ChemoCentryx Reports that Traficet-EN Maintains Remission in Crohn's Disease at the Digestive Disease Week (DDW) 2010 Conference
Definitive Clinical Evidence that Chemokine Receptors can be Successfully Targeted to Treat Major Inflammatory Diseases
NEW ORLEANS, May 4 /PRNewswire/ -- ChemoCentryx, Inc., today
announced that it reported positive data with Traficet-EN(TM)
(CCX282-B) in the Maintenance period of PROTECT-1 (Prospective
Randomized Oral Therapy Evaluation in Crohn's disease Trial-1).
Traficet-EN maintained a clinical remission rate (Crohn's Disease
Activity Index (CDAI) less than 150) of approximately 50% in
Crohn's patients over the course of 36 weeks, whereas in the
placebo group remission decreased progressively from 50% to 31%.
The difference in remission rate between the two groups was
statistically significant (p=0.01) at week 36. Also, at week 36, a
statistically significant percentage of patients receiving
Traficet-EN versus placebo were in corticosteroid-free remission
and had normalized C-reactive protein (CRP) levels. Traficet-EN
continued to be safe and well-tolerated for the entire course of
the PROTECT-1 study (aggregate dosing up to one year). These data
were presented today in an oral session at the Digestive Disease
Week (DDW) conference in New Orleans by Satish Keshav, M.D., Ph.D.,
Department of Gastroenterology, John Radcliffe Hospital, Oxford
University.
The results from the Maintenance period of PROTECT-1 reported
here confirmed and expanded the efficacy of Traficet-EN that was
observed in the preceding Induction period of the study, which was
reported in 2009.
"Treatment for inflammatory diseases of the bowel including
Crohn's has been woefully insufficient for far too long for such a
devastating disease," said Thomas J. Schall, Ph.D., President and
Chief Executive Officer of ChemoCentryx. "We believe Traficet-EN
represents a paradigm shift in terms of safety and efficacy for
these patients, offering the possibility of maintaining remission
without the serious complications associated with the current
standard of care. Additionally, these data provide a powerful
validation of targeting the chemokine system to treat major
inflammatory and autoimmune diseases."
Results for PROTECT-1 Maintenance Period of Study
Over the course of the Maintenance period, the remission rate in
the Traficet-EN group remained between 47% and 50%, whereas the
remission rate continued to decrease in the placebo group. At week
36, 47% of subjects in the Traficet-EN group were in remission
compared to 31% in the placebo group (p=0.01). Furthermore, at week
36, 41% of patients in the Traficet-EN group were in
corticosteroid-free remission compared to 28% in the placebo group
(p=0.04).
Study Design for PROTECT-1 Trial
This randomized, placebo-controlled, double-blind clinical trial
of 436 patients was comprised of three discrete periods which
allowed 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 period of the study was followed by a
4-week, open-label period, during which all subjects received
Traficet-EN. Patients who achieved a pre-specified 70-point or
greater reduction in CDAI were 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. 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)
CCX282-B is a small molecule, orally bioavailable drug that is
administered in capsule form and which is believed to modify 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 inflammatory T
cells that migrate to the digestive tract. The migration of
inflammatory cells to the small and large intestine is believed to
cause the persistent inflammation seen in Crohn's disease and
ulcerative colitis -- the two principal forms of IBD. In addition
to the recently completed PROTECT-1 study, ChemoCentryx has
completed six Phase I clinical trials and one four-week Phase II
Crohn's disease trial of CCX282-B at doses up to 1000 mg twice
daily, demonstrating that the drug candidate is well-tolerated and
appropriate for once-daily or twice-daily oral dosing. CCX282-B 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 now being developed under a
strategic alliance with GlaxoSmithKline's Center of Excellence for
External Drug Discovery (CEEDD). In January 2010, GlaxoSmithKline
(GSK) exercised an option to obtain an exclusive worldwide license
for the further development and commercialization of
Traficet-EN.
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
biological network that regulates inflammation via a collection of
secreted chemokine molecules, or ligands, and their specific cell
surface receptors. 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, where it demonstrated the
ability to induce a clinical response and to maintain clinical
remission over the course of the trial. In addition, CCX025, also a
CCR9 antagonist, has successfully completed a Phase I clinical
program. Other clinical programs include CCX140, which targets the
CCR2 receptor, in Phase II clinical development for the treatment
of type 2 diabetes mellitus; CCX354, a CCR1 antagonist in a Phase
II clinical trial for the treatment of rheumatoid arthritis; and
CCX168, a C5aR antagonist, in Phase I clinical development.
ChemoCentryx also has several programs in preclinical development.
ChemoCentryx is privately held. For more information, please refer
to www.chemocentryx.com.
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Source: ChemoCentryx, Inc.
CONTACT: Susan M. Kanaya, Senior Vice President, Finance and
Chief
Financial Officer, or Markus J. Cappel, Ph.D., Chief Business
Officer,
+1-650-210-2900, investor@chemocentryx.com;
or Media, Burns McClellan, Kathy
Nugent, Ph.D., +1-212-213-0006, knugent@burnsmc.com
Web Site: http://www.chemocentryx.com/
Posted: May 2010
