Opexa Reports Additional Favorable Data with Tovaxin(R) for Multiple Sclerosis

THE WOODLANDS, Texas, Sep 08, 2009 (BUSINESS WIRE) --
OPXA | Quote | Chart | News | PowerRating -- Opexa Therapeutics, Inc. (NASDAQ:OPXA), a company developing
Tovaxin(R), a personalized T-cell immunotherapy for multiple
sclerosis (MS), today announced results from further analysis of the
double-blind, placebo-controlled, 52-week Phase IIb TERMS clinical study
of 150 patients with Relapsing Remitting MS (RRMS). This analysis
evaluated patients with an annualized relapse rate of one or greater at
study entry (ARRgreater-than or equal to 1). More than 83% of the Tovaxin-treated group (n=85)
remained relapse free at one year and the annualized relapse rate after
treatment decreased to 0.20, a 42% reduction compared to placebo.

The results of this expanded analysis confirm those found in the
previously-reported per-protocol analysis of patients in the TERMS study
with ARR>1. This post-hoc analysis which represents 86% of the total
patient population in the TERMS study was conducted to evaluate Tovaxin
treatment among study patients with the same baseline disease activity
that is being targeted for inclusion in the forthcoming Phase IIb study.
Along with a marked reduction in relapses, 73% of the Tovaxin-treated
patients with ARRgreater-than or equal to 1 showed stabilization or improvement in MS
disability, including 16.5% with a sustained improvement in the Expanded
Disability Status Scale (EDSS) of at least one full point. On MRI, the
Tovaxin-treated group also demonstrated a reduction in brain atrophy and
fewer inflammatory brain lesions that progressed to "black holes," as
compared to the placebo-treated group. Treatment with Tovaxin was well
tolerated, with no serious adverse events reported in any
Tovaxin-treated patient.

"The expanded analysis represents the MS patient population with active
relapsing-remitting disease planned for recruitment into the next Phase
IIb trial of Tovaxin," stated Dawn McGuire, MD, a board certified
neurologist and a member of Opexa's Clinical Advisory Board. "Clinical
benefits include not only reduction in relapses, but a surprising
reversal of disability in over 16% of Tovaxin-treated patients. Along
with MRI data suggesting a reduction in neuronal cell loss, these
results raise the possibility that Tovaxin-treatment may have
neuroprotective as well as disease-modifying effects. Tovaxin's
favorable safety profile and these early efficacy signals strongly
support moving forward with a confirmatory Phase IIb trial."

Tovaxin is a personalized T-cell vaccine based on a patient's individual
immunologic profile. Detailed immunology data analysis from the TERMS
trial indicate that Tovaxin can successfully induce changes in T-cell
reactivity to all three targeted myelin antigens implicated in the
autoimmune attacks causing neurologic damage in MS. These changes appear
epitope-specific, are sustained for 6 months or more, and match each
patient's Tovaxin formulation. Tovaxin is not broadly immunosuppressive,
an important feature of its favorable safety profile.

"From an immunology perspective, the data generated thus far from the
TERMS trial, from thousands of patient samples, appear to correlate
nicely with the putative mechanism of action for Tovaxin. While
additional analyses are still in progress, we are also seeing early
associations between depletion of myelin reactive T-cells and favorable
clinical outcomes," commented Dr. McGuire.

About Opexa

Opexa Therapeutics, Inc. is dedicated to the development of
patient-specific cellular therapies for the treatment of autoimmune
diseases. The Company's leading therapy, Tovaxin(R), is an
individualized cellular immunotherapy treatment in Phase IIb clinical
development for multiple sclerosis (MS). Tovaxin is derived from T-cells
isolated from peripheral blood, expanded ex vivo, and
reintroduced into the patients via subcutaneous injections. This process
triggers a potent immune response against specific subsets of
autoreactive T-cells known to attack myelin, believed to be a primary
cause of MS attacks and nervous system damage.

For more information visit the Opexa Therapeutics website at 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 which are made
pursuant to the safe harbor provisions of Section 27A of the Securities
Act of 1933, as amended, and Section 21E of the Securities Exchange Act
of 1934, as amended. The forward-looking statements in this release do
not constitute guarantees of future performance. Investors are cautioned
that statements in this press release which are not strictly historical
statements, including, without limitation, statements regarding current
or future financial payments, returns, royalties, performance and
position, management's strategy, plans and objectives for future
operations, plans and objectives for product development, plans and
objectives for present and future clinical trials and results of such
trials, plans and objectives for regulatory approval, litigation,
intellectual property, product development, manufacturing plans and
performance, constitute forward-looking statements. Such forward-looking
statements are subject to a number of risks and uncertainties that could
cause actual results to differ materially from those anticipated,
including, without limitation, risks associated with: the success of
third party development and commercialization efforts with respect to
products covered by intellectual property rights transferred by the
Company, the success of third party patent prosecution efforts with
respect to such products, the ability of the Company to enter into and
benefit from a partnering arrangement for the Company's product
candidate, Tovaxin, on reasonably satisfactory terms (if at all), and
our dependence (if partnered) on the resources and abilities of any
partner for the further development of Tovaxin, our ability to
compete with larger, better financed pharmaceutical and biotechnology
companies, new approaches to the treatment of our targeted diseases, our
expectation of incurring continued losses, our uncertainty of developing
a marketable product, our ability to raise additional capital to
continue our treatment development programs, the success of our clinical
trials, our ability to develop and commercialize products, our ability
to obtain required regulatory approvals, our compliance with all Food
and Drug Administration regulations, our ability to obtain, maintain and
protect intellectual property rights for our products, the risk of
litigation regarding our intellectual property rights, our limited
manufacturing capabilities, our dependence on third-party manufacturers
and value added resellers, our ability to hire and retain skilled
personnel, our volatile stock price, and other risks detailed in our
filings with the Securities and Exchange Commission. We assume no
obligation to update any forward-looking information contained in this
press release or with respect to the announcements described herein.

SOURCE: Opexa Therapeutics, Inc.

Opexa Therapeutics, Inc. 
Neil K. Warma, 281-719-3437 
President & CEO 
nwarma@opexatherapeutics.com

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