06.04.2006 16:21:00
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The Immune Response Corporation's NeuroVax(TM) Restores FOXP3+ T-Cell Levels Believed to Help in Multiple Sclerosis; Oral Presentation at American Academy of Neurology
"NeuroVax(TM) is a promising candidate for development as a novelvaccine for treating patients with MS," said Dr. Bourdette, who isalso a member of the Company's Scientific Advisory Board guiding thedevelopment of NeuroVax(TM). "The TCR peptide vaccine works bydown-regulating the pathogenic T-cells causing the MS. Our clinicalfindings indicate that NeuroVax(TM) induces strong, disease-specificimmune responses in essentially all the MS patients treated. Thefindings indicate that an important part of the strongdisease-specific immune response induced by NeuroVax(TM) is thestimulation of FOXP3+ regulatory T-cells. This exciting approach couldplay an important role in the treatment of MS."
About the Study
This one-year open-label trial enrolled 25 patients who receivedmonthly injections of NeuroVax(TM). Seventeen of these werenewly-enrolled patients, and showed statistically lower baselinelevels of FOXP3+ mRNA measured by RT-PCR (p=0.03) and FOXP3 proteinexpression by Western blot (p=.02) when compared with healthycontrols. Following immunization of these MS patients withNeuroVax(TM), 14/17 patients at 52 weeks demonstrated increased FOXP3+mRNA expression over baseline (p=0.01) and FOXP3 protein expression asa group was also statistically increased over baseline (p=0.02). In anumber of patients, FOXP3 message and protein expression became higherthan those in healthy controls. These data indicate that a key portionof the strong immune responses induced in patients given NeuroVax(TM)include increases in expression of FOXP3, a marker which is associatedwith the activity of CD4+CD25+ regulatory T-cells. NeuroVax(TM) thusmay be boosting an important immune regulatory network which may beclinically beneficial for MS patients.
"These exciting findings on the regulatory mechanism of howNeuroVax(TM) can be influencing the pathogenic T-cells causing MS,coupled with our earlier MRI data that suggest NeuroVax(TM) maydecrease the number of total new Gadolinium enhancing lesions, are thebasis for the design of a Phase II study that will be initiated laterthis year in Eastern Europe and the United States that will test theclinical benefit of NeuroVax(TM) by assessing its effect on MRI andrelapse rates," commented Dr. Joseph O'Neill, President and ChiefExecutive Officer of The Immune Response Corporation.
About Multiple Sclerosis
MS is an autoimmune disease in which the immune system mistakenlyattacks normal tissues of the central nervous system. It afflictsapproximately 400,000 people in the United States and more than 2.5million worldwide (source: National MS Society). The disease is causedby activation of a specific subset of the patient's own white bloodcells, pathogenic T-cells, which then attack a fatty tissue calledmyelin that surrounds and protects nerve fibers and creates scarring(sclerosis) that interferes with the normal transmission of nerveimpulses. This damage, in turn, leads to a variety of chronic andhighly individual and unpredictable neurological symptoms, rangingfrom movement and balance problems to vision impairment.
Autoimmune diseases such as MS may result from the failure ofnormal immune regulatory mechanisms to prevent proliferation ofpathogenic T-cells. Specifically, The Immune Response Corporation'sresearch indicates that MS patients have diminished levels of FOXP3message and protein expression levels in peripheral T-cells. Thisobservation is the first to link a defect in functional peripheralimmunoregulation to an established genetic marker, FOXP3, whichpreviously has been shown to be involved in maintaining immunetolerance and repressing the development of autoimmune diseases suchas MS.
About The Immune Response Corporation
The Immune Response Corporation (OTCBB:IMNR) is animmuno-pharmaceutical company focused on developing products to treatautoimmune and infectious diseases. The Company's lead immune-basedtherapeutic product candidates are NeuroVax(TM) for the treatment ofMS and IR103 for the treatment of HIV infection. Both of thesetherapies are in Phase II clinical development and are designed tostimulate pathogen-specific immune responses aimed at slowing orhalting the rate of disease progression.
NeuroVax(TM), which is based on the Company's patented T-cellreceptor (TCR) peptide technology, has shown potential clinical valuein the treatment of relapsing forms of MS. NeuroVax(TM) has been shownto stimulate strong, disease-specific cell-mediated immunity in nearlyall patients treated and appears to work by enhancing levels of FOXP3+Treg cells that are able to down-regulate the activity of pathogenicT-cells that cause MS. Increasing scientific findings have associateddiminished levels of FOXP3+ Treg cell responses with the pathogenesisand progression of MS and other autoimmune diseases such as rheumatoidarthritis (RA), psoriasis and Crohn's disease. In addition to MS, theCompany has open Investigational New Drug Applications (IND) with theFDA for clinical evaluation of TCR peptide-based immune-basedtherapies for RA and psoriasis.
IR103 is based on the Company's patented whole-inactivated virustechnology, co-invented by Dr. Jonas Salk and indicated to be safe andimmunogenic in extensive clinical studies of REMUNE(R), the Company'sfirst generation HIV product candidate. IR103 is a more potentformulation that combines its whole-inactivated antigen with asynthetic Toll-like receptor (TLR-9) agonist to create enhancedHIV-specific immune responses. The Company is currently testing IR103in two Phase II clinical studies as a first-line treatment fordrug-naive HIV-infected individuals not yet eligible forantiretroviral therapy according to current medical guidelines.
NeuroVax(TM) and IR103 are in clinical development by The ImmuneResponse Corporation and are not approved by any regulatory agenciesin any country at this time. Please visit The Immune ResponseCorporation at www.imnr.com for more information.
This news release contains forward-looking statements.Forward-looking statements are often signaled by forms of words suchas should, could, will, might, plan, projection, forecast, expect,guidance, potential and developing.
Actual results could vary materially from those expected due to avariety of risk factors, including whether the Company will continueas a going concern and successfully raise proceeds from financingactivities sufficient to fund operations and additional clinicaltrials of its product candidates, the uncertainty of successfulcompletion of any such clinical trials, the fact that the Company hasnot succeeded in commercializing any drug, the risk that its productcandidates might not prove to be effective as either a therapeutic orpreventive vaccine, whether future trials will be conducted andwhether the results of such trials will coincide with the results ofits product candidates in preclinical trials and/or earlier clinicaltrials. A more extensive set of risks is set forth in The ImmuneResponse Corporation's SEC filings including, but not limited to, itsAnnual Report on Form 10-K for the year ended December 31, 2005. TheCompany undertakes no obligation to update the results of theseforward-looking statements to reflect events or circumstances aftertoday or to reflect the occurrence of unanticipated events.
NeuroVax(TM) is a trademark of The Immune Response Corporation.REMUNE(R) is a registered trademark of The Immune ResponseCorporation.
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