Opexa Therapeutics Recognizes World MS Day and Will Present Poster With Secondary Progressive Multiple Sclerosis Data at CMSC /

  Opexa Therapeutics Recognizes World MS Day and Will Present Poster With
  Secondary Progressive Multiple Sclerosis Data at CMSC / ACTRIMS Annual
  Meeting

2013 CMSC-ACTRIMS Meeting

Business Wire

THE WOODLANDS, Texas -- May 29, 2013

Opexa Therapeutics, Inc. (NASDAQ: OPXA), a biotechnology company developing a
patient specific T-cell immunotherapy for multiple sclerosis (MS), today
honored World MS Day with a renewed commitment to the multiple sclerosis
community. Opexa will be sponsoring a booth and will be presenting baseline
data from its Immune Monitoring Program in a poster session at the 2013 Annual
Meeting of the Consortium of Multiple Sclerosis Centers (CMSC) & the Fifth
Cooperative Meeting with Americas Committee for Treatment and Research in
Multiple Sclerosis (ACTRIMS) May 29 – June 1 in Orlando, Florida.

Since May 2009, the Multiple Sclerosis International Federation (MSIF) has
organized a World Multiple Sclerosis Day and this year it is being celebrated
on May 29th. The purpose of this day is to raise global awareness of MS and
how it impacts the lives of those living with the disease and their families.

Multiple Sclerosis affects over 2 million people worldwide. Although much
progress has been made in the development of new drugs to treat the Relapsing
Remitting form of MS over the past several years, unfortunately, side effects
continue to be a concern to many patients. Additionally, while Secondary
Progressive MS affects approximately 35% of all people with MS, there still
remains very limited treatment options for these patients. Recognizing this,
Opexa embarked on a clinical trial for Secondary Progressive MS patients and
hopes to bring its lead product candidate, Tcelna^TM, to market in an
efficient manner.

“We can still do a lot more as a community to raise awareness of those
suffering from MS,” commented Neil K. Warma, President and Chief Executive
Officer of Opexa. “There is still a great deal that is unknown about the
disease and its mechanism of action and further understanding of the
immunology behind the disease is required. Additional development of novel,
safe and effective therapies is a necessity as side effects continue to plague
patients and the current medications to which they have access. At Opexa we
remain committed to every MS patient. We are focused on developing Tcelna as a
personalized immunotherapy for Secondary Progressive MS and are pleased to
play a role in supporting World MS Day. We look forward to speaking with those
attending the ACTRIMS symposium who wish to come by the Opexa booth to learn
more about MS and Tcelna.”

The Company’s poster, entitled "Profiling Of Secondary Progressive Multiple
Sclerosis By Multicolor Flow Cytometry," will be presented on Saturday, June
1, 2013 from 12:00 pm – 2:00 pm EDT. It highlights baseline data from the
immune monitoring program that is part of Opexa’s ongoing Phase 2b Abili-T
clinical trial in Secondary Progressive MS patients.

About Opexa

Opexa’s mission is to lead the field of Precision Immunotherapy™ by aligning
the interests of patients, employees and shareholders. The Company’s leading
therapy candidate, Tcelna™, is a personalized T-cell immunotherapy that is in
a Phase IIb clinical development program (the Abili-T trial) for the treatment
of Secondary Progressive Multiple Sclerosis. Tcelna is derived from T-cells
isolated from the patient’s 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.

About Multiple Sclerosis (MS)

Multiple Sclerosis is a chronic, inflammatory condition of the central nervous
system and is the most common, non-traumatic, disabling neurological disease
in young adults. It is estimated that approximately two million people have MS
worldwide.

While symptoms can vary, the most common symptoms of MS include blurred
vision, numbness or tingling in the limbs and problems with strength and
coordination. The relapsing forms of MS are the most common. The Secondary
Progressive form of MS represents about a third of the MS patient population.

About Tcelna

Tcelna is a potential personalized therapy that is under development to be
specifically tailored to each patient's disease profile. Tcelna is
manufactured using ImmPath™, Opexa's proprietary method for the production of
a patient-specific T-cell immunotherapy, which encompasses the collection of
blood from the MS patient, isolation of peripheral blood mononuclear cells,
generation of an autologous pool of myelin-reactive T-cells (MRTCs) raised
against selected peptides from myelin basic protein (MBP), myelin
oligodendrocyte glycoprotein (MOG) and proteolipid protein (PLP), and the
return of these expanded, irradiated T-cells back to the patient. These
attenuated T-cells are reintroduced into the patient via subcutaneous
injection to trigger a therapeutic immune system response.

Opexa is currently conducting a Phase IIb study of Tcelna. Named “Abili-T,”
the trial is a randomized, double-blind, placebo-controlled clinical study in
patients who demonstrate evidence of disease progression with or without
associated relapses. The trial is expected to enroll 180 patients at
approximately 30 leading clinical sites in the U.S. and Canada with each
patient receiving two annual courses of Tcelna treatment consisting of five
subcutaneous injections per year. The trial’s primary efficacy outcome is the
percentage of brain volume change (atrophy) at 24 months. Study investigators
will also measure several important secondary outcomes commonly associated
with MS, including disease progression as measured by the Expanded Disability
Status Scale (EDSS), annualized relapse rate and changes in disability as
measured by EDSS and the MS Functional Composite.

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.
Statements contained in this report, other than statements of historical fact,
constitute "forward-looking statements." The words "expects," "believes,"
"anticipates," "estimates," "may," "could," "intends," and similar expressions
are intended to identify forward-looking statements. The forward-looking
statements in this report do not constitute guarantees of future performance.
Investors are cautioned that statements in this report which are not strictly
historical statements, including, without limitation, statements regarding the
development of the Company's product candidate, Tcelna (imilecleucel-T),
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. These risks and uncertainties
include, but are not limited to, risks associated with: market conditions; our
capital position; the rights and preferences provided to the Series A
convertible preferred stock and investors in the convertible secured notes we
issued in July 2012 (including a secured interest in all of our assets); 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 development programs (including to undertake and complete any
ongoing or further clinical studies for Tcelna), including in this regard our
ability to satisfy various conditions required to access the financing
potentially available under the purchase agreements with Lincoln Park Capital
Fund, LLC ("Lincoln Park") (such as the minimum closing price for our common
stock and the requirement for an ongoing trading market for our stock); our
ability to regain and maintain compliance with NASDAQ listing standards; the
success of our clinical trials (including the Phase IIb trial for Tcelna in
secondary progressive MS which, depending upon results, may determine whether
Merck elects to exercise its Option); whether Merck exercises its Option and,
if so, whether we receive any development or commercialization milestone
payments or royalties from Merck pursuant to the Option; our dependence (if
Merck exercises its Option) on the resources and abilities of Merck for the
further development of Tcelna; the efficacy of Tcelna for any particular
indication, such as for relapsing remitting MS or secondary progressive MS;
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 (including for Tcelna); the risk of litigation
regarding our intellectual property rights or the rights of third parties; the
success of third party development and commercialization efforts with respect
to products covered by intellectual property rights that we may license or
transfer; our limited manufacturing capabilities; our dependence on
third-party manufacturers; our ability to hire and retain skilled personnel;
our volatile stock price; and other risks detailed in our filings with the
SEC. These forward-looking statements speak only as of the date made. We
assume no obligation or undertaking to update any forward-looking statements
to reflect any changes in expectations with regard thereto or any change in
events, conditions or circumstances on which any such statement is based. You
should, however, review additional disclosures we make in our Annual Report on
Form 10-K, Quarterly Reports on Form 10-Q, and Current Reports on Form 8-K
filed with the SEC.

Contact:

Company
Karthik Radhakrishnan
Opexa Therapeutics, Inc.
Chief Financial Officer
281-775-0600
kradhakrishnan@opexatherapeutics.com
or
Investor Relations
Adam Cutler
The Trout Group
646-378-2936
opexa@troutgroup.com
 
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