Pharmacopeia
(Nasdaq: PCOP), an innovator in the discovery and development of novel
small molecule therapeutics, announced that based on initial results
from the Company's Phase 1 multiple ascending dose (MAD) study of its lead
internal product candidate, PS433540 (DARA), no safety or tolerability
issues were observed with any of the doses under evaluation. As a result,
the study will be expanded to include a 1,000 mg dose. This study designed
to evaluate 14 days of daily dosing in healthy volunteers, has already
completed evaluation of 50, 100, 250 and 500 mg doses of PS433540. The
Company expects to report findings from the 1,000 mg dose later this year.
"The purpose of a multiple ascending dose study of this nature is to
determine the maximally tolerated dose of a compound in healthy volunteers.
Since we did not reach that threshold with this study's original four
doses, we've decided to expand the trial and evaluate this fifth dose
level," stated Rene Belder, M.D., Pharmacopeia's Vice President of Clinical
and Regulatory Affairs. "The fact that this compound appears safe and well
tolerated at a wide dose range will provide added dosing flexibility for
subsequent clinical trials."
In addition, results from the initial Phase 1 trial of PS433540, a
single ascending dose (SAD) study, indicated that the compound was well
tolerated at all six doses administered, while also suggesting that
PS433540 possesses a half-life that is consistent with once daily oral
administration.
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 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 three partnered
programs in Phase 1 clinical trials targeting rheumatoid arthritis,
oncology, and inflammatory disease. Four additional partnered compounds are
in preclinical development.
Pharmacopeia's current strategic alliances 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 product
candidate from its DARA program, Pharmacopeia's Phase 1 and Phase 2
clinical studies with respect to PS433540, including timing and expected
outcomes of such studies, Pharmacopeia's estimates of the market
opportunities for its product candidates, including PS433540,
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 sec
and from Pharmacopeia at pharmacopeia. 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
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