTNews Staff Writer   ✉  | Published:  | Google News Follow Us  | Join Us
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Thursday morning, biopharmaceutical company EPIX Pharmaceuticals, Inc. (EPIX) said that it has discontinued its clinical development of PRX-00023 due to lack of significant efficacy shown in the recently completed Phase 2a trial in patients with major depressive disorder. Following the news, the company's shares plummeted more than 48%.

The company said that PRX-00023 continued to show a highly desirable safety and tolerability profile but the overall results observed in its recently completed Phase 2b trial in major depressive disorder failed to prove significant efficacy. In light of these results, the company has made the strategic decision to discontinue further development of this product candidate.

EPIX said that it has received regulatory clarity on Vasovist and has initiated the requested Phase 3 image re-reads. EPIX expects to complete the re-read and resubmit the New Drug Application to the NDA in mid-2008. Data from the re-read is anticipated to be available in the second quarter of 2008.

The company is also making important progress in its promising Alzheimer's disease program. EPIX continues to expect to initiate a right-heart catheter study by mid-2008 for PRX-08066 in patients with PH associated with COPD.

The company has decided to advance its novel 5-HT6 antagonist PRX-07034 into cognitive impairment, based upon the program's statistically significant Phase 1b results and compelling safety profile.

Chief Executive Officer of EPIX, Michael Kauffman stated, We continue to enjoy strong partnerships with GlaxoSmithKline, Amgen and Cystic Fibrosis Foundation Therapeutics around several of our early stage programs, as well as our collaboration with GSK for our Phase 2b Alzheimer's disease program and Bayer Schering Pharma for Vasovist.

EPIX's stock is currently trading at $1.58, down $1.50 or 48.70% from its previous closing of $3.08.

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