Tonix Pharmaceuticals to Present Additional Clinical Results of Military-Related PTSD Study at the 2017 American Society of C...
May 24 2017 - 7:00AM
Tonix Pharmaceuticals Holding Corp. (Nasdaq:TNXP) (Tonix), a
company that is developing innovative pharmaceutical products to
address public health challenges, announced upcoming presentations
of additional analyses of data from its Phase 2 study in
military-related posttraumatic stress disorder, or PTSD. Details of
the additional analyses will be featured in oral and poster
presentations by Gregory Sullivan, M.D., Tonix’s chief medical
officer, at the Annual Meeting of the American Society of Clinical
Psychopharmacology (ASCP) to be held May 29 – June 2, 2017, at the
Loews Miami Beach Hotel in Miami Beach, FL. Information on the
presentations is as follows:
Oral presentation
Title: Low-Dose Bedtime
Sublingual Cyclobenzaprine (TNX-102 SL*) for the Treatment of
Military-Related PTSD: Retrospective Analyses of the Mediators and
Moderators of Treatment Response
Date: Tuesday, May 30,
2017Time: 2:10 p.m.
EDTLocation: Salon 3 – Americana
Ballroom, Loews Miami Beach Hotel, Miami Beach, FL
Poster presentation
Title: Low-Dose Bedtime
Sublingual Cyclobenzaprine (TNX-102 SL) for the Treatment of
Military-Related PTSD: Retrospective Analyses of the Mediators and
Moderators of Treatment Response (Poster Board
T9)Date: Thursday, June 1,
2017Time: 12:30 – 2:00 p.m.
EDTLocation: Salon 4 – Americana
Ballroom, Loews Miami Beach Hotel, Miami Beach, FL
*TNX-102 SL (cyclobenzaprine HCl sublingual
tablets) is an investigational new drug and has not been approved
for any indication.
About TNX-102 SL and the Phase 3 HONOR
Study
TNX-102 SL is a patented sublingual transmucosal
formulation of cyclobenzaprine that is in Phase 3 development. PTSD
is a serious condition characterized by chronic disability,
inadequate treatment options especially for military-related PTSD,
and an overall high utilization of healthcare services that
contributes to significant economic burdens. In a Phase 2 study,
TNX-102 SL 5.6 mg was found to be effective in treating
military-related PTSD, which formed the basis of the Breakthrough
Therapy designation granted by the FDA. Tonix is currently
conducting a Phase 3 trial of TNX-102 SL in military-related PTSD
in the United States, the HONOR study, which is a 12-week
randomized, double-blind, placebo-controlled trial evaluating the
efficacy of TNX-102 SL 5.6 mg. This two-arm, adaptive-design trial
is targeting enrollment of up to approximately 550 participants
across approximately 35 clinical sites. An unblinded interim
analysis will be conducted once the study has accumulated efficacy
results from approximately 275 participants. In a recent
Cross-disciplinary Breakthrough meeting, the FDA confirmed that a
single-study new drug application (NDA) approval could be possible
if the topline data from the HONOR study are statistically very
persuasive. Additional details of the HONOR study are available at
www.thehonorstudy.com or
https://clinicaltrials.gov/ct2/show/NCT03062540. The U.S. Patent
and Trademark Office has issued a patent (U.S. Patent No.
9,636,408) protecting the composition and manufacture of the unique
TNX-102 SL formulation. The Protectic™ protective eutectic and
Angstro-Technology™ formulation claimed in the patent are important
elements of Tonix’s proprietary TNX-102 SL composition. This patent
is expected to provide TNX-102 SL with U.S. market exclusivity
until 2034 upon NDA approval.
About Tonix Pharmaceuticals Holding
Corp.
Tonix is developing innovative pharmaceutical
products to address major public health challenges. In addition to
TNX-102 SL for PTSD, Tonix is developing TNX-601 (tianeptine
oxalate), a clinical candidate at pre-IND (Investigational New
Drug) application stage, designed as a daytime treatment for PTSD
and TNX-801, a live synthetic version of horsepox virus, at the
pre-IND application stage, as a potential smallpox-preventing
vaccine.
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, 2016, as filed with the Securities and Exchange
Commission (the “SEC”) on April 13, 2017, 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.
Contacts
Jessica Smiley
Investor Relations
investor.relations@tonixpharma.com
(212) 980-9155 x185
Edison Advisors (Investors)
Tirth Patel
tpatel@edisongroup.com
(646) 653-7035
Russo Partners (media)
Rich Allan
rich.allan@russopartnersllc.com
(646) 942-5588
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