SCOTTSDALE, Ariz., Nov. 22 /PRNewswire-FirstCall/ -- Research and development bio-pharmaceutical company, ImmuneRegen BioSciences, a wholly owned subsidiary of IR BioSciences Holdings, Inc. , announced today that it is preparing to respond to the Department of Health and Human Services (DHHS) Request for Proposals (RFP) regarding countermeasures for Acute Radiation Sickness (ARS). The Company received notification from the DHHS that the RFP will be released around December 5, 2005.
ImmuneRegen plans to file a formal response to the RFP respective to its compound Radilex(TM), currently in development for treating the negative effects of toxic radiation exposure, including ARS. Included in its response will be the latest findings on the efficacy of Radilex in treating the negative effects of toxic radiation exposure. Recent testing of Radilex using Total Body Irradiation (TBI) showed a 50% survival rate among irradiated mice treated with the compound Post Lethal Exposure (PLE).
“Our response will show that, after seven rounds of animal testing for ARS using lethal dosages of radiation and reaching a 50% survival rate, there is little doubt that Radilex has incredible potential to save lives in the event of a terrorist attack,” states co-founder and CEO Michael Wilhelm. “While we applaud the release of this long anticipated RFP, we also hope to see the DHHS continue to be aggressive in identifying and funding drugs that will enable survival in those communities exposed to high levels of radiation.”
According to the communication from the DHHS, the RFP will remain focused on the procurement and stockpiling of up to 100,000 treatments of medical countermeasures to mitigate or treat Neutropenia associated with ARS as a result of a radiological or nuclear event. “Several experts in counter- terrorism have stressed that a nuclear or radiological attack on American soil is only a matter of time and is likely to effect several hundreds of thousands of citizens,” states Hal Siegel, Ph.D., Sr. Director of Development at ImmuneRegen. “With the number of treatments authorized by this RFP limited to 100,000, and the focus on treating lower levels of exposure, we sincerely hope that the DHHS issues another RFP to bridge the gap without delay.”
This RFP is another step under the U.S. Government’s Project BioShield to uncover effective new treatments for ARS. Project BioShield is legislation enacted by Congress and signed into law by the President to provide incentives and dedicated funds to encourage private industry to develop original medical technology to meet the Nation’s bio-terrorism defense needs. Under a provision known as an Emergency Use Authorization, the RFP data will be used by DHHS in the procurement of new medical counter-measures for the Strategic National Stockpile, in advance of formal FDA approval. ImmuneRegen BioSciences has begun preparations to produce the compound on a large scale should such potential purchases of Radilex occur. The company’s current production of Radilex is manufactured under GMP standards.
About Radilex(TM)
Radilex(TM) is a treatment currently in development for the negative effects of radiation, anthrax, ricin poisoning and other poisonous inhalants. Testing has shown a significant survival rate of radiation exposure at a 7.75 Gy, which is a lethal dosage. Radilex was derived from discoveries made during research funded by the Air Force Office of Scientific Research in the early 1990s. During this research, Dr. Mark Witten, co-founder of ImmuneRegen BioSciences, Inc., and his associates observed that exposure to jet fuels resulted in pathological changes in the lungs and immune systems of those exposed. It was also observed that such exposure resulted in depletion of Substance P from the lungs. These studies further showed that the administration of substance P might help prevent and reverse the effects of jet fuel exposure in the lungs, as well as protect and regenerate the immune system.
About IR BioSciences Holdings, 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 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.
Disclaimer
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.
Contact: W. Jason Grimley Senior Account Executive Spelling Communications 310-477-9500 310-477-9530 - Fax jgrimley@spellcom.com
ImmuneRegen BioSciences
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//
