ImmuneRegen BioSciences(R) Partners With University of Rochester in BARDA Funding Bid
09 Settembre 2009 - 2:00PM
Marketwired
ImmuneRegen BioSciences®, a wholly owned subsidiary of IR
Biosciences Holdings Inc. (OTCBB: IRBS), today announced that, in
collaboration with Dr. Jacob Finkelstein at the University of
Rochester School of Medicine, they have submitted a proposal to the
U.S. government seeking funding to develop Homspera® as a
post-exposure therapy for injury resulting from ionizing radiation
exposure.
The proposal [a Broad Agency Announcement (BAA), sponsored by
The Biomedical Advanced Research and Development Authority (BARDA)
of the U.S. Department of Health and Human Services] expands on
research ImmuneRegen has previously performed demonstrating
efficacy of Homspera in treating pulmonary injury as well as
mitigating acute effects, including the hematopoietic syndrome,
resulting from exposure to ionizing radiation. The proposal
utilizes animal models validated at the University of Rochester
using NIAID funding that accurately depict the short- and long-term
pulmonary symptomatology (pneumonitis and fibrosis respectively)
that follow exposure to ionizing radiation. ImmuneRegen recently
filed an Investigational New Drug (IND) application with the FDA
for a similar indication, idiopathic pulmonary fibrosis.
If funded, the proposal will facilitate more rapid development
of Homspera toward clinical use, and under the Animal Efficacy
Rule, which permits the FDA to approve drugs and biologics for
indications where it is unethical or unfeasible to conduct human
efficacy studies, perhaps accelerate FDA approval of Homspera for
this specific use.
"The support from the agency thru BARDA legislation to advance
Homspera's development to mitigate injury caused in a potential
terrorist attack takes our company full circle," said ImmuneRegen
CEO Michael Wilhelm. "On behalf of the company we are all honored
to be working with someone as well-respected and experienced in the
field as Dr. Finkelstein."
Dr. Finkelstein, a professor in the departments of Pediatrics,
Radiation Oncology and Environmental Medicine at the University of
Rochester Medical School, is recognized for his investigations into
the effects of radiation on the pulmonary system. Dr. Finkelstein's
work has identified early immune system markers of pulmonary
fibrosis, as well as agents that can potentially mitigate the
lethal impact of this sequela of radiation exposure.
The Biomedical Advanced Research and Development Authority
(BARDA), within the Office of the Assistant Secretary for
Preparedness and Response in the U.S. Department of Health and
Human Services, provides an integrated, systematic approach to the
development and purchase of the necessary vaccines, drugs,
therapies, and diagnostic tools for public health medical
emergencies.
BARDA manages Project BioShield, which includes the procurement
and advanced development of medical countermeasures for chemical,
biological, radiological, and nuclear agents, as well as the
advanced development and procurement of medical countermeasures for
pandemic influenza and other emerging infectious diseases that fall
outside the auspices of Project BioShield. In addition, BARDA
manages the Public Health Emergency Medical Countermeasures
Enterprise (PHEMCE).
For this particular BAA, BARDA is anticipating program funding
of up to $750MM dependent on congressional approval and intends to
fund awards for up to 5 years in length.
About ImmuneRegen BioSciences Inc.
ImmuneRegen BioSciences Inc., a wholly owned subsidiary of IR
BioSciences Holdings, Inc. (OTCBB: IRBS), is a development-stage
biotechnology company focused on the research, development and
licensing of Homspera® and its derivatives. Homspera is an adult
stem cell active compound that in study results has been shown to
regenerate and strengthen the immune system and enhance wound
healing. Viprovex®, a derivative of Homspera, is being developed
for potential use against infectious diseases as a stand-alone or
combination therapy and as a vaccine adjuvant. To advance its
mission, the Scottsdale, Arizona based company has forged numerous
study partnerships with industry and academic leaders, including
Celgene Cellular Therapeutics, HemoGenix, Lovelace Respiratory
Research Institute and Virion Systems. For more information, please
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.
Add to Digg Bookmark with del.icio.us Add to Newsvine
Contact: John Fermanis ImmuneRegen BioSciences Inc. Phone:
480-922-3926 E-mail: Email Contact
Grafico Azioni IR BioSciences (CE) (USOTC:IRBS)
Storico
Da Giu 2024 a Lug 2024
Grafico Azioni IR BioSciences (CE) (USOTC:IRBS)
Storico
Da Lug 2023 a Lug 2024