NEW YORK, Nov. 07, 2016 (GLOBE NEWSWIRE) -- Tonix Pharmaceuticals Holding Corp. (Nasdaq:TNXP) (Tonix), which is developing a next-generation treatment for posttraumatic stress disorder (PTSD), announced today that it will present efficacy and safety results from the Phase 2 AtEase clinical trial evaluating TNX-102 SL* for the treatment of military-related PTSD (“AtEase Study”) in a poster at the ISTSS 32nd Annual Meeting being held November 10-12, 2016 in Dallas, Texas.
Gregory Sullivan, M.D., chief medical officer of Tonix, will present the poster, titled, “Low-Dose Sublingual Cyclobenzaprine (TNX-102 SL) in Military-Related PTSD: Results of a 12-Week Randomized, Double-Blind, Placebo-Controlled Multicenter Phase 2 Trial” (Poster No.: THU 200). Included in this presentation will be new results from a retrospective analysis of the data from the AtEase Study on the effects of TNX-102 SL on reckless and self-destructive behaviors in patients with military-related PTSD.
Tonix recently held a successful End-Of-Phase 2 meeting with the U.S. Food and Drug Administration (FDA) based on positive data from the AtEase Study. Tonix intends to commence a 12-week Phase 3 study evaluating the efficacy and safety of TNX-102 SL, 5.6 mg, in military-related PTSD in the first quarter of 2017.
||ISTSS 32nd Annual Meeting
|Title:||Low-Dose Sublingual Cyclobenzaprine (TNX-102 SL) in Military-Related PTSD: Results of a 12-Week Randomized, Double-Blind, Placebo-Controlled Multicenter Phase 2 Trial|
||Thursday, November 10, 2016
|Time:||5:30pm - 6:30pm (CST)|
|Location:||Grand Hall, Poster Number THU 200, Sheraton Dallas Hotel - Dallas, TX|
*TNX-102 SL (cyclobenzaprine HCl sublingual tablets) is an Investigational New Drug and has not been approved for any indication.
About Tonix Pharmaceuticals Holding Corp.
Tonix is developing next-generation medicines for common disorders of the central nervous system, with its lead program focusing on PTSD. This disorder is characterized by chronic disability, inadequate treatment options, high utilization of healthcare services, and significant economic burden. This press release and further information about Tonix can be found at www.tonixpharma.com.
Forward Looking Statements
Certain statements in this press release are forward-looking within the meaning of the Private Securities Litigation Reform Act of 1995. These statements may be identified by the use of forward-looking words such as “anticipate,” “believe,” “forecast,” “estimate,” “expect,” and “intend,” among others. These forward-looking statements are based on Tonix's current expectations and actual results could differ materially. There are a number of factors that could cause actual events to differ materially from those indicated by such forward-looking statements. These factors include, but are not limited to, substantial competition; our need for additional financing; uncertainties of patent protection and litigation; uncertainties of government or third party payor reimbursement; limited research and development efforts and dependence upon third parties; and risks related to failure to obtain FDA clearances or approvals and noncompliance with FDA regulations. As with any pharmaceutical under development, there are significant risks in the development, regulatory approval and commercialization of new products. Tonix does not undertake an obligation to update or revise any forward-looking statement. Investors should read the risk factors set forth in the Annual Report on Form 10-K for the year ended December 31, 2015, as filed with the Securities and Exchange Commission (the “SEC”) on March 3, 2016, and future periodic reports filed with the SEC on or after the date hereof. All of Tonix's forward-looking statements are expressly qualified by all such risk factors and other cautionary statements. The information set forth herein speaks only as of the date hereof.
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