Tonix Pharmaceuticals Announces Presentation of Clinical and Non-Clinical TNX-1900 Data at the Annual Headache Cooperative of the Pacific (HCOP) Winter Conference
January 31 2023 - 7:00AM
Tonix Pharmaceuticals Holding Corp. (Nasdaq: TNXP) (Tonix or the
Company), a clinical-stage biopharmaceutical company, today
announced that David C. Yeomans, Ph.D., presented data from
clinical and nonclinical studies in an oral presentation at the
16th Annual Headache Cooperative of the Pacific (HCOP) Winter
Conference on January 27, 2023. The oral presentation titled,
“
Primary vs Secondary Sex Hormones and
Migraine,” includes research sponsored by and licensed to
Tonix Pharmaceuticals. Professor Yeomans was a founder of
Trigemina, which Tonix acquired, and he remains a consultant to
Tonix. A copy of the presentation is available under the Scientific
Presentations tab of the Tonix Pharmaceuticals corporate website at
www.tonixpharma.com.
“In addition to data showing that magnesium
(Mg++) potentiates the analgesic effects of oxytocin, the
presentation includes new preliminary data from a Positron Emission
Tomography (PET) study in human volunteers dosed with a proprietary
nitrogen-13 (13N) radioisotope of oxytocin formulated with Mg++,”
said Seth Lederman, M.D., Chief Executive Officer of Tonix
Pharmaceuticals. “A signal was observed in the trigeminal ganglia,
indicating that intranasal oxytocin plus Mg++ delivers oxytocin to
the trigeminal ganglia which have known roles in migraine headache.
These studies were a collaboration with Aarhus University and the
principal investigator, Michael Winterdahl, PhD.”
In addition to the PET study, the presentation
includes data collected from isolated human trigeminal ganglia
neurons in vitro which show oxytocin receptor co-expressed with
calcitonin gene-related peptide (CGRP). The results of these
studies, which were performed by postdoctoral fellow Vimala
Bharadwaj, PhD, are believed to represent the first observation of
oxytocin receptors in human tissue rather than in an animal model.
Previously, it has been shown that oxytocin receptors and CGRP
co-localize in rat trigeminal ganglia neurons. The cytokine IL-6
functionally upregulated expression of human trigeminal oxytocin
receptors in vitro, similar to what has been shown previously in
rats, in which oxytocin has been shown to functionally inhibit
electrically evoked activity of trigeminal neurons.
Finally, the presentation highlights data which
suggest a sex difference in oxytocin potency. “The results indicate
that oxytocin is more potent in inhibiting trigeminal ganglion
neuronal excitability in female rats compared to males,” said
Professor David C. Yeomans. “Moreover, treating male rats with
estrogen for four days increased the responsiveness of their
isolated trigeminal ganglia to oxytocin in vitro such that they
show a similar level of responsiveness to oxytocin as female
trigeminal ganglia. The Company believes that together, these
findings have potential dosing implications in humans who suffer
from chronic migraine.”
In late 2021, Tonix received Investigational New
Drug clearance from the U.S. Food and Drug Administration to
support the initiation of a Phase 2 study of TNX-1900 (intranasal
magnesium potentiated oxytocin) for the prevention of migraine
headache in chronic migraineurs. The Company expects to begin
enrollment in the Phase 2 study during the first quarter of
2023.
Tonix Pharmaceuticals Holding
Corp.*
Tonix is a clinical-stage biopharmaceutical
company focused on discovering, licensing, acquiring and developing
therapeutics to treat and prevent human disease and alleviate
suffering. Tonix’s portfolio is composed of central nervous system
(CNS), rare disease, immunology and infectious disease product
candidates. Tonix’s CNS portfolio includes both small molecules and
biologics to treat pain, neurologic, psychiatric and addiction
conditions. Tonix’s lead CNS candidate, TNX-102 SL (cyclobenzaprine
HCl sublingual tablet), is in mid-Phase 3 development for the
management of fibromyalgia with a new Phase 3 study launched in the
second quarter of 2022 and interim data expected in the second
quarter of 2023. TNX-102 SL is also being developed to treat Long
COVID, a chronic post-acute COVID-19 condition. Tonix initiated a
Phase 2 study in Long COVID in the third quarter of 2022 and
expects interim data in the third quarter of 2023. TNX-1300
(cocaine esterase) is a biologic designed to treat cocaine
intoxication and has been granted Breakthrough Therapy designation
by the FDA. A Phase 2 study of TNX-1300 is expected to be initiated
in the first quarter of 2023. TNX-1900 (intranasal potentiated
oxytocin), a small molecule in development for chronic migraine, is
expected to enter the clinic with a Phase 2 study in the first
quarter of 2023. TNX-601 ER (tianeptine hemioxalate
extended-release tablets) is a once-daily formulation of tianeptine
being developed as a potential treatment for major depressive
disorder (MDD) with a Phase 2 study expected to be initiated in the
first quarter of 2023. Tonix’s rare disease portfolio includes
TNX-2900 (intranasal potentiated oxytocin) for the treatment of
Prader-Willi syndrome. TNX-2900 has been granted Orphan Drug
designation by the FDA. Tonix’s immunology portfolio includes
biologics to address organ transplant rejection, autoimmunity and
cancer, including TNX-1500, which is a humanized monoclonal
antibody targeting CD40-ligand (CD40L or CD154) being developed for
the prevention of allograft and xenograft rejection and for the
treatment of autoimmune diseases. A Phase 1 study of TNX-1500 is
expected to be initiated in the first half of 2023. Tonix’s
infectious disease pipeline includes a vaccine in development to
prevent smallpox and monkeypox, TNX-801, a next-generation vaccine
to prevent COVID-19, TNX-1850, a platform to make fully human
monoclonal antibodies to treat COVID-19, TNX-3600, and humanized
anti-SARS-CoV-2 monoclonal antibodies, TNX-3800, recently licensed
from Curia. TNX-801, Tonix’s vaccine in development to prevent
smallpox and monkeypox, also serves as the live virus vaccine
platform or recombinant pox vaccine (RPV) platform for other
infectious diseases. A Phase 1 study of TNX-801 is expected to be
initiated in Kenya in the second half of 2023.
*All of Tonix’s product candidates are
investigational new drugs or biologics and have not been approved
for any indication.
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 the failure to obtain FDA clearances or approvals and
noncompliance with FDA regulations; delays and uncertainties caused
by the global COVID-19 pandemic; risks related to the timing and
progress of clinical development of our product candidates; 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, 2021, as filed with the Securities and
Exchange Commission (the “SEC”) on March 14, 2022, 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(862) 904-8182
Olipriya Das, Ph.D. (media)Russo
PartnersOlipriya.Das@russopartnersllc.com (646) 942-5588
Peter Vozzo (investors)ICR
Westwickepeter.vozzo@westwicke.com(443) 213-0505
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