Coley Pharmaceutical Group Diversifies Pipeline with First-in-Class TLR Antagonist for the Treatment of Systemic Lupus Erythemat
October 29 2007 - 9:00AM
PR Newswire (US)
-- CPG 52364, Coley's First Orally-Available, Small Molecule Drug
Candidate, Enters Phase I Clinical Development -- WELLESLEY, Mass.,
Oct. 29 /PRNewswire-FirstCall/ -- Coley Pharmaceutical Group, Inc.
(NASDAQ:COLY), today announced that it has dosed its first subject
in a Phase I safety study of its novel, orally-available TLR
Therapeutic(TM) drug candidate for the treatment of Systemic Lupus
Erythematosus, or SLE. The candidate, CPG 52364, is a small
molecule Toll- Like Receptor (TLR) antagonist designed to
specifically inhibit TLRs 7, 8 and 9 and inhibit disease
development in SLE and other autoimmune disorders. CPG 52364 has
been designed to interfere at an early stage of the immune cascade
by blocking the inappropriate immune activation of all three of
these TLRs, and to treat the underlying cause of the disease
without causing general suppression of immune function. The Phase I
study is a double-blind, placebo-controlled, randomized clinical
trial designed to examine the safety, tolerability and
pharmacokinetics of ascending doses of CPG 52364. The compound will
be administered as a single oral dose in approximately 40 healthy
volunteers. "Coley is committed to innovation in TLR Therapeutic
drug development, and we are pleased to have furthered our
objective of pipeline diversification by advancing this
first-in-class TLR antagonist compound into the clinic," commented
Robert L. Bratzler, Ph.D., President and Chief Executive Officer of
Coley Pharmaceutical Group. "We believe there is solid preclinical
evidence and strong scientific rationale that validate CPG 52364
for the treatment of SLE, and potentially other autoimmune
diseases, such as rheumatoid arthritis (RA) and psoriasis, where
TLRs 7, 8 and 9 are inappropriately activated. As with our other
clinical efforts, we are hopeful that we can make a contribution to
medicine with a new potential therapy for a disease that today
remains a large unmet medical need." CPG 52364's Mechanism of
Action in SLE The defining characteristic of SLE is the production
of autoantibodies, abnormal antibodies produced against the body's
own tissues or organs. In SLE, these autoantibodies bind to DNA
and/or RNA, and their associated cellular proteins, forming "immune
complexes". Immune complexes containing anti-DNA antibodies
activate TLR9, while immune complexes that contain RNA activate
TLR7 and TLR8. Recent studies show that the development and
progression of SLE are driven by the inappropriate activation of
TLR7, TLR8 and TLR9. TLRs7 and 9 are present within B cells, which
secrete high levels of interferon-alpha and contribute to disease
severity. TLR8 is expressed in monocytes and other dendritic cells,
which are thought to produce proinflammatory cytokines, which
further contribute to disease process. Other studies have indicated
that autoimmunity in rheumatoid arthritis (RA) and psoriasis also
is mediated through one or more of these TLRs. Coley evaluated and
selected TLR7, 8 and 9 as important targets by elucidating the
therapeutic mechanism of action for a commonly used treatment for
SLE and RA. For many years, SLE and RA patients have been treated
with certain antimalarial drugs as a treatment for SLE, such as
hydroxychloroquine (HCQ), which was serendipitously discovered to
be a moderately effective therapy for the disease. The therapeutic
mechanism for HCQ in these autoimmune diseases had been unknown,
until research from Coley and other scientists revealed that the
compound is an antagonist of TLR9, and to a lesser extent TLRs7 and
8. Based on the new recognition by Coley that the efficacy of HCQ
appears to result from blocking TLRs 7, 8 and 9, Coley designed and
developed CPG 52364 to inhibit these TLRs more effectively. In
Coley's preclinical studies, CPG 52364 showed a marked increase in
therapeutic potency compared to HCQ, preventing the development of
anti-DNA antibodies in SLE-prone mice, while also exhibiting an
improved safety profile. In addition to its activity as a
monotherapy, preclinical data showed that the combination of CPG
52364 with HCQ delivers added efficacy, suggesting that CPG 52364
could be used clinically either in combination with HCQ or as a
replacement therapy for HCQ in the first-line treatment of SLE.
Coley plans to present data from its preclinical research with CPG
52364 at The 71st annual meeting of the American College of
Rheumatology (ACR) at the new Boston Convention and Exhibition
Center in Boston, Massachusetts. Dr. Arthur Krieg, Coley's
Executive Vice President of Research and Development and Chief
Scientific Officer will deliver a presentation on Friday, November
9, 2007 at 2:45pm EST, entitled, "Antimalarials are More Effective
at Inhibiting Toll-Like Receptor 9 than at Inhibiting Antigen
Presentation" (Presentation #1310). Dr. Grayson Lipford, Vice
President, Basic Research for Coley Pharmaceutical Group, plans to
present a poster entitled, "Selective Toll-like Receptor 7/8/9
Antagonists for the Oral Treatment of Autoimmune Diseases," (Poster
Board #210). The poster will be available for viewing on Saturday,
November 10, 2007 from 8:00am to 4:30pm EST. About Systemic Lupus
Erythematosus (SLE)(1) SLE is a chronic autoimmune disease that
affects nearly 500,000 Americans. The disease, which is nine times
more prevalent in women than men, and is also more prevalent in
minorities, occurs when the immune system produces antibodies that
cause inflammation, pain and damage to various tissues and organs
in the body. SLE is a leading cause of kidney disease, stroke, and
premature cardiovascular disease in women of childbearing age.
There is no known cure for this disease. 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, asthma and
allergy, autoimmune disorders and to enhance the effectiveness of
vaccines. Coley has established a pipeline of TLR Therapeutic
product candidates currently advancing through clinical development
either independently or 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 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. These
statements include, but are not limited to, the safety and
tolerability of CPG 52364 for the treatment of Systemic Lupus
Erythematosus (SLE); confirmation of TLR7/8/9 as a target for SLE;
; Coley's ability to enroll subjects in a Phase I clinical trial of
CPG 52364; and, the timing of results of a Phase I clinical trial
with CPG 52364. 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.
(1) Lupus Foundation of America, Inc., 2007 DATASOURCE: Coley
Pharmaceutical Group, Inc. CONTACT: INVESTORS, Susan Hager, Senior
Director, Investor Relations and Corporate Communications,
+1-781-431-9019, ; MEDIA, Karen L. Bergman or Michelle Corral, BCC
Partners (US), +1-650-575-1509 or +1-415-794-8662, , ; all for
Coley Pharmaceutical Group, Inc. Web site:
http://www.coleypharma.com/
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