PRINCETON, N.J., Feb. 26 /PRNewswire-FirstCall/ -- Pharmacopeia (Nasdaq: PCOP), an innovator in the discovery and development of novel small molecule therapeutics, today announced the completion of recruitment in the company's multi-center Phase 2a clinical study of PS433540 (DARA), the company's lead internal product candidate. The objective of the Phase 2a randomized, double-blind, placebo-controlled, parallel-group study is to evaluate the efficacy and safety of 200 and 500 mg of PS433540 in subjects with Stage I and Stage II hypertension.
"We have made good progress advancing DARA's clinical development. Not only did we initiate this Phase 2a study approximately six months ahead of our original clinical development timeline, but we have now completed enrollment in the study with the expectation of reporting results in the second quarter of 2008," said Les Browne, Ph.D., Pharmacopeia's President and Chief Executive Officer. "As this is the first PS433540 study to include hypertensive patients, we are pleased to have the opportunity to demonstrate that DARA can effectively lower blood pressure in this patient population."
Results from Phase 1 studies of PS433540 in normal subjects have indicated that the compound was well tolerated at all doses up to and including 1,000 mg a day for 14 days. Several studies including the multiple ascending dose (MAD) and angiotensin II challenge studies have shown that PS433540 appears to have a pharmacokinetic profile consistent with once-daily oral administration. In the angiotensin challenge study, 250 and 500 mg of PS433540 fully blocked the increase in blood pressure induced by administration of angiotensin II (AII) to healthy volunteers at least as well as 300 mg of irbesartan, the top dose of the marketed AII antagonist. Numerous similar studies with other agents that block the renin-angiotensin system support that this result is a strong indication that PS433540 can be expected to lower blood pressure in hypertensive patients. Additional data from the MAD study demonstrated that PS433540 produced statistically significant, dose dependent increases versus placebo in plasma-renin activity, as well as reductions in systolic and diastolic blood pressure in non-hypertensive healthy volunteers.
PS433540 is a dual-acting angiotensin (AII) and endothelin (ET1) receptor antagonist that is being developed as a potential treatment for hypertension and diabetic nephropathy. PS433540, the first and only DARA compound in development, possesses two clinically validated mechanisms of action in a single compound. There is considerable preclinical and initial clinical data suggesting that compared to either agent alone, simultaneously blocking the actions of both AII and ET1 may provide significantly improved treatment options for several cardiovascular diseases.
Pharmacopeia is a clinical development stage biopharmaceutical company
dedicated to discovering and developing novel small molecule therapeutics
to address significant medical needs. The company has a broad portfolio of
clinical and preclinical candidates under development internally or by
partners including seven clinical compounds in Phase 2 or Phase 1
development addressing multiple indications including hypertension,
diabetic nephropathy, muscle wasting, inflammation and respiratory disease.
The company is leveraging its fully integrated drug discovery platform to
sustain the growth of its development pipeline. Pharmacopeia has
established strategic agreements with major pharmaceutical and
biotechnology companies, including Bristol-Myers Squibb, Celgene, Cephalon,
GlaxoSmithKline, Schering-Plough, and Wyeth Pharmaceuticals. For more
information please visit the company's website at
Brian M. Posner
Executive Vice President and Chief Financial Officer
This press release, and oral statements made with respect to information contained in this press release, constitute forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Such forward-looking statements include those which express plan, anticipation, intent, goal, contingency or future development and/or otherwise are not statements of historical fact. These statements are based upon management's current expectations and are subject to risks and uncertainties, known and unknown, which could cause actual results and developments to differ materially from those expressed or implied in such statements. These forward- looking statements include, but are not limited to, statements about the successful implementation of Pharmacopeia's strategic plans, Pharmacopeia's plans to develop PS433540, a product candidate from its DARA program, Pharmacopeia's Phase 2 and Phase 1 clinical studies with respect to PS433540, including timing and expected outcomes of such studies, Pharmacopeia's plans to develop PS178990, a product candidate from its SARM program, Pharmacopeia's Phase 1 clinical studies with respect to PS178990, including timing and expected outcomes of such studies, Pharmacopeia's plans to develop PS031291, a product candidate from its chemokine receptor CCR1 program, Pharmacopeia's estimates of the market opportunities for its product candidates, including PS433540, PS178990 and PS031291, Pharmacopeia's ability to successfully perform under its collaborations with Bristol-Myers Squibb, Cephalon, GlaxoSmithKline, Schering-Plough and Wyeth, Pharmacopeia's ability to build its pipeline of novel drug candidates through its own internally-funded drug discovery programs, third party collaborations and in-licensing, Pharmacopeia's ability to raise additional capital, Pharmacopeia's expectations concerning the development priorities of its collaborators, their ability to successfully develop compounds and its receipt of milestones and royalties from the collaborations, Pharmacopeia's anticipated operating results, financial condition, liquidity and capital resources, Pharmacopeia's expectations concerning the legal protections afforded by U.S. and international patent law, Pharmacopeia's ability to pursue the development of new compounds and other business matters without infringing the patent rights of others, additional competition, and changes in economic conditions.
Further information about these and other relevant risks and uncertainties may be found in Pharmacopeia's Reports on Form 8-K, 10-Q and 10-K filed with the U.S. Securities and Exchange Commission. Pharmacopeia urges you to carefully review and consider the disclosures found in its filings which are available in the SEC EDGAR database at http://www.sec.gov and from Pharmacopeia at http://www.pharmacopeia.com. All forward-looking statements in this press release and oral statements made with respect to information contained in this press release are qualified entirely by the cautionary statements included in this press release and such filings. These risks and uncertainties could cause actual results to differ materially from results expressed or implied by such forward-looking statements. These forward-looking statements speak only as of the date of this press release. Pharmacopeia undertakes no obligation to (and expressly disclaims any such obligation to) publicly update or revise the statements made herein or the risk factors that may relate thereto whether as a result of new information, future events, or otherwise.
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