Opexa Therapeutics, Inc. (NASDAQ:OPXA), a company leading in the development of
cell therapies for multiple sclerosis announced that the Data Safety Monitoring
Board (DSMB) overseeing the on-going Phase IIb clinical study of Tovaxin has
recommended that the trial continue unmodified. This positive recommendation
follows a regularly scheduled meeting of the DSMB in June and is based upon an
evaluation of clinical, magnetic resonance imaging (MRI) and safety data that
had been recorded for all patients to date.
The TERMS trial (Tovaxin for
Early Relapsing Multiple Sclerosis) is nearing completion and the DSMB has two
additional scheduled meetings in July and August of this year. Tovaxin is being
evaluated in a multi-center, randomized, double blind, placebo controlled study
in 150 patients suffering from Relapse Remitting Multiple Sclerosis (RRMS) or
Clinically Isolated Syndrome (CIS).
The trial was initiated in the third
quarter of 2006 and enrollment was completed in the second quarter of 2007.
Dosing was completed in the first quarter of 2008 and currently patients are
completing their final weeks 44 and 52 follow-up visits. The primary endpoint
being evaluated in this trial is the cumulative number of contrast (gadolinium)
enhancing brain lesions (CEL) using MRI, an important and objective measure of
MS disease activity. Secondary endpoints include Annualized Relapse Rate (ARR)
and additional MRI measurements.
Opexa expects to announce top line
results in September 2008.
About Tovaxin Tovaxin is an
individualized T-cell therapeutic vaccine that consists of attenuated
patient-specific myelin-reactive T-cells (MRTCs) against peptides of proteins
from Myelin basic protein (MBP), Myelin oligodendrocyte glycoprotein (MOG) and
Proteolipid protein (PLP) or combinations thereof. Recently announced two-year
follow up data from Phase I/II clinical studies of 22 patients showed 73% of
patients on Tovaxin remained relapse free after two years with 86% experiencing
no disease progression. Tovaxin is manufactured in Opexa's in-house cGMP
facility.
About Opexa 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 is Tovaxin, 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
http://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," 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.
Opexa
Therapeutics
