Neurovax update

A board to discuss future MS therapies in early stage (Phase I or II) trials.

Neurovax update

Postby dignan » Wed Feb 08, 2006 2:37 pm

The Immune Response Corporation Announces New Business Strategy; Emphasizes Focus on Promising MS Treatment and Second Generation HIV Therapy

2/8/2006 - The Immune Response Corporation (OTCBB:IMNR) announced today that its management and the Board of Directors are implementing a new corporate and clinical strategy designed to position the Company for long-term success by more effectively leveraging its core immune-based technology for autoimmune and infectious diseases. Specifically, this strategy will focus on the accelerated development of the Company's most promising immune-based therapies currently in clinical trials: NeuroVax(TM) for multiple sclerosis (MS) and IR103 for human immunodeficiency virus (HIV).

This new strategic initiative is being led by Chief Executive Officer and President, Dr. Joseph O'Neill, who joined the Company late last year after a distinguished career leading federal AIDS policy at the White House, the Office of the U.S. Secretary of Health and Human Services, and the Office of the Global AIDS Coordinator at the U.S. Department of State. Dr. O'Neill developed the strategic plan along with the Company's management team after a thorough analysis of the Company's technology and clinical development programs.

"We believe we have a number of important, under-valued assets that we plan to maximize immediately, starting with NeuroVax(TM)," said Dr. O'Neill. "Our recent clinical findings show that NeuroVax(TM) induces strong, durable disease-specific immune responses in essentially all patients. Importantly, the new data indicates that this product's mechanism of action appears to be restoration and stimulation of FOXP3+ Regulatory T-cells. This exciting mechanism could play an important role in the treatment of MS and other autoimmune diseases, such as psoriasis and rheumatoid arthritis. We plan to move forward with the clinical development of NeuroVax(TM) with new trials that will assess its effect on relapse rates and long term disability. Our intellectual property position in autoimmune therapy is strong and we will work to pursue and leverage commercial partnerships to create value for patients and shareholders.

About NeuroVax(TM)
NeuroVax(TM) is the Company's T-cell receptor (TCR) peptide-based immunotherapy for the treatment of MS. Autoimmune diseases such as MS may result from the failure of immune regulatory mechanisms to prevent proliferation of pathogenic T-cells. Specifically, research indicates that MS patients have abnormalities in FOXP3+ message and protein expression levels in peripheral T Regulatory (Treg) cells. This observation is the first to link a defect in functional peripheral immunoregulation to an established genetic marker, FOXP3+, previously shown to be involved in maintaining immune tolerance and preventing development of autoimmune diseases.

Preliminary results reported last year from a now completed Phase I/II study showed that NeuroVax(TM) restored normal levels of FOXP3+ Treg cells in patients who, at baseline, had statistically significant diminished levels of FOXP3+ Treg cells compared to healthy controls (p less than 0.02). After 24 weeks, the patients treated with NeuroVax(TM) who completed the trial showed stimulation of their FOXP3+ Treg cells to levels well above their suppressed baseline levels, and often to levels higher than healthy controls. These elevated levels of FOXP3+ Treg activity remained stable through the complete 52 week study. These new data indicate a novel, specific mechanism of action for NeuroVax(TM) that could restore regulatory functions of the immune system in MS patients that are critical to controlling the pathogenesis of the disease.

The Company is currently planning additional Phase II studies of NeuroVax(TM) to test the clinical benefits of the product. Further, the Company holds Investigational New Drug (IND) applications on similar TCR peptide-based therapies targeted at rheumatoid arthritis and psoriasis, two other autoimmune diseases in which the same mechanism of action may be therapeutic. The Company may seek to develop or out-license these products, depending upon the availability of resources.

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