RegeneRx data from Phase II trial due the last week of October Print E-mail
By Staff and Wire Reports   
Friday, 21 October 2011 05:01
fda calendarMicro-cap biotech, RegeneRx Biopharmaceuticals, Inc. (OTCBB:RGRX)) announced Friday morning that preliminary data analysis from their Phase 2 clinical trial with RGN-259 for the treatment of dry eye syndrome should be available the week of October 31st.

The analysis will include primary and secondary endpoints, as well as other key parameters identified in the clinical protocol. The double-masked, placebo-controlled clinical trial is assessing the safety and efficacy of RGN-259, the Company’s proprietary preservative-free eye drops, in reducing signs and symptoms of dry eye. Patients received RGN-259 or placebo twice daily for 30 days. Signs and symptoms of dry eye, such as the degree of ocular surface damage and ocular discomfort, were graded periodically during and following the treatment period. The trial is being conducted by Ora Inc., an ophthalmic contract research organization that specializes in dry eye research and clinical trials.


The BioMedReports FDA Calendar
and Worldwide Catalyst Tracker shows at least two other pending milestones for the company scheduled to take place in the near term. As such, shares may climb higher in anticipation of those forward looking catalysts.

Shares of the company had begun to climb in early August and topped off near the $.32 level before pulling back, basing and trading sideways during the past few sessions.

 RegeneRx is developing products based on Thymosin beta 4 (T Beta 4)- a naturally occurring peptide 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. 

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.

RegeneRx research and development efforts are primarily focused on collaborating with major research institutions to expand its technology platform for manufacturing and formulation of its products, and the sponsorship of human clinical trials. The company has collaborations with National Heart, Lung, and Blood Institute (NHLBI), University of Maryland, National Institutes of Health, The US Department of Health and Human Services  and others.

Dry eye syndrome is a common disorder affecting a significant percentage of the population, especially those older than 40 years of age, including an estimated 25-30 million in the U.S. Worldwide, the incidence is similar to that of the U.S. According to Global Data, an industry market research firm, the worldwide annual market for dry eye disorders was approximately $1.9 billion in 2010 and is estimated to reach $2.8 billion by 2017. 

The company has 79.96M shares outstanding with roughly 42.48M in the float. 31.35% of those are held by insiders and only 1.30% by institutions.

The company's recent financing events include the following:

January 7, 2011  Sigma-Tau Group, purchased USD 950,000 of the Company's common stock, and a new institutional investor, Lincoln Park Capital Fund, LLC has purchased USD 500,000 of the Company's common stock. All shares were purchased at USD 0.27 per share, a 35% premium over the previous day's closing price. In connection with these purchases, the Company issued to the purchasers common stock warrants to purchase 40% of the number of shares purchased, or an aggregate of 2,148,148 shares, at an exercise price of USD 0.38 per share over a five-year period. The transactions closed on January 7, 2011. In addition to the USD 1.45 million investment, RegeneRx entered into a separate purchase agreement with Lincoln Park that, subject to certain conditions and at RegeneRx's sole discretion, commits LPC to purchase up to USD 11 million of RegeneRx's common stock over a 30-month period. RegeneRx is required to file a registration statement with the U.S. Securities and Exchange Commission covering the resale of the shares that may be issued to Lincoln Park.  

June 02, 2010  RegeneRx completed a public offering of units have exercised an option to purchase an additional 1,624,750 units at USD 0.41 per unit, consisting of an aggregate of 1,624,750 shares of common stock and warrants to purchase an aggregate of 649,900 shares of common stock. 

May 18, 2010 RegeneRx announced the pricing of its previously announced underwritten public offering of 11,500,000 units of its securities at a public offering price of USD 0.41 per unit. Each unit consists of one share of RegeneRx common stock and 0.40 warrants to purchase common stock. Each warrant has a term of five years and represents the right to purchase one share of common stock at an exercise price of USD 0.56 per share. 

May 13, 2010  RegeneRx announced that it has been awarded a USD 3 million grant from the National Institutes of Health's National Heart, Lung and Blood Institute.  

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