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September 2008 Off the Wire . . .

 

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Opexa Therapeutics And Myelin Repair Foundation Partner On Novel Multiple Sclerosis Research Program

Main Category: Multiple Sclerosis
Article Date: 05 Sep 2008
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

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