Drug Represents Potential New Approach for the Treatment of Inflammatory
Disease
Milestone Triggers $10 Million Payment from Partner GlaxoSmithKline
MOUNTAIN VIEW, Calif., May 13 /PRNewswire/ -- ChemoCentryx, Inc., today
announced the initiation of a Phase I clinical trial of CCX354, an
orally-available, novel small molecule compound designed to specifically
target the CCR1 chemokine receptor which is associated with inflammatory
diseases such as rheumatoid arthritis. With the dosing of the first patient
in this trial, ChemoCentryx will be entitled to receive a $10 million
milestone payment from alliance partner GlaxoSmithKline (NYSE: GSK).
The Phase I clinical trial is designed to assess the safety,
tolerability and pharmacokinetics of CCX354 in healthy volunteers in single
ascending dose and multiple ascending dose cohorts. Preclinical studies
showed that the development candidate is a potent and selective antagonist
of the CCR1 receptor without binding to other receptors, which might
minimize off-target effects. The high potency and selectivity of the
molecule is designed to provide a wider therapeutic window allowing
continuous receptor coverage throughout the dosing regimen thought to be
critical for efficacy.
The chemokine receptor CCR1 drives the recruitment of immune cells,
such as monocytes and macrophages, associated with the inflammation
underlying certain autoimmune diseases such as rheumatoid arthritis (RA),
as well as other inflammatory diseases. Significant levels of CCR1 ligands,
including a set of so-called "C6 super-activated ligands" (which are a
result of enzymatic cleavage in the inflamed joints) have been shown to be
present in synovial fluid from the joints of RA patients. By blocking the
CCR1 ligands including the super-activated forms from interacting with the
CCR1 receptor, CCX354 is designed to reduce the migration of inflammatory
cells leading to rheumatoid arthritis and subsequently joint destruction.
"CCX354 is the third product candidate to enter the clinic from our
discovery platform and marks another important milestone for ChemoCentryx,"
said Thomas J. Schall, Ph.D., President and Chief Executive Officer.
"ChemoCentryx has repeatedly shown that it can develop clearly
differentiated product candidates by leveraging its technology platform and
that it can also advance them expeditiously into clinical development. In
less than a year, our product pipeline has expanded from a single ongoing
clinical program to now three clinical assets in development."
"We are delighted that this CCR1 antagonist program with ChemoCentryx
has progressed to the clinic," said Hugh Cowley, Senior Vice President of
GSK's Center of Excellence for External Drug Discovery (CEEDD). "CCX354 may
become a promising drug candidate against a number of potential
inflammatory diseases and we look forward to seeing the data as it emerges
from the clinical trial program."
ChemoCentryx and GSK's Center of Excellence for External Drug Discovery
(CEEDD) entered into a multi-product strategic alliance in August 2006 for
the discovery, development and commercialization of novel medicines
targeting four defined chemokine and chemoattractant receptors for the
treatment of a variety of inflammatory disorders. Under the terms of the
agreement, ChemoCentryx is responsible for the discovery and development of
up to six small molecule drug candidates across four targets through
clinical proof-of-concept, at which point GSK will have exclusive options
to license each product for further development and commercialization on a
worldwide basis. CCX354 is the second compound under the GSK alliance to
enter the clinic. ChemoCentryx's lead compound, Traficet-EN(R), is in a
Phase II/III clinical trial in patients with moderate-to-severe Crohn's
disease. Outside the GSK alliance, the company has a third clinical asset
in development, a proprietary CCR2 inhibitor in Phase I clinical trials, as
well as a number of late-stage preclinical programs.
About Rheumatoid Arthritis and CCX354
Rheumatoid arthritis (RA) is a chronic and debilitating inflammatory
disease which causes pain, stiffness, swelling and limitation in the motion
and function of multiple joints. RA is estimated to affect more than two
million people in the U.S. and is a leading cause of work disability. The
exact cause of RA is unknown, but is believed to be the body's immune
system attacking the synovium, the tissue that lines the joints. More than
three million Americans suffer from RA. Although therapy has improved
dramatically over the last 25 years, there is still no single therapy that
is effective for all patients. Treatment of RA can be divided into
Disease-Modifying Antirheumatic Drugs (DMARDs), anti-inflammatory agents
and analgesics, addressing a $10 billion market.
During the development and progression of RA, the recruitment of immune
cells, both innate and adaptive, into affected joints plays a key role in
the inflammatory process and the ensuing joint destruction. There is strong
evidence implicating CCR1 in the pathology of RA. ChemoCentryx's approach
to specifically target the CCR1 receptor with CCX354 represents a new
mechanism of action in the potential treatment of RA.
About ChemoCentryx
ChemoCentryx, Inc. is a clinical-stage biopharmaceutical company
focused on discovering, developing and commercializing orally-administered
therapeutics that target the chemokine and chemoattractant systems in order
to treat autoimmune diseases, inflammatory disorders and cancer. The
chemokine system is a network of secreted chemokine molecules, or ligands,
and cell surface receptors that regulates inflammation. Based on its
proprietary drug discovery and drug development platform, ChemoCentryx has
internally generated several clinical and preclinical-stage programs, each
targeting distinct chemokine and chemoattractant receptors with different
small molecule compounds. ChemoCentryx's lead compound, Traficet-EN(R), a
specific CCR9 antagonist, is currently in a Phase II/III multi-national
clinical trial, called PROTECT-1, in patients with moderate-to-severe
Crohn's disease. CCX140, which targets the CCR2 receptor, is currently in
Phase I and may subsequently be developed for diseases such as vascular
restenosis, Type 2 diabetes and/or multiple sclerosis, and CCX354, a CCR1
antagonist in Phase I, is being developed for inflammatory diseases such as
rheumatoid arthritis. ChemoCentryx is privately held. For more information,
please refer to http://www.chemocentryx.com.
Any statements in this press release about ChemoCentryx's expectations,
beliefs, plans, objectives, assumptions or future events or performance are
not historical facts and are forward-looking statements. These statements
are often, but not always, made through the use of words or phrases such as
may, believe, will, expect, anticipate, estimate, intend, predict, seek,
potential, continue, plan, should, could and would or the negative of these
terms or other comparable terminology. Forward-looking statements are not
guarantees of performance. They involve known and unknown risks,
uncertainties and assumptions that may cause actual results, levels of
activity, performance or achievements to differ materially from any
results, levels of activity, performance or achievements expressed or
implied by any forward-looking statement. Some of the risks, uncertainties
and assumptions that could cause actual results to differ materially from
estimates or projections contained in the forward-looking statements
include but are not limited to (i) the initiation, timing, progress and
results of ChemoCentryx's preclinical studies and clinical trials, (ii)
ChemoCentryx's ability to advance product candidates into clinical trials,
(iii) GSK's exercise of its license options, (iv) the commercialization of
ChemoCentryx's product candidates, (v) the implementation of ChemoCentryx's
business model, strategic plans for its business, product candidates and
technology, (vi) ChemoCentryx's ability to maintain and establish
collaborations or obtain additional government grant funding, (vii)
ChemoCentryx's estimates of its expenses, future revenues, capital
requirements and its needs for additional financing, (viii) the timing or
likelihood of regulatory filings and approvals, (ix) the availability of
corporate partners, (x) the scope of protection ChemoCentryx is able to
establish and maintain for intellectual property rights covering its
product candidates and technology, (xi) the impact of competitive products
and technological changes, (xii) the availability of capital and the cost
of capital, (xiii) ChemoCentryx's financial performance, (xiv) developments
relating to ChemoCentryx's competitors and other vagaries in the
biotechnology industry and (xv) other risks.
You are cautioned not to place undue reliance on these forward-looking
statements, which speak only as of the date hereof. All forward-looking
statements are qualified in their entirety by this cautionary statement and
ChemoCentryx undertakes no obligation to revise or update this press
release to reflect events or circumstances after the date hereof. This
caution is made under the safe harbor provisions of Section 21E of the
Private Securities Litigation Reform Act of 1995.
SOURCE ChemoCentryx, Inc.
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Related links:
http://www.chemocentryx.com
CONTACT:
Susan M. Kanaya, Senior Vice President,
Finance and Chief Financial Officer, or Markus J. Cappel, Ph.D.,
Chief Business Officer, both of ChemoCentryx, Inc.,
+1-650-210-2900, investor@chemocentryx.com; or Karen L. Bergman,
+1-650-575-1509, or Susan Pietropaolo, +1-201-923-2049, both of
BCC Partners for ChemoCentryx, Inc.
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