ImmuneRegen BioSciences Submits Homspera(R) for FDA Orphan Drug Product Designation for the Treatment of Idiopathic Pulmonary Fi
March 04 2010 - 8:00AM
Marketwired
ImmuneRegen BioSciences Inc.®, a wholly owned subsidiary of IR
Biosciences Holdings Inc. (OTCBB: IRBS), today announced the
submission of an application for Orphan Drug Product Designation
for the company's lead compound, Homspera®, for the application of
treating Idiopathic Pulmonary Fibrosis, a deadly pulmonary disease
with no FDA-approved treatments.
The United States Orphan Drug Act was created in 1983 to provide
incentives for companies to develop and market treatments for
diseases or conditions affecting fewer than 200,000 people in the
United States. The designation provides eligibility for a
seven-year period of market exclusivity in the United States after
product approval, a waiver of user fees, the potential for grant
funding, and tax benefits for clinical trials. Many orphan products
receive expedited review or accelerated approval because they are
for serious or life-threatening diseases.
Idiopathic Pulmonary Fibrosis is a progressive interstitial lung
disease characterized by scarring of lung tissue. Over time, the
formation of scars replaces air sacs with fibrotic tissue,
preventing the lung from effectively transferring oxygen into the
bloodstream. Recent research suggests pulmonary fibrosis may be a
reaction to microscopic injury to the lung resulting from the
inhalation of pollutants, radiation exposure, and other
insults.
ImmuneRegen continues to advance the development of its Homspera
drug candidate for the treatment of Idiopathic Pulmonary Fibrosis
in collaboration with Dr. Jacob Finkelstein at the University of
Rochester and several Contract Research Organizations.
"ImmuneRegen is excited to be pursuing the indication of
Idiopathic Pulmonary Fibrosis most aggressively, as this disease is
still without an effective licensed treatment in the U.S., although
many expect InterMune's pirfenidone to eventually be approved. The
relative lethality yet low prevalence of IPF confers Orphan Drug
Status and Fast Track eligibility for many potential therapeutics,
and most analysts believe IPF therapies will have a multi-billion
dollar commercial market. Leveraging the support of our industry
and academia partners will allow us to expedite the development of
Homspera for this indication, and will expand opportunities for
more rapid development in the other areas we are and or expect to
pursue, such as neutropenia, Influenza and Melanoma," explained
ImmuneRegen CEO Michael Wilhelm.
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®. 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. 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 the Company's future expectations, including
statements about the potential use and scientific results 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 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-Q
for the three months ended September 30, 2009 as filed with the
Securities and Exchange Commission and report on Form 10-K for the
year ended December 31, 2008 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: Michael K. Wilhelm OR John Fermanis ImmuneRegen
BioSciences Inc. Phone: 480-922-3926 Email: Email Contact Email:
Email Contact
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