MOUNTAIN VIEW, Calif., May 26, 2012 (GLOBE NEWSWIRE) -- ChemoCentryx, Inc. (Nasdaq:CCXI), today announced the presentation of results from the Company's development program for CCX168, an investigational orally administered inhibitor of the complement anaphylatoxin receptor known as C5aR. CCX168 is currently in a multinational, randomized, double-blind, placebo-controlled Phase II clinical trial for the treatment of anti-neutrophil cytoplasmic antibody (ANCA)-associated renal vasculitis, an inflammation of small blood vessels in the kidney. ANCA-associated renal vaculitis can lead to renal failure and a high mortality if untreated. As presented in two posters at the 49th European Renal Association - European Dialysis and Transplant Association (ERA-EDTA) Congress in Paris, France, Phase I clinical trial results, supported by findings from preclinical in vivo studies, established the target dosing level for the Company's ongoing Phase II clinical trial.
"CCX168 is a novel treatment approach to help patients with ANCA-associated renal vasculitis. Our CCX168 Phase II clinical program is evaluating the safety, tolerability, and early signs of treatment efficacy of CCX168 to reduce or possibly eliminate concomitant use of corticosteroids," stated Thomas J. Schall, Ph.D., President and CEO, ChemoCentryx. "ANCA vasculitis currently is treated with high-dose corticosteroids and cyclophosphamide, among other noxious treatment regimens in severe cases. Therefore, a novel medicine such as CCX168 could provide a more safe and tolerable treatment option for these patients."
In a poster titled, "Clinical Dose Selection of the C5a Receptor Antagonist CCX168 for the Phase II ANCA-Associated Renal Vasculitis Clinical Trial (the CLEAR Trial)," the pharmacokinetic (PK) and pharmacodynamic (PD) profiles and therapeutic effectiveness achieved with CCX168 in an anti-myeloperoxidase antibody (anti-MPO IgG) preclinical model of ANCA nephropathy were presented. In addition, the Phase I clinical trial PK/PD data were also shown. Analysis of these results led to the selection of the dosing regimen of 30 mg twice daily for the Company's Phase II CLEAR (for C5aR inhibitor on Leukocytes Exploratory ANCA-associated Renal vasculitis) clinical trial in ANCA-associated renal vasculitis. Furthermore, the Phase I clinical trial demonstrated that CCX168 was well-tolerated and caused no serious adverse events.
Also presented at the ERA-EDTA Congress, a second poster titled, "Oral C5a Receptor Antagonist CCX168 in a Phase 2 Clinical Trial in ANCA Associated Renal Vasculitis," outlined the clinical protocol for the CLEAR trial. In this study, eligible patients with ANCA-associated renal vasculitis are being randomized in a 1:2 ratio to receive either placebo or 30 mg CCX168 twice daily for a 12-week treatment period, with a 12-week follow-up period. The trial is assessing the safety and tolerability of CCX168, as well as the feasibility of reducing or eliminating the concomitant use of corticosteroids and evaluating the effect of CCX168 treatment on renal function and ANCA disease. To date, CCX168 has been well-tolerated in the Phase II clinical trial.
ABOUT C5aR AND CCX168
The complement system consists of a set of proteins that regulate certain types of inflammatory responses. Fragments of complement proteins, including the chemoattractant complement fragment known as C5a, work to recruit inflammatory cells, including neutrophils, to sites of inflammation by means of its receptor (C5aR). Given molecular structure similarities between the C5aR and chemokine receptors, ChemoCentryx researchers successfully applied the Company's proprietary drug discovery technologies to the design of small molecule C5aR inhibitors and selected CCX168 based on its potency, selectivity and favorable pharmacokinetics. CCX168 was discovered and is being developed by ChemoCentryx and is the final drug candidate subject to option under an alliance with GlaxoSmithKline (GSK).
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. ChemoCentryx'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. ChemoCentryx'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, and CCX168, a C5aR inhibitor in Phase II clinical development for the treatment of anti-neutrophil cytoplasmic antibody (ANCA)-associated vasculitis. 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. 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 risk and uncertainties inherent in the ChemoCentryx business and other risks described in the Company's filings with the Securities and Exchange Commission. 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 Securities and Exchange Commission ("SEC"), including ChemoCentryx's Annual Report on Form 10-K for the year ended December 31, 2011 and Quarterly Report on Form 10-Q for the three-month period ended March 31, 2012, which are 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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