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Pharmacopeia Completes Enrollment In Phase 2 Hypertension Study With PS433540 (DARA)
Pharmacopeia
(Nasdaq: PCOP), an innovator in the discovery and development of novel
small molecule therapeutics, 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.
About Pharmacopeia
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
http://www.pharmacopeia.com.
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.
Pharmacopeia
http://www.pharmacopeia.com
Pharmacopeia completeazã de înscriere în studiu de fazã 2 cu hipertensiune arterialã PS433540 (Dara) - Pharmacopeia Completes Enrollment In Phase 2 Hypertension Study With PS433540 (DARA) - articole medicale engleza - startsanatate