THE WOODLANDS, Texas--(BUSINESS WIRE)--
Opexa Therapeutics, Inc. (NASDAQ: OPXA), a biotechnology company
developing Tcelna®, a patient-specific T-cell immunotherapy
for the treatment of multiple sclerosis (MS), is pleased to announce the
enrollment of the 126th patient in the Phase IIb “Abili-T”
clinical study of Tcelna (imilecleucel-T) in patients with Secondary
Progressive Multiple Sclerosis (SPMS).
“We are pleased with the continued progress we have made in the Abili-T
clinical trial and that patient enrollment has increased steadily over
the past several months,” commented Neil K. Warma, Opexa’s President and
Chief Executive Officer. “With the enrollment of patient number 126 in
the trial, we have reached the 70% enrollment target out of a total of
180 patients. We are continuing our efforts to have the trial fully
enrolled in early 2014. Furthermore, we are working with a few
additional key multiple sclerosis centers and hope to have two more
trial sites up and running shortly to support enrollment. This would
increase the total number of clinical trial sites to 35 in the U.S. and
Canada. We are especially pleased that many of the first sites that
began enrolling patients at the trial’s outset continue to recruit
patients into the study. This may reflect the interest that the
Secondary Progressive MS patients have in participating in the Abili-T
trial and the realization that there are limited treatments options
currently available on the market for these patients. Additionally, we
are proceeding well with our Immune Monitoring program, which is an
important component of the Abili-T trial. The value of the Immune
Monitoring program may enable us to evaluate a comprehensive panel of
key anti-inflammatory and pro-inflammatory biomarkers associated with MS
throughout the course of the Abili-T study. The analysis remains blinded
during the course of the trial and we expect it to yield very
interesting data on the disease profile of MS and on the mechanism of
action of Tcelna.”
Opexa management will be meeting investors in San Francisco from January
13th through the 16th, 2014. Please send meeting
requests to opexa@troutgroup.com.
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 33 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.
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," “potential” 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 release which are not
strictly historical statements, including, without limitation,
statements regarding the patient enrollment for the ongoing Abili-T
clinical trial, development of the Company's product candidate, Tcelna
(imilecleucel-T), and the Immune Monitoring program 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; whether the Immune
Monitoring program will yield any useful or valuable data on MS and the
mechanism of action of Tcelna; 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.
For more information visit the Opexa Therapeutics website at www.opexatherapeutics.com.
Source: Opexa Therapeutics, Inc.