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RegeneRx Biopharmaceuticals 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
ROCKVILLE, MD, USA | September 23, 2011 | RegeneRx Biopharmaceuticals, Inc. (OTC Bulletin Board: RGRX) (“the Company” or “RegeneRx”) today 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.
“We are very excited about the potential for development of RGN-259 to treat dry eye syndrome and are looking forward to reporting top-line data in the latter part of October”
This double-masked, placebo-controlled clinical trial will evaluate the safety and efficacy of RGN-259, the Company’s proprietary preservative-free eye drops, in patients with dry eye syndrome. 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, ocular itching, burning and grittiness, among others, was 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 are available at:
http://www.clinicaltrials.gov/ct2/show/NCT01387347?term=thymosin+beta+4&rank=5
“We are very excited about the potential for development of RGN-259 to treat dry eye syndrome and are looking forward to reporting top-line data in the latter part of October,” said J.J. Finkelstein, chief executive officer of RegeneRx. “Dry eye syndrome is an all-too-common disorder and current treatments are inadequate in a majority of cases. As such, should the data be positive, we believe a Phase 3 study could be initiated early next year, either by a strategic partner or RegeneRx, providing a relatively low-cost clinical development opportunity for a high-value indication.”
In two animal models RGN-259 reduced ocular surface defects associated with dry eye syndrome compared with 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 clinical improvements with RGN-259 were statistically significant. These data were presented at the 2011 ARVO meeting this past spring.
Published human data indicate 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 during 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 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 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 punctate epithelial defects of the cornea reported reduction in eye inflammation and increased comfort following treatment with RGN-259. RegeneRx is also supporting a small physician-sponsored Phase 2 dry eye study with RGN-259.
RGN-352 is an injectable formulation of Tβ4 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 of Tβ4, 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.
SOURCE: RegeneRx |
