Opexa Therapeutics' (OPXA) Phase 2b Abili-T Trial of Tcelnaa in Secondary Progressive MS Misses Primary Endpoint
- Wall Street dips on Trump protectionism, Qualcomm drag
- Yahoo! (YHOO) Tops Q4 EPS by 4c; Sees Verizon Deal Closing in Q2, Not Q1
- Aetna's (AET) Humana (HUM) Takeover Blocked by Judge as Anticompetative
- Trump signs order withdrawing U.S. from Trans-Pacific trade deal
- After-Hours Stock Movers 1/23: (REXX) (MRCY) (SYNC) Higher; (FSM) (OCUL) (CASC) Lower (more...)
Get daily under-the-radar research with StreetInsider.com's Stealth Growth Insider Get your 2-Wk Free Trial here.
Opexa Therapeutics (Nasdaq: OPXA), a biopharmaceutical company developing personalized immunotherapies for autoimmune disorders, today announced that the Phase 2b Abili-T clinical trial designed to evaluate the efficacy and safety of Tcelna® (imilecleucel-T) in patients with secondary progressive multiple sclerosis (SPMS) did not meet its primary endpoint of reduction in brain volume change (atrophy), nor did it meet the secondary endpoint of reduction of the rate of sustained disease progression. Tcelna did show a favorable safety and tolerability profile.
"We are disappointed that Tcelna did not meet the predefined endpoints in the Abili-T trial," said Neil K. Warma, President and Chief Executive Officer of Opexa. "We will evaluate the full data set over the coming weeks and review cash preservation options while we consider the best path forward for the company."
Abili-T is a 183-patient, randomized, double-blind, placebo-controlled Phase 2b study (ClinicalTrials.gov Identifier: NCT01684761) that was conducted at 35 clinical trial sites in the U.S. and Canada. Patients in the Tcelna arm of the study received two annual courses of Tcelna treatment consisting of five subcutaneous injections per year.
"We would like to express our sincere thanks to the patients in the Abili-T trial, as well as to the principal investigators and study coordinators, for their contributions to the study," said Mr. Warma.
Serious News for Serious Traders! Try StreetInsider.com Premium Free!
You May Also Be Interested In
- Merus N.V. (MRUS) Enters Strategic Research Collaboration with Incyte (INCY); Includes Upfront Payment of $120M
- Ocular Therapeutix (OCUL) Commences Public Offering of Common Stock
- International Paper (IP) Comments on Pensacola Mill Incident; Reports Structural Damage to Pulp Digester
Create E-mail Alert Related CategoriesCorporate News, FDA, Hot Corp. News, Hot FDA News
Sign up for StreetInsider Free!
Receive full access to all new and archived articles, unlimited portfolio tracking, e-mail alerts, custom newswires and RSS feeds - and more!