nani
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Joined: 09 Oct 2005
Posts: 191
Location: USA- California
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 Posted: Mon Feb 05, 2007 7:02 am Post subject: new trial of medication for MS |
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for Multiple Sclerosis
[Business Wire]
Release Date: 1/30/2007
Business Wire via NewsEdge Corporation :
THE WOODLANDS, Texas--(BUSINESS WIRE)--Jan. 30, 2007--Opexa Therapeutics,
Inc. (NASDAQ: OPXA), a company involved in the development and
commercialization of cell therapies, announced today that it has admitted
the first 75 patients in its 150-patient Phase IIb clinical trial of
Tovaxin(TM) in multiple sclerosis. Enrollment is expected to be completed by
mid-2007. There are currently 34 trial sites in the U.S., all of which are
actively recruiting patients.
David McWilliams, president and chief executive officer of Opexa, commented,
"Given the efficacy and safety demonstrated in our Phase I/II study of
Tovaxin and the emerging understanding in the scientific literature of the
involvement of pathogenic T-cells in multiple sclerosis, this trial has been
highly anticipated in the MS community. We are excited about the enrollment
interest we are receiving and feel comfortable that we will be able to
achieve our 100% enrollment goal in the first half of this year."
Jim Williams, Ph.D., chief operating officer of Opexa, commented, "We are
pleased to have reached this important milestone in our clinical program for
the development of Tovaxin as a first line therapy for multiple sclerosis.
The admission of 75 patients into the Phase IIb trial attests to the ability
of Opexa to organize its clinical trials, including patient recruitment,
site selection and manufacturing capacity as we meet the challenge of
developing a patient-specific autologous T-cell vaccination therapy for
multiple sclerosis."
As previously announced, this 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 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(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 type 1 diabetes.
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.
CONTACT: Opexa Therapeutics, Inc. Lynne Hohlfeld, 281-719-3421
lhohlfeld@opexatherapeutics.com or Investor Relations Contacts:
Lippert/Heilshorn & Associates Kim Sutton Golodetz, 212-838-3777
kgolodetz@lhai.com Bruce Voss, 310-691-7100 bvoss@lhai.com KEYWORD:
TEXASINDUSTRY KEYWORD: PHARMACEUTICAL MEDICAL BIOTECHNOLOGY PRODUCTSOURCE:
Opexa Therapeutics, Inc.
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Welcome to my info site, as I call it. I have Multiple Sclerosis in secondary progression stage. I post what I find useful and hope you can help out with a donation of $1 if you can. If not it's ok... thanks Nani |
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