THE WOODLANDS, TX -- (Marketwired) -- 05/12/16 --
Opexa Therapeutics, Inc. (NASDAQ: OPXA), a biopharmaceutical company developing personalized immunotherapies for autoimmune disorders, including Tcelna® for multiple sclerosis (MS) and OPX-212 for neuromyelitis optica (NMO), today reported financial results for the quarter ended March 31, 2016, and provided an update on the Company's recent corporate developments.
"We are pleased to be coming off a productive quarter and progressing further towards the completion of our Phase 2b Abili-T trial in secondary progressive MS," stated Neil K. Warma, President and Chief Executive Officer of Opexa. "Approximately 98% of all patient visits in the Abili-T trial have been completed, and we are excited to be approaching the release of our top-line data expected in early fourth quarter of this year. The trial is being conducted in over 180 patients and is coupled with a comprehensive immune monitoring, biomarker study. We believe this is the first clinical trial that is delivering a personalized T-cell immunotherapy to patients with secondary progressive MS and we are hopeful that we may be the first to commercialize a safe and effective therapy for these individuals. There are currently no treatments for patients with secondary progressive MS so the unmet medical need is significant and the market for this indication could be significant. As Tcelna has been partnered, through an option and license agreement, with Merck Serono, Opexa hopes to be able to leverage our combined expertise to move into a Phase III clinical trial should the Phase 2b data be positive."
"We were also pleased that Opexa was invited to present at the Third International Conference on the Progress of Regenerative Medicine and its Cultural Impact, in Vatican City, and to participate in the important discussions surrounding the potential of immunotherapies to transform the treatment of diseases with serious unmet medical need, such as secondary progressive MS and neuromyelitis optica. We are continuing to advance OPX-212 through preclinical development for NMO and are pleased with the progress demonstrated on this program during this quarter," added Mr. Warma.
Clinical and Preclinical Efforts
Financial Results for the Quarter Ended March 31, 2016
For additional information please see Opexa's Quarterly Report on Form 10-Q filed today with the SEC.
Conference Call and Webcast Details
To listen to the 4:30 P.M. ET conference call, dial 201-689-8040 or toll free 877-407-8133. The conference ID number is 13636799.
A live webcast of the call can also be accessed here or via the webcast link on the Investor Relations page of Opexa's website (www.opexatherapeutics.com). An archive of the webcast will be available on the Company's website until August 12, 2016.
There will be a brief Question & Answer session following management commentary.
Opexa is a biopharmaceutical company developing a personalized immunotherapy with the potential to treat major illnesses, including multiple sclerosis (MS) as well as other autoimmune diseases such as neuromyelitis optica (NMO). These therapies are based on Opexa's proprietary T-cell technology. The Company's leading therapy candidate, Tcelna®, is a personalized T-cell immunotherapy that is in a Phase 2b clinical development program (the Abili-T trial) for the treatment of secondary progressive MS. Tcelna consists of myelin-reactive T-cells, which are expanded ex vivo from the patient's peripheral blood and reintroduced into the patient in an attenuated form via subcutaneous injections. This process triggers a potent immune response against specific subsets of autoreactive T-cells known to attack myelin for each individual patient.
For more information, visit the Opexa Therapeutics website at www.opexatherapeutics.com or follow company news on Twitter via @OpexaCEO.
Cautionary Statement Relating to Forward-Looking Information for the Purpose of "Safe Harbor" Provisions of the Private Securities Litigation Reform Act of 1995
Statements contained in this release, other than statements of historical fact, constitute "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995. The words "expects," "believes," "may," "intends," "potential" and similar expressions are intended to identify forward-looking statements. These forward-looking statements do not constitute guarantees of future performance. Investors are cautioned that forward-looking statements, including without limitation statements regarding the safety, efficacy and projected development timeline of drug candidates such as Tcelna® and OPX-212 as well as the sufficiency of our resources, constitute forward-looking statements. These forward-looking statements are based upon our current expectations and involve assumptions that may never materialize or may prove to be incorrect. Actual results and the timing of events could differ materially from those anticipated in such forward-looking statements as a result of various risks and uncertainties, which include without limitation our ability to raise additional capital to continue our development programs, our ability to successfully develop potential products such as Tcelna and OPX-212, our ability to obtain, maintain and protect intellectual property rights (including for Tcelna and OPX-212), as well as other risks associated with the process of discovering, developing and commercializing drug candidates that are safe and effective for use as human therapeutics. These and other risks are described in detail in our SEC filings, including our Annual Report on Form 10-K for the year ended December 31, 2015 and our Quarterly Reports on Form 10-Q. All forward-looking statements contained in this release speak only as of the date on which they were first made by us, and we undertake no obligation to update such statements to reflect events that occur or circumstances that exist after such date.
Opexa Therapeutics, Inc.
Source: Opexa Therapeutics, Inc.