Tonix Pharmaceuticals Will Present Results from Pharmacokinetic Analyses of TNX-102 SL in a Poster Presentation at the Americ...
May 21 2019 - 4:15PM
Tonix Pharmaceuticals Holding Corp. (Nasdaq: TNXP) (Tonix or the
Company) today announced that it will be presenting pharmacokinetic
analyses of TNX-102 SL* in a poster at the American Society of
Clinical Psychopharmacology (ASCP) 2019 Annual Meeting. The meeting
is being held May 28-31, 2019 in Scottsdale, Ariz.
Details of poster presentation at ASCP 2019
Title: Steady-State Pharmacokinetic
Properties of a Sublingual Formulation of Cyclobenzaprine (CBP)HCl
(TNX-102 SL): Comparison to Simulations of Oral Immediate Release
CBP
Date and Time: Poster Session 1 on
Wednesday, May 29, 2019, 11:15 a.m. - 1:00 p.m. ET
Location: Palomino Room 4-10, Hotel
Fairmont Scottsdale Princess
Poster Number: W30
Presenter: Gregory M. Sullivan, M.D., Chief
Medical Officer, Tonix Pharmaceuticals Holdings Corp.
About Tonix Pharmaceuticals Holding Corp.
Tonix is a clinical-stage biopharmaceutical company focused on
discovering and developing pharmaceutical products to treat
psychiatric and pain conditions, and biological products to improve
biodefense through potential medical counter-measures. Tonix’s lead
program is for the development of Tonmya** (TNX-102 SL), which is
in Phase 3 development as a bedtime treatment for PTSD. Tonix is
also developing TNX-102 SL as a bedtime treatment for fibromyalgia
and agitation in Alzheimer’s disease under separate INDs to support
potential pivotal efficacy studies. The fibromyalgia program is in
Phase 3 development and the agitation in Alzheimer’s program is
Phase 2 ready. The agitation in Alzheimer’s disease IND has been
designated a Fast Track development program by the FDA.
TNX-601 (tianeptine oxalate) is in the pre-IND application stage,
also for the treatment of PTSD but by a different mechanism from
TNX-102 SL and designed for daytime dosing. TNX-601 is also in
development for a potential indication - neurocognitive dysfunction
associated with corticosteroid use. A Phase 1 clinical formulation
selection pharmacokinetic study of TNX-601 will be conducted
outside of the U.S. in 2019. Tonix’s lead biologic candidate,
TNX-801, is a potential smallpox-preventing vaccine based on a live
synthetic version of horsepox virus, currently in the pre-IND
application stage.
* TNX-102 SL (cyclobenzaprine HCl sublingual tablets) is an
investigational new drug and has not been approved for any
indication.
**Tonmya has been conditionally accepted by the U.S. Food and
Drug Administration (FDA) as the proposed trade name for TNX-102 SL
for the treatment of PTSD.
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, risks related to
failure to obtain FDA clearances or approvals and noncompliance
with FDA regulations; 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
substantial competition. 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, 2018, as filed with the Securities and Exchange
Commission (the “SEC”) on March 18, 2019, and periodic reports
filed with the SEC on or after the date thereof. 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 thereof.
Contacts
Jessica Morris (corporate)Tonix
Pharmaceuticalsinvestor.relations@tonixpharma.com(212) 980-9159
Scott Stachowiak (media)Russo
Partnersscott.stachowiak@russopartnersllc.com (646) 942-5630
Peter Vozzo (investors)Westwicke
Partnerspeter.vozzo@westwicke.com (443) 213-0505
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