Phase IIb SPMS Trial Results

A board to discuss Tcelna as a treatment for Multiple Sclerosis

Phase IIb SPMS Trial Results

Postby NHE » Fri Nov 04, 2016 5:42 pm

Opexa's stock price crashed on Oct. 28th. It's now at 67 cents/share.

http://money.cnn.com/quote/quote.html?symb=OPXA
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Re: Phase IIb SPMS Trial Results

Postby NHE » Fri Nov 04, 2016 9:46 pm

Here's why...

Opexa Therapeutics Announces Phase 2b Abili-T Trial of Tcelna® (imilecleucel-T) in Secondary Progressive Multiple Sclerosis Did Not Meet Primary Endpoint
http://www.opexatherapeutics.com/news-a ... fault.aspx

10/28/2016

    THE WOODLANDS, TX, October 28, 2016 – 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.
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Re: Phase IIb SPMS Trial Results

Postby NHE » Fri Nov 04, 2016 9:47 pm

Opexa Announces Reduction in Workforce in Light of Top-Line Results from Phase 2b Abili-T Trial of Tcelna(R) (imilecleucel-T) in Secondary Progressive Multiple Sclerosis
http://www.opexatherapeutics.com/news-a ... fault.aspx

11/02/2016

    THE WOODLANDS, TX / ACCESSWIRE / November 2, 2016 / Opexa Therapeutics, Inc. (NASDAQ: OPXA), a company developing personalized immunotherapies for autoimmune disorders, including multiple sclerosis (MS) and neuromyelitis optica (NMO), today announced that it was implementing an approximately 40% reduction to the Company's current workforce in order to reduce operating expenses and conserve cash resources. The move comes as the Company recently 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.

    The Company estimates that it will incur incremental aggregate cash charges of approximately $95,000 associated with this current workforce reduction. Moreover, the Company expects that additional restructuring will occur by year-end.

    Additionally, the Company has accepted the resignations of Ms. Donna Rill, Opexa's Chief Development Officer, and Mr. Scott Seaman, a member of the Company's Board of Directors. Ms. Rill, who is leaving to pursue other career opportunities, will depart as of November 4, 2016.

    "This reduction in force is a difficult but necessary step as a result of the disappointing results of our lead product candidate, Tcelna, announced last week," said Neil K. Warma, President and Chief Executive Officer of Opexa. "I would like to personally express my appreciation to each of the employees impacted by this decision for their commitment to Tcelna and Opexa. The Opexa team has endeavored to increase the understanding of secondary progressive multiple sclerosis, and we hope our work will contribute to the development of a safe and effective therapy for this devastating disease. I would also like to thank Scott Seaman for his long-time service as a Director of Opexa and note our special heartfelt appreciation of Donna Rill who has dedicated over 15 years to Opexa."
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Re: Phase IIb SPMS Trial Results

Postby NHE » Sat Nov 05, 2016 12:12 am

It seems to me that the failure of Tcelna/Tovaxin is a deafening declaration that the autoimmune hypothesis for MS may be fundamentally flawed. If rogue T cells were the problem, then this treatment should have likely helped.
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