-- Phase I Data in Healthy Volunteers to be Presented at AACR Indicate That CCX872 is a Potent and Selective Inhibitor of CCR2 --
-- Initial Phase Ib Clinical Data in Pancreatic Cancer Patients Anticipated by Year-End --
MOUNTAIN VIEW, Calif., April 20, 2015 (GLOBE NEWSWIRE) -- ChemoCentryx, Inc., (Nasdaq:CCXI), a clinical-stage biopharmaceutical company focused on autoimmune diseases, inflammatory disorders and cancer, today announced the commencement of patient enrollment in a Phase Ib clinical trial with CCX872, in patients with non-resectable pancreatic cancer. CCX872 is the Company's second clinical compound which is an orally administered inhibitor of the chemokine receptor known as CCR2.
"Despite recent advancements in treating pancreatic cancer, tumors undermine inflammatory and effector immune responses through suppressor cells thought to be controlled by the chemokine receptor known as CCR2," said Thomas J. Schall, Ph.D., President and Chief Executive Officer, ChemoCentryx. "Our belief is that by blocking CCR2 with the specific receptor inhibitor CCX872, we can eliminate the CCR2-guided immune suppressor cells in the tumor microenvironment and consequently promote a more effective anti-tumor response."
The open-label, multi-center Phase Ib clinical trial will evaluate the safety and efficacy of orally administered CCX872 plus FOLFIRINOX (5-fluorouracil, leucovorin, irinotecan and oxaliplatin) in up to 54 patients with non-resectable pancreatic cancer. Patients will initially be treated for 12 weeks and those who achieve at least stable disease, as measured by Response Evaluation Criteria In Solid Tumors, or RECIST 1.1, will be eligible to continue treatment unless disease progression occurs. The primary efficacy measurement will be progression-free survival. The Company plans to report initial data from the trial by year-end.
"We are pleased to commence this pancreatic cancer clinical trial with our next-generation CCR2 inhibitor, CCX872, particularly since most patients with this disease have such limited treatment options and poor prognosis," said Pirow J. Bekker, M.D., Ph.D., Chief Medical Officer, ChemoCentryx. "In partnership with our clinical investigators, we look forward to determining if CCX872 in combination with standard of care treatment can improve responses in pancreatic cancer."
CCX872 Development Program
CCX872 has been evaluated in preclinical studies and completed a Phase I single and multiple ascending dose study (3 mg to 300 mg) in 40 healthy volunteers. At all evaluated dose levels, including those doses being used in the Phase Ib pancreatic cancer trial, CCX872 was observed to be safe and well tolerated.
Results from the Phase I clinical trial in healthy volunteers will be presented in the form of a poster titled CCX872: Pharmacodynamic Study of a Potent and Selective CCR2 Antagonist in Human Volunteers and Plans for Phase Ib Trial in Patients with Pancreatic Cancer, at the American Association for Cancer Research (AACR) meeting today at the Philadelphia Convention Center in Philadelphia, PA. Pharmacodynamic data from the CCX872 Phase I trial in healthy volunteers indicated that CCX872 is a potent and selective inhibitor of CCR2 in treated subjects. Also included in the poster is an analysis of data from a human genomic database that has profiled and analyzed large numbers of human tumors. These data implicate CCR2 and its ligand MCP-1 (CCL2) in pancreatic cancer.
CCX872 is an orally administered, potent and selective inhibitor of the chemokine receptor known as CCR2. CCR2 is found on subsets of monocytes, macrophages and myeloid derived suppressor cells (MDSCs) which are believed to regulate the immune response. Inhibition of CCR2 has been associated with decreased tumor growth in many preclinical solid tumor models including pancreatic cancer, metastatic melanoma, breast cancer and other solid tumors.
About Pancreatic Cancer
It is estimated that over 337,000 cases of pancreatic cancer are diagnosed worldwide every year, accounting for 2.4 percent of all cancers. Almost 67 percent of cases are diagnosed in people aged 65 and over. In the United States, pancreatic cancer is the fourth most common cause of deaths due to cancer. Pancreatic cancer has a low survival rate regardless of stage of disease, with 93 percent of patients dying from their disease within five years.
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, successfully completed a Phase II clinical trial where it was shown to be safe and well tolerated while demonstrating statistically significant improvements in kidney function in patients with 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. CCX872, a next generation CCR2 inhibitor, successfully completed Phase I development and is in Phase Ib development for the treatment of non-resectable pancreatic cancer. Vercirnon (also known as Traficet-EN or CCX282) is a specific CCR9 inhibitor for the treatment of inflammatory bowel disease. Other clinical programs include 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 CCX872 will be shown to be effective in Phase Ib clinical trials or enable underlying chemotherapy treatments to be even more effective when combined with CCX872 and statements regarding when the Company's clinical trials will be completed. 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-K filed with the SEC March 13, 2015 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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