NEW YORK, April 9, 2014 (GLOBE NEWSWIRE) -- Tonix Pharmaceuticals Holding Corp. (Nasdaq:TNXP), a development stage pharmaceutical company, was spotlighted in the April 7, 2014 issue of BioCentury: The Bernstein Report on BioBusiness.
An article titled "Confirming Endpoints" focused on the U.S. Food and Drug Administration's (FDA) March 26 disease area meeting in which testimony from fibromyalgia (FM) patients was solicited. According to the article, patient testimony suggests that there is a need for better medicines because many patients said existing approved or off-label use drugs do not provide adequate relief.
Seth Lederman, M.D., president and CEO of Tonix, was one of several key thought leaders quoted. In the article, Dr. Lederman says, "[An FM drug] will only be an important medication if it decreases pain and treats FM overall."
During the workshop, Dr. Rappaport, director of the FDA's Division of Anesthesia, Analgesia and Addiction Products, discussed the hypothesis that sleep disturbance may be at the center of FM and asked patients whether a product that addresses sleep would be useful. Tonix's TNX-102 SL, given daily at bedtime, is currently being evaluated in the "BESTFIT" trial, a 12-week randomized, double-blind, placebo-controlled study, for its ability to improve pain and possibly sleep quality in subjects with FM. Initial results from BESTFIT are expected to become available in the fourth quarter of 2014.
BioCentury: The Bernstein Report on BioBusiness serves a worldwide audience in the biopharma, investment and public policy communities.
About Tonix Pharmaceuticals Holding Corp.
Tonix is developing innovative prescription medications to treat fibromyalgia, post-traumatic stress disorder, and episodic tension-type headache, all characterized by inadequate treatment options, dissatisfaction expressed among patients and physicians, and significant expense burden. Tonix leverages the established human safety and pharmacokinetics of known drugs and, through a directed process of repurposing and reformulation, creates novel products to address important problems that often lack validated animal models or defined molecular targets. Tonix is currently enrolling patients into the first anticipated pivotal trial of TNX-102 SL in fibromyalgia, the BESTFIT trial (BEdtime Sublingual TNX-102 SL as Fibromyalgia Intervention Therapy). With TNX-102 SL, Tonix approaches the treatment of people suffering from fibromyalgia and post-traumatic stress disorder by targeting their inability to obtain restorative sleep. TNX-201 is in development for the treatment of episodic tension-type headache. To learn more, please visit 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" 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 ability to continue as a going concern; our need for additional financing; uncertainties of patent protection and litigation; uncertainties of government or third party payer reimbursement; limited sales and marketing 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 filed with the SEC on March 28, 2014 and future periodic reports filed with the Securities and Exchange Commission. All of the Company'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.