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Pharmacopeia Announces Positive Results From Initial DARA Clinical Trial
Pharmacopeia
(Nasdaq: PCOP), an innovator in the discovery and development of novel
small molecule therapeutics, today announced positive results from the
initial Phase 1 clinical trial of PS433540, the company's lead internal
product candidate for the treatment of hypertension and diabetic
nephropathy. Data from the single ascending dose (SAD) study indicated that
PS433540 was well tolerated at all six doses administered. In addition,
study findings suggested that the compound possesses linear
pharmacokinetics and a half-life that is consistent with once daily
administration.
PS433540 is the first and only dual-acting angiotensin and endothelin
receptor antagonist (DARA) in development. The compound, which possesses
two clinically validated mechanisms of action in a single molecule, works
by selectively blocking the action of two potent vasoconstrictor and
mitogenic agents, angiotensin II (AII) and endothelin 1 (ET1), at their
respective receptors. PS433540 is highly selective (10,000-fold) for the
AII receptor sub-type 1 and the ET receptor sub-type A. As such, PS433540
combines the properties of an angiotensin receptor blocker (ARB) and an
endothelin receptor antagonist (ERA) in the same molecule. Preclinical data
suggests that, compared to either mechanism alone, simultaneously blocking
the actions of both AII and ET1 may provide improved treatment options for
several cardiovascular diseases.
"By showing that PS433540 is well tolerated over a broad range of doses
while also possessing characteristics consistent with once-a-day dosing, we
have taken an important initial step in the development of this
first-in-class compound," said Rene Belder, M.D., Pharmacopeia's Vice
President of Clinical and Regulatory Affairs. "Based on these findings, we
are moving forward with our clinical development of DARA in an effort to
complete the overall Phase 1 program in a timely fashion."
The objective of this randomized, placebo-controlled, dose-escalation
study was to evaluate the compound's preliminary safety and tolerability by
treating six separate groups of healthy volunteers. Each group consisted of
eight subjects, with six individuals receiving the active DARA compound and
two receiving placebo. PS433540 doses administered to the study groups
ranged from 20 mg to 1000 mg and were increased for each successive group.
In addition to safety and tolerability, dose-related pharmacokinetics were
also evaluated.
Phamacopeia's Phase 1 program for PS433540 is comprised of multiple
studies. In addition to the recently completed SAD trial, other planned
studies include a multiple ascending dose (MAD) study to further evaluate
safety after repeated administration of PS433540 over 14 days, as well as
an angiotensin challenge study and an endothelin challenge study to
demonstrate PS433540's dual pharmacology. Pharmacopeia expects the entire
Phase 1 program to be complete in late 2007 with a Phase 2 trial beginning
in the first half of 2008.
ABOUT PHARMACOPEIA
Pharmacopeia is committed to discovering and developing novel
therapeutics to address significant medical needs. The Company has a broad
portfolio advancing toward clinical validation, both independently and with
partners. Pharmacopeia's most advanced internal program is a dual-acting
angiotensin and endothelin receptor antagonist (DARA) for hypertension and
diabetic kidney disease for which Phase 1 clinical trials are underway.
Other internal proprietary programs address primarily immunoregulation.
Pharmacopeia's collaborative efforts have resulted in a portfolio that
includes one partnered program currently in Phase 2 clinical trials
targeting chronic obstructive pulmonary disease (COPD) and four partnered
programs in Phase 1 clinical trials targeting rheumatoid arthritis,
oncology, metabolic diseases and inflammatory diseases. Three additional
partnered compounds are in preclinical development. Pharmacopeia's current
strategic partnerships are with Cephalon, GlaxoSmithKline, Organon and
Wyeth.
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 compound from
its DARA program, Pharmacopeia's Phase 1 clinical studies and proposed
Phase 2 clinical studies with respect to PS433540, including timing and
expected outcomes of such studies, Pharmacopeia's ability to successfully
perform under its collaborations with Cephalon, GlaxoSmithKline, Organon
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 anunþã rezultate pozitive de la studiul clinic iniþial Dara - Pharmacopeia Announces Positive Results From Initial DARA Clinical Trial - articole medicale engleza - startsanatate