ImmuneRegen BioSciences(R) Announces Partnership With Bachem, Inc., for Manufacturing of Homspera(R)
22 Setembro 2009 - 9:00AM
Marketwired
ImmuneRegen BioSciences®, Inc., a wholly owned subsidiary of IR
BioSciences Holdings, Inc. (OTCBB: IRBS), today announced an
agreement with Bachem, Inc., enabling Bachem to be the primary
manufacturer of ImmuneRegen's Homspera® drug substance. Homspera is
a peptide analog of the endogenous neurokinin Substance P, and is
actively being developed by ImmuneRegen for a number of therapeutic
indications including cancer, infectious diseases, pulmonary
diseases such as Idiopathic Pulmonary Fibrosis, and wound healing.
Under the agreement Bachem will produce the active
pharmaceutical ingredient Homspera under current Good Manufacturing
Practices (cGMP) in quantities necessary to support formulation,
pre-clinical studies and to perform a number of Phase I studies in
humans under an FDA-cleared Investigation New Drug Application
(IND). Only drugs produced under cGMP may be administered to
humans.
"The opportunity to partner with Bachem for our manufacturing
needs is priceless for ImmuneRegen," said Michael Wilhelm, CEO of
ImmuneRegen. "Bachem has produced a broad range of peptides under
cGMP for use in preclinical and clinical studies. Having a
relationship with a manufacturer as well-known and well-respected
as Bachem eliminates a number of manufacturing-related hurdles, and
provides ImmuneRegen with a partner who understands what the U.S.
FDA is looking for from peptide manufacturers. We feel this
relationship will thus facilitate ImmuneRegen's FDA interactions
regarding Homspera."
About Bachem, Inc.
Bachem is an independent, technology-based, public biochemicals
company providing full service to the pharma and biotech industry.
Bachem is specialized in the process development and the
manufacturing of peptides and complex organic molecules as active
pharmaceutical ingredients (APIs), as well as innovative
biochemicals for research purposes. With headquarters in Bubendorf,
Switzerland, and affiliates in Europe and the US, Bachem works on a
global scale and holds a leading position in the field of peptides.
For more information please visit www.bachem.com
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.
Contact: John Fermanis ImmuneRegen BioSciences Inc. Phone:
480-922-3926 E-mail: Email Contact Michael K. Wilhelm Email: Email
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