ROCKVILLE, Md.--(BUSINESS WIRE)--RegeneRx Biopharmaceuticals, Inc. (OTC Bulletin Board: RGRX) (“the Company” or “RegeneRx”) is reporting preliminary results from a double-masked, vehicle-controlled, physician-sponsored Phase 2 clinical trial evaluating RGN-259 for the treatment of severe dry eye. RGN-259 (Tβ4 preservative-free eye drops) was found to be safe and well-tolerated and met key efficacy objectives with statistically significant sign and symptom improvements, compared to vehicle control, at various time intervals, including 28 days post-treatment.
Nine patients with severe dry eye (18 eyes) were treated with RGN-259 or vehicle control six times daily over a period of 28 days. They were evaluated upon entering the study after a two week washout period, at weekly intervals during the treatment phase, at the end of the 28-day treatment period, and at a follow-up visit 28 days after treatment. Statistically significant differences in sign and symptom assessments, such as ocular discomfort and corneal fluorescein staining, were seen at various time points throughout the study. Of particular note were the differences between RGN-259 and vehicle control 28 days post-treatment, or the follow-up period. The RGN-259-treated group had a 35.1% reduction of ocular discomfort compared to vehicle control (p=0.0141), and a 59.1% reduction of total corneal fluorescein staining compared to vehicle control (p=0.0108).
Consistent with the reduction of ocular discomfort and fluorescein staining at the 28-day follow-up visit, other improvements seen in the RGN-259-treated patients included tear film breakup time and increased tear volume production. Likewise, these improvements were seen at other time points in the study.
The researchers are conducting additional analysis of the patient groups and will be submitting a manuscript for publication later this year.
“While the RGN-259 patients showed impressive clinical improvements over vehicle control patients during treatment, data from the 28-day follow-up period were equally impressive. Twenty-eight days after completing treatment, ocular improvements in the vehicle control group reverted toward their original pre-treatment scores while the ocular improvements in the RGN-259 group remained relatively stable, suggesting a more lasting clinical effect with RGN-259. This is an important observation when comparing an active compound to a control, such as an eye lubricant, that can sometimes provide limited but temporary relief for dry eyes,” commented Dr. Steven Dunn, holder of the physician-sponsored IND and an ophthalmologist at Michigan Cornea Specialists in Southfield, Michigan.
“We are very excited about the outcome of this Phase 2 trial. The fact that the study achieved statistically significant clinical differences between RGN-259 and vehicle control in key ocular assessments in this small number of patients is extremely encouraging. Moreover, these patients had severe dry eye, three of whom suffered from graft vs. host disease, giving us some confidence that we may see a positive effect in various types of dry eye patients,” stated Dr. Gabriel Sosne, an ophthalmologist at Wayne State University and the Kresge Eye Institute. Dr. Sosne is a member of RegeneRx’s scientific advisory board.
“The significant reduction in the signs and symptoms of dry eye are consistent with the anti-inflammatory, anti-apoptotic, and wound healing properties of thymosin beta 4, the active pharmaceutical ingredient in RGN-259. These results give us additional confidence that RGN-259 may be an effective therapeutic agent for the treatment of dry eye syndrome,” stated Dr. Allan L. Goldstein, professor of biochemistry and molecular biology at The George Washington University School of Medicine. Dr. Goldstein is also chairman of and chief scientific advisor to RegeneRx.
The clinical trial was conducted by Drs. Steven Dunn, David G. Heidemann, and Christopher Y.C. Chow at Michigan Cornea Specialists in Southfield, Michigan and Dr. Gabriel Sosne at the Wayne State University Detroit Medical Center/Kresge Eye Institute in Detroit, Michigan. The statistics were performed by Dr. Chaesik Kim at the Wayne State University/Kresge Eye Institute.
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 lid margins with alterations in surface lipids 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.
Dry eyes associated with Graft vs. Host Disease (GvHD) can be particularly severe and may result in significant patient discomfort and reduction in quality of life. Eye-related symptoms include blurry vision, foreign body sensation, burning sensation, severe light sensitivity, chronic conjunctivitis (pink eye), dry eyes and eye pain.
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 products.
RGN-259 is a sterile, preservative-free topical eye drop for ophthalmic indications. Based on a recently completed Phase 2 clinical trial in 72 patients with moderate dry eye syndrome, RGN-259 was found to show statistically significant improvements in several signs and symptoms of dry eye, as well as positive trends in other outcome measures. The results from two Phase 2 trials reflect RGN-259’s reported mechanisms of action and provide RegeneRx with FDA-approvable endpoints to be targeted in future clinical trials. Additionally, in separate studies, RGN-259 was shown to be an effective promoter of corneal healing in patients with chronic, medically unresponsive, non-healing corneal defects related to loss of corneal innervation (primarily associated with diabetes and herpes zoster).
RGN-352 is an injectable formulation to treat cardiovascular and central nervous system diseases, as well as other medical indications. RegeneRx is initially targeting RGN-352 for the treatment of patients who have suffered an acute myocardial infarction, or heart attack. Recent pre-clinical efficacy data suggests that RGN-352 may also benefit patients with multiple sclerosis, stroke and traumatic brain injury. 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. In 2010, 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. RegeneRx previously received $675,000 in grants from the U.S. FDA to support this clinical trial.
Forward-Looking Statements
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; that the clinical trial described herein is not predictive of future clinical results; 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, 2011, filed with the SEC on March 31, 2012, 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. 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.