ORNL and ImmuneRegen Continue Testing the Effects of Radilex(TM) for Possible Use to Treat the Effects of Acute Radiation Exposure SCOTTSDALE, Ariz., Aug 30 /PRNewswire-FirstCall/ -- ImmuneRegen BioSciences, a wholly owned subsidiary of IR BioSciences Holdings, Inc. (OTC:IRBO) (BULLETIN BOARD: IRBO) , continues its ongoing radioprotectant research program at the Oak Ridge National Laboratory (ORNL) with further studies designed to support submission of its Radilex(TM) product to the U.S. Food and Drug Administration (FDA) for marketing approval for possible use to treat the effects of acute radiation exposure. This program is designed to be compliant with the FDA's Animal Efficacy Rule. Originally proposed by the FDA in October, 1999 and finalized on May 31, 2002 (effective date July 1, 2002), this rule enables drug and biological products that are intended to reduce or prevent serious or life-threatening conditions to be approved for marketing based on studies of effectiveness in animals rather than in humans. The purpose of this study, which has been initiated this past week, is to attempt to replicate previously observed results and compile additional neutropenia and thrombocytopenia data. These decreases in blood neutrophils and platelets (respectively) following radiation exposure are believed to allow the infections and uncontrolled bleeding that are proximate causes of morbidity and mortality following irradiation. Protection against radiation-induced neutropenia and thrombocytopenia are reported to be predictors of subsequent survival in animal studies and might be expected to be indicative of the ability to protect against the lethal effects of gamma radiation that might result from terrorist activity or accidental radiation release. Previous studies have provided indications of the possible benefits of Radilex(TM) to treat the effects of radiation exposure including radiation- induced neutropenia and thrombocytopenia. To better provide and maintain an appropriately robust testing environment for this upcoming study, and in order to better meet FDA expectations for Animal Rule submissions, the company has acquired additional instrumentation and has retained an aerosol scientist from Southern Research Institute's Aerobiology Program to provide nebulization expertise and assistance. "We are enthusiastic about test results which our contract labs are providing and feel our test compound may be a candidate for this indication," says John Fermanis, ImmuneRegen CFO. Upcoming studies are being planned to examine Radilex(TM) activity in various defined inbred mouse lines and potentially identify genetic correlates with phenotypic expression of radiation resistance. Planned collaborative studies with other facilities are intended to further explore mechanisms of Radilex(TM) protection at the molecular level in different mice strains and larger, mammalian species. Additional studies with ImmuneRegen's lead compound, Homspera, formulated as Radilex(TM) or Viprovex(TM), also reveal efficacy in treating viral, bacterial and chemical exposures. Pre-clinical studies performed in a well- established mouse model system of anthrax exposure have revealed Viprovex(TM) can both prophylactically and therapeutically protect against anthrax-induced mortality. The company is optimistic that greater survival might be attained at higher doses, as no toxicity was observed in animals treated with the highest concentrations of Homspera. Experiments using immunocompromised animals exposed to an H3N2 avian influenza viral challenge reveal Viprovex(TM) normalizes pulmonary function and protects against viral-induced morbidity and mortality. Additionally, experimental animals exposed to Homspera prior to inhalation of formalin vapors have been shown to be protected from both lethality and the electron micrographically visualized destruction of the capillary-alveolar barrier. In vitro studies confirm elevation of multiple classes of immunomodulators in response to Homspera, and add further support to putative mechanisms such as enhanced innate and/or reactive immunity in Homspera-mediated protection against a variety of Homeland Security and terror threats. The company is committed to performing additional studies that will more clearly reveal the full scope of Homspera's activities. About Radilex(TM) and Viprovex(TM) Radilex(TM) is the trade name used in referring to formulations of Homspera for potential indications for treatment of exposure to ionizing radiation. Viprovex(TM) is the trade name used in referring to formulations of Homspera for potential indications for treatment of viral and bacterial infections. Homspera is a generic name used by the Company to describe the synthetic peptide Sar9, Met (O2)11-Substance P. Sar9, Met (O2)11-Substance P is 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 the Company's research and development efforts are early, pre-clinical stage and Homspera, as Viprovex(TM) and Radilex(TM), has only undergone exploratory studies to evaluate its biological activity in small animals. About Oak Ridge National Laboratory ORNL is an international leader in a range of scientific areas that support the Department of Energy's mission in the Office of Science. The laboratory's six major scientific competencies include neutron science, energy, high performance computing, complex biological systems, advanced materials and national security. ORNL is the Department of Energy's largest science and energy laboratory. Managed since April 2000 by a partnership of the University of Tennessee and Battelle, ORNL was established in 1943. About ImmuneRegen BioSciences, Inc. IR BioSciences Holdings Inc., through its wholly owned subsidiary ImmuneRegen BioSciences, Inc., is a development stage biotechnology company focused on the research and development of Homspera(TM) and its derivatives Radilex(TM) and Viprovex(TM), which are under study as candidate therapeutic countermeasures for multiple homeland security bioterrorism threats. Homspera is derived from modified Substance P, a naturally occurring peptide immunomodulator. Radilex(TM) is the trade name used in referring to formulations of Homspera for potential indications for the possible treatment of the effects of exposure to ionizing radiation. Viprovex(TM) is the trade name used in referring to formulations of Homspera for potential indications for the possible treatment of the effects of viral and bacterial infections. Homspera is a generic name used by the Company to describe the synthetic peptide Sar9, Met (O2)11-Substance P. Sar9, Met (O2)11-Substance P is 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 the Company's research and development efforts are early, pre-clinical stage and Homspera, as Viprovex(TM) and Radilex(TM), has only undergone exploratory studies to evaluate its biological activity in small animals. For more information, please visit the company's website at http://www.immuneregen.com/. Statements about the Company's future expectations, including statements about the potential for the Company'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. The Company 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 the Company's business, are subject to various risks and uncertainties. The Company's actual results could differ materially from expected results as a result of a number of factors, including the fact that preliminary results involved only a small number of test mice, the subsequent investigations were limited in scope, 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 the Company's periodic report on Form 10-QSB for the three months ended June 30, 2006 and on Form 10-KSB for the twelve months ended December 31, 2005 as filed with the Securities and Exchange Commission. There are no guarantees that any of the Company's proposed products will prove to be commercially successful. The Company undertakes no duty to update forward-looking statements. Contact: Investor relations: Tony Schor or Lindsay Kenoe Investor Awareness, Inc. 847-945-2222 http://www.investorawareness.com/ MEDIA CONTACT: W. Jason Grimley Spelling Communications 310-477-9500 DATASOURCE: ImmuneRegen BioSciences, Inc. CONTACT: Investor Relations, Tony Schor or Lindsay Kenoe, both of Investor Awareness, Inc., +1-847-945-2222, for ImmuneRegen BioSciences, Inc.; or Media, W. Jason Grimley of Spelling Communications, +1-310-477-9500, , for ImmuneRegen BioSciences, Inc. Web site: http://www.immuneregen.com/

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