MOUNTAIN VIEW, Calif., June 19, 2013 (GLOBE NEWSWIRE) -- ChemoCentryx, Inc. (Nasdaq:CCXI) announced that it has completed the target enrollment of 270 patients in a Phase II clinical trial in diabetic nephropathy with CCX140, an inhibitor of the chemokine receptor known as CCR2 and the Company's lead wholly owned drug candidate. Enrollment will be closed by June 30, 2013, at which time ChemoCentryx expects total enrollment to exceed 300 patients in the randomized, double-blind, placebo-controlled study.
"We are very pleased to have successfully completed this important Phase II enrollment milestone with an over-enrollment of patients in the study. This achievement will enable us to report 12-week data in approximately 200 patients in the third quarter of 2013, on track with our timeline projections," said Thomas J. Schall, PhD, President and Chief Executive Officer of ChemoCentryx. "As our most advanced wholly owned program, CCX140 is a key component of the ChemoCentryx pipeline targeting high-value therapeutic areas with large unmet medical needs."
The Phase II trial, taking place at over 90 sites throughout Europe, is evaluating the safety, tolerability and signs of clinical effect of CCX140 in patients with diabetic nephropathy. Patients are randomized to receive orally-administered CCX140 (at a dose of either 5 mg or 10 mg), or a placebo once daily.
The 12-week interim data set will primarily examine effects of the drug on protein levels, or proteinuria, and hemoglobin A1c (HbA1c), the latter of which was significantly improved in diabetics receiving CCX140 in a previous Phase IIa clinical trial in type 2 diabetes.
Subsequent 52-week data are intended also to assess potential benefits of CCX140 on kidney function including effects on levels of serum creatinine and estimated glomerular filtration rates, among other measures of kidney health. The 52 week data are expected in the third quarter of 2014.
CCX140 is an inhibitor of the chemokine receptor known as CCR2 and is ChemoCentryx's lead wholly owned drug candidate. CCR2 is found on subsets of monocytes and macrophages, which are cells of the immune system believed to play an important role in inflammatory processes. Blocking CCR2 is intended to reduce the abnormal monocyte- and macrophage-driven inflammatory response implicated in renal disease.
About Diabetic Nephropathy
Diabetic nephropathy is a progressive kidney disease characterized by proteinuria in patients with diabetes. Diabetic nephropathy is the leading cause of end-stage renal disease (ESRD) in the United States, resulting in the need for dialysis or kidney transplantation. Of the 26 million patients with chronic kidney disease, approximately 35 percent of those are patients with diabetes.
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 biological network that regulates inflammation via a collection of secreted chemokine molecules, or ligands, and their specific cell surface receptors. Based on its proprietary drug discovery and drug development platform, ChemoCentryx has generated multiple clinical and preclinical-stage programs, each targeting distinct chemokine and chemoattractant receptors with different small molecule compounds. The Company's most advanced drug candidate, vercirnon (also known as Traficet-EN, CCX282 or GSK1605786), a specific CCR9 inhibitor, completed a multi-national clinical trial, called PROTECT-1, in patients with moderate-to-severe Crohn's disease, where it demonstrated the ability to induce a clinical response and to maintain clinical remission, and is now in Phase III clinical development. The Company's lead independent drug candidate, CCX140, a CCR2 inhibitor, has been shown to be safe and well tolerated while demonstrating clinical activity on glycemic indices in a Phase II clinical trial in type 2 diabetics, and is now in Phase II clinical development for the treatment of diabetic nephropathy. Other clinical programs include CCX354 (also known as GSK2941266), a CCR1 inhibitor which successfully completed a Phase II clinical trial for the treatment of rheumatoid arthritis, CCX168, a C5aR inhibitor in Phase II clinical development for the treatment of anti-neutrophil cytoplasmic antibody (ANCA)-associated vasculitis, as well as CCX872, a CCR2 inhibitor, and CCX507, an inhibitor of CCR9, both of which are in Phase I clinical testing. ChemoCentryx also has several programs in advanced preclinical development.
ChemoCentryx cautions you that statements included in this press release that are not a description of historical facts are forward-looking statements. Words such as "may," "could," "will," "would," "should," "expect," "plan," "anticipate," "believe," "estimate," "intend," "predict," "seek," "contemplate," "potential" or "continue" or the negative of these terms or other comparable terminology are intended to identify forward-looking statements. These statements are based on the Company's current beliefs and expectations and include the Company's statements regarding its expectations as to when the Company will be able to report interim data. The inclusion of forward-looking statements should not be regarded as a representation by ChemoCentryx that any of its plans will be achieved. Actual results may differ from those set forth in this release due to the risks and uncertainties inherent in the ChemoCentryx business and other risks described in the Company's filings with the Securities and Exchange Commission ("SEC"). You are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof, and ChemoCentryx undertakes no obligation to revise or update this news release to reflect events or circumstances after the date hereof. Further information regarding these and other risks is included under the heading "Risk Factors" in ChemoCentryx's periodic reports filed with the SEC, including ChemoCentryx's Annual Report on Form 10-K for the year ended December 31, 2012, which is available from the SEC's website (www.sec.gov) and on ChemoCentryx's website (www.ChemoCentryx.com) under the heading "Investors." All forward-looking statements are qualified in their entirety by this cautionary statement. This caution is made under the safe harbor provisions of Section 21E of the Private Securities Litigation Reform Act of 1995.
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