ChemoCentryx Presents Positive Phase 2 Clinical Data for Traficet-EN in Crohn's Disease at the Digestive Disease Week 2007 ConferenceClear Anti-Inflammatory Activity Demonstrated Among Patients with Active Disease
MOUNTAIN VIEW, Calif., May 23, 2007 /PRNewswire/ -- ChemoCentryx, Inc., a clinical-stage biopharmaceutical company focused on discovering, developing and commercializing orally-administered therapeutics that target the chemokine system, presented data today from the company's Phase 2 clinical trial of Traficet-EN (CCX282-B), an orally-active anti-inflammatory agent that targets the chemokine receptor CCR9. Clinical results demonstrate that Traficet-EN is well tolerated and shows clinical activity in the treatment of patients with active Crohn's disease. These data (Abstract #1031) were presented in an oral session, "Advances in Crohn's Disease," at the Digestive Disease Week (DDW) 2007 Conference in Washington, D.C. by Satish Keshav, M.D., Ph.D., Gastroenterologist at the John Radcliffe Hospital, Oxford, and a clinical investigator for the study.
"Traficet-EN demonstrated promising evidence of efficacy in the treatment of Crohn's disease patients, particularly among patients with elevated CDAI and CRP measurements at baseline. These results, achieved after only four weeks of treatment, justify broader study of Traficet-EN," said Dr. Keshav. "Traficet-EN's potential to control Crohn's disease with a safe and effective oral capsule represents a paradigm shift in the treatment of this condition and a truly meaningful improvement in patient care."
Patients enrolled in the Phase 2 clinical trial were randomized to receive a once-daily 250 mg capsule of Traficet-EN or placebo for 28 days. Both Crohn's Disease Activity Index (CDAI) scores and C-reactive protein (CRP) levels were measured at baseline and on study days 8, 15 and 29. Among a defined subgroup of 39 patients identified as having more active disease, with CDAI scores of greater than or equal to 250 and CRP of greater than 7.5 mg/L at baseline, Traficet-EN demonstrated clinical benefit. Fifty-eight percent of patients in the Traficet-EN group experienced a 70 point or greater drop in CDAI scores compared to 31 percent of those who received placebo. Importantly, Traficet-EN's anti-inflammatory activity was demonstrated by a decrease in CRP levels, which serve as a systemic marker of inflammation, of 11 mg/L in the treatment group compared to placebo.
"We are very pleased to have seen clear signs of clinical activity in this four week study of Traficet-EN. Patients with active disease reported significant improvement in their condition when treated with Traficet-EN compared to those in the control group," said Pirow Bekker, M.D., Ph.D., Vice President, Medical and Clinical Affairs of ChemoCentryx, Inc. "In addition, the results from this group of patients in our Phase 2 trial are in line with the latest research from key opinion leaders. Current research has shown that CDAI scores of 250 and above, combined with elevated CRP serum levels at baseline, help to identify patients with actual Crohn's disease and may thereby reduce the high placebo response rate frequently observed in Crohn's disease clinical trials. We are currently using these parameters as enrollment criteria in our ongoing long-term clinical study, known as PROTECT-1, which
will evaluate Traficet-EN's ability to induce response or remission, as well as at the drug's potential as maintenance therapy."
The oral presentation of Phase 2 data, titled "CCX282-B, an orally active inhibitor of chemokine receptor CCR9, shows anti-inflammatory and clinical activity in the treatment of Crohn's Disease" was provided today by Dr. Keshav as part of the Advances in Crohn's Disease session. Data from the Phase 2 trial were also selected for presentation during the "Best of UEGW" session sponsored by the American Gastroenterological Association (AGA) yesterday afternoon. The Phase 2 randomized double-blind, placebo-controlled clinical trial was designed to evaluate Traficet-EN's safety and tolerability among patients with moderate-to-severe Crohn's disease. Traficet-EN was well-tolerated by patients participating in the Phase 2 study and the incidence of adverse events reported was generally similar in both the placebo and Traficet-EN groups.
ChemoCentryx is currently evaluating Traficet-EN in a large multi-national clinical trial. PROTECT-1 or the Prospective Randomized Oral Therapy Evaluation in Crohn's disease Trial is a randomized, double-blind, placebo-controlled study to evaluate the safety and efficacy of Traficet-EN in patients with moderate-to-severe Crohn's disease. The study includes a 12-week Induction Period to evaluate the drug's ability to induce response/remission and a 36-week Maintenance Period to evaluate the drug's ability to maintain a treatment response.
Traficet-EN, a small molecule, orally-available drug, is intended to control the inappropriate immune system response underlying inflammatory bowel disease (IBD) by blocking the activity of 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 Crohn's disease. ChemoCentryx has completed four Phase I trials and one four-week Phase 2 trial of Traficet-EN demonstrating that the product candidate is well-tolerated and appropriate for once- or twice-daily oral dosing.
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 or periods characterized by intense symptoms, interspersed with periods of 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 or no 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 complex network of chemokine molecules, or ligands, and receptors that regulates inflammation. Based on their 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 multi-national clinical trial, called PROTECT-1, in patients with moderate-to-severe Crohn's disease. 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 believe, will, expect, anticipate, estimate, intend, plan and would. 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 timing, success and cost of preclinical research and clinical studies, (ii) the timing, acceptability and review periods for regulatory filings, (iii) the availability of corporate partners, (iv) uncertainties relating to patent protection and intellectual property rights of third parties, (v) the impact of competitive products and technological changes, (vi) the availability of capital and the cost of capital, (vii) other vagaries in the biotechnology industry and (viii) other risks. ChemoCentryx undertakes no obligation to update or revise any forward-looking statements.
CONTACT: Media, Karen L. Bergman, +1-650-575-1509, or Michelle Corral,+1-415-794-8662, both of BCC Partners, for ChemoCentryx, Inc.; Investors,Susan M. Kanaya, Senior Vice President, Finance and Chief FinancialOfficer, or Markus J. Cappel, Ph.D. Chief Business Officer, both ofChemoCentryx, Inc., +1-650-210-2900, firstname.lastname@example.org
Web site: http://www.chemocentryx.com/
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Posted: May 2007