Tonix Pharmaceuticals to Present Breakthrough Therapy Designated-PTSD Program at Oppenheimer’s 27th Annual Healthcare Confe...
March 15 2017 - 7:00AM
TNX-102 SL, a Drug in Phase 3 Development,
Recently Granted Breakthrough Therapy Designation by the FDA
Tonix Pharmaceuticals Holding Corp. (Nasdaq:TNXP) (Tonix), a
company that is developing innovative pharmaceutical products to
address public health challenges, announced today that it will
present at Oppenheimer’s 27th Annual Healthcare Conference, being
held March 21-22, 2017 in New York, NY.
Seth Lederman, M.D., president and chief executive officer of
Tonix, will provide a corporate update and an overview of Tonix’s
posttraumatic stress disorder (PTSD) clinical program. TNX-102 SL*
was recently granted Breakthrough Therapy designation by the U.S.
Food and Drug Administration (FDA) for the treatment of PTSD. Tonix
will commence in this month the “HONOR” study, a 12-week
placebo-controlled Phase 3 clinical study evaluating TNX-102 SL 5.6
mg, in military-related PTSD. The interim analysis of the HONOR
study is expected in the first half of 2018 and topline results are
expected in the second half of 2018. Additional details of the
HONOR study are available at www.thehonorstudy.com or
https://clinicaltrials.gov/ct2/show/NCT03062540.
In his presentation, Dr. Lederman will also provide details of
Tonix’s recently expanded therapeutic pipeline in PTSD and the new
development program in a potential smallpox-preventing vaccine
containing a live form of horsepox virus (HPXV).
Event: |
27th Annual Oppenheimer
Healthcare Conference |
Date: |
Tuesday, March 21,
2017 |
Time: |
11:30am ET |
Location: |
Track 61 - The Westin
New York Grand Central, New York, NY |
The podium presentation will be webcast live and remain
available for 90 days. To access the webcast, please visit the
Events tab of the Investor Relations section of Tonix’s website at
www.tonixpharma.com.
*TNX-102 SL (cyclobenzaprine HCl sublingual tablets) is an
investigational new drug and has not been approved for any
indication.
About Tonix Pharmaceuticals Holding Corp.
Tonix is developing innovative pharmaceutical products to
address public health challenges. TNX-102 SL is in Phase 3
development and has been granted Breakthrough Therapy designation
by the FDA for the treatment of PTSD. 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. The Protectic™ protective eutectic and
Angstro-Technology™ formulation are essential elements of the
proprietary TNX-102 SL composition for which a Notice of Allowance
has been issued by the U.S. Patent and Trademark Office. Other
development efforts include TNX-601 (tianeptine oxalate), a
clinical candidate at Pre-IND (Investigational New Drug)
application stage, designed for daytime use for the treatment of
PTSD, and TNX-801, a potential smallpox-preventing vaccine based on
a live synthetic version of HPXV. HPXV has protective vaccine
activity in mice, using a model of lethal vaccinia infection.
Vaccine manufacturing activities have been initiated to support
further nonclinical testing of TNX-801.
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, 2015, as filed
with the Securities and Exchange Commission (the “SEC”) on March 3,
2016, 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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