Opexa Therapeutics Recognizes World MS Day and Will Present Poster With Secondary Progressive Multiple Sclerosis Data at CMSC / ACTRIMS Annual Meeting 2013 CMSC-ACTRIMS Meeting Business Wire THE WOODLANDS, Texas -- May 29, 2013 Opexa Therapeutics, Inc. (NASDAQ: OPXA), a biotechnology company developing a patient specific T-cell immunotherapy for multiple sclerosis (MS), today honored World MS Day with a renewed commitment to the multiple sclerosis community. Opexa will be sponsoring a booth and will be presenting baseline data from its Immune Monitoring Program in a poster session at the 2013 Annual Meeting of the Consortium of Multiple Sclerosis Centers (CMSC) & the Fifth Cooperative Meeting with Americas Committee for Treatment and Research in Multiple Sclerosis (ACTRIMS) May 29 – June 1 in Orlando, Florida. Since May 2009, the Multiple Sclerosis International Federation (MSIF) has organized a World Multiple Sclerosis Day and this year it is being celebrated on May 29th. The purpose of this day is to raise global awareness of MS and how it impacts the lives of those living with the disease and their families. Multiple Sclerosis affects over 2 million people worldwide. Although much progress has been made in the development of new drugs to treat the Relapsing Remitting form of MS over the past several years, unfortunately, side effects continue to be a concern to many patients. Additionally, while Secondary Progressive MS affects approximately 35% of all people with MS, there still remains very limited treatment options for these patients. Recognizing this, Opexa embarked on a clinical trial for Secondary Progressive MS patients and hopes to bring its lead product candidate, Tcelna^TM, to market in an efficient manner. “We can still do a lot more as a community to raise awareness of those suffering from MS,” commented Neil K. Warma, President and Chief Executive Officer of Opexa. “There is still a great deal that is unknown about the disease and its mechanism of action and further understanding of the immunology behind the disease is required. Additional development of novel, safe and effective therapies is a necessity as side effects continue to plague patients and the current medications to which they have access. At Opexa we remain committed to every MS patient. We are focused on developing Tcelna as a personalized immunotherapy for Secondary Progressive MS and are pleased to play a role in supporting World MS Day. We look forward to speaking with those attending the ACTRIMS symposium who wish to come by the Opexa booth to learn more about MS and Tcelna.” The Company’s poster, entitled "Profiling Of Secondary Progressive Multiple Sclerosis By Multicolor Flow Cytometry," will be presented on Saturday, June 1, 2013 from 12:00 pm – 2:00 pm EDT. It highlights baseline data from the immune monitoring program that is part of Opexa’s ongoing Phase 2b Abili-T clinical trial in Secondary Progressive MS patients. About Opexa Opexa’s mission is to lead the field of Precision Immunotherapy™ by aligning the interests of patients, employees and shareholders. The Company’s leading therapy candidate, Tcelna™, is a personalized T-cell immunotherapy that is in a Phase IIb clinical development program (the Abili-T trial) for the treatment of Secondary Progressive Multiple Sclerosis. Tcelna is derived from T-cells isolated from the patient’s peripheral blood, expanded ex vivo, and reintroduced into the patients via subcutaneous injections. This process triggers a potent immune response against specific subsets of autoreactive T-cells known to attack myelin. About Multiple Sclerosis (MS) Multiple Sclerosis is a chronic, inflammatory condition of the central nervous system and is the most common, non-traumatic, disabling neurological disease in young adults. It is estimated that approximately two million people have MS worldwide. While symptoms can vary, the most common symptoms of MS include blurred vision, numbness or tingling in the limbs and problems with strength and coordination. The relapsing forms of MS are the most common. The Secondary Progressive form of MS represents about a third of the MS patient population. About Tcelna Tcelna is a potential personalized therapy that is under development to be specifically tailored to each patient's disease profile. Tcelna is manufactured using ImmPath™, Opexa's proprietary method for the production of a patient-specific T-cell immunotherapy, which encompasses the collection of blood from the MS patient, isolation of peripheral blood mononuclear cells, generation of an autologous pool of myelin-reactive T-cells (MRTCs) raised against selected peptides from myelin basic protein (MBP), myelin oligodendrocyte glycoprotein (MOG) and proteolipid protein (PLP), and the return of these expanded, irradiated T-cells back to the patient. These attenuated T-cells are reintroduced into the patient via subcutaneous injection to trigger a therapeutic immune system response. Opexa is currently conducting a Phase IIb study of Tcelna. Named “Abili-T,” the trial is a randomized, double-blind, placebo-controlled clinical study in patients who demonstrate evidence of disease progression with or without associated relapses. The trial is expected to enroll 180 patients at approximately 30 leading clinical sites in the U.S. and Canada with each patient receiving two annual courses of Tcelna treatment consisting of five subcutaneous injections per year. The trial’s primary efficacy outcome is the percentage of brain volume change (atrophy) at 24 months. Study investigators will also measure several important secondary outcomes commonly associated with MS, including disease progression as measured by the Expanded Disability Status Scale (EDSS), annualized relapse rate and changes in disability as measured by EDSS and the MS Functional Composite. For more information visit the Opexa Therapeutics website at www.opexatherapeutics.com. Cautionary Statement Relating to Forward-Looking Information for the Purpose of "Safe Harbor" Provisions of the Private Securities Litigation Reform Act of 1995 This press release contains forward-looking statements which are made pursuant to the safe harbor provisions of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. Statements contained in this report, other than statements of historical fact, constitute "forward-looking statements." The words "expects," "believes," "anticipates," "estimates," "may," "could," "intends," and similar expressions are intended to identify forward-looking statements. The forward-looking statements in this report do not constitute guarantees of future performance. Investors are cautioned that statements in this report which are not strictly historical statements, including, without limitation, statements regarding the development of the Company's product candidate, Tcelna (imilecleucel-T), constitute forward-looking statements. Such forward-looking statements are subject to a number of risks and uncertainties that could cause actual results to differ materially from those anticipated. These risks and uncertainties include, but are not limited to, risks associated with: market conditions; our capital position; the rights and preferences provided to the Series A convertible preferred stock and investors in the convertible secured notes we issued in July 2012 (including a secured interest in all of our assets); our ability to compete with larger, better financed pharmaceutical and biotechnology companies; new approaches to the treatment of our targeted diseases; our expectation of incurring continued losses; our uncertainty of developing a marketable product; our ability to raise additional capital to continue our development programs (including to undertake and complete any ongoing or further clinical studies for Tcelna), including in this regard our ability to satisfy various conditions required to access the financing potentially available under the purchase agreements with Lincoln Park Capital Fund, LLC ("Lincoln Park") (such as the minimum closing price for our common stock and the requirement for an ongoing trading market for our stock); our ability to regain and maintain compliance with NASDAQ listing standards; the success of our clinical trials (including the Phase IIb trial for Tcelna in secondary progressive MS which, depending upon results, may determine whether Merck elects to exercise its Option); whether Merck exercises its Option and, if so, whether we receive any development or commercialization milestone payments or royalties from Merck pursuant to the Option; our dependence (if Merck exercises its Option) on the resources and abilities of Merck for the further development of Tcelna; the efficacy of Tcelna for any particular indication, such as for relapsing remitting MS or secondary progressive MS; our ability to develop and commercialize products; our ability to obtain required regulatory approvals; our compliance with all Food and Drug Administration regulations; our ability to obtain, maintain and protect intellectual property rights (including for Tcelna); the risk of litigation regarding our intellectual property rights or the rights of third parties; the success of third party development and commercialization efforts with respect to products covered by intellectual property rights that we may license or transfer; our limited manufacturing capabilities; our dependence on third-party manufacturers; our ability to hire and retain skilled personnel; our volatile stock price; and other risks detailed in our filings with the SEC. These forward-looking statements speak only as of the date made. We assume no obligation or undertaking to update any forward-looking statements to reflect any changes in expectations with regard thereto or any change in events, conditions or circumstances on which any such statement is based. You should, however, review additional disclosures we make in our Annual Report on Form 10-K, Quarterly Reports on Form 10-Q, and Current Reports on Form 8-K filed with the SEC. Contact: Company Karthik Radhakrishnan Opexa Therapeutics, Inc. Chief Financial Officer 281-775-0600 email@example.com or Investor Relations Adam Cutler The Trout Group 646-378-2936 firstname.lastname@example.org
Opexa Therapeutics Recognizes World MS Day and Will Present Poster With Secondary Progressive Multiple Sclerosis Data at CMSC /
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