ImmuneRegen BioSciences, Inc., a wholly owned subsidiary of IR BioSciences Holdings, Inc. (OTCBB: IRBS), will present pre-clinical study results that indicate that its drug candidate Viprovex(R) enhances the safety and efficacy of Tamiflu(R) (manufactured by Hoffmann-La Roche Inc.) in treating influenza at the 2008 Biomedical Advanced Research and Development Authority (BARDA) Industry Day. Heidi L. Pinyerd, scientific program manager at ImmuneRegen, will display findings in the poster entitled, “Viprovex Enhances Tamiflu Safety/Efficacy in Influenza A/H3N2 Exposed Cotton Rat” at 6 p.m., Sept. 24 and 25th, at the Crystal Gateway Marriott, Arlington, Va.
“Studies conducted by ImmuneRegen, Virion Systems, Inc. and PanFlu, LLC indicated that a combination of Viprovex and Tamiflu was more effective in treating viral infection with human influenza A/H3N2 in cotton rats compared to treatment with Tamiflu alone,” said Hal Siegel, Ph.D., ImmuneRegen’s vice president and chief scientific officer. “Results showed that Viprovex reduced the lung inflammation resulting from infection in cotton rats — the preferred small animal for studying influenza virus pathogenesis — while those treated only with Tamiflu experienced no reduction.”
Added Siegel, “The other key finding indicated that influenza-infected animals experienced infection-associated hypothermia and weight loss, but those administered Viprovex underwent substantial improvement. Good Laboratory Practice compliant safety studies are underway and our goal is that human clinical trials involving Viprovex will start in 2009.”
Studies also indicated that animals on the combined drug regimen had a lower mortality rate (7 percent) compared to those on Tamiflu alone (14 percent) while those that only received Viprovex all survived.
Viprovex is an intranasal drug candidate for potential use against infectious diseases as a vaccine adjuvant or as part of combination therapy. It is based on Homspera(R), ImmuneRegen’s adult stem cell active compound, which has shown in studies that it may function to regenerate and strengthen the immune system and enhance wound healing. Tamiflu is an antiviral drug approved by the U.S. Food and Drug Administration for the treatment and prevention of uncomplicated influenza in adults and children at least one year old. It has been taken by tens of millions of patients and stockpiled by governments worldwide. However, increasing reports of adverse events in children and viral resistance to Tamiflu have sparked concern about Tamiflu’s effectiveness against influenza.
The 2008 BARDA Industry Day provides an open forum for companies interested in working with the Federal Government to showcase technological advances in medical countermeasures to man-made and naturally occurring threats. Presenters will demonstrate the progress of current activities in advanced research and development of medical countermeasures that will contribute to the success of the U.S Health and Human Services Pandemic Influenza Plan, Project BioShield, BARDA, and the HHS Public Health Emergency Medical Countermeasures Enterprise (PHEMCE) Strategy and Implementation Plan.
About Viprovex(R) and Homspera(R)
Viprovex is the trade name used that refers to formulations of Homspera for potential indications for treatment of viral and bacterial infections. Homspera is a generic name used by ImmuneRegen to describe the synthetic peptide Sar9, Met (O2)11-Substance P, an analog of the naturally occurring human neuropeptide Substance P, which can be found throughout the body, including in the airways of humans and many other species. All of ImmuneRegen’s research and development efforts are in the early, pre-clinical stage, and Homspera, as Viprovex, has undergone exploratory studies to evaluate its biological activity in small animals.
About ImmuneRegen BioSciences, Inc.
ImmuneRegen BioSciences, Inc., a wholly owned subsidiary of IR BioSciences Holdings, Inc., (OTCBB: IRBS), is a development-stage biotechnology company focused on the research, development and licensing of Homspera(R) and its derivatives. Homspera is an adult stem cell active compound that, in study results, has been shown that it may have effects on the regeneration and strengthening of the immune system and on enhancing wound healing. To advance its mission, the Scottsdale, Arizona-based company has forged numerous study partnerships with industry and academic leaders, including Celgene Cellular Therapeutics, HemoGenix, Lovelace Respiratory Research Institute and Virion Systems, Inc. For more information, please visit www.immuneregen.com.
Statements about ImmuneRegen’s future expectations, including statements about the potential use and scientific results for ImmuneRegen’s drug candidates, science and technology, and all other statements in this press release other than historical facts, are “forward-looking statements” within the meaning of Section 27A of the Securities Act of 1933, Section 21E of the Securities Exchange Act of 1934, and as that term is defined in the Private Securities Litigation Reform Act of 1995. ImmuneRegen intends that such forward-looking statements be subject to the safe harbors created thereby. These future events may not occur as and when expected, if at all, and, together with ImmuneRegen’s business, are subject to various risks and uncertainties. ImmuneRegen’s actual results could differ materially from expected results as a result of a number of factors, including the uncertainties inherent in research and development collaborations, pre-clinical and clinical trials and product development programs (including, but not limited to the fact that future results or research and development efforts may prove less encouraging than current results or cause side effects not observed in current pre-clinical trials), the evaluation of potential opportunities, the level of corporate expenditures and monies available for further studies, capital market conditions, and others set forth in ImmuneRegen’s periodic report on Form 10-Q for the three months ended June 30, 2008 and on Form 10-KSB for the year ended December 31, 2007 as filed with the Securities and Exchange Commission. There are no guarantees that any of ImmuneRegen’s proposed products will prove to be commercially successful. ImmuneRegen undertakes no duty to update forward-looking statements.
CONTACT: Amendola Communications for ImmuneRegen www.acmarketingpr.com Jan Shulman 480-664-8412 ext. 12 Email Contact Jodi Amendola 480-664-8412 ext 11 Email Contact
SOURCE: ImmuneRegen BioSciences, Inc.
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