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PROTECT-1 Phase II/III Induction-Stage Results for ChemoCentryx's Traficet-EN(TM) Presented in Oral Session at DDW 2009 Conference

Posted on: Monday, 1 June 2009, 15:30 CDT

Oral CCR9 Antagonist Demonstrates Clinical Efficacy with Favorable Tolerability Profile

MOUNTAIN VIEW, Calif., June 1 /PRNewswire/ -- ChemoCentryx, Inc., announced 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 evidence of clinical efficacy in the reduction of disease severity, as defined by a decrease from baseline in the Crohn's Disease Activity Index (CDAI) score of at least 70 points over the course of 12 weeks; the more stringent criterion of at least a 100 point decrease in the CDAI score was also met by week 12. In addition, Traficet-EN treatment resulted in colonoscopic evidence of improvement. These data, reported from the Induction Stage of the ongoing PROTECT-1 trial, were presented at Digestive Disease Week (DDW) 2009 in Chicago, IL, by Satish Keshav, M.D., Ph.D., Department of Gastroenterology, John Radcliffe Hospital, Oxford University, in an oral session today.

The study, "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," showed that the 500 mg once-daily dose (QD) of Traficet-EN in patients with small bowel and/or colonic Crohn's disease was consistently superior to placebo across multiple efficacy endpoints. At week 12, the CDAI greater than or equal to 70-point response was 61 percent in the 500 mg QD group versus 47 percent for placebo (p=0.039). Similarly, the CDAI greater than or equal to 100-point response was 55 percent in this group versus 40 percent for placebo (p=0.029). In his oral presentation, Dr. Keshav further noted that colonoscopic evidence of improvement based on the Crohn's Disease Endoscopic Index of Severity (CDEIS) was observed in the 500 mg QD group compared to placebo (CDEIS decrease of -8.4 vs. -1.1 for placebo, p=0.049). C-reactive protein (CRP) results confirmed the effect of 500 mg QD Traficet-EN. Traficet-EN may offer a new orally available treatment option with a favorable side effect profile to patients with this chronic gastrointestinal disease.

"Targeting the CCR9 chemokine receptor represents a new and highly specific approach to treating patients with Crohn's disease and potentially ulcerative colitis," said Pirow Bekker, M.D., Ph.D., Senior Vice President, Medical and Clinical Affairs of ChemoCentryx. "No cure exists for inflammatory bowel diseases and many patients do not respond to or cannot tolerate current treatment options, including the newer biologics such as anti-Tumor Necrosis Factor (TNF) agents, which need to be injected or infused. There was no evidence of an increased risk of infection with Traficet-EN in PROTECT-1. This safety and efficacy profile may translate into a meaningful treatment option for patients."

"These data highlight a year of unparalleled clinical development progress by the ChemoCentryx team. This is true not only for our CCR9 program, but throughout our entire pipeline," said Thomas J. Schall, Ph.D., President and Chief Executive Officer of ChemoCentryx. "Traficet-EN results announced today underscore our leadership position in CCR9-based therapeutics for the treatment of inflammatory bowel diseases."

The randomized, placebo-controlled, double-blind PROTECT-1 clinical trial of more than 430 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 Induction Phase of the study is followed by a four-week, open label 'Active Period', 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 Period', thereby permitting an evaluation of the drug's ability to maintain a treatment response.

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.

About Traficet-EN(TM) (CCX282-B)

Traficet-EN is a small molecule, orally-available 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 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. In addition to the ongoing PROTECT-1 clinical trial in Crohn's disease, Traficet-EN is being evaluated for patients with celiac disease, a sensitivity to gluten and gluten derivatives in which digestive tract T cells are thought to play an important role. ChemoCentryx has completed five Phase I clinical trials and one four-week Phase II Crohn's disease trial of Traficet-EN, demonstrating that the product candidate is well-tolerated and appropriate for once-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 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 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, 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 a Phase I clinical trial and intended for subsequent development to treat diseases such as Type 2 diabetes, multiple sclerosis and vascular restenosis, and CCX354, a CCR1 antagonist in a Phase I clinical trial, 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.

SOURCE ChemoCentryx, Inc.

Source: PR Newswire

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