|RegeneRx Receives Key U.S. Heart Patent|
|By Staff and Wire Reports|
|Friday, 07 October 2011 06:02|
RegeneRx 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.
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.
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.