ImmuneRegen BioSciences, Inc. and Virion Systems, Inc. Continue Testing Viprovex(R) and Tamiflu(R) as Possible Influenza Co-Trea
19 July 2007 - 9:00PM
PR Newswire (US)
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. (OTC:IRBO)
(BULLETIN BOARD: 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). All
trademarks used or mentioned in this release are protected by law.
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/.
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 March 31, 2007 and on Form 10-KSB
for the twelve months ended December 31, 2006 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. MEDIA CONTACT: W. Jason Grimley
Spelling Communications 310-477-9500 DATASOURCE: ImmuneRegen
BioSciences, Inc. CONTACT: W. Jason Grimley of Spelling
Communications, +1-310-477-9500, , for ImmuneRegen BioSciences,
Inc. Web site: http://www.immuneregen.com/
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