Tonix Pharmaceuticals to Present Additional Phase 2 Clinical Results and Design of Ongoing Phase 3 Trial in Military-Related ...
August 21 2017 - 7:00AM
Tonix Pharmaceuticals Holding Corp. (Nasdaq:TNXP) (Tonix), a
company in Phase 3 development of Tonmya*, or TNX-102 SL, a U.S.
Food and Drug Administration-designated Breakthrough Therapy for
the treatment of posttraumatic stress disorder (PTSD), and in
various development stages for other innovative pharmaceutical and
biological products to address public health challenges, announced
today that it will present at the 2017 Military Health System
Research Symposium being held August 27-30, 2017 in Kissimmee,
Florida.
Gregory M. Sullivan, M.D., chief medical officer of Tonix, will
present the following posters:
Event: |
2017
Military Health System Research Symposium, Poster Session 2 |
|
|
Poster #521: |
Phase 2
Trial of a Low Dose, Bedtime, Proprietary Sublingual Formulation of
Cyclobenzaprine (TNX-102 SL) for the Treatment of Military-Related
PTSD: Mediators and Moderators of Treatment Response (Abstract ID:
MHSRS-17-1685) |
|
|
Poster #519: |
Efficacy
of a Low Dose, Bedtime, Proprietary Sublingual Formulation of
Cyclobenzaprine (TNX-102 SL) for the Treatment of Military-Related
PTSD: Study Protocol of a Phase 3 Randomized Placebo-Controlled
Trial (P301) (Abstract ID: MHSRS-17-1626) |
|
|
Date: |
Tuesday,
August 29, 2017 |
|
|
Time: |
10:00
a.m. – 4:40 p.m. EDT |
|
|
Location: |
Florida
Exhibit Hall D-F, Gaylord Palms Resort & Convention Center,
Kissimmee, Florida |
|
|
*Tonmya has been conditionally accepted by the U.S. Food and
Drug Administration (FDA) as the proposed trade name for TNX-102 SL
(cyclobenzaprine HCl sublingual tablets). TNX-102 SL is an
investigational new drug and has not been approved for any
indication.
About Tonmya and the Phase 3 HONOR Study
Tonmya 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, Tonmya 5.6 mg (2 x 2.8 mg
tablets), 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 Tonmya 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
Tonmya 5.6 mg in participants with military-related PTSD. 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
randomized participants. In a recent Cross-Disciplinary
Breakthrough Therapy 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
Tonmya formulation. The Protectic™ protective eutectic and
Angstro-Technology™ formulation claimed in the patent are important
elements of Tonix’s proprietary Tonmya composition. This patent is
expected to provide Tonmya, upon NDA approval, with U.S. market
exclusivity until 2034.
About Tonix Pharmaceuticals Holding Corp.
Tonix is developing innovative pharmaceutical and biological
products to address major public health challenges. In addition to
Tonmya 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, to be developed 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
Tonix Pharmaceuticals
investor.relations@tonixpharma.com
(212) 980-9155 x185
Media Contact
Rich Allan
Russo Partners
rich.allan@russopartnersllc.com
(646) 942-5588
Tonix Pharmaceuticals (NASDAQ:TNXP)
Historical Stock Chart
From Aug 2024 to Sep 2024
Tonix Pharmaceuticals (NASDAQ:TNXP)
Historical Stock Chart
From Sep 2023 to Sep 2024