IR BioSciences Announces Data Demonstrating Radilex Stimulation of Stem Cells Results in Hematopoietic Recovery Following Lethal
March 08 2007 - 9:11AM
PR Newswire (US)
Animal Data Shows Prolonged Survival AND Increased Platelet
Concentrations SCOTTSDALE, Ariz., March 8 /PRNewswire-FirstCall/ --
ImmuneRegen BioSciences, a wholly-owned subsidiary of IR
BioSciences Holdings, Inc. (OTC:IRBO) (BULLETIN BOARD: IRBO)
announced today that ongoing analysis of data acquired from
previously performed animal efficacy studies has revealed evidence
that ImmuneRegen's developmental stage product, Radilex(TM), may
stimulate hematopoietic stem cells. Studies performed at the Oak
Ridge National Laboratory reveal that ImmuneRegen's potential
radioprotectant product, Radilex, not only prolonged survival of
animals exposed to lethal gamma irradiation, but appeared to have
increased platelet concentrations in surviving animals. As the
experimental protocol required these animals to be subject to
repeated blood sampling as well as irradiation, saline injections
were relied on for plasma volume restoration. In the face of the
resulting hemodilution, compensatory hematopoietic mechanisms were
nonetheless adequately stimulated to enable survival of a number of
Radilex-treated, but no untreated, animals. Blood cell quantitation
showed trends in the surviving animals toward neutrophil
replenishment as well. ImmuneRegen has since filed a provisional
patent entitled "Method to Treat Blood Cell Depletion" to provide
intellectual property protection for this finding regarding
Radilex. Continuing radiation studies will be performed at both the
Translational Genomics Research Institute (TGen) and TGen Drug
Development Services (TD2, its drug development arm) and at the
Pacific Northwest National Laboratory to further explore the impact
of radiation on the hematopoietic system of Radilex-exposed
animals. ImmuneRegen's ongoing studies will be designed to examine
mechanistic indicators at both high levels of radiation where
Radilex has shown protection, as well as at lower levels. If
successful, these studies will enable Radilex to address both the
government market, as a countermeasure to radiological dispersion
devices ("dirty bombs"), as well as the cancer market, as an
adjuvant treatment candidate potentially ameliorating the side
effects resulting from cancer radiotherapy. "Recognizing our
candidate product has this effect is very motivating. These results
suggest a myriad of potential applications in which stem cell
replenishment is clinically useful, and not just leukemias and
lymphomas. We are excited about our research program and while
focused on our current development plan, fully expect to broaden
our understanding of the potential of Radilex based on upcoming and
planned studies at Battelle and TGen" said ImmuneRegen CEO Michael
Wilhelm. Hollis-Eden and Cleveland BioLabs recently reported
results on their respective radioprotectants in development.
Hollis-Eden reported on the effects of NEUMUNE(R) (HE2100) in
non-human primates exposed to 0.6 Gy total body irradiation and
without clinical support such as antibiotics, IV fluids and
platelet transfusions. They show an increase in survival in monkeys
injected daily with NEUMUNE for 5 days despite severe neutropenia
and thrombocytopenia. Of particular note, they find the
platelet-restoring effect of their steroid to be most predictive of
survival in treated animals. Studies carried out by Cleveland
BioLabs have revealed the ability of their CBLB502 radioprotectant
to protect non-human primates from the hematopoietic (as well as
gastrointestinal) damage of gamma radiation. Also, their CBLB612
compound has been reported to increase bone marrow hematopoietic
stem cells and enhance mobilization of these cells from bone
marrow. They hypothesize that these cells are useful in
repopulating irradiated animals with functionally competent
hematopoietic components, thus enhancing survival following lethal
doses of radiation. ImmuneRegen has routinely utilized lethal total
body radiation doses (7-9 Gy) in previously reported animal studies
of Radilex and has never artificially accelerated morbidity, or
provided clinical support, to post- radiation post-Radilex animals.
Thus, these future studies at TD2 and Pacific Northwest National
Laboratory have the potential to accelerate ImmuneRegen's Radilex
development program, and may support Radilex evaluation in
non-human primates later this year while advancing the
understanding of the underlying mechanisms by which its
radioprotectant activity is achieved. 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: IR
BioSciences Holdings, Inc. CONTACT: Media, W. Jason Grimley of
Spelling Communications, +1-310-477-9500, , for IR BioSciences
Holdings, Inc.; or Investors, Josh Reynolds of CEOcast, Inc.,
+1-212-732-4300, ; or In-House Investor Contact, Bill Lane of
ImmuneRegen BioSciences, Inc., +1-480-922-3926,
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