Biotech Values

[DewDiligence]

MNTA resumes enrollment in phase-2 Necuprarnib trial in first-line pancreatic cancer; trial completion now expected in 2H17:

http://finance.yahoo.com/news/momenta-resumes-patient-enrollment-necuparanib-130000942.html

“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.”

On 11/13/15, the DSMB recommended an enrollment hold on this trial pending a protocol change to address thrombocytopenia (#msg-118473682); however, patients already enrolled in the trial continued to be dosed while the protocol change was worked out.

As a reminder, this phase-2 trial is powered at 80% to detect a 50% improvement in OS for the Necuparanib + Gemzar + Abraxane arm relative to the control arm (Gemzar+Abraxane): #msg-107073252.