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Opexa Therapeutics Immune Monitoring Program Featured in Neurology Reviews

  Opexa Therapeutics Immune Monitoring Program Featured in Neurology Reviews

Business Wire

THE WOODLANDS, Texas -- October 21, 2013

Opexa Therapeutics, Inc. (NASDAQ: OPXA), a biotechnology company developing
Tcelna^®, a novel T-cell immunotherapy for the treatment of multiple sclerosis
(MS), today announced that the Company has been featured in Neurology Reviews.
The article, titled "Regulation May Be Impaired in Patients With Secondary
Progressive MS,” was written by Erik Greb, the publication's senior associate
editor, and presents data from Opexa’s Immune Monitoring program that is part
of its ongoing Phase IIb Abili-T trial in Secondary Progressive MS (SPMS).

The article presents baseline data on Opexa’s Immune Monitoring Program that
was previously presented at the 2013 Americas Committee for Treatment and
Research in Multiple Sclerosis (ACTRIMS) meeting. The immune monitoring data
will be used to assess the impact of Tcelna in SPMS patients compared to
patients receiving placebo. Opexa’s data supports the finding that immune
regulation appears to be impaired in individuals with SPMS. Opexa
characterized the status of patients with SPMS entering the Phase IIb trial at
baseline and compared the data sets to those of healthy donors. The results
showed a marked difference between key biomarkers of inflammation,
specifically TR1 and Treg cells, in patients suffering from SPMS versus
healthy donors. The results corroborated findings in the literature and
provide support for the assays being utilized by Opexa for the immune
monitoring program.

“As part of our Phase IIb Abili-T trial, we are undertaking a comprehensive
immune monitoring program for all patients enrolled in the study,” commented
Donald Healey, PhD, Chief Scientific Officer at Opexa. “The goals of this
program are to further understand the biology behind the mechanism of action
for Tcelna and to possibly identify novel biomarkers that are dominant in the
pathophysiology of SPMS patients. The program encompasses an analysis of
various pro-inflammatory and anti-inflammatory biomarkers. We believe that the
blinded data, which will be analyzed during the course of the trial, may
potentially signal responders and non-responders when correlated with clinical
data on completion of the Abili-T study.”

The article can be accessed here or from the home and investor relations pages
of Opexa’s website.

Neurology Reviewscovers innovative and emerging news in neurology and
neuroscience every month, with a focus on clinical research and practical
approaches to treating Parkinson’s disease, epilepsy, headache, stroke,
multiple sclerosis, Alzheimer’s disease, and other neurologic disorders.

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 MS. 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)

MS 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 release, 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 release 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; 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
raise additional capital through the sale of shares of our common stock under
the purchase agreements with Lincoln Park or under our at-the-market (ATM)
facility; our ability to 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 Ares Trading SA (“Merck”) elects to exercise its option for an
exclusive license to Tcelna for the treatment of MS (the “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 Reports
on Form 10 K, Quarterly Reports on Form 10-Q, and Current Reports on Form 8-K
filed with the SEC.

Contact:

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