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CAMBRIDGE, Mass., Aug. 28, 2013 (GLOBE NEWSWIRE) -- Merrimack Pharmaceuticals, Inc. (Nasdaq:MACK) announced today that the enrollment goal has been reached in the NAPOLI-1 trial. NAPOLI-1 is a randomized Phase 3 study of MM-398, with or without 5-fluorouracil (5-FU) and leucovorin (LV), versus 5-FU and LV, in patients with metastatic pancreatic cancer previously treated with gemcitabine-based therapy.
"We are grateful to the patients and their families for volunteering for the study, and to the doctors, nurses, and medical teams for their outstanding care. We hope that MM-398 is able to make a difference to these patients and look forward to presenting the final study analysis," said Eliel Bayever, M.D., Vice President and Medical Director of MM-398. "To our knowledge this is one of the largest controlled studies ever conducted in this patient population, which has very few treatment options."
Currently, there is no approved treatment for patients with metastatic pancreatic cancer after gemcitabine has failed, nor is there a clear consensus on the standard of care in this patient group. Limited data suggest that without effective treatment, these patients are expected to live only a few months once they have progressed on first line therapy. Metastatic pancreatic cancer is almost uniformly fatal, with a 73 percent death rate within one year of diagnosis (American Cancer Society) and a 5-year overall survival rate of approximately six percent in the United States (National Cancer Institute).
NAPOLI-1 was designed to enroll approximately 405 patients at over 100 sites in North America, South America, Europe, Asia and Australia. As recently as July 2013, a data safety monitoring board reviewed the available data from NAPOLI-1 for safety and recommended that the trial continue. The Global Principal Investigator is Daniel von Hoff, M.D., F.A.C.P. of TGen, University of Arizona, Mayo Clinic and Scottsdale Healthcare.