On December 21, 2015 Momenta Pharmaceuticals, Inc. (NASDAQ:MNTA) reported that it has resumed patient enrollment in its ongoing Phase 2 portion of the trial "A Phase I/II, Two-Part, Multicenter Study to Evaluate the Safety and Efficacy of M402 in Combination with nab-Paclitaxel and Gemcitabine in Patients with Metastatic Pancreatic Cancer (Press release, Momenta Pharmaceuticals, DEC 21, 2015, View Source [SID:1234508621]). Schedule your 30 min Free 1stOncology Demo! " Study enrollment was paused last month following Momenta’s acceptance of recommendations from its Data Safety Monitoring Board (DSMB) to develop guidelines for diagnosing and managing thrombocytopenia, based on a limited number of specific toxicities observed in the study.
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"We are pleased that following their review of the protocol amendment, the DSMB is supportive of resuming patient enrollment in our necuparanib study," said Jim Roach, M.D., Senior Vice President of Development and Chief Medical Officer of Momenta Pharmaceuticals. "Given the projected timelines to obtain Institutional Review Board approval of the protocol amendment across study sites, we now anticipate that the top-line data should be available in the second half of 2017."
About Necuparanib
Necuparanib (M402) is a novel oncology drug candidate engineered to have a broad range of effects on tumor cells. The use of heparins to treat venous thrombosis in cancer patients has generated numerous reports of antitumor activity; however, the dose of these products has been limited by their anticoagulant activity. Leveraging its experience in deciphering the structure-function relationships of complex therapeutics, Momenta engineered necuparanib from unfractionated heparin to have significantly reduced anticoagulant activity while preserving relevant antitumor properties associated with heparins. A Phase 2 randomized, double-blind, controlled study to evaluate the antitumor activity of necuparanib in combination with nab-paclitaxel (Abraxane) plus gemcitabine, versus nab-paclitaxel plus gemcitabine alone in pancreatic cancer is currently underway. Necuparanib has received Orphan Drug and Fast Track designations from the U.S. Food and Drug Administration (FDA) for the treatment of pancreatic cancer.