ChemoCentryx Completes Enrollment Of PROTECT-1, A Phase II/III Clinical Trial Of CCR9 Antagonist CCX282-B (Traficet-EN(TM)) In Crohn's Disease

Main Category: Crohn's
Also Included In: Clinical Trials / Drug Trials;  Pharma Industry / Biotech Industry
Article Date: 13 Jun 2008 - 2:00 PDT

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ChemoCentryx, Inc., announced the completion of enrollment of 436 patients in the company's PROTECT-1 (the Prospective Randomized Oral Therapy Evaluation in Crohn's disease Trial), a Phase II/III clinical trial of Traficet-EN(TM) (CCX282-B) in patients with moderate-to-severe Crohn's disease. This innovative clinical trial comprises 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. 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. The company is on track to report data from the induction phase of this trial in the fourth quarter of 2008.

PROTECT-1 is a randomized, placebo-controlled, double-blind study that includes a 12-week 'Induction Period', during which patients with moderate-to-severe Crohn's disease will receive either Traficet-EN or a 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 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. 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. In a separate clinical trial, Traficet-EN is also 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.

"We are very pleased to have completed enrollment of more than 430 patients for the PROTECT-1 study at clinical sites in 17 countries worldwide. This represents an important milestone in the development of this promising new drug, as well as an impressive accomplishment by a committed group of investigators throughout the world and our entire clinical team," said Pirow Bekker, M.D., Ph.D., Vice President, Medical and Clinical Affairs of ChemoCentryx. "Following completion of PROTECT-1, our goal is to expeditiously advance additional clinical development of Traficet-EN to support regulatory filings worldwide."

ChemoCentryx's Second-Generation CCR9 Program

ChemoCentryx is also advancing a second-generation, orally-active CCR9 antagonist through preclinical development and anticipates a regulatory filing to enable first-in-human studies on this compound in the second half of the year. Structurally diverse from Traficet-EN, this second-generation CCR9 antagonist strengthens ChemoCentryx's proprietary position in the CCR9 arena, and gives the company the potential to pursue additional gastrointestinal and other clinical indications with discrete compounds.

The CCR9 program is a part of a strategic alliance that ChemoCentryx signed in 2006 with GlaxoSmithKline's Center of Excellence for External Drug Discovery (CEEDD) for the discovery and development of small molecule antagonists targeting four defined chemokine and chemoattractant receptors. Under the terms of the agreement, ChemoCentryx is responsible for advancing product candidates through clinical proof-of-concept, at which point GSK will have options to license certain product candidates.

"We're delighted with the progress our team has made in advancing one of our second-generation CCR9 antagonist compounds towards the clinic," said Thomas J. Schall, Ph.D., President and Chief Executive Officer of ChemoCentryx. "This new compound adds to our existing clinical pipeline that already contains three other novel drug candidates, each targeting different chemokine receptors and currently in clinical trials. This growing clinical pipeline, in addition to our robust preclinical and discovery programs, clearly positions ChemoCentryx as an industry leader in chemokine-based therapeutics."

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

Traficet-EN is a small molecule, orally-available drug that is administered in capsule form and which controls 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 and the ongoing Phase II trial in celiac disease, 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- or twice-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.

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 several 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 currently in a Phase II/III multi-national clinical trial, called PROTECT-1, in patients with moderate-to-severe Crohn's disease. Additional programs include the clinical 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 vascular restenosis, Type 2 diabetes and/or multiple sclerosis; and CCX354, a CCR1 antagonist currently in a Phase I clinical trial, being developed for inflammatory diseases such as rheumatoid arthritis. 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 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.

ChemoCentryx, Inc
http://www.chemocentryx.com