First-in-class Oral Therapeutic for IBD with Novel Mode of Action
MOUNTAIN VIEW, Calif., May 19 /PRNewswire/ -- ChemoCentryx, Inc., today announced that data from the company’s PROTECT-1 (the Prospective Randomized Oral Therapy Evaluation in Crohn’s disease Trial) Phase II/III clinical trial of Traficet-EN(TM) (CCX282-B) in patients with moderate-to-severe Crohn’s disease will be presented in an oral session at the upcoming 2009 Digestive Disease Week (DDW) meeting. Traficet-EN is an orally-available small molecule drug that controls the inappropriate immune system response underlying inflammatory bowel diseases by blocking the CCR9 chemokine receptor. Targeting the CCR9 chemokine receptor represents a novel approach for the treatment of Crohn’s disease and other inflammatory disorders of the gastrointestinal system. DDW 2009 will be held on May 30 - June 4, 2009, at McCormick Place in Chicago, Illinois.
Satish Keshav, M.D., Ph.D., Department of Gastroenterology, John Radcliffe Hospital, Oxford University, will present Phase II/III clinical trial results from more than 430 patients in the induction phase of the PROTECT-1 study in the following session:
Abstract (#392): PROTECT-1 Study Demonstrated Efficacy of the Intestine-Specific Chemokine Receptor Antagonist CCX282-B (Traficet-EN) in Treatment of Patients with Moderate to Severe Crohn’s Disease
Session/Track: IBD Controlled Clinical Trials - Immunology, Microbiology & Inflammatory Bowel Disease
Location: McCormick Place, Room E450B
Date/Time: Monday, June 1, 2009, 3:30-3:45 PM
About CCX282-B (Traficet-EN)
Traficet-EN is an orally-available small molecule drug which 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 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. Traficet-EN may offer advantages over existing therapeutic approaches for Crohn’s disease by potentially offering convenient once-daily oral dosing and reduced side effects. Because of its specificity, Traficet-EN does not globally suppress the immune system.
About the PROTECT-1 Trial
PROTECT-1 is a randomized, placebo-controlled, double-blind study comprised of three discrete phases that allow 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 innovative trial design includes a 12-week induction phase, during which patients with moderate-to-severe Crohn’s disease will receive either Traficet-EN or 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 phase, 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 phase, 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.
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, is in 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, is in a Phase I clinical trial. Additional clinical programs include the development of CCX140, which targets the CCR2 receptor, currently in Phase I clinical development and intended for subsequent development to treat diseases such as Type 2 diabetes, multiple sclerosis and vascular restenosis, and CCX354, a CCR1 antagonist in Phase I clinical testing, being developed for inflammatory diseases such as 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.
CONTACT: Susan M. Kanaya, SVP, 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 Karen L. Bergman,
+1-650-575-1509 (mobile), or Susan Pietropaolo, +1-201-923-2049 (mobile),
both of BCC Partners, for ChemoCentryx, Inc.
Web site: http://www.chemocentryx.com/
