Company Also Reports Significant Progress in Advancing Second-Generation
CCR9 Drug towards Clinic
MOUNTAIN VIEW, Calif., June 12 /PRNewswire/ -- ChemoCentryx, Inc.,
today announced the completion of enrollment of 436 patients in the
company's PROTECT-1 (the Prospective Randomized Oral Therapy Evaluation in
Crohn's disease Trial), a Phase II/III clinical trial of Traficet-EN(TM)
(CCX282-B) in patients with moderate-to-severe Crohn's disease. This
innovative clinical trial comprises three discrete phases which allows for
evaluation of efficacy and safety of Traficet-EN in inducing a clinical
response or remission, as well as maintaining response/remission in Crohn's
disease over a combined total of 12 months. Traficet-EN is an orally-active
inhibitor of the chemokine receptor known as 'CCR9', which is selectively
expressed by inflammatory T cells to migrate to the digestive tract in a
process that ultimately results in the persistent inflammation underlying
the disease. Targeting the CCR9 chemokine receptor represents a novel
approach for the treatment of Crohn's disease and other inflammatory
disorders of the gastrointestinal system. The company is on track to report
data from the induction phase of this trial in the fourth quarter of 2008.
PROTECT-1 is a randomized, placebo-controlled, double-blind study that
includes a 12-week 'Induction Period', during which patients with
moderate-to-severe Crohn's disease will receive either Traficet-EN or a
placebo in order to evaluate the drug's ability to induce a clinical
response or remission. The induction phase of the study is followed by a
four-week, open label 'Active Period', during which all subjects receive
Traficet-EN. Patients who achieve a pre-specified reduction in disease
severity are re-randomized to active drug or placebo for an additional
36-week 'Maintenance Period', thereby permitting an evaluation of the
drug's ability to maintain a treatment response. The primary efficacy
endpoint in the induction phase of the study is the attainment of a
clinical response defined as a decrease from baseline in the Crohn's
Disease Activity Index (CDAI) score of at least 70 points. In a separate
clinical trial, Traficet-EN is also being evaluated for patients with
celiac disease, a sensitivity to gluten and gluten derivatives in which
digestive tract T cells are thought to play an important role.
"We are very pleased to have completed enrollment of more than 430
patients for the PROTECT-1 study at clinical sites in 17 countries
worldwide. This represents an important milestone in the development of
this promising new drug, as well as an impressive accomplishment by a
committed group of investigators throughout the world and our entire
clinical team," said Pirow Bekker, M.D., Ph.D., Vice President, Medical and
Clinical Affairs of ChemoCentryx. "Following completion of PROTECT-1, our
goal is to expeditiously advance additional clinical development of
Traficet-EN to support regulatory filings worldwide."
ChemoCentryx's Second-Generation CCR9 Program
ChemoCentryx is also advancing a second-generation, orally-active CCR9
antagonist through preclinical development and anticipates a regulatory
filing to enable first-in-human studies on this compound in the second half
of the year. Structurally diverse from Traficet-EN, this second-generation
CCR9 antagonist strengthens ChemoCentryx's proprietary position in the CCR9
arena, and gives the company the potential to pursue additional
gastrointestinal and other clinical indications with discrete compounds.
The CCR9 program is a part of a strategic alliance that ChemoCentryx
signed in 2006 with GlaxoSmithKline's Center of Excellence for External
Drug Discovery (CEEDD) for the discovery and development of small molecule
antagonists targeting four defined chemokine and chemoattractant receptors.
Under the terms of the agreement, ChemoCentryx is responsible for advancing
product candidates through clinical proof-of-concept, at which point GSK
will have options to license certain product candidates.
"We're delighted with the progress our team has made in advancing one
of our second-generation CCR9 antagonist compounds towards the clinic,"
said Thomas J. Schall, Ph.D., President and Chief Executive Officer of
ChemoCentryx. "This new compound adds to our existing clinical pipeline
that already contains three other novel drug candidates, each targeting
different chemokine receptors and currently in clinical trials. This
growing clinical pipeline, in addition to our robust preclinical and
discovery programs, clearly positions ChemoCentryx as an industry leader in
chemokine-based therapeutics."
About CCX282-B (Traficet-EN(TM))
Traficet-EN is a small molecule, orally-available drug that is
administered in capsule form and which controls the inappropriate immune
system response underlying inflammatory bowel disease (IBD) by blocking the
CCR9 chemokine receptor. In adults, CCR9 is a highly specific receptor
expressed by T cells that migrate selectively to the digestive tract. The
trafficking of T cells to the small and large intestine causes persistent
inflammation that may result in Crohn's disease or ulcerative colitis - the
two principal forms of IBD. In preclinical studies, the compound worked
both therapeutically and prophylactically in models of Crohn's disease and
ulcerative colitis. In addition to the ongoing PROTECT-1 clinical trial in
Crohn's disease and the ongoing Phase II trial in celiac disease,
ChemoCentryx has completed five Phase I clinical trials and one four-week
Phase II Crohn's disease trial of Traficet-EN, demonstrating that the
product candidate is well-tolerated and appropriate for once- or
twice-daily oral dosing. Traficet-EN may offer advantages over existing
therapeutic approaches for Crohn's disease by potentially offering reduced
side effects and convenient oral dosing to patients.
About Crohn's Disease
Crohn's disease is a chronic inflammatory condition of the
gastrointestinal tract. It is estimated that the disease affects over
500,000 patients in Europe and North America. Patients suffer periods of
flare-ups characterized by intense symptoms, interspersed with periods of
relative remission where symptoms decrease or disappear. As Crohn's disease
is a chronic condition, patients continue on a given therapeutic regimen
from the time of diagnosis over the course of a lifetime, layering
additional therapies as flare-ups recur or persist in an effort to reduce
symptoms. When medications can no longer control symptoms, patients have
few options beyond surgery.
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, 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. Additional programs include the clinical development of
CCX140, which targets the CCR2 receptor, currently in a Phase I clinical
trial and intended for subsequent development to treat diseases such as
vascular restenosis, Type 2 diabetes and/or multiple sclerosis; and CCX354,
a CCR1 antagonist currently in a Phase I clinical trial, 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:
Media, Karen L. Bergman, mobile,
+1-650-575-1509, or Susan Pietropaolo, mobile, +1-201-923-2049,
both of BCC Partners for ChemoCentryx, Inc.; or 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
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