Tonix Pharmaceuticals is currently enrolling participants in a Phase 3 trial for posttraumatic stress disorder (PTSD). For more information, please visit www.recoverystudy.com or www.clinicaltrials.gov (NCT03841773).
NEW YORK, Dec. 5, 2012 (GLOBE NEWSWIRE) -- Tonix Pharmaceuticals Holding Corp. (OTCQB:TNXP) ("TONIX" or the "Company"), a specialty pharmaceutical company developing novel treatments for challenging disorders of the central nervous system, including fibromyalgia ("FM") and post-traumatic stress disorder ("PTSD"), today announced that Seth Lederman, M.D., Chief Executive Officer of TONIX, will deliver a corporate overview at the LD Micro V: Main Event Conference on December 6, 2012 at 9:30 a.m. Pacific time. The conference will be held in Los Angeles on December 5-6, 2012 at the Luxe Hotel Sunset Boulevard. TONIX's management will be available during the conference for one-on-one meetings. Please contact LD MICRO to schedule a meeting.
The presentation will be webcast live and will be available on the Investor Relations section of the Company's website at www.tonixpharma.com, where it also will be archived for 90 days.
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, which is believed to translate into reductions in daytime pain. The Company's lead product candidate, TNX-102 SL, is a novel under-the-tongue tablet formulation of CBP, the active ingredient in two U.S. Food and Drug Administration ("FDA")-approved muscle relaxants, and is expected to enter a pivotal program in FM in early 2013. TNX-102 SL is an Investigational New Drug. An Investigational New Drug Application ("IND") has been filed with the U.S. FDA for TNX-102 SL for FM. TONIX is also exploring the utility of TNX-102 SL in a new bedtime treatment paradigm for PTSD. The Company has also held a pre-IND meeting with FDA to discuss PTSD and is planning to file a second IND in early 2013.
In a randomized, double-blind, placebo-controlled, eight-week Phase 2 trial, TONIX demonstrated that low-dose CBP given at bedtime resulted in a significant decrease in next-day pain and other core FM symptoms, as well as in a significant improvement in sleep quality. Legacy CBP products are widely used by FM patients, but are neither designed nor approved for this indication. TNX-102 SL has demonstrated faster systemic absorption relative to administration of the 5 mg CBP tablet in a Phase 1 comparative PK and safety study in healthy volunteers. In that study, TNX-102 SL 2.4 and 4.8 mg were generally well tolerated. There were no unexpected adverse events, with the exception of a mild, temporary numbness at the tongue experienced by less than one-third of the subjects that received TNX-102 SL tablets.
To learn more about the Company, 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.
CONTACT: Tonix Pharmaceuticals Holding Corp. Leland Gershell, Chief Financial Officer (212) 980-9155 x104 firstname.lastname@example.org LHA Anne Marie Fields (212) 838-3777 email@example.com or Bruce Voss (310) 691-7100 firstname.lastname@example.org @LHA_IR_PRSource: TONIX Pharmaceuticals Holding Corp.