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ORNL to Facilitate Final Mouse Studies on Radilex™

Scottsdale, AZ – December 7, 2005 –ImmuneRegen BioSciences, a wholly owned subsidiary of IR BioSciences Holdings, Inc. (OTC BULLETIN BOARD: IRBO), has announced today it will initiate its final phase of rodent studies utilizing Radilex™ as a treatment for Acute Radiation Sickness (ARS) at the Oak Ridge National Laboratory (ORNL). The recently signed contract between ImmuneRegen and ORNL includes these concluding pre-clinical trials, which are expected to begin in early January, 2006. Furthermore, ImmuneRegen has selected ORNL, an international leader in a range of scientific areas, to facilitate additional pre-clinical and clinical trials.

This final mouse study phase was requested by the NIH at the February 22, 2005 meeting in Bethesda, MD, with the specification that ImmuneRegen follow the format of radiation sickness studies done by the Armed Forces Radiobiology Research Institute (AFRRI) as a guideline. This was confirmed by AFRRI researchers at a meeting held with ImmuneRegen researchers on September 21, 2005. The purpose of the study is to provide more rigorous confirmation evidence supporting the efficacy of RadilexTM as a treatment to a lethal dose of radiation exposure. Several factors are being evaluated in this test, including dosage, route of administration, and need for, and extent of, required pretreatment.

“We anticipate these final rodent studies to not only support our rapid progress, in conformance with the Animal Efficacy Rule, toward FDA approval for treating ARS, but also to help demonstrate Radilex’s potential as a universal protectant,” says ImmuneRegen's CEO Michael Wilhelm. “We are also very happy to announce our relationship with Oak Ridge National Laboratory and are excited to have their expert aid in gathering the data that we hope will be used to save countless lives from radiation exposure.”

ImmuneRegen maintains that Radilex™ can potentially be utilized as a countermeasure against lethal gamma radiation exposure. In past tests in rodents, Radilex™ has shown a survival rate of approximately 50% after lethal radiation exposure.

"ORNL has decades of experience in the evaluation of the consequences of radiation exposure,” says Dabney Johnson, Group Leader, Mouse Genetics and Genomics, Life Sciences Division, Oak Ridge National Laboratory. “We welcome a role in helping evaluate the promise of new therapeutic compounds that might ameliorate the effects of high radiation doses to humans".

 


About ImmuneRegen BioSciences, Inc.
ImmuneRegen BioSciences, Inc., a wholly owned subsidiary of IR BioSciences Holdings, Inc. (BULLETIN BOARD: IRBO), is a biotechnology company engaged in the research and development of applications utilizing modified Substance P, a naturally occurring immunomodulator. Derived from homeostatic substance P, the company has named their proprietary compound "Homspera." The Company's initial focus is on the continuing development of Homspera for various applications for use in improving pulmonary function and stimulating the human immune system. For more information, please visit the company's website at www.immuneregen.com.

 

About ImmuneRegen BioSciences, Inc.

a wholly owned subsidiary of IR BioSciences Holdings, Inc., (OTC BB:IRBS.OB - News) 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-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
Jan Shulman, 480-664-8412 ext. 12
jshulman@ACmarketingPR.com

or


Jodi Amendola, 480-664-8412 ext 11
jamendola@ACmarketingPR.com

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