RegeneRx Receives Australian Patent Using TB4 to Protect Against Biological, Chemical and Toxic Agents
December 01 2010 - 10:30AM
Business Wire
RegeneRx Biopharmaceuticals, Inc. (NYSE Amex:RGN) (“the
Company” or “RegeneRx”) announced today that the Company received a
patent in Australia using thymosin beta 4 (Tβ4), and various
fragments and anologues of Tβ4, to treat or prevent biological and
immunological responses to reactive chemical, biological or toxic
agents. The patent claims include allergic reactions such as
contact dermatitis, poison ivy, and insect bites, as well as skin
indications such as psoriasis and eczema, among others. The patent
expires in 2024. RegeneRx has patents pending for this use in a
number of countries, including the U.S.
About RegeneRx Biopharmaceuticals, Inc.
RegeneRx is focused on the development of a novel therapeutic
peptide, Thymosin beta 4, or Tβ4, for tissue and organ protection,
repair and regeneration. RegeneRx currently has three drug
candidates in clinical development and has an extensive worldwide
patent portfolio covering its products.
RGN-352 is an injectable formulation to treat cardiovascular and
central nervous system diseases, as well as other medical
indications. RegeneRx is initially targeting RGN-352 for the
treatment of patients who have suffered an acute myocardial
infarction, or heart attack. Recent pre-clinical efficacy data
suggests that RGN-352 may also benefit patients with multiple
sclerosis, stroke and traumatic brain injury. RegeneRx has
successfully completed a Phase 1 clinical trial with RGN-352 in
which the drug candidate was found to be safe and well-tolerated.
The company has initiated a Phase 2 clinical trial and expects to
enroll the first patient by early 2011 at approximately 25 clinical
sites in the U.S., Israel, and Russia. RegeneRx is also supporting
a Phase 1/2 physician-sponsored clinical trial in patients with
multiple sclerosis that is expected to begin in 2011. RegeneRx
recently received a $3 million, three-year development grant from
the NIH to support the company’s acute myocardial infarction
program.
RGN-259 is a sterile, preservative-free topical eye drop for
ophthalmic indications. Based on recent human clinical data,
RegeneRx is currently supporting a physician-sponsored Phase 2 dry
eye study with RGN-259. Previously, seven patients with non-healing
corneal ulcers were treated with RGN-259 under compassionate use
INDs. Five had complete healing and two had substantial healing of
their wounds. Three additional patients with corneal defects,
called punctate keratitis, had no evidence of healing although they
did report reduction in eye inflammation and increased comfort.
RGN-137, a topical gel formulation, is currently being evaluated
by RegeneRx in a Phase 2 clinical trial for the treatment of the
orphan skin disease epidermolysis bullosa. Other potential uses for
RGN-137 include the treatment of chronic dermal wounds and
reduction of scar tissue. RegeneRx previously received $675,000 in
grants from the U.S. FDA to support this clinical trial.
In addition to the pharmaceutical product candidates described
above, RegeneRx is pursuing the commercial development of peptide
fragments of Tβ4 for potential cosmeceutical use. RegeneRx holds
numerous patents and patent applications worldwide related to its
products and holds an exclusive worldwide license from the National
Institutes of Health, as well as other licenses related to Tβ4. The
Company recently received $733,438 in funding under the Patient
Protection and Affordable Care Act to support each of its product
candidates.
Forward-Looking
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facts are forward-looking statements made under the provisions of
the Private Securities Litigation Reform Act of 1995.
Forward-looking statements involve risks and uncertainties that
could cause actual results to be materially different from
historical results or from any future results expressed or implied
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forward-looking. Factors that may cause actual results to differ
materially from any future results expressed or implied by any
forward-looking statements include the risks and uncertainties
inherent in our business, including, without limitation the risk
that our product candidates do not demonstrate safety and/or
efficacy in future non-clinical or clinical trials; risks related
to our ability to obtain financing to support our operations on
commercially reasonable terms; the progress, timing or success of
our clinical trials; difficulties or delays in development,
testing, obtaining regulatory approval for producing and marketing
our product candidates; regulatory developments; the size and
growth potential of the markets for our product candidates and our
ability to serve those markets; the scope and validity of patent
protection for our product candidates; competition from other
pharmaceutical or biotechnology companies; and other risks
described in the Company’s filings with the Securities and Exchange
Commission (“SEC”), including those identified in the “Risk
Factors” section of the annual report on Form 10-K for the year
ended December 31, 2009, filed with the SEC on March 31, 2010, and
the quarterly report on Form 10-Q for the quarter ended September
30, 2010, as well as other filings it makes with the SEC. Any
forward-looking statements in this press release represent the
Company’s views only as of the date of this release and should not
be relied upon as representing its views as of any subsequent date.
The Company anticipates that subsequent events and developments may
cause its views to change, and the Company specifically disclaims
any obligation to update this information, as a result of future
events or otherwise, except as required by applicable law.
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