News | September 25, 2008

ImmuneRegen Scientist To Present Viprovex® Pre-Clinical Study Findings At 2008 BARDA Industry Day

ImmuneRegen BioSciences, Inc., a wholly owned subsidiary of IR BioSciences Holdings, Inc., will present pre-clinical study results that indicate that its drug candidate Viprovex enhances the safety and efficacy of Tamiflu (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, 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 and Homspera
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., is a development-stage biotechnology company focused on the research, development and licensing of Homspera 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

SOURCE: ImmuneRegen BioSciences, Inc.