Date: Jul 19, 2007 Source:
ImmuneRegen's Viprovex(R) Shows Adjuvant Activity with Avian Influenza Vaccines and Decreases Lung Symptoms in Animals Exposed to Influenza Virus and Treated with Tamiflu(R)
SCOTTSDALE, Ariz., July 19 /PRNewswire-FirstCall/ -- ImmuneRegen BioSciences, a wholly owned subsidiary of IR BioSciences Holdings, Inc. (OTCBulletinBoard:IRBO), today announced adjuvant activity of its immunomodulator, Viprovex(R) when administered in conjunction with peptide vaccines in development at GenPhar Incorporated. Additional preliminary results from pre-clinical tests in small animals on Viprovex(R) in conjunction with Tamiflu(R) (Roche's FDA-approved influenza prophylactic and treatment) show that treating subjects with both Viprovex and Tamiflu protect lungs against the damaging inflammatory effect of influenza infection more successfully than treating with Tamiflu alone.
The adjuvant studies examined the effect of Viprovex administered as an adjuvant to CadVax-based pandemic influenza vaccines in development at GenPhar Inc. These previously announced studies have revealed the ability of intranasal Viprovex to speed up the immune response and enhance the breadth of neutralizing activity in animals vaccinated with GenPhar's flu vaccine. In a Spanish flu vaccine study, Viprovex enhanced the antibody responses two- to three-fold at early time points after the vaccination, and enabled the Spanish flu vaccine to provide 100% cross-protection against challenge with a highly pathogenic avian influenza (A/Indonesia/5/05) virus.
"These are desirable features of a modern vaccine adjuvant in providing early and broad protections in a flu pandemic scenario," said Dr. David Holman, who led the multi-party testing at GenPhar, Inc.
In the Tamiflu studies, performed on cotton rats at Virion Laboratories, animals infected with the H3N2 Influenza A/Wuhan/395/95 virus (as a model for the current pandemic-threatening H5N1 avian influenza virus) developed pulmonary inflammation in addition to the decreased temperature, weight loss and nasal and pulmonary viral accumulation reported previously. Analysis revealed equivalent or greater inflammatory pathology in the Tamiflu-treated animal lungs as in untreated infected lungs. Inflammation was diminished in influenza-exposed animals treated with Viprovex alone, or, interestingly, Viprovex in conjunction with Tamiflu. This finding, measured at 1, 2 and 4 days post-infection, suggests the potential for Viprovex to decrease virus- induced inflammatory responses in subject's lungs, in addition to the previously reported positive effects on viral load, temperature and weight.
"As announced previously, and as confirmed in this most recent work, Viprovex effectively lowers viral load in lung and nose, and diminishes the impact of infection on temperature and weight loss," said Hal Siegel, Ph.D. Senior Director of Product Development and Regulatory Affairs, ImmuneRegen BioSciences, Inc. "In light of these recent positive findings on pulmonary inflammation, we feel it is prudent to continue studying Viprovex as a potential adjunctive to Tamiflu. We hope to expand our studies to better define this protective effect and its relevance to treatments currently approved by FDA for use in humans."
Tamiflu (oseltamivir phosphate, Roche Pharmaceuticals) is an FDA-approved treatment and prophylactic against influenza in patients aged one year and older. Since 2004, governments of over 75 countries have purchased Tamiflu for stockpiling in anticipation of a feared pandemic influenza outbreak, and sales of Tamiflu were reported by Roche in 2006 to total 1.8 billion Swiss francs (approximately $1.5 billion).
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About Virion Systems, Inc.
Virion Systems, Inc. (VSI) is a Maryland biotechnology corporation focused on the prevention and treatment of infectious diseases, particularly those involving infants and children. Their core technology is the use of the cotton rat as an animal model of human infectious diseases. VSI performs contract research for academic and commercial groups, centered around the use of the cotton rat (genus Sigmodon) which has been shown to be permissive for a wide array of human viral, bacterial, rickettsial and parasitic pathogens, including influenza virus (types A and B). VSI is also developing an array of cotton rat-specific reagents that will eventually include both RNA and antibody-based reagents for the detection and quantitation of cytokines, chemokines, immunoglobulins and cell-surface markers.
About Radilex(TM) and Viprovex(R)
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(R) 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. Sar9, Met (O2)11-Substance P is 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(R) 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(R), 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.
