RegeneRx Biopharmaceuticals, Inc. (OTC Bulletin Board: RGRX) (“the Company” or “RegeneRx”) has announced that the first patients have been enrolled and randomized to receive RGN-259 or placebo in its 72-patient, Phase 2 clinical trial in patients with dry eye syndrome. The Company expects to complete patient enrollment in August and for the last patient to complete the study the third week in September, with preliminary data from the study scheduled to be available in October 2011. The trial is a double-masked, placebo-controlled clinical trial to evaluate the safety and efficacy of RGN-259, the Company's proprietary preservative-free eye drops. Patients will 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 grittiness, among others, will be 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. Additional details regarding the Phase 2 trial may be seen online at:
“We are pleased patient enrollment has proceeded as scheduled and look forward to completing this important clinical trial and evaluating patient data as quickly as possible,” stated David Crockford, RegeneRx's vice president for clinical and regulatory affairs.
RGN-259 has been shown to reduce ocular surface defects associated with dry eye syndrome in two animal models when compared to both positive and negative controls. In one experiment, RGN-259 performed better than Restasis™ in reducing such damage. Restasis is the only drug currently approved by the U.S. Food and Drug Administration to treat dry eye syndrome. In several comparisons to controls, the improvements with RGN-259 were statistically significant. These data were presented at the 2011 ARVO meeting this past spring.
Human data have been reported and published indicating that RGN-259 can successfully heal ocular surface defects, which most often occur as a result of dry eye syndrome and particularly in patients with moderate to severe dry eye. The first patient ever treated with RGN-259, who had a non-healing corneal wound 23 days after surgery, healed within 11 days after treatment with RGN-259. In a series of six patients with neurotrophic corneal epithelial defects that had not healed for a minimum of six weeks, all either completely healed or substantially healed within the treatment period.
About Dry Eye Syndrome
Dry eye syndrome (DES) is a common disorder affecting a significant percentage of the population, especially those older than 40 years of age. It estimate that the number of people affected ranges from 25-30 million in the United States. Worldwide, the incidence rate is similar to that of the United States. According to Global Data, an industry market research firm, the world-wide annual market for dry eye disorders was approximately $1.9 billion in 2010 and is estimated to reach $2.8 billion by 2017. The development of dry eyes can have many causes. They include: (1) age – people over age 65 often experience some symptoms of dry eyes; (2) gender – women are more likely to develop dry eyes due to hormonal changes caused by pregnancy, the use of oral contraceptives, and menopause; (3) medications – certain medicines, including antihistamines, decongestants, blood pressure medications and antidepressants; (4) medical conditions – persons with rheumatoid arthritis, diabetes, thyroid problems, Sjögren's syndrome, and lupus are more likely to have symptoms of dry eyes; (5) blepharitis – inflammation of the surfaces of the eye, or the inward or outward turning of eyelids can cause dry eyes to develop; (6) environmental conditions – exposure to smoke, wind and dry climates can increase tear evaporation resulting in dry eye symptoms; (7) other factors – long term use of contact lenses, and refractive eye surgeries, such as LASIK.
About RegeneRx Biopharmaceuticals, Inc. (www.regenerx.com)
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 drug candidates in clinical development and has an extensive worldwide patent portfolio covering its product candidates.
RGN-259 is a sterile, preservative-free topical eye drop for ophthalmic indications. RegeneRx has recently completed two animal studies showing RGN-259's positive effects on dry eye symptoms and has positive human data indicating its ability to heal corneal ulcers. Based on these data, the Company is sponsoring a double-masked, placebo-controlled Phase 2 clinical trial. Of seven previous patients with non-healing ocular surface defects who were treated with RGN-259, all had complete or substantial healing. Three additional patients with corneal defects, called punctate keratitis, reported reduction in eye inflammation and increased comfort. RegeneRx is currently also supporting a small physician-sponsored Phase 2 dry eye study with RGN-259.
RGN-352 is an injectable formulation to treat cardiovascular and central nervous system diseases, as well as other medical indications. 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 over a wide dose range. The Company previously planned to initiate a Phase 2 clinical trial at approximately 20 clinical sites in the U.S., Israel, and Russia; however, this trial is currently on an FDA-imposed clinical hold due to cGMP issues at an outside contract manufacturer. Last year, RegeneRx received a $3 million, three-year development grant from the NIH to support the company's acute myocardial infarction program.
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.
Any statements in this press release that are not historical facts are forward-looking statements made under the provisions of the Private Securities Litigation Reform Act of 1995. These forward-looking statements involve risks and uncertainties that could cause actual results to be materially different from historical results or from any future results expressed or implied by such forward-looking statements. You are urged to consider statements that include the words “expect,” “estimate,” “will,” “may,” “potential” or the negative of those words or other similar expressions to be uncertain and forward-looking. Factors that may cause actual results to differ materially from any future results expressed or implied by any forward-looking statements include risks related to uncertainties inherent in our business, including, without limitation the risk that our product candidates do not demonstrate safety and/or efficacy in clinical trials; risks related to our ability to obtain financing to support our operations on commercially reasonable terms; the progress, timing or success of our clinical trials; difficulties or delays in development, testing, obtaining regulatory approval for producing and marketing our product candidates; regulatory developments; the size and growth potential of the markets for our product candidates and our ability to serve those markets; the scope and validity of patent protection for our product candidates; competition from other pharmaceutical or biotechnology companies; and other risks described in the Company's filings with the Securities and Exchange Commission (“SEC”), including those identified in the “Risk Factors” section of the annual report on Form 10-K for the year ended December 31, 2010, filed with the SEC on March 31, 2011, and subsequent quarterly reports filed on Form 10-Q, as well as other filings it makes with the SEC. Any forward-looking statements in this press release represent the Company's views only as of the date of this release and should not be relied upon as representing its views as of any subsequent date. The Company anticipates that subsequent events and developments may cause its views to change, and the Company specifically disclaims any obligation to update this information, as a result of future events or otherwise, except as required by applicable law.
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