RegeneRx Receives Mexican Patent for the Use of TB4 for Prevention and Treatment of Cardiac Damage
09 Dicembre 2010 - 4:51PM
Business Wire
RegeneRx Biopharmaceuticals, Inc. (NYSE Amex:RGN) (“the
Company” or “RegeneRx”) announced today that the Company received a
patent from the Mexico Patent and Trademark Office for the use of
thymosin beta 4 (Tβ4), its analogues, isoforms, and other
derivatives, for preventing or healing the damage that occurs from
a myocardial event, or heart attack. The patent expires in 2022.
RegeneRx has similar patents pending in a number of countries,
including the U.S. Based on recent clinical data, this year the
Company filed additional worldwide patent applications, which, if
granted, could potentially extend patent protection in this area
until 2030.
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 products
in clinical development.
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.
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