Enrollment of 177 Patients Completed Over Eight Months Ahead of Schedule
REDWOOD CITY, Calif., Aug. 31, 2015 (GLOBE NEWSWIRE) -- OncoMed Pharmaceuticals Inc. (NASDAQ:OMED), a clinical-stage company developing novel anti-cancer stem cell and immuno-oncology therapeutics, today announced that it has completed patient enrollment in its Phase 2 "ALPINE" clinical trial of tarextumab (anti-Notch2/3, OMP-59R5) for the treatment of pancreatic cancer more than eight months ahead of schedule. The ALPINE study enrolled 177 patients with advanced pancreatic cancer who had not received prior treatment. Enrollment in the randomized, double-blinded, multi-center clinical study began in July 2014.
"We are encouraged to have accrued patients in this expanded trial over eight months ahead of our original projections and by the enthusiasm of theALPINE investigators for the potential of tarextumab in combination with chemotherapy for the treatment of patients with pancreatic cancer," said Jakob Dupont, M.D., Chief Medical Officer of OncoMed. "The ALPINE clinical study will be the first of our ongoing Phase 2 trials testing novel anti-cancer stem cell therapeutics to read out, and we expect to report data from this trial in the second half of 2016. The primary endpoint of the study is overall survival."
The Phase 2 ALPINE trial is designed to evaluate the efficacy of tarextumab in combination with Abraxane® (paclitaxel protein-bound particles for injectable suspension) (albumin bound) plus gemcitabine in patients with previously untreated Stage IV pancreatic cancer. The Phase 2 clinical trial will compare the overall survival of patients receiving tarextumab 15 mg/kg every two weeks versus placebo in combination with Abraxane plus gemcitabine. Secondary and exploratory endpoints, including progression-free survival and overall response rate, pharmacokinetics, safety and other biomarkers, will also be evaluated. Overall survival, progression-free survival and overall response rates will be assessed using a predictive biomarker for high tumor Notch3 expression. Increased Notch3 expression is estimated to occur in approximately 70 percent of pancreatic tumors and is associated with poor patient outcomes.
Read More: http://investor.shareholder.com/oncomed/releasedetail.cfm?ReleaseID=929392
OncoMed Pharmaceuticals Completes Enrollment of Phase 2 ALPINE Clinical Trial of Tarextumab in Pancreatic Cancer