THE WOODLANDS, Texas--(BUSINESS WIRE)--
Opexa Therapeutics, Inc. (NASDAQ: OPXA), a biotechnology company
developing Tcelna® (imilecleucel-T), a novel T-cell
immunotherapy for the treatment of multiple sclerosis (MS), today
disclosed that the Company has commenced development in a second
indication, Neuromyelitis optica (NMO). NMO is a rare autoimmune
disorder, which is designated as an Orphan disease by the U.S. Food and
Drug Administration (FDA). There is currently no cure and there are no
FDA approved therapies for this disease.
Opexa initiated preclinical development activities for OPX-212, its drug
development candidate for NMO, earlier this year and has achieved
several regulatory and early development milestones to date. These
include conducting a pre-IND meeting with the FDA and performing
in-house manufacturing runs with NMO patient samples. The Company is
continuing with preclinical development activities with a goal of filing
an IND with the FDA by mid-2015 and then moving into clinical
development with a Phase 1/2 proof-of-concept study. The Company
believes OPX-212 will qualify for Orphan drug designation and plans also
to apply for Fast Track designation for OPX-212.
“We are pleased to announce our development activities in a second
indication utilizing our novel T-cell technology platform,” said Neil K.
Warma, President and Chief Executive Officer of Opexa. “NMO is a disease
with a significant unmet medical need. We believe our approach to the
treatment of NMO with OPX-212 is highly differentiated as we are
directly targeting the T-cell component of the disease and, therefore,
addressing the root cause.”
“We believe part of the value of our Precision ImmunotherapyTM
T-cell platform comes from the ability to move relatively quickly and
cost effectively into new autoimmune diseases. We do not expect our
preclinical development activities related to the NMO program to
materially affect the Company’s cash burn through IND submission,” Mr.
Warma continued. “We are enthusiastic about moving forward with our NMO
development program, while remaining firmly committed to the conduct of
our ongoing Phase 2b Abili-T clinical trial with Tcelna in Secondary
Progressive MS patients.”
Conference Call and Webcast Details
Opexa will host a virtual panel discussion with Benjamin Greenberg,
M.D., Associate Professor of Neurology, University of Texas,
Southwestern Medical Center, and Michael Levy, M.D., Ph.D., Assistant
Professor of Neurology, The Johns Hopkins University and Staff
Neurologist, The Johns Hopkins Hospital, to provide an overview of NMO
and discuss Opexa’s differentiated T-cell treatment approach today at
9:30 a.m. EDT.
To listen to the conference call, dial in approximately ten minutes
before the scheduled 9:30 a.m. EDT time to (253) 237-1170 or toll free
at (877) 372-0867. Please reference conference ID 84494085 or the Opexa
Therapeutics Business Update.
A live webcast of the call can also be accessed here
or via the webcast link on the Investor Relations page of Opexa's
website (www.opexatherapeutics.com).
There will be a brief Question & Answer session following the panel
discussion.
About Opexa
Opexa is a biopharmaceutical company developing personalized
immunotherapies with the potential to treat major illnesses, including
multiple sclerosis (MS) as well as other autoimmune diseases, such as
neuromyelitis optica (NMO). These therapies are based on Opexa’s
proprietary T-cell technology. 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. Opexa’s mission is to lead
the field of Precision Immunotherapy™ by aligning the
interests of patients, employees and shareholders.
About NMO
NMO is a rare autoimmune disorder in which immune system cells and
antibodies mistakenly attack and destroy myelin cells in the optic
nerves and the spinal cord. The damage to the optic nerves produces
swelling and inflammation that cause pain and loss of vision; the damage
to the spinal cord causes weakness or paralysis in the legs or arms,
loss of sensation, and problems with bladder and bowel function. NMO
affects approximately 4,800 people in the U.S., and the estimated
worldwide prevalence is 1-2 people per 100,000 population. There is no
cure for NMO and there are no FDA-approved therapies.
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 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,” “potential,” “possibly,” “estimates,”
“may,” “could” and “intends,” as well as similar expressions, are
intended to identify forward-looking statements. These forward-looking
statements do not constitute guarantees of future performance. Investors
are cautioned that statements which are not strictly historical
statements, including, without limitation, statements regarding plans
and objectives for product development (including for Tcelna
(imilecleucel T) and OPX-212), 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, without
limitation, risks associated with the following: 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 such as MS and NMO; 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, to complete preclinical
development activities and potentially file an IND for OPX-212, and
potentially to conduct a Phase 1/2 proof-of-concept study for OPX-212 in
NMO; 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), a wholly owned subsidiary
of Merck Serono S.A., elects to exercise its option (Option) to acquire
an exclusive, worldwide (excluding Japan) license of our Tcelna program
for the treatment of MS); the success of our development programs
(including the preclinical development activities with respect to
OPX-212); 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 FDA
regulations; our ability to obtain, maintain and protect intellectual
property rights (including for Tcelna and future pipeline candidates
such as OPX-212); the risk of litigation regarding our intellectual
property rights or the rights of third parties; our limited
manufacturing capabilities; our dependence on third-party suppliers and
manufacturers; 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. These forward-looking statements
speak only as of the date made. We assume no obligation or undertaking
to update or revise any forward-looking statements contained herein to
reflect any changes in our 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.
Source: Opexa Therapeutics, Inc.