PHOENIX, AZ--(Marketwire - May 28, 2009) - ImmuneRegen BioSciences, a wholly owned
subsidiary of IR BioSciences Holdings, Inc. (OTCBB: IRBS), is announcing
today the submission of an Investigational New Drug Application (IND) to
the U.S. Food and Drug Administration (FDA) to begin human clinical testing
of Homspera, an
analog of the endogenous neurokinin Substance P. The company plans to
evaluate Homspera initially as a treatment for Idiopathic Pulmonary
Fibrosis, a condition for which there are no consistently effective drugs
approved for human use in the U.S.
"This marks a major milestone in our efforts to explore the molecular
mechanisms and capabilities of Homspera and its potential to treat a range
of complications arising from damage to the immune system," commented
ImmuneRegen BioSciences CEO Michael K. Wilhelm. "We are encouraged by the
results of pre-clinical studies of Homspera and look forward to taking our
research to this next important level," he added.
Fibrosis is a progressive interstitial lung disease characterized by
scarring of lung tissue. Over time, the formation of scars replaces air
sacs with fibrotic tissue, preventing the lung from effectively
transferring oxygen into the bloodstream. The disease currently afflicts 5
million people worldwide and kills 40,000 annually, though these numbers
are believed to be artificially low due to misdiagnosis
(http://www.pulmonaryfibrosis.org/ipf.htm). Recent research suggests
Pulmonary Fibrosis is a reaction to microscopic injury to the lung
resulting from the inhalation of pollutants, radiation exposure, and other
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
ImmuneRegen BioSciences, a wholly owned subsidiary of IR BioSciences
Holdings, Inc. (OTCBB: IRBS), is a development-stage biotechnology company
engaged in the research, development and licensing of the potential drug
candidate Homspera and its derivatives Radilex® and Viprovex®.
Management is focused on the development of these drug candidates as
potential treatments for blood disorders and to accelerate wound healing.
Findings to date suggest additional opportunities for these compounds as a
vaccine adjuvant and potential treatment for influenza or other microbial
ailments, as well as for use as a possible countermeasure for homeland
security threats including radiological, chemical and biological agents.
For more information, 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-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.