FDA Requests That ImmuneRegen BioSciences Conduct an Additional Study
26 March 2004 - 8:05AM
PR Newswire (US)
FDA Requests That ImmuneRegen BioSciences Conduct an Additional
Study SCOTTSDALE, Ariz., March 25 /PRNewswire/ -- During the March
12, 2004 meeting with the U.S. Food & Drug Administration's
Division of Counter-Terrorism (DCT), ImmuneRegen was requested to
conduct an additional mouse study utilizing its proprietary drug,
"Homspera," in a direct muscle injection delivery rather than our
previous aerosol method of administration. "This new method of drug
delivery has vast potential benefits for military personnel, first
responders to a terrorist attach or accident involving radioactive
material," said Michael Wilhelm, CEO for ImmuneRegen. The FDA
requested a subsequent meeting once this short study is completed.
This new research project will begin immediately at ImmuneRegen's
laboratory in collaboration with the University of Arizona College
of Medicine in Tucson, Arizona. About ImmuneRegen BioSciences, Inc.
ImmuneRegen BioSciences, Inc., a wholly owned subsidiary of IR
BioSciences Holdings,Inc. (OTC:IRBH) (BULLETIN BOARD: IRBH) , is a
biotechnology company engaged in the research and development of
applications utilizing modified Substance P, a naturally occurring
immunomodulator. Derived from homeostatic substance P, the company
has named their proprietary compound "Homspera." The Company's
initial focus is on the continuing development of Homspera for
various applications for use in improving pulmonary function and
stimulating the human immune system. For more information, please
visit the company's website at http://www.immuneregen.com/. About
Homspera ImmuneRegen's patents and continued substance P research
are derived from discoveries made during research funded by the Air
Force Office of Scientific Research in the early 1990s. During this
research, Dr. Witten and his associates observed that the exposure
of animals to jet fuels resulted in pathological changes in the
lung and immune systems of those exposed. It was also observed that
such exposure resulted in depletionof substance P from the lungs of
the animals. These studies further showed that the administration
of substance P may help prevent and reverse the effects of jet fuel
exposure in the lungs, as well as protect and regenerate the immune
system. The immune findings led to early research on the treatment
of exposure to acute radiation and on the possible reversal of lung
damage caused by ARDS and cigarette smoke. Statements about the
Company's future expectations, including future revenues and
earnings, 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. The Company's actual results
could differ materially from expected results as a result of a
number of factors, including the uncertainties inherent in research
collaborations, clinical trials and product development programs,
the evaluation of potential opportunities, the level of corporate
expenditures, capital market conditions, and others set forth in
the Company's SEC filings. DATASOURCE: ImmuneRegen BioSciences,
Inc. CONTACT: media, Michelle Derden of Spelling Communications,
+1-310-477-9500, ; or investors, Tony Schor of Investor Awareness,
+1-847-945-2222, ; both for ImmuneRegen BioSciences, Inc. Web site:
http://www.immuneregen.com/
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