THE WOODLANDS, Texas--(BUSINESS WIRE)--
Opexa Therapeutics, Inc. (NASDAQ: OPXA), a biotechnology company
developing Tcelna™, a novel T-cell therapy for multiple sclerosis (MS),
today announced that Neil K. Warma, President and Chief Executive
Officer, will present at The Second International Vatican Adult Stem
Cell Conference: Regenerative Medicine — A Fundamental Shift in Science
& Culture, taking place from within The Vatican, April 11-13, 2013.
The conference is part of a five-year collaboration between The Stem for
Life Foundation, a not-for-profit organization devoted to raising global
awareness of the therapeutic potential of adult stem cells, NeoStem, a
leader in the emerging cellular therapy industry and The Vatican's
Pontifical Council for Culture and its foundation, called STOQ
International (Science, Theology and the Ontological Quest). Among the
conference goals are to raise awareness of existing therapies, reduce
misperceptions surrounding the field of cellular research and to foster
dialogue among researchers, physicians, philanthropists, faith leaders
and policy makers to identify unmet medical needs that can benefit from
the development of cell therapies.
“Opexa is proud to be a part of this international forum designed to
highlight the important contributions made by the cell therapy industry
to date and to increase awareness of cellular research and the potential
of cell therapies to address unmet medical needs,” commented Neil K.
Warma, President and Chief Executive Officer of Opexa.
Opexa will be included in a special luncheon, Living with Multiple
Sclerosis, featuring Meredith Vieira from NBC news and Richard M. Cohen,
journalist and husband of Ms. Vieira.
About Tcelna
Tcelna is a personalized therapy that is 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, attenuated 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 believes the potential combination of efficacy, superior safety,
excellent tolerability and administration may position Tcelna as the MS
treatment of choice as compared to existing therapeutics.
About Opexa
Opexa is dedicated to the development of patient-specific cellular
therapies for the treatment of autoimmune diseases such as MS. The
Company’s leading therapy candidate, Tcelna™, is a personalized cellular
immunotherapy that is in Phase IIb clinical development for MS. Tcelna
is derived from T-cells isolated from 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.
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. 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
press release 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 (such as the minimum closing price for our common
stock, the registration of the underlying shares of common stock under
the Securities Act of 1933, as amended, 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 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
Securities and Exchange Commission.
Source: Opexa Therapeutics, Inc.