MOUNTAIN VIEW, Calif., Dec. 4, 2014 (GLOBE NEWSWIRE) -- ChemoCentryx, Inc., (Nasdaq:CCXI), a clinical-stage biopharmaceutical company focused on autoimmune diseases, inflammatory disorders and cancer, reported today that the European Commission has granted orphan medicinal product designation for CCX168, an orally administered inhibitor targeting the receptor for the complement protein known as C5a (C5aR), for the treatment of microscopic polyangiitis (MPA) and granulomatosis with polyangiitis (GPA) (formerly known as Wegener's Granulomatosis, or WG). Both conditions are forms of anti-neutrophil cytoplasmic autoantibody (ANCA)-associated vasculitis (AAV).
"We are very pleased that the European Medicines Agency provided orphan designation for CCX168 for the treatment of patients with MPA and GPA. There exists a significant unmet medical need in these serious and life-threatening disease settings where all current treatment options such as corticosteroids, cyclophosphamide, and rituximab globally suppress the immune system and potentiate the risk of serious infections," said Thomas J. Schall, Ph.D., President and Chief Executive Officer, ChemoCentryx. "We believe that CCX168 may have therapeutic value in treating MPA and GPA since CCX168 targets the chemo-attractant C5a receptor which we believe plays an essential role in the inflammatory process in ANCA-associated diseases."
This year, the U.S. Food and Drug Administration (FDA) also granted orphan-drug designation for CCX168 ("antagonist of complement 5a receptor") for the treatment of for anti-neutrophil cytoplasmic autoantibodies (ANCA)-associated vasculitides (granulomatosis with polyangiitis, microscopic polyangiitis, and Churg-Strauss syndrome) and for atypical hemolytic uremic syndrome (aHUS).
About Orphan-Drug Designation
The European Commission grants orphan drug status for medicinal products intended to treat diseases or conditions that affect fewer than five in 10,000 people in the European Union (EU). The designation provides certain benefits and incentives in the EU, including protocol assistance, fee reductions, and ten years of market exclusivity once the medicine is on the market.
About microscopic polyangiitis (MPA) and granulomatosis with polyangiitis (Wegener's granulomatosis)
Microscopic Polyangiitis (MPA) and Granulomatosis with polyangiitis (GPA) are two rare disorders that cause blood vessel inflammation (vasculitis). Vasculitis in patients with MPA and GPA can lead to tissue damage. MPA commonly affects the kidneys, lungs, nerves, skin, and joints while GPA mostly affects the respiratory tract (sinuses, nose, trachea, and lungs) and kidneys. Both of these diseases affect people of all ages and ethnicities, and both genders. Even though genetic and factors such as infection and pollution are contributing, the exact cause of these disorders is unknown.
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. 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. CCX168, a C5aR inhibitor, is in Phase II development for the treatment of anti-neutrophil cytoplasmic antibody-associated vasculitis (AAV). CCX168 appears to be safe, well tolerated and successful in allowing both reduction and elimination of high-dose corticosteroids, part of standard of care for AAV patients, without compromising efficacy or safety during a 12-week treatment period. Vercirnon (also known as Traficet-EN or CCX282) is a specific CCR9 inhibitor for the treatment of inflammatory bowel disease. Other clinical programs include CCX872, a next generation CCR2 inhibitor currently in Phase I clinical development, CCX507, a next generation CCR9 inhibitor, which has successfully completed Phase I development and CCX354, a CCR1 inhibitor which successfully completed a Phase II clinical trial for the treatment of rheumatoid arthritis. ChemoCentryx also has several programs in advanced preclinical development.
ChemoCentryx cautions 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 include statements regarding whether CCX168 will obtain regulatory approval or the speed with which such approval might be obtained. 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"). Investors 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 Quarterly Report on Form 10-Q filed with the SEC November 6, 2014 and its other reports 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.
Source: ChemoCentryx (CCXI-G)
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