T-cell vaccination technology for the treatment of multiple sclerosis.
THE WOODLANDS, Texas, USA—
Opexa Therapeutics, Inc. (NASDAQ:OPXA), a company involved in the development and commercialization of cell therapies, made a poster presentation at the 2007 Annual Meeting of the Federation of Clinical Immunology
The presentation covered laboratory and clinical data from the
Company’s proprietary T-cell vaccination technology for the
treatment of multiple sclerosis. Key highlights of research detailed
in the poster presentation include:
* Data accumulated from over 173 assays (using a T-cell Epitope
Analysis Assay (EAA)) have allowed Opexa to identify several myelin
protein peptides from myelin basic protein (MBP), myelin proteolipid
protein (PLP) and myelin oligodendrocyte glycoprotein (MOG) as being
immunodominant, including some peptides never before reported, and
others as being non-reactive,
* The EAA can be utilized to screen additional or combinations
of peptides that have biological significance and;
* These results have permitted Opexa to optimize the number of
myelin peptides across the lengths of MBP, PLP and MOG in the
screening assay for Tovaxin™ vaccine production to qualify subjects
for Opexa’s current 150-patient Phase IIb safety and efficacy
clinical trial (TERMS).
“These findings mark an important development for Tovaxin, which is
a patient-specific autologous T-cell vaccine, because it helps us
qualify subjects for our current clinical trial and improves
production of the vaccine. The EAA is an important assay for further
refinement of the T-cell vaccination technology, which is truly
personalized, to make the therapy as efficacious as possible for each
patient,” said Jim Williams, PhD, chief operating officer.
About T-cell Vaccination
For a T-cell vaccine to be effective, it should be able to induce T-
cell cytotoxic and/or regulatory immune responses against the
pathogenic T-cells. Studies of T-cell vaccine have indicated that T-
cell vaccination with peripheral blood-derived autologous myelin-
peptide selected T-cells in multiple sclerosis patients resulted in
the in vivo induction of CD8+ cytotoxic T-cells and CD4+CD25+FoxP3
Tregs specific for T-cell vaccine. The induction of anti-idiotypic
cytotoxic CD8+ effector T-cells and anti-ergotypic CD4+CD25+FoxP3
positive Tregs is believed to provide a therapeutically effective
dual mechanism of protection to patients treated with Tovaxin™. The
observed regulatory immune responses have been shown to collectively
correlate with clinical improvement in treated patients.
About TERMS
The Tovaxin Phase IIb clinical study will include 150 patients in a
multicenter, randomized, double blind, placebo-controlled trial
designed primarily to evaluate the efficacy, safety and tolerability
of the Tovaxin T Cell vaccination with clinically isolated syndrome
(CIS) and relapsing-remitting MS (RR-MS) patients. A total of 100
patients will receive Tovaxin, while 50 will receive placebo. The
study is designed as a two-arm, 52-week, parallel-group study,
whereby patients will be given five subcutaneous injections at 0, 4,
8, 12 and 24 weeks. The analyses will be performed at the end of the
52-week study to assess the safety and efficacy of Tovaxin. The
primary efficacy variable is the cumulative number of gadolinium-
enhancing lesions on T1-weighted MRI scans summed over the Week 28,
36, 44, and 52 MRIs. The secondary efficacy variables are the
cumulative number of new gadolinium-enhancing lesions at Weeks 28-52,
the change in T2-weighted lesion volume, and the annualized relapse
rate.
All patients who complete the trial will be eligible to participate
in an optional one-year extension study, in which they will receive
Tovaxin under an open-label protocol. The open-label study is being
planned under a different protocol that will be submitted to the FDA.
About Opexa Therapeutics
Opexa Therapeutics develops and commercializes cell therapies to
treat autoimmune diseases such as multiple sclerosis, rheumatoid
arthritis, 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, Tovaxin(TM), a T-cell therapy
for multiple sclerosis is in Phase IIb trials. The Company holds the
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 preclinical development for
diabetes mellitus. For more information, visit the Opexa Therapeutics
website at www.opexatherapeutics.com.
Safe Harbor Statement
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,
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.