ImmuneRegen BioSciences Responds To National Institutes of Health (NIH) Request For Information
SCOTTSDALE, Ariz., Aug. 3 /PRNewswire/ -- Research and development biotechnology company ImmuneRegen BioSciences, a wholly owned subsidiary of IR BioSciences Holdings, Inc. , announced today that it will respond to a Request for Information (RFI) regarding the National Institutes of Health (NIH) Program on the Development of Medical Countermeasures to Chemical Threats. ImmuneRegen's response will present its proprietary drug, Radilex(TM), as a potential universal treatment for a wide range of chemical threats.
ImmuneRegen's formal response to the RFI will refer to its drug Radilex, currently in development for treating toxic radiation exposure, including Acute Radiation Sickness. Recent testing of Radilex using Total Body Irradiation (TBI) in an animal model showed a 50% survival rate among mice treated with Radilex following lethal irradiation. Additional tests have provided evidence that Radilex is a prospective countermeasure for many chemical threats, and could possibly demonstrate efficacy against many chemical and biological agents as well.
The RFI data will provide the initial steps in designing a program with the goals of discovering and developing specific post-exposure therapeutics and diagnostic tools, and moving them through the regulatory process for eventual inclusion in the Strategic National Stockpile. ImmuneRegen BioSciences has begun preparations to produce Radilex on a large scale should such potential purchases occur. The company's current production of Radilex is manufactured under cGMPs.
The primary objective of the NIH program will be to develop medical countermeasures against chemical threat agents. The civilian chemical threat spectrum involves chemical warfare agents, toxic industrial chemicals (TICs), plant/animal toxins, and other chemical threats. These include neurotoxic compounds, such as organophosphorus nerve agents; vesicating agents, such as sulfur mustard; pulmonary toxicants, such as chlorine gas; and metabolic/cellular poisons, such as cyanide.
"We believe that Radilex is at the forefront of becoming a Universal Bioterror Protectant," comments Michael Wilhelm, co-founder and Chief Executive Officer of ImmuneRegen Biosciences, Inc. "After completing six rounds of animal testing with lethal dosages of radiation, Radilex has shown a 50% survival rate. We have confidence that further testing of Radilex and its complementary agent Homspera will show similar results for anthrax, ricin, mustard gas, and other threats to the respiratory and immune systems."
The formal response to the NIH Program on the Development of Medical Countermeasures to Chemical Threats RFI will be submitted within the deadline of September 15, 2005. This response will include the following specific information on Radilex: Product Description, Description of Mechanism of Action, Description of Proposed Dosage Form, Dosing Information, Proposed Indications for Use, Proposed Production Process and Current State of GMP Compliance, Estimate of Production Capacity, Timelines and Cost, Product Development Plan and Overall Stage of Product Development.
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. 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 efficacy in treating anthrax, ricin poisoning, 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 the exposure to jet fuels resulted in pathological changes in the lung 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 a stable substance P analog might help prevent and reverse the effects of jet fuel exposure in the lungs, as well as protect and regenerate 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 immunomodulator 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.
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 September 30, 2004 as filed with the Securities and Exchange Commission.
Contact: W. Jason Grimley Spelling Communications 310-477-9500 jgrimley@spellcom.com
ImmuneRegen BioSciences, Inc.CONTACT: W. Jason Grimley of Spelling Communications, +1-310-477-9500,jgrimley@spellcom.com, for ImmuneRegen BioSciences, Inc.
Web site: http://www.immuneregen.com/