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ImmuneRegen's Viprovex Demonstrates Immune Response Potential In Treatment Of Avian Influenza And Spanish Flu

ImmuneRegen BioSciences, a wholly-owned subsidiary of IR BioSciences Holdings, Inc. (OTC Bulletin Board: IRBO) announced today that Viprovex(TM)has demonstrated the potential for treating potentially resurgent Spanish Flu (H1N1), Avian Flu (H5N1) and other infectious diseases based upon studies the Company has conducted in animal models showing protection from infection by Bacillis anthracis and influenza A viruses. Studies looking at potential mechanisms have examined cellular components of the host immune system and have found that in both animals and in cultured cells, Viprovex causes differential activation of components of the innate immune system, supporting the whole animal findings and suggesting that Viprovex may be capable of thwarting the immune system over-stimulation which might underlie the severe lethality of H1N1 (Spanish flu) as well as H5N1 influenza ("bird flu").

Pre-clinical results of Viprovex, used in the treatment of cotton rats infected with the H3N2/Wuhan human influenza virus, provided indications that Viprovex may have positive effects on enhancing immunity against influenza infection and supports ongoing development of Viprovex as a potential treatment for seasonal influenza. In those studies, cotton rats treated with Viprovex displayed diminished intrapulmonary and intrapharyngeal viral titers as well as enhanced well-being (as evidenced by weight gain and temperature maintenance).

Reporting in the journal Nature, scientists from Canada's Public Health Agency, in Winnipeg, Manitoba, have reported on what might be the underlying mechanism by which some influenza viruses can be so deadly (Kobasa D et al, Nature (2007) 445:319-323). Both the 1918 flu virus (Spanish Flu), which caused a pandemic in which an estimated 40-100 million died worldwide, and the threatening avian flu virus, seem to cause a "cytokine storm" in infected individuals and, as reported by Kobasa et al., in infected cynomolgus macaque monkeys. Normally, in the presence of an invading virus, the immune cells release chemicals (such as cytokines and chemokines) that cause inflammation, attract more immune cells and stimulate the development of cells and antibodies that attack the invading virus. Cytokine storm occurs when an infected individual's immune system remains activated against the virus beyond the point of being helpful to where the immune response turns deadly. Persistent, highly elevated levels of pro- and anti-inflammatory cytokines induce a complex, dysregulated condition resulting in massive pulmonary inflammation and fluid accumulation, vascular dysfunction and eventually shock and death. Thus, in cytokine storm, the body's immune system fights to rid itself of the virus, but somehow escapes from the normal controls that prevent an overzealous immune system from killing its owner.

As noted in the Nature publication, there are other disease conditions in which a hyperactive immune system is involved, and other drugs under development for treating those conditions might be beneficial in treating a pandemic influenza infection that could trigger cytokine storm. Specifically mentioned as central to regulation of the immune system, inflammation and hematopoiesis is the cytokine interleukin-6 (IL-6).

Normal production and release of IL-6 is integral to functioning immune and hematopoietic systems, activating lymphocytes and increasing B cell antibody production, but its generation has also been implicated in a number of other diseases, such as rheumatoid arthritis, multiple sclerosis, Alzheimer's Disease and AIDS dementia. Indeed, IL-6 overproduction has been reported to result in unregulated cell growth, and has specifically been associated with the blood cancer malignant myeloma. Interestingly, striking elevations in IL-6 were seen in both Kobasa (2007) and a retrospective study of H5N1-infected Vietnamese patients in 2004-5, in which 13 of the 16 studied had died.

IL-6 levels have been explored in studies performed by ImmuneRegen in which PCR experiments have probed messenger RNA molecules that code for immune system proteins. Viprovex was shown to elevate multiple components of the host immune system, among them IL-1, IL-6, IL-10, TNF-alpha (all involved in the response to Spanish and avian flu viruses) and a variety of cellular sensors such as TLRs (Toll-Like Receptors), intracellular pathogen recognition molecules such as nucleotide-binding oligomerization domains (NODs) and regulatory factors such as SOCS (suppressor of cytokine signaling). The interleukin mRNA elevations were noteworthy in that IL-1 and IL-10 increased 28x and 21x more than IL-6.

Animal studies in cotton rats confirm that in the lungs of animals treated with Viprovex (and more resistant to the effects of H3N2/Wuhan influenza virus), immunostimulatory cytokines are elevated significantly but IL-6 levels do not significantly increase. This relative underexpression of IL-6 mRNA relative to other immunostimulatory cytokines in these macrophage-like cells and lack of circulating IL-6 in animals treated with Viprovex, suggests that Viprovex might stimulate the immune system in a preferential way that conveys a lower tendency to trigger cytokine storm while enabling decreased viral titers and enhanced well-being.

In commenting on the ability of the 1918 virus to rapidly kill as documented in the Canadian study, Dr. Anthony Fauci, director of the National Institute of Allergy and Infectious Disease at the National Institutes of Health, stated, "There aren't a lot of things that can induce that robust of an inflammatory response that quickly." Clearly, agents that can blunt the lethality of such a response would be of significant value in treating the current H5N1 bird flu, as well as any possibly pandemic viral mutation that retained lethality.

Current studies are planned to confirm both anti-viral efficacy as well as these specific mechanistic findings in animal models for H5N1 and Spanish Flu, as well as expand efficacy observations against Anthrax to viral diseases such as Hepatitis C and Dengue Fever. Based on this work, management believes that focusing on infectious disease applications will continue to be the company's scientific and business strategy.

About Radilex(TM) and Viprovex(TM)

Radilex is the trade name used in referring to formulations of Homspera for potential indications for treatment of exposure to ionizing radiation. Viprovex 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 and Radilex, 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 http://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.

ImmuneRegen BioSciences, Inc.
http://www.immuneregen.com





ImmuneRegen lui Viprovex demonstreazã potenþialul de rãspuns imun la tratamentul de gripa aviarã ºi gripa spaniolã - ImmuneRegen's Viprovex Demonstrates Immune Response Potential In Treatment Of Avian Influenza And Spanish Flu - articole medicale engleza - startsanatate