YM BioSciences Inc. (NYSE Amex: YMI, TSX: YM) provided an update today on CYT387 for the treatment of myelofibrosis. It intends to initiate its Phase 3 trial during 2H 2012. By the end of 2012 both final data from its Phase 1/2 Core trial and interim data from the Phase 1/2 Extension trial are expected to be reported. Interim data from the BID (twice-daily dosing) Phase 2 trial of CYT387 are also expected to be reported by the end of calendar 2012.
Orexigen Therapeutics, Inc. (Nasdaq: OREX) said on Wednesday that it is set to initiate its cardiovascular outcomes trial (CVOT) for its obesity candidate, Contrave, during late-2Q 2012 . An interim analysis and New Drug Application resubmission is planned once at least 87 major adverse cardiovascular events have occurred, which is anticipated to be by about mid-2014.
Immunomedics, Inc. (Nasdaq: IMMU) noted that it has initiated a new Phase 1b trial of 90Y-labeled clivatuzumab in patients with pancreatic cancer who have failed at least two prior therapies. Its planned Phase 3 trial will be initiated once the Phase 1b trial has been completed.
BioDelivery Sciences International, Inc. (NASDAQ: BDSI) said that together with Endo, they hope to initiate two Phase 3 efficacy studies for BEMA Buprenorphine for chronic pain, one in opioid experienced and one in opioid naive patient groups, during 3Q 2012. Data from its pivotal pharmacokinetic study of BEMA Buprenorphine/Naloxone (BNX) versus Suboxone, for the treatment of opioid dependence, are due in late 3Q 2012, with a possible NDA filing during 1H 2013.
Amicus Therapeutics (Nasdaq:FOLD) provided a pipeline update noting that final enrollment in its Phase 3 trial (Study 012) of migalastat HCl monotherapy for Fabry disease is on track by to be completed by the end of 2012. Data from its Phase 3 (Study 011) trial are due 3Q12. A Phase 2 update of migalastat HCl co-administered two hours prior to ERT (Study 013) for Fabry disease is due 3Q 2012 with final results to be presented at a scientific conference during Fall 2012. Preliminary results from its Phase 2 trial of AT2220 co-administered with the ERT alglucosidase alfa (Study 010) for Pompe disease are due 2Q 2012.