This Is MS Multiple Sclerosis Knowledge & Support Community

It was interesting to read that this study has finally started...however..i've been a little frustrated on how long it seems to take to start these trials...i know that there are certain mechanisms necessary to get a study off the ground (e.g. pass an IRB, funding, etc...), but i can't imagine there are not better ways to get these studies goin quicker...does anyone know if this has been brought up before to different powers that be ?(e.g. NMSS, FDA, other relevant committees)...anyways, i'll stop my griping and pass on the info...here is both the link and the article..

thinkingoutloud

http://www.earthtimes.org/articles/show ... 1537.shtml


The Immune Response Corporation Injects First Patient in Trial of NeuroVax(TM) for Treatment of Multiple Sclerosis
Posted on : Wed, 07 Mar 2007 22:47:00 GMT | Author : The Immune Response Corporation
News Category : PressRelease

CARLSBAD, Calif., March 7 /PRNewswire-FirstCall/ -- The Immune Response Corporation (BULLETIN BOARD: IMRP) today announced the injection of the first patient in a large multi-center Phase II study of NeuroVax(TM), an investigational T-Cell Receptor peptide vaccine for the treatment of relapsing-remitting multiple sclerosis (MS). NeuroVax(TM) may represent a significant advance in the treatment of MS, which affects more than 2.5 million people worldwide, including more than 400,000 in the United States.

"We are pleased to initiate this important trial," said Dr. Joseph O'Neill, President and CEO of The Immune Response Corporation. "This study will allow us to examine the potential of NeuroVax(TM) to help patients with multiple sclerosis, to better understand our platform technology in autoimmune diseases, and position our MS program for a strong commercial partnership."

In MS, a specific subset of a patient's own white blood cells, pathogenic T-cells, attack myelin, a fatty tissue in the central nervous system, which surrounds and protects nerve fibers. This pathologic process creates multiple areas of inflammation that ultimately lead to scarring (sclerosis) and that interfere with normal transmission of nerve impulses. This nerve damage, in turn, leads to a variety of chronic and often debilitating neurological symptoms, ranging from serious movement and balance problems to vision impairment.

NeuroVax(TM), which is based on the Company's patented T-cell receptor (TCR) peptide vaccine technology, has shown potential clinical value in the treatment of relapsing forms of MS. NeuroVax(TM) has been shown to stimulate strong, disease-specific cell-mediated immunity in nearly all treated patients. NeuroVax(TM) appears to work by enhancing levels of FOXP3+ regulatory T-cells (Treg cells) which may help regulate expression of pathogenic T-cells in MS patients. Previous clinical trials conducted by the Company and other independent researchers 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. In addition to MS, the Company has proprietary technology and prior clinical experience for evaluation of TCR peptide-based immune-based therapies for RA and psoriasis.

"By restoring FOXP3+ Regulatory T-cell functions to levels seen in healthy individuals, NeuroVax(TM) may offer a new and highly targeted mechanism to control pathogenic T-cell activity and limit or prevent nerve tissue damage in MS patients," said Dr. O'Neill. "Additionally, NeuroVax(TM)'s once-a-month dosing, attractive side effect profile and ease of manufacture could benefit the millions of MS patients in need of effective and more tolerable treatment options."

The goal of The Immune Response Corporation's research program is to develop safe, effective and affordable therapies for patients suffering from devastating diseases. The Company's investigational vaccines for MS and other autoimmune diseases, as well as for treatment of HIV, are highly targeted, potentially less toxic medicines that seek to harness the body's own defenses to control and possibly prevent disease. This approach may prove valuable in the discovery of novel immune-based therapies for a host of autoimmune and infectious diseases.

About the Study

This trial is a multi-center, randomized, double-blind, placebo-controlled 48-week study to assess the safety and efficacy of NeuroVax(TM). Two hundred subjects with relapsing-remitting MS, with an Expanded Disability Status Scale (EDSS) score of less than or equal to 5.5 and meeting all inclusion/exclusion criteria, will be enrolled in the study in several Central and Eastern European countries. The first trial patient was injected at a study site in Bulgaria and regulatory approval to begin enrolling has been obtained in Slovakia. Enrollment will continue in other countries as pending regulatory approvals to initiate the trial are approved.

The primary clinical endpoint of the study is to compare the cumulative number of new gadolinium enhancing lesions, a key marker of MS disease activity, using MRI scans at 24, 32, 40, and 48 weeks. Secondary objectives include additional MRI measurements, analysis of clinical relapses, measures of neurologic disability, immunologic evaluations, and safety.

Study participants will be randomized equally to receive NeuroVax (TM) (100 micrograms/mL of each of three selected TCR Peptides), emulsified in Incomplete Freund's Adjuvant (IFA) or placebo (IFA) intramuscularly in the deltoid muscle every four weeks. Evaluation will occur every eight weeks by brain MRI scan and patients will also undergo evaluation by neurology examinations at 12, 24, 36, and 48 weeks. Safety will be monitored by routine physical exams that will be performed at 24 and 48 weeks, and lab tests of hematology, chemistry panel and urinalysis will be performed at weeks 4, 12, 24, 36, and 48.

About The Immune Response Corporation

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 clinical trials of NeuroVax(TM), REMUNE(R) 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 NeuroVax(TM), REMUNE(R) 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 NeuroVax(TM), REMUNE(R) or IR103 in preclinical trials and/or earlier clinical trials. A more extensive set of risks is 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, 2005, 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.

A question reflecting my general ignorance about the FDA regulatory process: it looks like these are Phase II trials going on in Europe only; assuming these are successful, to have Neurovax approved in the US, could they move straight to Phase III here, or would they first have to conduct Phase II all over in this country? More broadly speaking, I see more and more drug trials being conducted abroad first and I was just wondering what this means for me as a patient and (a very impatient, pardon the pun) potential consumer.

connieb, interesting question about the validity of international clinical trials for FDA approval (and I'm not even American). I didn't have a clue, so I went looking around. There's too much information, so it's a bit hard to sift through, but I found something (below) that I think basically means if you conduct the research properly, the FDA will approve a drug regardless of the location of the trial.



Research conducted at foreign sites
In contrast to U.S. research, FDA does not require sponsors of foreign-based research to conduct research under an IND, although these sponsors can choose to do so.

Foreign research conducted under an Investigational New Drug Application.
Sponsors of foreign-based research who choose to submit an IND to FDA must also conduct research according to FDA regulations. However, FDA has less information about this research than it does for U.S. based research because it does not track investigators through a comprehensive database of signed attestations.

Foreign research not conducted under an Investigational New Drug Application.
If sponsors submit an NDA containing foreign research that was not conducted under an IND, that research must adhere to FDA regulations for foreign clinical studies not conducted under an IND. This type of foreign clinical research must be conducted according to the ethical principles of the Declaration of Helsinki, or the countries’ own regulations, whichever offers the greater protection to the human subject. Many countries have adopted the Good Clinical Practice guidelines from the International Conference on Harmonization as their regulatory standard. Sponsors are not required to obtain attestations for investigators conducting research under these guidelines.

http://oig.hhs.gov/oei/reports/oei-01-00-00190.pdf

Thanks Dignan!