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


Postby scoobyjude » Mon Apr 10, 2006 7:25 pm

News about NeuroVax at the AAN. Sounds promising but I didn't read anything about disability progression.

The Immune Response Corporation's NeuroVax Restores FOXP3+ T-Cell Levels Believed to Help in Multiple Sclerosis
Oral Presentation at American Academy of Neurology

CARLSBAD, C.A. -- April 10, 2006 -- The Immune Response Corporation (OTCBB:IMNR.OB) announced that its T-cell receptor peptide vaccine candidate, NeuroVax™, induces increased FOXP3 expression resulting in re-establishment of normal levels of the FOXP3+ regulatory T-cells believed to be important in controlling the development of multiple sclerosis (MS).

Results of the recently completed open-label trial in MS patients were presented yesterday by Dr. Dennis Bourdette, Oregon Health and Sciences University (OHSU) Department of Neurology Chair, during an oral presentation at the 58th Annual Meeting of the American Academy of Neurology in San Diego, CA.

"NeuroVax™ is a promising candidate for development as a novel vaccine for treating patients with MS," said Dr. Bourdette, who is also a member of the Company's Scientific Advisory Board guiding the development of NeuroVax™. "The TCR peptide vaccine works by down-regulating the pathogenic T-cells causing the MS. Our clinical findings indicate that NeuroVax™ induces strong, disease-specific immune responses in essentially all the MS patients treated. The findings indicate that an important part of the strong disease-specific immune response induced by NeuroVax™ is the stimulation of FOXP3+ regulatory T-cells. This exciting approach could play an important role in the treatment of MS."

About the Study
This one-year open-label trial enrolled 25 patients who received monthly injections of NeuroVax™. Seventeen of these were newly-enrolled patients, and showed statistically lower baseline levels of FOXP3+ mRNA measured by RT-PCR (P =.03) and FOXP3 protein expression by Western blot (p=.02) when compared with healthy controls.

Following immunization of these MS patients with NeuroVax™, 14/17 patients at 52 weeks demonstrated increased FOXP3+ mRNA expression over baseline (P =.01) and FOXP3 protein expression as a group was also statistically increased over baseline (P =.02). In a number of patients, FOXP3 message and protein expression became higher than those in healthy controls.

These data indicate that a key portion of the strong immune responses induced in patients given NeuroVax™ include increases in expression of FOXP3, a marker which is associated with the activity of CD4+CD25+ regulatory T-cells. NeuroVax™ thus may be boosting an important immune regulatory network which may be clinically beneficial for MS patients.

"These exciting findings on the regulatory mechanism of how NeuroVax™ can be influencing the pathogenic T-cells causing MS, coupled with our earlier MRI data that suggest NeuroVax™ may decrease the number of total new Gadolinium enhancing lesions, are the basis for the design of a 300-patient Phase II study that will be initiated later this year in Eastern Europe and the United States that will test the clinical benefit of NeuroVax™ by assessing its effect on MRI and relapse rates," commented Dr. Joseph O'Neill, President and Chief Executive Officer of The Immune Response Corporation.

About Multiple Sclerosis
MS is an autoimmune disease in which the immune system mistakenly attacks normal tissues of the central nervous system. It afflicts approximately 400,000 people in the United States and more than 2.5 million worldwide (source: National MS Society).

The disease is caused by activation of a specific subset of the patient's own white blood cells, pathogenic T-cells, which then attack a fatty tissue called myelin that surrounds and protects nerve fibers and creates scarring (sclerosis) that interferes with the normal transmission of nerve impulses. This damage, in turn, leads to a variety of chronic and highly individual and unpredictable neurological symptoms, ranging from movement and balance problems to vision impairment.

Autoimmune diseases such as MS may result from the failure of normal immune regulatory mechanisms to prevent proliferation of pathogenic T-cells. Specifically, The Immune Response Corporation's research indicates that MS patients have diminished levels of FOXP3 message and protein expression levels in peripheral T-cells. This observation is the first to link a defect in functional peripheral immunoregulation to an established genetic marker, FOXP3, which previously has been shown to be involved in maintaining immune tolerance and repressing the development of autoimmune diseases such as MS.

About The Immune Response Corporation
The Immune Response Corporation (OTCBB: IMNR.OB) is an immuno-pharmaceutical company focused on developing products to treat autoimmune and infectious diseases. The Company's lead immune-based therapeutic product candidates are NeuroVax™ for the treatment of MS and IR103 for the treatment of HIV infection. Both of these therapies are in Phase II clinical development and are designed to stimulate pathogen-specific immune responses aimed at slowing or halting the rate of disease progression.

NeuroVax™, which is based on the Company's patented T-cell receptor (TCR) peptide technology, has shown potential clinical value in the treatment of relapsing forms of MS. NeuroVax™ has been shown to stimulate strong, disease-specific cell-mediated immunity in nearly all patients treated and appears to work by enhancing levels of FOXP3+ Treg cells that are able to down-regulate the activity of pathogenic T-cells that cause MS.

Increasing scientific findings have associated diminished levels of FOXP3+ Treg cell responses with the pathogenesis and progression of MS and other autoimmune diseases such as rheumatoid arthritis (RA), psoriasis and Crohn's disease.

NeuroVax™ is in clinical development by The Immune Response Corporation and is not approved by any regulatory agencies in any country at this time.

NeuroVax™ is a trademark of The Immune Response Corporation.

SOURCE: The Immune Response Corporation
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