BETHESDA, Md.--(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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INDUSTRY KEYWORDS: Health Biotechnology Pharmaceutical