NEW YORK--(BUSINESS WIRE)--Tonix Pharmaceuticals Holding Corp. (OTCBB: TNXP) (“TONIX” or the “Company”), a specialty pharmaceutical company developing therapies for challenging disorders of the central nervous system (“CNS”), including fibromyalgia syndrome (“FM”) and post-traumatic stress disorder (“PTSD”), today announced that Chief Executive Officer Seth Lederman, MD, was interviewed by CEOLive.TV. In the interview, Dr. Lederman said that the Company has the technology and management team well-positioned to meet unmet medical needs with potential new products for FM and PTSD. The interview is available at: http://www.ceonews.tv/tnxp/.
The Company’s lead programs are potential new treatments for FM and PTSD. TONIX seeks to use new doses and formulations of cyclobenzaprine in new treatment regimens in each of these programs. Cyclobenzaprine is the active ingredient of two prescription muscle relaxants that have been approved by the U.S. Food and Drug Administration (“FDA”) and are marketed by other companies.
Dr. Lederman, a physician, scientist, and specialty pharmaceuticals entrepreneur, said that TONIX’s core technology improves the quality of sleep which can decrease pain and suffering in patients with chronic pain syndromes. Increasing the quality of sleep is an important and often overlooked problem in such patients, Dr. Lederman noted. TNX-102 is TONIX’s product candidate for FM and is being prepared for a pivotal trial early next year.
For PTSD, which impacts an estimated 25% of troops returning from Afghanistan and Iraq, TONIX’s re-formulation of cyclobenzaprine is TNX-105, Dr. Lederman said.
Dr. Lederman cited recent additions to TONIX’s management team and board that underscore the Company’s goals of advancing its clinical development programs to FDA approval and commercialization and improving communications to investors.
Leland Gershell, MD, PhD joined TONIX as Chief Financial Officer in April 2012. Dr. Gershell was most recently Managing Director and Senior Analyst at Madison Williams and Company, where he was responsible for research on specialty pharmaceutical and biotechnology companies.
Bruce Daugherty, PhD, MBA joined TONIX as Senior Director, Drug Development in April 2012. Dr. Daugherty has extensive experience in drug development and basic biomedical research. For the majority of his career, Dr. Daugherty was with Merck & Co., most recently as Senior Research Fellow.
Samuel R. Saks, MD joined TONIX’s Board of Directors in May 2012. Dr. Saks has more than 25 years of experience developing pharmaceutical products for central nervous system conditions, including Xyrem® and Concerta®. Dr. Saks is the former CEO of Jazz Pharmaceuticals, Inc. (NASDAQ: JAZZ), which he co-founded in 2003.
Prior to founding TONIX, Dr. Lederman co-founded and was a Managing Partner of Konanda Pharma Partners, LLC and Konanda Pharma Fund I, LP. He co-founded and served as Chairman of its wholly-owned operating companies Validus and Fontus Pharmaceuticals Inc. In 2000 Dr. Lederman founded Targent Pharmaceuticals to develop late-stage oncology drugs. In 1998 Dr. Lederman co-founded Vela Pharmaceuticals, which developed several drugs for central nervous system disorders, including VLD-cyclobenzaprine. A member of the faculty of Columbia University’s College of Physicians and Surgeons since 1985, Dr. Lederman maintains an appointment as Associate Professor.
TONIX is developing innovative prescription medications for challenging disorders of the central nervous system. The Company targets conditions characterized by significant unmet medical need, inadequate existing treatment options, and high dissatisfaction among both patients and physicians. TONIX’s core technology improves the quality of sleep in patients with chronic pain syndromes. TONIX’s lead products are designed to be fundamental advances in sleep hygiene and pain management and to be safer and more effective than currently available treatments. TONIX’s products are the result of a program to harvest advances in science and medicine to search for potential therapeutic solutions among known pharmaceutical agents. TONIX is developing new formulations that have been optimized for new therapeutic uses. Its most advanced product candidates, TNX-102 for FM and TNX-105 for PTSD, are novel dosage formulations of cyclobenzaprine, the active ingredient in two U.S. FDA-approved muscle relaxants. To learn more about the Company and its pipeline of treatments for CNS conditions, please visit www.tonixpharma.com.
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," "estimated" 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 30, 2012 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.