Coley Pharmaceutical Group Announces Pfizer's Discontinuation of Clinical Trials for PF-3512676 Combined with Cytotoxic Chemothe
20 Giugno 2007 - 8:57PM
PR Newswire (US)
WELLESLEY, Mass., June 20 /PRNewswire-FirstCall/ -- Coley
Pharmaceutical Group, Inc. (NASDAQ:COLY) today announced that its
partner Pfizer has discontinued the development program in lung
cancer for PF-3512676, an investigational compound, in combination
with cytotoxic chemotherapy. This includes two Phase 3 clinical
trials and two Phase 2 clinical trials. A scheduled interim
analysis of the Phase 3 clinical trials by an independent Data
Safety Monitoring Committee (DSMC) showed that there was no
evidence that PF-3512676 produced additional clinical efficacy over
that achieved with the standard cytotoxic chemotherapy regimen
alone. The DSMC concluded that the risk-benefit profile did not
justify continuation of the trials. "This news is surprising based
on the signs of clinical activity observed with PF-3512676 in
Coley's Phase II randomized clinical trial and we are disappointed
with this setback in the program," said Robert L. Bratzler, Ph.D.,
President and Chief Executive Officer of Coley Pharmaceutical
Group. "We remain focused on advancing our portfolio of TLR
Therapeutic candidates for the treatment of cancer, allergy and
asthma, lupus and rheumatoid arthritis, and as a vaccine adjuvant,
including novel small molecules and RNA- based drugs targeting
TLRs7, 8 and 9." Investor Call Coley will be hosting a conference
call and webcast today, Wednesday, June 20, 2007 at 4:30 p.m. U.S.
Eastern Daylight Time with company management to discuss this
development. To access the live audio broadcast or the subsequent
archived recording, visit the Investor Center section of the Coley
website located at http://www.coleypharma.com/. Please log onto
Coley's website several minutes prior to the start of the call to
ensure adequate time for any software download that may be
required. The webcast is also being distributed through the Thomson
StreetEvents Network to both institutional and individual
investors. Individual investors can listen to the call at
http://www.fulldisclosure.com/ and institutional investors can
access the call via http://www.streetevents.com/. Investors may
participate in the conference call by dialing either +
1.866.770.7051 in the U.S. or +1.617.213.8064 outside the U.S. and
typing in the passcode 87620189. A replay of the call may also be
accessed via telephone by dialing +1.888.286.8010 (U.S.) or
+1.617.801.6888(international) with the passcode 61166535. The
archived webcast and replay of the call will be available through
July 4, 2007. About Coley Pharmaceutical Group Coley Pharmaceutical
Group, Inc. is an international biopharmaceutical company,
headquartered in Wellesley, Massachusetts, USA, that discovers and
develops TLR Therapeutics(TM), a new class of investigational drug
candidates that direct the human immune system to fight cancers,
allergy and asthma disorders and to enhance the effectiveness of
vaccines. Coley has established a pipeline of TLR Therapeutic
product candidates currently advancing through clinical development
with partners and has additional product candidates in preclinical
development. Coley has product development, research and license
agreements with Pfizer, sanofi-aventis, GlaxoSmithKline, Merck,
Novartis Vaccines and the United States government. For further
information on Coley Pharmaceutical Group please visit
http://www.coleypharma.com/. Safe Harbor Statement Certain
statements in this news release concerning Coley's business are
considered "forward-looking statements" within the meaning of the
Private Securities Litigation Reform Act of 1995. Any or all of the
forward-looking statements in this press release may turn out to be
wrong. They can be affected by inaccurate assumptions Coley might
make or by known or unknown risks and uncertainties, including, but
not limited to: the early stage of product development;
uncertainties as to the future success of ongoing and planned
clinical trials; the risk that results from early stage clinical
trials may not be indicative of results in later stage trials; the
unproven safety and efficacy of products under development;
intellectual property rights and litigation; competitive products;
and other risks identified in Coley's filings with the Securities
and Exchange Commission including, but not limited to, Coley's
Annual Report on Form 10-K for the fiscal year ended December 31,
2006. Consequently, no forward-looking statement can be guaranteed,
and actual results may vary materially. Coley undertakes no
obligation to publicly update forward-looking statements, whether
because of new information, future events or otherwise, except as
required by applicable law. DATASOURCE: Coley Pharmaceutical Group
CONTACT: Susan Hager, Senior Director, Investor Relations and
Corporate Communications, Coley Pharmaceutical Group,
+1-781-431-9019, ; or Karen L. Bergman, +1-650-575-1509 , or
Michelle Corral, +1-415-794-8662, , both of BCC Partners (US) Web
site: http://www.coleypharma.com/
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