ChemoCentryx Reports Positive PROTECT-1 Study Results for Traficet-EN(TM) at the GASTRO 2009 UEGW/WCOG Conference
Traficet-EN - the First Oral CCR9 Antagonist to Demonstrate Clinical Efficacy in Crohn's Disease
MOUNTAIN VIEW, Calif., Nov. 25 /PRNewswire/ -- ChemoCentryx,
Inc., announced today that Phase II/III clinical data from the
Company's PROTECT-1 (the Prospective Randomized Oral Therapy
Evaluation in Crohn's disease Trial) of Traficet-EN(TM) (CCX282-B)
in patients with moderate-to-severe Crohn's disease demonstrated
clinical efficacy with a favorable safety and tolerability profile.
The study demonstrated evidence of clinical efficacy in the
reduction of disease severity as defined as a 70-point decrease in
the Crohn's Disease Activity Index (CDAI) in patients treated with
Traficet-EN over the course of 12 weeks; the more stringent measure
of at least a 100-point decrease in the CDAI score was also met by
week 12. In addition, Traficet-EN treatment benefited patients who
had previously not responded to anti-TNF treatment. These results
reported from the Induction phase of the PROTECT-1 trial, were
presented today in a poster titled "PROTECT-1 Study of
Intestine-Specific Chemokine Receptor Antagonist CCX282-B
(TRAFICET-EN) in Crohn's Disease" by Satish Keshav, M.D.,
Department of Gastroenterology, John Radcliffe Hospital, Oxford
University at the GASTRO 2009 United European Gastroenterology
Federation and World Gastroenterology Organization (UEGW/WCOG)
conference in London.
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.
Study Results
Results showed that the CDAI >/= 70-point response in
patients with small bowel and/or colonic Crohn's disease treated
with 500 mg once-daily dose (QD) of Traficet-EN for 12 weeks was
61% versus 47% for placebo (p=0.039). Similarly, the CDAI >/=
100-point response was 55% in patients treated with 500 mg QD of
Traficet-EN as compared to 40% in the placebo group (p=0.029).
C-reactive protein (CRP) results confirmed the effect of 500 mg QD
Traficet-EN. Traficet-EN was well tolerated with a favorable
side-effect profile.
"By blocking the CCR9 chemokine receptor, we believe that
Traficet-EN has the potential to offer a dramatically new treatment
paradigm with significantly fewer side effects than currently
available therapies for Crohn's disease," said Pirow Bekker, M.D.,
Ph.D., Senior Vice President, Medical and Clinical Affairs of
ChemoCentryx. "Additionally, an effective oral capsule given once
daily would represent a significant improvement in patient
convenience and compliance as compared to existing infusion or
injection regimens - an important milestone considering the
lifestyle disruption already experienced by these patients as a
result of Crohn's debilitating effects."
"Targeting the CCR9 chemokine receptor is therapeutically
unprecedented," said Thomas J. Schall, Ph.D., President and Chief
Executive Officer of ChemoCentryx. "These results solidify our
leadership position in CCR9-based therapies and position
Traficet-EN as a first-in-class anti-inflammatory agent for the
treatment of Crohn's disease. More importantly, this study
demonstrates that Traficet-EN has the potential to offer patients a
novel, meaningful treatment option."
Study Design
The randomized, placebo-controlled, double-blind clinical trial
of 436 patients is comprised of 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. The 12-week Induction phase of the study is followed by a
4-week, open-label phase, during which all subjects receive
Traficet-EN. Patients who achieve a pre-specified 70-point or
greater reduction in CDAI are re-randomized to active drug or
placebo for an additional 36-week Maintenance phase, thereby
permitting an evaluation of the drug's ability to maintain a
treatment response. CDAI is a research tool used for determining a
patient's level of disease activity and is the key measure regarded
by regulatory agencies as an appropriate endpoint to assess the
efficacy of a drug for the treatment of Crohn's disease.
About Traficet-EN(TM) (CCX282-B)
Traficet-EN is a small molecule, orally bioavailable drug that
is administered in capsule form and which is believed to control
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 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. ChemoCentryx has completed six
Phase I clinical trials and one four-week Phase II Crohn's disease
trial of Traficet-EN at doses up to 1000 mg twice daily,
demonstrating that the product candidate is well-tolerated and
appropriate for once-daily 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. Traficet-EN is being developed
under a strategic alliance with GlaxoSmithKline's Center of
Excellence for External Drug Discovery (CEEDD).
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 therapy 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 multiple 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, completed a Phase II/III multi-national clinical trial,
called PROTECT-1, in patients with moderate-to-severe Crohn's
disease. CCX025, also a CCR9 antagonist, successfully concluded a
Phase I clinical program. Additional clinical programs include the
development of CCX140, which targets the CCR2 receptor, expected to
enter Phase II clinical development in the first quarter of 2010
for the treatment of type 2 diabetes mellitus, and CCX354, a CCR1
antagonist expected to enter Phase II by year end for the treatment
of rheumatoid arthritis. ChemoCentryx also has several programs in
preclinical development. ChemoCentryx is privately held. For more
information, please refer to 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.
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 Media,
Kathy Nugent, Ph.D. of Burns McClellan, +1-212-213-0006, knugent@burnsmc.com,
for ChemoCentryx, Inc.
Web Site: http://www.chemocentryx.com/
Posted: December 2009
