posted
This is a very promissing biopharmaceutical company with 2 good products under research (REMUNE(R)for HIV and NeuroVax(TM) Multiple Sclerosis)..........Take a luck at their resent PRs.
June 21, 2005
The Immune Response Corporation's NeuroVax Demonstrates Increase in FOXP3 Gene Marker Levels and Treg Cell Functional Activity in MS Patients to Levels Similar to Human Controls
Related newsImmune Response Shows Good NeuroVax Data The Immune Response Corporation and Oregon Health & Science University Collaboration Identifies FOXP3 as the Gene Marker for Impaired Immune Regulation in Multiple Sclerosis; Results May Lead to a New The Immune Response Corporation IMNR, a biopharmaceutical company dedicated to becoming a leading immune-based therapy company in HIV and multiple sclerosis (MS), announced today that results from an ongoing clinical study demonstrated its investigational T-cell receptor (TCR) peptide vaccine, NeuroVax(TM), stimulated a significant increase in FOXP3, a gene marker recently shown to track regulatory T-cells (Treg cells). The new data, presented yesterday at the European Neurological Society (ENS) in Vienna, demonstrated that monthly NeuroVax(TM) injections during a one-year period increased the FOXP3 marker and Treg cell functional activity in MS patients to a level equivalent to that seen in healthy controls. Recently published research indicates that FOXP3, known to be associated with maintaining immune tolerance and regulation of autoimmune diseases, is significantly reduced in patients with MS compared to healthy controls.
"These preliminary results are an important indication that NeuroVax(TM) can restore Treg cell activity that may help reestablish regulatory control of pathogenic inflammatory T-cells," said Arthur A. Vandenbark, Ph.D., Senior Research Career Scientist at the Portland Veterans Affairs Medical Center, and Professor of Neurology and Molecular Microbiology and Immunology at the School of Medicine at Oregon Health & Science University in Portland, Ore., presenter of this research at ENS. "Successful boosting of Treg cell activity may reduce the immune system attack on the myelin sheath that contributes to the MS disease progression."
The clinical research presented at ENS yesterday was conducted by the Company in association with Oregon Health & Science University (OHSU). The preliminary results were based on the nine NeuroVax(TM) treated patients who have completed the 52-week study. Patients were analyzed at baseline and at 52 weeks, and were compared to a group of gender and age-matched healthy controls.
Autoimmune diseases such as MS may result from the failure of tolerance mechanisms to prevent expansion of pathogenic inflammatory T-cells. Previous research indicated that MS patients have abnormalities in FOXP3 message and protein expression levels in peripheral Treg cells. This observation linked a defect in functional peripheral immunoregulation to an established genetic marker, FOXP3, previously shown to be associated with maintaining immune tolerance and preventing development of autoimmune diseases. Diminished FOXP3 levels indicate impaired immunoregulation by Treg cells that may contribute to MS. The Company believes that induction of these Treg cells is important to the mechanism of action for NeuroVax(TM). The new data presented at the conference directly indicates for the first time that treatment with NeuroVax(TM) does stimulate FOXP3 Treg cells.
About Multiple Sclerosis and NeuroVax(TM)
MS is an autoimmune disease in which the immune system, the body's principal defense against foreign substances such as bacteria, 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. Specifically, the disease results in damage to a fatty tissue called myelin that surrounds and protects nerve fibers, creating 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. The disease is largely caused by activation of a specific subset of the patient's own white blood cells, pathogenic T-cells, which then attack the myelin and are largely responsible for disease progression.
The Company postulates that an immune-based therapy containing TCR peptides with Incomplete Freund's Adjuvant (IFA) stimulates regulatory T-cells capable of suppressing these autoreactive pathogenic T-cells. NeuroVax(TM), which combines three TCR peptides with IFA, was designed to increase the likelihood of this immune correction. The Company also intends to search for a corporate partner to help take this program to commercialization.
About OHSU
Oregon Health & Science University, located in Portland, Ore., includes the schools of dentistry, medicine, nursing and science and engineering; OHSU Hospital and Doernbecher Children's Hospital; numerous primary care and specialty clinics; multiple research institutes; and several outreach and community service units.
About The Immune Response Corporation
The Immune Response Corporation IMNR is a biopharmaceutical company dedicated to becoming a leading immune-based therapy company in HIV and MS. The Company's HIV products are based on its patented whole-killed virus technology, co-invented by Company founder Dr. Jonas Salk to stimulate HIV immune responses. REMUNE(R), currently in Phase II clinical trials, is being developed as a first-line treatment for people with early-stage HIV. We have initiated development of a new immune-based therapy, IR103, which incorporates a second-generation immunostimulatory oligonucleotide adjuvant and is currently in Phase I/II clinical trials in Canada and the United Kingdom.
The Immune Response Corporation is also developing an immune-based therapy for MS, NeuroVax(TM), which is currently in Phase II clinical trials and has shown potential therapeutic value for this difficult-to-treat disease.
Please visit The Immune Response Corporation at www.imnr.com
This news release contains forward-looking statements. Forward-looking statements are often signaled by forms of words such as should, could, will, might, plan, projection, forecast, expect, guidance, potential and developing. Actual results could vary materially from those expected due to a variety of risk factors, including whether the Company will continue as a going concern and successfully raise proceeds from financing activities sufficient to fund operations and additional clinical trials of REMUNE(R), NeuroVax(TM) or IR103, the uncertainty of successful completion of any such clinical trials, the fact that the Company has not succeeded in commercializing any drug, the risk that REMUNE(R), NeuroVax(TM) or IR103 might not prove to be effective as either a therapeutic or preventive vaccine, whether future trials will be conducted and whether the results of such trials will coincide with the results of REMUNE(R), NeuroVax(TM) or IR103 in preclinical trials and/or earlier clinical trials. These risks, among others, are set forth in The Immune Response Corporation's SEC filings including, but not limited to, its Annual Report on Form 10-K for the year ended December 31, 2004, and its subsequent Quarterly Reports filed on Form 10-Q. The Company undertakes no obligation to update the results of these forward-looking statements to reflect events or circumstances after today or to reflect the occurrence of unanticipated events.
REMUNE(R) is a registered trademark of The Immune Response Corporation. NeuroVax(TM) is a trademark of The Immune Response Corporation.
The Immune Response Corporation Presents Encouraging Results Demonstrating That REMUNE May Stabilize CD4+ Counts in HIV Patients; Phase II HIV Trial In Italy Presented at British HIV Association
All Business Wire NewsThe Immune Response Corporation IMNR, a biopharmaceutical company dedicated to becoming a leading immune-based therapy company in HIV and multiple sclerosis, presented today results from a Phase II clinical trial with REMUNE(R), the Company's lead HIV immune-based therapy. The study (IR101-215), conducted at four sites in Italy, was designed to explore the potential utility of REMUNE(R) and ongoing analysis will explore immunological information. Today's oral presentation at the 11th Annual Conference of the British HIV Association in Dublin, Ireland, focused on data demonstrating stabilization of CD4+ cell counts which is believed to indicate immune responses against HIV disease in antiretroviral-naive patients treated with REMUNE(R).
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July 27, 2005 3:00:00 PM ET The Immune Response Corporation Presents REMUNE(R) Data at the International AIDS Society Meeting in Rio; Results from Spanish Trial Presented in Two Posters
Immune Response Corporation IMNR, a biopharmaceutical company dedicated to becoming a leading immune-based therapy company in HIV and multiple sclerosis (MS), announced that results from a Phase II trial with REMUNE(R), conducted in Spain, were presented in two posters at today's sessions at the International AIDS Society (IAS) meeting in Rio de Janeiro, Brazil.
The first poster presented results from the recently completed extension of the Phase II study, known as REMIT, which showed that treatment with REMUNE(R) was effective in delaying virologic failure during antiretroviral treatment interruption. Patients receiving the greatest number of injections showed the longest time to reach a failure endpoint. This study also showed a correlation to the magnitude of HIV-specific immune responses induced in studied patients. Long-term vaccination with REMUNE(R) may enhance host HIV-1 specific CD4+ and CD8+ T-cell responses and result in a better control of plasma viral load after antiviral therapy withdrawal.
The second poster presented results obtained in a subset of patients from the original Spanish Phase II study (STIR-2102), and demonstrated that in addition to induction of HIV-1 specific immune responses previously described, therapeutic vaccination with REMUNE(R) also resulted in induction of allo-specific responses. Following 24 months of treatment, anti-HLA antibodies were present in 25/34 (74%) of REMUNE(R)-treated patients, but only in 8/32 (25%) of patients treated with Incomplete Freud's Adjuvant (IFA) as a placebo. Development of anti-HLA antibodies was correlated with increases in HIV-specific T-cell proliferation in the REMUNE(R) group.
The importance of allo-specific responses, as shown in this subset study, has been recently highlighted by the suggestion that immunization against HLA alloantigens could be a strategy for developing an AIDS vaccine. Allo-responses could be useful in strategies of therapeutic vaccination against HIV infection.
About the REMIT Study
The REMIT study enrolled 39 patients who had previously participated in the STIR-2102 Phase II double-blind study in Spain (Vaccine 2004; 22: 2966-73) in which they received either REMUNE(R) or IFA, and then subsequently received REMUNE(R) in an open-label extension. For the REMIT study, the patients were randomized to receive either REMUNE(R) (n = 21) or IFA placebo (n= 18) at the time of discontinuation of highly active antiretroviral therapy (HAART). Endpoints in the 48-week study measured immunologic or virologic failure of patients during treatment interruption, defined as time to reach HIV RNA viral load failure (defined as HIV RNA greater than 55,000 copies/mL), time to reach CD4+ failure (as defined as less than 350 cells/mL), and/or time to re-initiation of HAART.
The trial was intended to explore the potential utility of REMUNE(R) and was not designed to have enough statistical power to be used for regulatory approval. The Company is planning a clinical program that would use the data from this trial to design registration trials in the near future.
REMUNE(R) is in Phase II development by The Immune Response Corporation and is not approved by any regulatory agencies in any country at this time.
About The Immune Response Corporation
The Immune Response Corporation IMNR is a biopharmaceutical company dedicated to becoming a leading immune-based therapy company in HIV and MS. The Company's HIV products are based on its patented whole-killed virus technology, co-invented by Company founder Dr. Jonas Salk to stimulate HIV immune responses. REMUNE(R), currently in Phase II clinical trials, is being developed as a first-line treatment for people with early-stage HIV. We have initiated development of a new immune-based therapy, IR103, which incorporates a second-generation immunostimulatory oligonucleotide adjuvant and is currently in Phase I/II clinical trials in Canada and the United Kingdom.
The Immune Response Corporation is also developing an immune-based therapy for MS, NeuroVax(TM), which is currently in Phase II clinical trials and has shown potential therapeutic value for this difficult-to-treat disease.
Please visit The Immune Response Corporation at www.imnr.com
This news release contains forward-looking statements. Forward-looking statements are often signaled by forms of words such as "should," "could," "will," "might," "plan," "projection," "forecast," "expect," "guidance," "potential" and "developing." Actual results could vary materially from those expected due to a variety of risk factors, including whether the Company will continue as a going concern and successfully raise proceeds from financing activities sufficient to fund operations and additional clinical trials of REMUNE(R), NeuroVax(TM) or IR103, the uncertainty of successful completion of any such clinical trials, the fact that the Company has not succeeded in commercializing any drug, the risk that REMUNE(R), NeuroVax(TM) or IR103 might not prove to be effective as either a therapeutic or preventive vaccine, whether future trials will be conducted and whether the results of such trials will coincide with the results of REMUNE(R), NeuroVax(TM) or IR103 in preclinical trials and/or earlier clinical trials. These risks, among others, are set forth in The Immune Response Corporation's SEC filings including, but not limited to, its Annual Report on Form 10-K for the year ended December 31, 2004 and its subsequent Quarterly Reports filed on Form 10-Q. The Company undertakes no obligation to update the results of these forward-looking statements to reflect events or circumstances after today or to reflect the occurrence of unanticipated events.
REMUNE(R) is a registered trademark of The Immune Response Corporation. NeuroVax(TM) is a trademark of The Immune Response Corporation.
Contact Information: Immune Response Corporation Michael K. Green, 760-431-7080 (Investor Contact) info@imnr.com or Sam Brown Inc. Corporate Communications Laura Silver, 323-848-2051 (Media Contact) silver@sambrown.com
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