RegeneRx Receives Key U.S. Heart Patent Print E-mail
By Staff and Wire Reports   
Friday, 07 October 2011 06:02
FDA calendarRegeneRx Biopharmaceuticals (OTCBB:RGRX) announced late Thursday afternoon that it has received a notice of allowance from the U.S. Patent and Trademark Office for its application claiming methods for treating, preventing, inhibiting or reducing tissue deterioration due to congestive heart failure disease using Thymosin beta 4 (Tβ4), its isoforms and fragments, and important analogs. The patent is projected to expire July 2027.

Shares rose 7.41% on the news on slightly higher than average volume.

“We are very pleased to be receiving this important patent using Tβ4 to treat congestive heart failure,” said J.J. Finkelstein, chief executive officer of RegeneRx. “We have a number of other patent applications in this field in the U.S. and around the world where we are awaiting similar action. This new patent will be an important part of our intellectual property estate that we will continue to expand for treatment of the heart and surrounding tissues.”

The micro-cap firm is developing products based on Thymosin beta 4 (T Beta 4); a naturally occurring peptide which is found in high concentrations in blood platelets, wound fluid and other tissues in the body. T Beta 4 has been found to play an important role in protection, regeneration and remodeling of injured or damaged tissues. Its T Beta 4 involved in a wide variety of biological activities includes regulation of actin, epithelialization, angiogenesis, apoptosis and anti-inflammation.

A look at the BioMedReports FDA Calendar shows three upcoming catalysts for the stock, including two Phase II trial events scheduled this quarter (4Q 2011) and a Phase I/II trial initiation scheduled to take place during the first quarter of 2012.

Late last month, RegeneRx announced that treatment and follow-up have been completed on 69 patients in the Company’s Phase 2 clinical trial with RGN-259 for the treatment of dry eye syndrome, five more than the number of evaluable patients contemplated in the trial’s protocol. After all study data completes the quality control process and data lock it will then undergo statistical analyses. The trial is on schedule for top-line results to be reported in late October. That trial is a double-masked, placebo-controlled trial testing the safety and efficacy of RGN-259, the Company's proprietary preservative-free eye drops, against a placebo.

Patients enrolled in that trial were scheduled to receive RGN-259 or placebo twice daily for 30 days. Signs and symptoms of dry eye, such as the degree of ocular surface damage, ocular itching, burning and inflammation, among others, will be measured periodically during the treatment period.

RegeneRx also announced on Thursday afternoon that it had received a patent in Mexico for treating or preventing biological or immunological response to reactive chemical, biological, or toxic agents using Tβ4.

RGRX is a clinical-stage, biopharmaceutical company engaged in the design, research and development of novel peptides targeted at diseases with unmet medical needs. It was founded in 1982 with a mission to research and develop novel pharmaceuticals that protect and repair tissue and organ damage caused by disease, trauma or other pathology.

RegeneRx's products include: RGN352 for the treatment of Acute Myocardial Infarction; RGN137, a topical gel formulation of the peptide Tbeta4, as a novel treatment to accelerate dermal wound healing; RGN-259, a Tbeta4-based sterile eye drop, as a novel treatment for corneal healing; and RGN-457 as a novel inhaled (via nebulization) treatment for cystic fibrosis and bronchiectasis.

In March 2011 the FDA placed a “clinical hold” on the Company's Phase 2 AMI trial due to cGMP issues at a contract manufacturer’s site formulating RGN-352. The timing for the resumption of that trial are unclear.

The firm has 79.96M shares outstanding with 42.48M in the float. 31.35% of those shares are held by insiders. Shares are currently in an up-trend and trading just above their 50-day moving average, only three cents below their 52-week high.

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