ImmuneRegen's Viprovex Demonstrates Immune Response Potential in Treatment of Avian Influenza and Spanish Flu
08 Febbraio 2007 - 2:00PM
PR Newswire (US)
Leading Scientific Publication Highlights Likely Mechanism of
Action Underlying Avian Influenza and Spanish Flu deaths;
ImmuneRegen animal study results illustrate potential ability to
impact virus spread SCOTTSDALE, Ariz., Feb. 8
/PRNewswire-FirstCall/ -- ImmuneRegen BioSciences, a wholly-owned
subsidiary of IR BioSciences Holdings, Inc. (OTC:IRBO) (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. MEDIA CONTACT: W. Jason Grimley
Spelling Communications 310-477-9500 INVESTOR CONTACT: Josh
Reynolds CEOcast, Inc. 212-732-4300 DATASOURCE: ImmuneRegen
BioSciences, Inc. CONTACT: MEDIA, W. Jason Grimley of Spelling
Communications, +1-310-477-9500, or ; or INVESTORS, Josh Reynolds
of CEOcast, Inc., +1-212-732-4300, or Web site:
http://www.immuneregen.com/
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