MOUNTAIN VIEW, Calif., Sept. 01, 2016 (GLOBE NEWSWIRE) -- ChemoCentryx, Inc., (Nasdaq: CCXI ) today announced initial 12 week overall response rate (ORR) results from an ongoing open label, single arm Phase Ib clinical trial with CCX872 in patients with advanced pancreatic cancer. CCX872 is a selective inhibitor of the chemokine receptor known as CCR2.
The ongoing Phase Ib clinical study aims to evaluate the safety and effects of orally administered CCX872 when added to standard of care FOLFIRINOX (5-fluorouracil, leucovorin, irinotecan and oxaliplatin) in patients with advanced non-resectable pancreatic cancer. Under the study protocol, patients may continue to receive CCX872 for an indefinite treatment period as long as there is no evidence of disease progression. The Company expects to report progression-free survival (PFS) by the end of 2016.
Patients enrolled in the study had advanced non-resectable pancreatic cancer (78% of patients having metastatic disease), and an Eastern Cooperative Oncology Group (ECOG) Performance Status score of less than or equal to 2. In order to assess the initial treatment effect of CCX872, the study provided for assessment of overall response rate (ORR) based on computerized tomography (CT) imaging following 12 weeks of treatment.
The pre-specified evaluable ORR population consists of all patients who have at least one post-baseline disease CT assessment. Response rate results at 12 weeks of treatment were as follows:
| Pre-Specified Evaluable Patient Population 1 (N=41) | ITT Patient Population (N=50) | |
| Tumor control rate 2 | 32/41 (78%) | 32/50 (64%) |
| Overall response rate 3 | 15/41 (37%) | 15/50 (30%) |
| Stable disease | 17/41 (41%) | 17/50 (34%) |
| Progressive disease | 9/41 (22%) | 9/50 (18%) |
| Not evaluable 4 | 9/50 (18%) |
1 Pre-specified as the primary efficacy population = pre-defined as all patients who have a least one post baseline CT scan. ITT = all patients randomized, including those with no post baseline CT scan. 2 Tumor control rate includes stable disease, partial response and complete response. 3 Overall response rate measured by Response Evaluation Criteria for Solid Tumors version 1.1 (RECIST 1.1). All responses included in ORR were partial responses (PRs). 4 Not evaluable due to no post baseline CT scan due to early withdrawal.
CCX872 was well tolerated by advanced pancreatic cancer patients. The incidence and rate of adverse events were consistent with data reported historically for FOLFIRINOX alone, suggesting no apparent additional safety burdens of combining CCX872 with FOLFIRINOX.
“Advanced pancreatic cancer is particularly challenging to treat, and represents a very high unmet medical need,” said Pirow Bekker, M.D., Ph.D., Chief Medical Officer of ChemoCentryx. “While some earlier work with this mechanism looked at non-metastatic pancreatic cancer patients, we were keen on examining the effects of CCR2 inhibition in non-operable, metastatic disease in a multi-center setting. Given patients in our study may continue to receive treatment with CCX872 for as long as they are in a progression-free state, we will continue the study according to plan and evaluate progression-free survival later this year. Those data, as well as the potential longer term survival beyond that time, will help us in determining how best to proceed with CCR2 inhibition for pancreatic cancer.”
About CCX872 Phase Ib Trial Design The open-label, multi-center, ongoing Phase Ib clinical trial is designed to evaluate the safety and efficacy of orally administered CCX872 plus FOLFIRINOX in 50 patients with non-resectable pancreatic cancer. Patients receive 150 mg CCX872 twice daily for 12 weeks. After 12 weeks, patients who achieved stable disease or better (as measured by Response Evaluation Criteria In Solid Tumors, or RECIST 1.1), are eligible to continue on study for at least an additional 12 weeks unless disease progression occurs. Per protocol, the Eastern Cooperative Oncology Group (ECOG) performance status of patients in the trial is 0, 1 or 2. The primary efficacy measurement of the trial is progression-free survival (PFS) following at least 24 weeks of treatment.
About Pancreatic Cancer It is estimated that over 337,000 cases of pancreatic cancer are diagnosed worldwide every year. In the United States, the annual incidence of pancreatic cancer is approximately 45,000; prevalence is only negligibly higher owing to the poor survival rates on current therapy. Within five years of diagnosis, 93 percent of patients die from their disease. Current standards of care include chemotherapeutic regimens that have significant toxicities and, in a minority of cases, surgical resection.
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 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. 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 reduction and elimination of high-dose steroids, part of standard of care for AAV patients, without compromising efficacy or safety in clinical studies to date. CCX168 is also in Phase II studies for the treatment of atypical hemolytic uremic syndrome (aHUS) and immunoglobulin A nephropathy, or IgA nephropathy (IgAN). ChemoCentryx has licensed exclusive rights to Vifor Pharma to commercialize CCX168 in Europe and certain other markets outside of the U.S. and most of Asia. CCX872, a CCR2 inhibitor, successfully completed Phase I development and is in development for the treatment of non-resectable pancreatic cancer. CCX140, a distinct CCR2 inhibitor, successfully completed a Phase II clinical trial where it was shown to be safe and well tolerated while demonstrating statistically significant improvement in albuminuria in patients with diabetic nephropathy. Other clinical programs include CCX507, a next generation CCR9 inhibitor, which has successfully completed Phase I development, vercirnon (also known as Traficet-EN or CCX282) a specific CCR9 inhibitor for the treatment of inflammatory bowel disease, 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.
Forward-Looking Statements 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," "continue" or "project" or the negative of these terms or other comparable terminology are intended to identify forward-looking statements. These statements include the Company's statements regarding the timing of additional data including progression-free survival results from the ongoing Phase Ib clinical trial with CCX872 in patients with advanced pancreatic cancer. 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 Annual Report on Form 10-K filed with the SEC March 14, 2016 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.
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Contacts: Susan M. Kanaya Senior Vice President, Finance and Chief Financial Officer investor@chemocentryx.com Media: Denise Powell denise@redhousecomms.com 510.703.9491 Investors: Steve Klass Burns McClellan 212.213.0006 sklass@burnsmc.com
