CARLSBAD, Calif., April 4 /PRNewswire-FirstCall/ -- The Immune Response Corporation announced today that effective April 16 the company will be known as Orchestra Therapeutics, Inc. This new corporate identity reflects the Company's expanded focus on the treatment of autoimmune diseases. The Company will announce a new ticker symbol prior to April 16.
"This is a transformative moment in the Company's history," said Dr. Joseph O'Neill, President and CEO of The Immune Response Corporation. "We believe we have a substantial opportunity to benefit patients living with autoimmune diseases by concentrating our resources and further leveraging the scientific technology pioneered with our investigational MS therapy NeuroVax(TM)."
Autoimmune processes are implicated in more than 60 conditions, including multiple sclerosis (MS), rheumatoid arthritis (RA), Crohn's disease, psoriasis, lupus and type-1 diabetes. Orchestra Therapeutics' unique approach to controlling autoimmune diseases uses small peptide vaccines that appear to stimulate FOXP3+ Regulatory T-cells; a component of the immune system that is now recognized as being key in autoimmune pathogenesis.
In MS, for example, 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), an investigational T-Cell Receptor peptide vaccine for the treatment of relapsing-remitting forms of MS, appears to work by enhancing levels of FOXP3+ Regulatory T-cells within the immune system, which may help control levels of pathogenic T-cells in MS patients. Data from the Company's most recent Phase II clinical trial in MS showed that reduced levels of FOXP3 can be restored to normal levels after repeated vaccinations with NeuroVax(TM). The Company recently announced the injection of the first patient in a large multi-center Phase II study to assess the safety and efficacy of NeuroVax(TM).
Recognizing that a growing base of scientific research has demonstrated the potential significance of the role of FOXP3+ Regulatory T-cells in the prevention and treatment of a variety of autoimmune diseases, the Company has made a strategic decision to emphasize this program and will redirect its resources toward the execution and expansion of product development in this area.
The Company is in discussions with several academic institutions to conduct pre-clinical work on therapeutic vaccines to treat psoriasis and RA. Based on findings to be derived from these product development programs, the Company plans to initiate Phase I trials in one of these new autoimmune areas in 2008.
The transition to the new name coincides with the Company's decision to terminate the HIV clinical trials to fully focus the weight of the Company's resources on the autoimmune program. The 52-week data from the first large cohort of HIV clinical-trial participants have already been gathered, and analysis of the data will be completed and disclosed in the second quarter of 2007. Based on this data, the Company will consider strategic alternatives for the HIV program.
Additionally the Company has decided to scale back operations at its manufacturing facility in King of Prussia, Pennsylvania, effective immediately. This decision will reduce costs by approximately $3 million per year, while allowing the Company to maintain the facility pending strategic decisions about the HIV program.
The Company raised $902,000, gross, from the exercise of warrants in the last week of March 2007. These were from the second tranche of warrants issued in the Company's spring 2006 Private Placement. Under special amended terms, each exercising warrant holder received 2.5 common shares for each $2 of exercise price paid. A total of 5,530,125 second tranche warrants expired on March 30, thereby significantly reducing the Company's overhang.
Orchestra Therapeutics, which will soon be the new name of The Immune Response Corporation , is an immuno-pharmaceutical company focused on the discovery and development of novel treatments for autoimmune diseases. The Company's lead immune-based therapeutic product candidate is NeuroVax(TM) for the treatment of MS. In addition to MS, the Company has proprietary technology and prior clinical experience for clinical evaluation of TCR peptide-based immune-based therapies for RA and psoriasis. The targeted strategy behind the Company's autoimmune therapies is reflected in the name Orchestra. Rather than disrupting the function of the entire immune system, these therapeutic vaccines are designed to elicit a very specific response -- akin to correcting one instrument in an orchestra that is out of tune -- to help control disease.
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 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 and the unresolved status of the Company's HIV program. 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's Annual Report on Form 10-K for the year ended December 31, 2006 will be filed soon and the set of risks set forth there should also be studied. 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.
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The Immune Response Corporation