THE WOODLANDS, Texas--(BUSINESS WIRE)--
Opexa Therapeutics, Inc. (NASDAQ: OPXA), a biotechnology company
developing Tcelna®, a novel T-cell immunotherapy for the
treatment of multiple sclerosis (MS), today announced the addition of
two highly experienced individuals to join the Company’s Board of
Directors. Hans-Peter Hartung, MD, PhD, FRCP, a world leading clinician
and expert in the treatment of Multiple Sclerosis and other neurological
diseases, and Timothy Barabe, a proven CFO with global operational and
financial expertise, have each been appointed to the Company's Board of
Directors, effective March 19th.
“We are thrilled to be adding such esteemed individuals to complement
our existing Board,” commented Neil K. Warma, Opexa’s President and CEO.
“Hans Peter has been a critical member of our Scientific Advisory Board
for several years and has been instrumental to the design of the Phase
IIb trial we are currently running in Secondary Progressive MS. He is a
recognized worldwide leader in the field of clinical immunology with a
strong standing in the MS and neurology fields. Complementing the
addition of Hans Peter, Tim brings a wealth of expertise in operations
and finance, including in international settings. Tim served in senior
executive roles in Novartis, including as CFO of its Sandoz Generics
business unit, and CFO of Affymetrix and Human Genome Sciences,
combining knowledge from both the pharmaceutical and biotech industries.”
“I am honored to join Opexa's Board and work closely with an outstanding
management team,” commented Professor Hartung. “I believe that Opexa’s
novel personalized T-cell immunotherapy platform has tremendous
potential in MS and possibly in other immune mediated diseases. I look
forward to contributing to the Company.”
Mr. Barabe remarked, “I am thrilled to be joining such an innovative and
forward-looking company. I am impressed by the potential of Tcelna and I
believe my operational and financial experience can be useful to the
Company’s future.”
Professor Hartung holds the Chair of Neurology at Heinrich-Heine
University, Düsseldorf, and is chairman of the Department of Neurology.
He was educated at the medical schools of the Universities of
Düsseldorf, Glasgow, Oxford, Harvard and Johns Hopkins, and at the
Institute of Neurology, Queen Square, London. Professor Hartung is a
member of various international and national societies, serving on
executive boards for ECTRIMS, the European Neurological Society, the
International Society for Neuroimmunology, the International Federation
of Multiple Sclerosis Societies and the World Health Organization
Advisory Board on Multiple Sclerosis, as well as on the editorial board
of various international journals. He has written extensively on
neurology, neuroimmunology, peripheral nerve disease and MS.
Mr. Barabe retired in 2013 as EVP and CFO of Affymetrix, Inc.
Previously, he was SVP and CFO of Human Genome Sciences, Inc. and CFO of
Regent Medical Limited, a U.K.-based, privately owned, surgical supply
company. Mr. Barabe was also with Novartis AG for more than 20 years
where he served in a succession of senior executive positions in finance
and general management, most recently as the CFO of Sandoz GmbH, the
generic pharmaceutical subsidiary of Novartis. Mr. Barabe serves on the
board of ArQule, a Boston-based, NASDAQ-listed biotech company. Mr.
Barabe received his undergraduate degree from the University of
Massachusetts (Amherst) and his MBA from the University of Chicago.
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 a patient’s
peripheral blood, expanded ex vivo, and reintroduced into the patient
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 earnings 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 the related Immune Monitoring
Program) and for potential expansion of the T-cell platform into other
disease indications, 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 Multiple Sclerosis (MS); 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 or clinical studies
related to our T-cell platform); 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); 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 and future pipeline
candidates); 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
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 its 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 the reports we file with the SEC.
Source: Opexa Therapeutics, Inc.