Opexa Therapeutics, Inc. (NASDAQ:OPXA), a company involved in the
development and commercialization of cell therapies, announced that Brian
Loftus, M.D., of Bellaire Neurology and the Principal Investigator of the
Tovaxin Phase I/II studies, presented data titled "Autologous Attenuated T-Cell
Vaccine (Tovaxin®) Dose Escalation in Multiple Sclerosis Relapse-Remitting and
Secondary Progressive Patients Nonresponsive to Approved Immunomodulatory
Therapies" at the American Academy of Neurology meeting. The AAN meeting is
taking place at the McCormick Place West Convention Center in Chicago, IL.
The objective of the Tovaxin Phase I/II dose escalation study was to
assess the safety and effectiveness of T cell vaccine (Tovaxin®) in MS patients
non-responsive to approved immunomodulatory therapies. The trial results
indicate statistically significant improvements from baseline observed using the
annualized relapse rate and myelin-reactive T-cell count effectiveness
measurements.
"The positive therapeutic effects of safety, early
effectiveness and tolerability observed in this study suggest that depletion of
myelin-reactive T-cells using Tovaxin, a trivalent T-cell vaccine, may be an
appropriate treatment strategy for patients with MS and warrants further study,"
said Dr. Loftus.
About T-cell Vaccination
For a T-cell
vaccine to be effective, it should be able to induce T-cell cytotoxic and/or
regulatory immune responses against the pathogenic T-cells. Studies of T-cell
vaccine have indicated that T-cell vaccination with peripheral blood-derived
autologous myelin-peptide selected T-cells in multiple sclerosis patients
resulted in the in vivo induction of CD8+ cytotoxic T-cells and CD4+CD25+FoxP3
Tregs specific for T-cell vaccine. The induction of anti-idiotypic cytotoxic
CD8+ effector T-cells and anti-ergotypic CD4+CD25+FoxP3 positive Tregs is
believed to provide a therapeutically effective dual mechanism of protection to
patients treated with Tovaxin. The observed regulatory immune responses have
been shown to collectively correlate with clinical improvement in some patients
treated in earlier clinical studies.
About Opexa Therapeutics
Opexa Therapeutics develops and commercializes cell therapies to treat
autoimmune diseases such as MS, rheumatoid arthritis, and diabetes. The Company
is focused on autologous cellular therapy applications of its proprietary T-cell
and stem cell therapies. The Company's lead product, Tovaxin, a T-cell therapy
for multiple sclerosis is in Phase IIb trials. The Company holds the exclusive
worldwide license for adult multipotent stem cells derived from mononuclear
cells of peripheral blood. The technology allows large quantities of monocyte
derived stem cells to be produced efficiently for use in autologous therapy,
thus circumventing the threat of rejection. The Company is in preclinical
development for diabetes mellitus.
http://www.opexatherapeutics.com
Cautionary Statement
Relating to Forward - Looking Information for the Purpose of "Safe Harbor"
Provisions of the Private Securities Litigation Reform Act of 1995
This press release contains "forward-looking statements," including
statements about Opexa Therapeutics' growth and future operating results,
discovery and development of products, strategic alliances and intellectual
property, as well as other matters that are not historical facts or information.
These forward-looking statements are based on management's current assumptions
and expectations and involve risks, uncertainties and other important factors,
specifically including those relating to Opexa Therapeutics' ability to obtain
additional funding, develop its stem cell technologies, obtain FDA approval for
its therapeutic products, achieve its operational objectives, and obtain patent
protection for its discoveries, that may cause Opexa Therapeutics' actual
results to be materially different from any future results expressed or implied
by such forward-looking statements. Opexa Therapeutics undertakes no obligation
to update or revise any such forward-looking statements, whether as a result of
new information, future events or otherwise.
Opexa
Therapeutics
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