On November 13, 2015 Momenta Pharmaceuticals, Inc. (NASDAQ:MNTA) reported that it has put a temporary hold on 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," pending the institution of a protocol amendment following receipt of recommendations from its independent Data Safety Monitoring Board (DSMB) (Press release, Momenta Pharmaceuticals, NOV 13, 2015, View Source [SID:1234508230]). Schedule your 30 min Free 1stOncology Demo! The DSMB met to discuss a limited number of specific toxicities, including thrombocytopenia, risk of bleeding, and thromboembolic events. After thorough review, the DSMB found no safety signals to suggest the need to unblind results, close the study, or discontinue dosing in patients already enrolled in the trial. The DSMB did recommend that the company amend its protocol to standardize the approach to diagnosing and managing thrombocytopenia and consider holding new patient accrual until the amendment is instituted. The DSMB also noted that the causes of thrombocytopenia and subsequent bleeding in these patients can be multifactorial. The Company is assessing whether its protocol amendment and enrollment pause will delay release of top-line data beyond the first half of 2017.
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"We support the DSMB’s recommendations regarding the most appropriate path forward for the Phase 2 portion of the trial. As always, patient safety is our primary concern, and we will work diligently to institute their recommendations and resume enrollment in this study," stated Jim Roach, M.D., Senior Vice President of Development and Chief Medical Officer of Momenta Pharmaceuticals.
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.