Mesoblast's MSC-100-IV successful in pre-specified interim futility analysis in phase three aGVHD trial.
M2 EQUITYBITES-November 16, 2016-Mesoblast's MSC-100-IV successful in pre-specified interim futility analysis in phase three aGVHD trial
(C)2016 M2 COMMUNICATIONS http://www.m2.com
Australia-based Mesoblast's intravenous product candidate, MSC-100-IV, has been successful in a pre-specified interim futility analysis in the phase three trial of the product that was used as front-line therapy in children with steroid-resistant acute graft versus host disease (aGVHD), it was reported yesterday.
The company is enrolling 60 patients across multiple sites in the United States and the trial completion is expected in the first half of 2017, while commercial launch activities are underway.
The independent Data Safety Monitoring Board notified the company that an interim analysis indicated that the predefined Bayesian futility rule used to determine the probability of the trial's success using the trial's primary endpoint of Day 28 overall response, had been passed. The analysis method determined the likelihood of obtaining a statistically significant treatment effect at study completion, based on the data observed at this interim time point. Based on guidance from the United States Food and Drug Administration, the company believes that positive data from this Phase three trial is likely to be sufficient for filing for accelerated approval of MSC-100-IV in the United States. The company plans to expand its use in adult patients with high-risk steroid-refractory aGVHD.
((Comments on this story may be sent to firstname.lastname@example.org))
|Printer friendly Cite/link Email Feedback|
|Publication:||M2 EquityBites (EQB)|
|Date:||Nov 16, 2016|
|Previous Article:||Midatech Pharma selects MTR104 for formal IND-enabling programme during 2017.|
|Next Article:||Teva achieves higher GAAP net income of USD412m for Q3 2016.|