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SCOTTSDALE, AZ – (July 29, 2009)—ImmuneRegen BioSciences®, a wholly owned subsidiary of IR BioSciences Holdings, Inc. (OTC BB:IRBS.OB), reports preliminary evidence that its selective Neurokinin 1-receptor agonist Homspera® is both active on oral administration and provides therapeutic effects against the current pandemic H1N1 virus infection.
Preliminary analysis of ongoing bioavailability studies in rats had revealed the oral administration of Homspera resulted in measurable amounts of drug in lung tissue. Systemic absorption and accumulation in lungs was found after both oral and intra-duodenal administration in studies performed by a major, global contract research organization, with analytical work performed at MDx Bioanalytical Inc. of Tucson, Arizona.
Based on these findings, the Company commissioned H1N1 virus studies to be performed in the laboratories of a widely-respected University scientist. Using the accepted ferret model of H1N1 influenza virus infection, animals were treated orally (initially) with Homspera starting 24 hours following infection. While data collection and analysis is ongoing, preliminary evaluation of temperatures of infected ferrets reveals that orally-administered Homspera lessened the impact of influenza infection, resulting in shortened duration and more rapid resolution of the hyperthermia associated with infection.
Immune markers of infection remain to be assessed, but this pilot study apparently reveals that the ability of Homspera to attenuate symptoms of influenza virus infection, which have previously been reported in cotton rats infected with H3N2 influenza and in ferrets infected with H5N1 influenza, also extends to the current pandemic H1N1 strain.
These results, although preliminary, support the hypothesized mechanism of Homspera's immune system activation, and expands the therapeutic range over which activity of the compound has been shown in accepted animal models. Perhaps just as important is the demonstration that oral administration of Homspera results in therapeutic effects. This suggests appropriate oral formulations could provide convenient, efficacious immune system augmentation in a number of medical (e.g., cancer therapy, vaccine adjuvancy) and homeland security-related scenarios (e.g., CBRN threats, including unique and/or weaponized microbiological and viral agents).
About Homspera
Homspera is an adult stem cell active compound that has been shown in study results to regenerate and strengthen the immune system and enhance wound healing. Originally identified as providing protection from the lethal effects of acute radiation exposure, Homspera has been shown to affect a number of immunological and non-immunological cell types via its receptor-binding activity at the neurokinin-1 receptor (NK-1R). Studies also demonstrate the compound's hematopoietic stem cell stimulatory activity as well as immunomodulatory and anti-inflammatory activity in a number of model systems. To date, the FDA has issued Pre-Investigational New Drug (PIND) numbers to two derivatives of Homspera: one for Radilex® as a potential treatment of acute radiation exposure, and the other for Viprovex® as a potential treatment for novel forms of influenza.
About ImmuneRegen BioSciences, Inc.
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, 2008 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:
Michael K. Wilhelm OR John N. Fermanis
ImmuneRegen BioSciences Inc.
Phone: 480-922-3926
E-mail: mwilhelm@immuneregen.com
E-mail: jfermanis@immuneregen.com
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