IR BioSciences, Inc. Responds to the Recently Cancelled Acute Radiation Syndrome (ARS) RFP by DHHS
15 March 2007 - 2:47AM
PR Newswire (US)
ImmuneRegen to Meet With Government Agency to Present Recent
Findings/Data Utilizing Radilex as a Countermeasure for ARS
SCOTTSDALE, Ariz., March 14 /PRNewswire-FirstCall/ -- ImmuneRegen
BioSciences, Inc., a wholly owned subsidiary of IR BioSciences
Holdings, Inc. (OTC:IRBO) (BULLETIN BOARD: IRBO) announced today
that it believes Radilex(TM), its proprietary compound which has
already demonstrated through animal studies the potential for
treatment of acute radiation syndrome (ARS) following lethal doses
of radiation, may meet the new requirements of the expected
Department of Health and Human Services (DHHS) Request For
Proposals (RFP) for medical countermeasures to treat ARS. The
Company is meeting with HHS within the next two weeks to discuss
the upcoming opportunity, and update DHHS on their development
program. The Company will also address the role that Radilex can
play in mitigating the effects of a "dirty bomb." The original RFP
DHHS-ORDC-DDA-05-12 entitled "Medical Countermeasures to Mitigate
or Treat Neutropenia Alone or in Combination with Co-Morbidities
Associated with Acute Radiation Syndrome (ARS)" was closed on
February 23, 2006, with the award date set for June, 2006. After
multiple delays, the RFP was cancelled on March 7, 2007 because
none of the companies that submitted to the RFP met the
government's requirements. ImmuneRegen's Radilex was not submitted
in response to the initial RFP in early 2006 as insufficient data
had been collected. While this leaves the Nation without a
next-generation candidate radioprotective compound for procurement
into the Strategic National Stockpile, it highlights the
possibility that ImmuneRegen's Radilex, an 11-amino acid,
non-steroid, peptide analog of the endogenous neuromodulator
Substance P, could provide a safe and effective candidate once
additional data is collected. Animal studies have shown Radilex to
protect mice from lethal gamma irradiation, as well as a number of
bacterial and viral infections. Initial evidence suggests Radilex
may accomplish this by mobilizing hematopoietic stem cells to
mature and enter the circulation, replenishing the disease-fighting
and hemostatic components of the blood, the white blood cells and
platelets. Further studies are necessary for confirmation. "We
believe Radilex, although at an early stage of development,
represents a viable acquisition for Project BioShield," said
ImmuneRegen's Senior Director of Product Development and Regulatory
Affairs Hal Siegel, Ph.D. "Radilex has shown efficacy in small
animals. We're planning for non-human primate studies in the coming
months. In addition, this compound has demonstrated efficacy in
animals exposed to influenza, not merely radiation. Our drug is a
small peptide, not a steroid, which may have some additional value.
Also, Radilex has been administered by inhalation, as a powder,
which may make for a more stable formulation." The Company
continues to work with national laboratories and others such as
TGen and TD2 as testing facilities to perform additional research
and development activities on ImmuneRegen's proprietary compound.
TGen Drug Development Services (TD2), helps investigators from
research institutions, biotech and pharmaceutical companies
evaluate the efficacy of their drug candidate by using preclinical
models, genomic tools and coordination of Phase I clinical trials
at various clinical facilities, including Mayo Clinic Scottsdale,
Scottsdale Healthcare, the Arizona Cancer Center, and U.S.
Oncology. The Translational Genomics Research Institute (TGen), a
non-profit 501(c)(3) organization, is focused on developing earlier
diagnostics and smarter treatments. ImmuneRegen plans to utilize
these capabilities to perform various studies in support of the
Radilex development program for ARS. About Radilex(TM) and
Viprovex(TM) 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(TM) 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(TM) 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(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. Contact: MEDIA CONTACT: W. Jason
Grimley Spelling Communications 310-477-9500 INVESTOR CONTACT: Josh
Reynolds CEOcast, Inc. 212-732-4300 IN-HOUSE INVESTOR CONTACT: Bill
Lane ImmuneRegen BioSciences, Inc. 480-922-3926 DATASOURCE:
ImmuneRegen BioSciences, Inc. CONTACT: Media, W. Jason Grimley of
Spelling Communications, +1-310-477-9500, ; or Investors, Josh
Reynolds of CEOcast, Inc., +1-212-732-4300, , both for ImmuneRegen
BioSciences, Inc.; or Investors, Bill Lane of ImmuneRegen
BioSciences, Inc., +1-480-922-3926, Web site:
http://www.immuneregen.com/
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