SCOTTSDALE, Ariz., Dec. 7 /PRNewswire-FirstCall/ -- ImmuneRegen BioSciences, a wholly owned subsidiary of IR BioSciences Holdings, Inc. , has announced today it will initiate its final phase of rodent studies utilizing Radilex(TM) 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 Radilex(TM) 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 Radilex(TM)
Radilex(TM), derived from ImmuneRegen’s modified Substance P compound Homspera(TM), is a treatment currently in development for the negative effects of radiation. Animal testing has shown a survival rate of approximately 50% after radiation exposure at a 7.75 Gray level, which is a lethal dosage. Homspera(TM) itself has shown animal efficacy in treating Acute Respiratory Distress Syndrome (ARDS), Hong Kong Influenza, and other toxic conditions involving jet diesel fuel. During early research, Dr. Mark L. Witten, co-founder of ImmuneRegen BioSciences, and his associates observed that exposure to jet fuels depleted endogenous pulmonary Substance P levels and resulted in pathological changes in the lungs and immune system of experimental animals. It was also observed that the administration of exogenous Substance P seemed to protect the lungs, as well as stimulate the immune system.
About ImmuneRegen BioSciences, Inc.
IR BioSciences Holdings Inc., through its wholly owned subsidiary ImmuneRegen BioSciences, Inc., is developing Homspera(TM) and its derivatives Radilex(TM) and Viprovex(TM) as a family of countermeasures for multiple homeland security threats, including chemical agents, Acute Radiation Sickness (ARS) from a dirty bomb or nuclear disaster, and infectious disease/biological warfare scenarios. This positions the base compound Homspera as a potential Universal Protectant. Homspera is derived from modified homeostatic Substance P, a naturally occurring peptide immunomodulator and homeostatic compound with the dual effect of improving pulmonary function and the stimulation of the human immune system. Further advances with the Office of Naval Research (ONR) and the U.S. Air Force are currently being pursued. The development of Homspera and its derivatives is pursuant to the U.S. Food and Drug Administration’s “animal efficacy” rule, which allows an expedited development and approval process. In addition, these compounds are candidates for the Strategic National Stockpile under current BioShield law. For more information, please visit the company’s website at www.immuneregen.com.
About Oak Ridge National Laboratory (ORNL)
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. Oak Ridge National Laboratory 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.
Statements about the Company’s future expectations, including future revenues and earnings, 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. The Company’s actual results could differ materially from expected results as a result of a number of factors, including the uncertainties inherent in research collaborations, clinical trials and product development programs, the evaluation of potential opportunities, the level of corporate expenditures, capital market conditions, and others set forth in the Company’s periodic report on Form 10-Q for the three months ended June 30, 2005 as filed with the Securities and Exchange Commission.
For more information, please contact: W. Jason Grimley, Senior Account Executive of Spelling Communications, +1-310-477-9500, or fax, +1-310-477- 9530, jgrimley@spellcom.com, for ImmuneRegen BioSciences
ImmuneRegen BioSciences, Inc.
CONTACT: W. Jason Grimley, Senior Account Executive of SpellingCommunications, +1-310-477-9500, or fax, +1-310-477-9530,jgrimley@spellcom.com, for ImmuneRegen BioSciences
Web site: http://www.immuneregen.com/
