July 15 Clinical Quick Takes: Zejula meets in Phase III for 1L ovarian cancer; plus Capricor, Avrobio and NIH
Zejula improves 1L ovarian cancer PFS
Zejula niraparib met the primary endpoint in the Phase III PRIMA trial to treat first-line ovarian cancer following platinum chemotherapy, significantly improving progression-free survival regardless of patients' biomarker status vs. placebo. The PARP inhibitor from the Tesaro Inc. unit of GlaxoSmithKline plc (LSE:GSK; NYSE:GSK) is approved in the maintenance setting for ovarian cancer. GSK will present full results from PRIMA at an upcoming scientific meeting.
Capricor climbs on interim Phase II DMD data
Capricor Therapeutics Inc. (NASDAQ:CAPR) jumped $3.01 (93%) to $6.23 Monday after reporting interim data from the Phase II HOPE-2 trial to treat Duchenne muscular dystrophy showing that CAP-1002 vs. placebo improved muscle function at six months as assessed by mid-level performance of the upper limb and grip strength (p=0.0389 for both) and improved inspiratory flow reserve, a measure of pulmonary function, at three months (p=0.0473). The allogeneic cardiosphere-derived stem cell therapy has regenerative medicine advanced therapy (RMAT) and Orphan Drug designations from FDA...