RegeneRx Awarded $733,438 from U.S. Government Under the Patient Protection and Affordable Care Act
01 Novembro 2010 - 2:56PM
Business Wire
RegeneRx Biopharmaceuticals, Inc. (NYSE Amex:RGN) (the
“Company” or “RegeneRx”) announced today that it has been awarded
$733,438 under HR: 3590 – Patient Protection and Affordable Care
Act (the “Act”) in immediately available funds. Under the Act, $1
billion was made available to stimulate promising therapeutic
research for serious and life-threatening diseases by small
biotechnology companies. Applicants were required to submit
detailed information demonstrating that their research conformed to
the parameters of the Act, along with a summary of qualifying
expenditures that formed the basis for the award. RegeneRx
submitted three applications, one for each of its drug candidates
under active development. All three applications received an
award.
Individual companies, regardless of the number of applications
filed, were eligible to receive awards equal to 50% of qualifying
research and development expenses incurred during 2009 and 2010, up
to an aggregate maximum of $5 million per applicant. RegeneRx
applied for approximately $5 million in the aggregate. The award of
$733,438 represents a pro rata reduction applied to all applicants,
as the program was significantly over-subscribed. RegeneRx will
recognize the full award as revenue during the fourth quarter of
2010.
“This award is extremely valuable to companies like ours as it
provides significant non-dilutive capital in furtherance of our
clinical development activities, a specific objective of this
grant. While we are disappointed that we did not receive the full
amount under our application, we understand the broad appeal of
this program which led to the significant over-subscription of
funds available,” stated J.J. Finkelstein, RegeneRx’s president and
chief executive officer.
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 and stroke. 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 early 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 75
issued patents and has 261 patent applications pending worldwide
related to its products and holds an exclusive worldwide license
for Tβ4 from the National Institutes of Health.
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