ImmuneRegen BioSciences, Inc. Partners With University of Rochester in BARDA Funding Bid

Published: Sep 09, 2009

SCOTTSDALE, AZ--(Marketwire - September 09, 2009) - ImmuneRegen BioSciences®, a wholly owned subsidiary of IR Biosciences Holdings Inc. (OTCBB: IRBS), today announced that, in collaboration with Dr. Jacob Finkelstein at the University of Rochester School of Medicine, they have submitted a proposal to the U.S. government seeking funding to develop Homspera® as a post-exposure therapy for injury resulting from ionizing radiation exposure.

The proposal [a Broad Agency Announcement (BAA), sponsored by The Biomedical Advanced Research and Development Authority (BARDA) of the U.S. Department of Health and Human Services] expands on research ImmuneRegen has previously performed demonstrating efficacy of Homspera in treating pulmonary injury as well as mitigating acute effects, including the hematopoietic syndrome, resulting from exposure to ionizing radiation. The proposal utilizes animal models validated at the University of Rochester using NIAID funding that accurately depict the short- and long-term pulmonary symptomatology (pneumonitis and fibrosis respectively) that follow exposure to ionizing radiation. ImmuneRegen recently filed an Investigational New Drug (IND) application with the FDA for a similar indication, idiopathic pulmonary fibrosis.

If funded, the proposal will facilitate more rapid development of Homspera toward clinical use, and under the Animal Efficacy Rule, which permits the FDA to approve drugs and biologics for indications where it is unethical or unfeasible to conduct human efficacy studies, perhaps accelerate FDA approval of Homspera for this specific use.

"The support from the agency thru BARDA legislation to advance Homspera's development to mitigate injury caused in a potential terrorist attack takes our company full circle," said ImmuneRegen CEO Michael Wilhelm. "On behalf of the company we are all honored to be working with someone as well-respected and experienced in the field as Dr. Finkelstein."

Dr. Finkelstein, a professor in the departments of Pediatrics, Radiation Oncology and Environmental Medicine at the University of Rochester Medical School, is recognized for his investigations into the effects of radiation on the pulmonary system. Dr. Finkelstein's work has identified early immune system markers of pulmonary fibrosis, as well as agents that can potentially mitigate the lethal impact of this sequela of radiation exposure.

The Biomedical Advanced Research and Development Authority (BARDA), within the Office of the Assistant Secretary for Preparedness and Response in the U.S. Department of Health and Human Services, provides an integrated, systematic approach to the development and purchase of the necessary vaccines, drugs, therapies, and diagnostic tools for public health medical emergencies.

BARDA manages Project BioShield, which includes the procurement and advanced development of medical countermeasures for chemical, biological, radiological, and nuclear agents, as well as the advanced development and procurement of medical countermeasures for pandemic influenza and other emerging infectious diseases that fall outside the auspices of Project BioShield. In addition, BARDA manages the Public Health Emergency Medical Countermeasures Enterprise (PHEMCE).

For this particular BAA, BARDA is anticipating program funding of up to $750MM dependent on congressional approval and intends to fund awards for up to 5 years in length.

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® and its derivatives. Homspera is an adult stem cell active compound that in study results has been shown to regenerate and strengthen the immune system and enhance wound healing. Viprovex®, a derivative of Homspera, is being developed for potential use against infectious diseases as a stand-alone or combination therapy and as a vaccine adjuvant. 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. 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-KSB for the year ended December 31, 2008 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.