Press Release Source: Opexa Therapeutics, Inc.
Opexa Therapeutics Announces Completion of Mid Study Descriptive Analysis on
Phase IIb Trial of Tovaxin(R) for Treatment of Multiple Sclerosis
Tuesday March 11, 7:00 am ET
Data Safety Monitoring Board Recommends Continuing Trial as Scheduled
THE WOODLANDS, Texas--(BUSINESS WIRE)--Opexa Therapeutics, Inc. (NASDAQ:OPXA
<
http://finance.yahoo.com/q?s=opxa&d=t> - News
<
http://finance.yahoo.com/q/h?s=opxa> ) today announced that the independent
Data Safety Monitoring Board (DSMB) of its ongoing 150-patient Phase IIb
safety and efficacy study (TERMS) of Tovaxin in multiple sclerosis
recommended that the trial be continued as scheduled.
Opexa's Data Safety Monitoring Board is an independent group of multiple
sclerosis experts which is responsible for monitoring the ongoing safety and
conduct of the study. At each DSMB meeting, the board may recommend
continuing the trial unmodified, continue the trial with modifications or
discontinue the trial.
The DSMB meeting reviewed 28-week data for approximately 50% of the patients
in the study. The DSMB noted in their report very few dropouts and that the
study appears to be proceeding well. In addition, the report indicated that
baseline MRI data is consistent with the assumptions used in the design of
the study. Edward Fox, M.D., Ph.D. commented, "As the lead investigator of
the TERMS trial, I continue to anticipate the conclusion of this
experimental protocol, which has been designed to evaluate the efficacy,
tolerability, and safety of Tovaxin in the treatment of patients in the
early stages of Multiple Sclerosis."
David McWilliams, president and chief executive officer of Opexa
Therapeutics, stated, "I am pleased by the steady progress of the trial and
the recommendation of the DSMB. We have delivered all Tovaxin doses to
patients in the study and now look forward to presenting 52-week topline
results of the TERMS Phase IIb study in September. McWilliams continued,
"with this report, we are aggressively moving forward with our regulatory
plans and furthering our discussion with potential strategic development
partners."
About TERMS Descriptive Analysis
The descriptive analysis provided to the DSMB included clinical laboratory
results, adverse events, vital signs and physical examination data as well
as the cumulative number of gadolinium-enhancing lesions on T1-weighted MRI
scans, the cumulative number of new gadolinium-enhancing lesions, the change
in T2-weighted lesion volume, and annualized relapse rates. Disease
progression, as measured by changes in disability scores using the
industry-standard Kurtzke Expanded Disability Status Scale (EDSS) along with
other select qualitative/quantitative MS-specific instruments, was also
assessed.
About TERMS
The Tovaxin Phase IIb clinical study includes 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.
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 some patients treated in
earlier clinical studies.
About Opexa Therapeutics
Opexa Therapeutics develops and commercializes cell therapies to treat
autoimmune diseases such as MS, 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, 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 <
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.
Contact:
Opexa Therapeutics, Inc.
Lynne Hohlfeld, 281-719-3421
lhohlfeld@opexatherapeutics.com
