IR BioSciences, Inc. Responds to the Recently Cancelled Acute Radiation Syndrome (ARS) RFP by DHHSImmuneRegen to Meet With Government Agency to Present Recent Findings/Data Utilizing Radilex as a Countermeasure for ARS
SCOTTSDALE, Ariz., March 14, 2007 /PRNewswire-FirstCall/ -- ImmuneRegen BioSciences, Inc., a wholly owned subsidiary of IR BioSciences Holdings, Inc. announced today that it believes Radilex(TM), its proprietary compound which has already demonstrated through animal studies the potential for treatment of acute radiation syndrome (ARS) following lethal doses of radiation, may meet the new requirements of the expected Department of Health and Human Services (DHHS) Request For Proposals (RFP) for medical countermeasures to treat ARS. The Company is meeting with HHS within the next two weeks to discuss the upcoming opportunity, and update DHHS on their development program. The Company will also address the role that Radilex can play in mitigating the effects of a "dirty bomb."
The original RFP DHHS-ORDC-DDA-05-12 entitled "Medical Countermeasures to Mitigate or Treat Neutropenia Alone or in Combination with Co-Morbidities Associated with Acute Radiation Syndrome (ARS)" was closed on February 23, 2006, with the award date set for June, 2006. After multiple delays, the RFP was cancelled on March 7, 2007 because none of the companies that submitted to the RFP met the government's requirements. ImmuneRegen's Radilex was not submitted in response to the initial RFP in early 2006 as insufficient data had been collected.
While this leaves the Nation without a next-generation candidate radioprotective compound for procurement into the Strategic National Stockpile, it highlights the possibility that ImmuneRegen's Radilex, an 11-amino acid, non-steroid, peptide analog of the endogenous neuromodulator Substance P, could provide a safe and effective candidate once additional data is collected. Animal studies have shown Radilex to protect mice from lethal gamma irradiation, as well as a number of bacterial and viral infections. Initial evidence suggests Radilex may accomplish this by mobilizing hematopoietic stem cells to mature and enter the circulation, replenishing the disease-fighting and hemostatic components of the blood, the white blood cells and platelets. Further studies are necessary for confirmation.
"We believe Radilex, although at an early stage of development, represents a viable acquisition for Project BioShield," said ImmuneRegen's Senior Director of Product Development and Regulatory Affairs Hal Siegel, Ph.D. "Radilex has shown efficacy in small animals. We're planning for non-human primate studies in the coming months. In addition, this compound has demonstrated efficacy in animals exposed to influenza, not merely radiation. Our drug is a small peptide, not a steroid, which may have some additional value. Also, Radilex has been administered by inhalation, as a powder, which may make for a more stable formulation."
The Company continues to work with national laboratories and others such as TGen and TD2 as testing facilities to perform additional research and development activities on ImmuneRegen's proprietary compound. TGen Drug Development Services (TD2), helps investigators from research institutions, biotech and pharmaceutical companies evaluate the efficacy of their drug candidate by using preclinical models, genomic tools and coordination of Phase I clinical trials at various clinical facilities, including Mayo Clinic Scottsdale, Scottsdale Healthcare, the Arizona Cancer Center, and U.S. Oncology. The Translational Genomics Research Institute (TGen), a non-profit 501(c)(3) organization, is focused on developing earlier diagnostics and smarter treatments. ImmuneRegen plans to utilize these capabilities to perform various studies in support of the Radilex development program for ARS.
About Radilex(TM) and Viprovex(TM)
Radilex(TM) is the trade name used in referring to formulations of Homspera(TM) 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, 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 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 designed to be used as countermeasures for multiple homeland security bioterrorism threats. Homspera is derived from 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. For more information, please visit the company's website at 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 September 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: MEDIA CONTACT: W. Jason Grimley Spelling Communications 310-477-9500 INVESTOR CONTACT: Josh Reynolds CEOcast, Inc. 212-732-4300 IN-HOUSE INVESTOR CONTACT: Bill Lane ImmuneRegen BioSciences, Inc. email@example.com firstname.lastname@example.org email@example.com
CONTACT: Media, W. Jason Grimley of Spelling Communications,+1-310-477-9500, ; or Investors, Josh Reynolds ofCEOcast, Inc., +1-212-732-4300, , both for ImmuneRegenBioSciences, Inc.; or Investors, Bill Lane of ImmuneRegen BioSciences,Inc., +1-480-922-3926, firstname.lastname@example.org email@example.com firstname.lastname@example.org
Web site: http://www.immuneregen.com/
Ticker Symbol: (NASDAQ-OTCBB:IRBO)
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Posted: March 2007
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