Opexa Therapeutics, Inc. (NASDAQ:OPXA), a company dedicated to the development
of patient-specific cellular therapies for the treatment of autoimmune diseases
such as multiple sclerosis (MS) and diabetes, announced the establishment of a
novel MS research partnership with the Myelin Repair Foundation, Inc. (MRF). As
part of this collaboration, Opexa and the MRF will work to identify
therapeutically relevant biomarkers in MS that may provide important insight to
support the continued development of Tovaxin®, Opexa's T-cell vaccine currently
in Phase IIb clinical testing in MS patients. In addition, biomarkers identified
as part of the research program may also assist in guiding the discovery and
development of novel diagnostics and treatments for MS.
Under terms of
its collaboration with Opexa, the MRF will receive and analyze patient samples
and clinical data from Opexa's Phase IIb clinical study with Tovaxin to identify
biomarkers related to safety and efficacy of the therapy in MS patients. As part
of this analysis, the MRF will leverage its network of leading MS researchers,
as well as its proprietary biochemical and biological assays which are designed
for the discovery and characterization of novel biomarkers that may have
clinical use in diagnosing and/or treating MS.
"Through our
collaboration with Opexa and our analysis of patient samples from the Tovaxin
Phase IIb study, we hope to discover novel therapeutic, diagnostic and surrogate
biomarker targets of components and pathways involved in the destruction, repair
and re-myelination of axons in the central nervous system," said Russell
Bromley, chief operating officer of the MRF. "Research has shown that MS attacks
individual patients differently. Accordingly, we expect that clinical samples
from this study, in which T-cell vaccines were tailored for each subject, will
help us better understand how we can identify specific myelin repair therapeutic
targets to assist in the rapid development and commercialization of personalized
MS treatments."
The collaboration will be jointly managed by research
and development experts from Opexa and the MRF. Under terms of the agreement,
each party will own all program intellectual property that is conceived of
solely by its representatives. Intellectual property that is conceived of
collaboratively will be jointly owned by both Opexa and the MRF with Opexa
retaining the option to negotiate an exclusive license for any of the
collaboration's joint intellectual property or that which is solely owned by the
MRF.
The MRF is a non-profit medical research foundation dedicated to
accelerating basic medical research into myelin repair treatments aimed at
dramatically improving the lives of people suffering from MS. The group's
innovative Accelerated Research Collaboration™ (ARC) model involves the
establishment of collaborations with a number of leading MS researchers at
prestigious institutions who agree to work jointly to develop and conduct
experiments that will lead to targeted myelin repair discoveries. To date, the
MRF has entered into collaborations with researchers at Stanford University,
Northwestern University, University of Chicago and Case Western Reserve
University.
"Organizations such as the MRF are critical to the discovery
and development of safe and effective MS therapies, and data generated from the
MRF's analysis of the patient samples from our Phase IIb Tovaxin study will
provide valuable insight into the treatment of the disease," stated Jim
Williams, Ph.D., chief operating officer of Opexa. "Together with the MRF, we
have the potential to uncover breakthroughs in an area of important medical
research, discover additional promising MS therapies for development under
Opexa's T-cell platform, and gain invaluable data to guide the appropriate
design of future clinical trials with Tovaxin to support future regulatory
filings for the biologic."
Opexa is currently evaluating Tovaxin in 150
patients in a multi-center, randomized, double-blind, placebo-controlled Phase
IIb clinical trial in patients suffering from Relapsing-Remitting Multiple
Sclerosis (RRMS) or Clinically Isolated Syndrome (CIS). The company expects to
announce top-line results from the Phase IIb study in September 2008.
About Tovaxin Tovaxin is an autologous attenuated whole
T-cell vaccine manufactured by specifically selecting Myelin Reactive T-Cells
(MRTCs) from a patient's blood and expanding them ex-vivo to a therapeutic dose.
In this way, the vaccine is tailored to each patient's disease state. The
reintroduction of the attenuated T-cells via subcutaneous inoculation induces an
immune response against the MRTCs, thereby triggering the immune system to
attack the pathogenic T-cells in the body.
Opexa recently announced
two-year follow-up data from its Phase I/II clinical studies. Data from 22
patients demonstrated that 73 percent of patients on Tovaxin remained relapse
free after two years with 86 percent experiencing no disease progression.
Tovaxin is manufactured in Opexa's in-house cGMP facility.
About
Opexa Therapeutics Opexa Therapeutics develops and commercializes
cell therapies to treat autoimmune diseases such as multiple sclerosis (MS) and
diabetes. The Company is focused on autologous cellular therapy applications of
its proprietary T-cell and stem cell therapies. The Company's lead product is
Tovaxin, a T-cell therapy for MS which is in Phase IIb trials. The Company holds
an exclusive worldwide license for adult multipotent stem cells derived from
mononuclear cells of peripheral blood. The technology allows large quantities of
monocyte-derived stem cells to be produced efficiently for use in autologous
therapy, thus circumventing the threat of rejection. The Company is in the
preclinical stages of the development of insulin-producing monocyte-derived
islets as a replacement therapy for diabetes mellitus. For more information
visit the Opexa Therapeutics website at
http://www.opexatherapeutics.com.
About the Myelin
Repair Foundation The Myelin Repair Foundation (MRF) -
http://www.myelinrepair.org - is a Northern California-based
not-for-profit research foundation created to provide a collaborative
environment in which leading research scientists at multiple universities, and
experienced business executives, can work together to execute a five-year
research plan - with milestones, parallel experiments, collaboration, and, most
important, a constant focus on developing effective treatments for multiple
sclerosis. Many believe MRF's Accelerated Research Collaboration model could
change the way in which all medical research is conducted.
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," including
statements about Opexa Therapeutics' growth and future operating results,
discovery and development of products, strategic alliances and intellectual
property, as well as other matters that are not historical facts or information.
These forward-looking statements are based on management's current assumptions
and expectations and involve risks, uncertainties and other important factors,
specifically including those relating to Opexa Therapeutics' ability to obtain
additional funding, develop its stem cell technologies, obtain FDA approval for
its therapeutic products, achieve its operational objectives, and obtain patent
protection for its discoveries, that may cause Opexa Therapeutics' actual
results to be materially different from any future results expressed or implied
by such forward-looking statements. Opexa Therapeutics undertakes no obligation
to update or revise any such forward-looking statements, whether as a result of
new information, future events or otherwise.
Myelin Repair
Foundation
