NEW ORLEANS, May 4 /PRNewswire/ -- ChemoCentryx, Inc., today announced that it reported positive data with Traficet-EN™ (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™ (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.
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.
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.
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|SOURCE ChemoCentryx, Inc.|
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