MOUNTAIN VIEW, Calif., Oct. 15 /PRNewswire/ -- ChemoCentryx, Inc., announced today that it has initiated a Phase I clinical trial of CCX025, the company's fourth investigational new drug and second orally administered compound that inhibits the chemokine receptor known as CCR9. Structurally distinct from Traficet-EN(TM) (CCX282-B; ChemoCentryx's CCR9 antagonist currently in a Phase II/III clinical trial for Crohn's disease), CCX025 strengthens ChemoCentryx's position in the CCR9 arena and expands the company's gastrointestinal franchise with the potential to pursue different clinical indications with discrete compounds.
"With the advancement of CCX025 into the clinic, ChemoCentryx can pursue a greater breadth of diseases associated with CCR9 receptor inhibition with the clear advantage of having two structurally distinct, very potent and highly-selective oral therapeutics," said Thomas J. Schall, Ph.D., President and Chief Executive Officer of ChemoCentryx. "CCX025 is our fourth product candidate in the clinic, all discovered and developed at ChemoCentryx, and establishes our position as a leader in the industry in developing chemokine-based therapeutics."
The Phase I double-blind, placebo-controlled trial of CCX025 is being conducted in healthy male and female volunteers to evaluate the safety, tolerability and pharmacokinetics of CCX025 over a range of dose levels. In preclinical studies, the compound has been shown to be well-tolerated and highly selective. Like Traficet-EN, CCX025 is differentiated from existing inflammatory bowel disease therapies such as biologics (which are typically injected or infused), steroids and immunosuppressives and may offer a novel, safe and conveniently administered treatment option.
CCX025 and Traficet-EN are oral, highly-specific inhibitors of the chemokine receptor known as 'CCR9', which is predominantly expressed by inflammatory T cells. Targeting the CCR9 chemokine receptor represents a novel approach for the treatment of Crohn's disease, ulcerative colitis and other inflammatory disorders of the gastrointestinal system. This chemokine receptor is known to play a pivotal role in the migration of inflammatory T cells to the digestive tract, resulting in the persistent inflammation and tissue damage underlying these diseases. CCR9 is one of four defined chemokine and chemoattractant receptor targets covered under a 2006 alliance between ChemoCentryx and GlaxoSmithKline's Center of Excellence for External Drug Discovery (CEEDD), under which GSK has option rights to license certain product candidates.
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 currently 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 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.
CONTACT: Susan M. Kanaya, Senior Vice President, 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
media, Karen L. Bergman, mobile, +1-650-575-1509, or Susan Pietropaolo,
mobile, +1-201-923-2049 both of BCC Partners, for ChemoCentryx, Inc.
Web site: http://www.chemocentryx.com/