RegeneRx Releases Results of Phase 2 Clinical Trial on Patients with Epidermolysis Bullosa

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RegeneRx Releases Results of Phase 2 Clinical Trial on Patients with Epidermolysis Bullosa

ROCKVILLE, Md.--(BUSINESS WIRE)-- RegeneRx Biopharmaceuticals, Inc. (OTC Bulletin Board: RGRX) ("the Company" or "RegeneRx") today announced results from its dose-escalating, double-blind, placebo-controlled Phase 2 clinical trial in 30 patients with dystrophic and junctional epidermolysis bullosa (EB), a severe "orphan" skin disorder with limited prevalence in the U.S. and Europe. RGN-137 (a topical formulation of Thymosin beta 4 or Tβ4) was administered to a single non-healing index lesion in these patients daily for 56 days and followed for an additional 14 days post-treatment.

The clinical trial, initiated in 2006, met its primary outcome measure of safety. There were no serious adverse events associated with RGN-137 and the drug candidate was deemed safe and well-tolerated. These safety data are important as EB patients are severely compromised by their wounds.

The secondary outcome measures to determine the time (in number of days) to complete wound healing and the number of patients with complete wound healing could not be statistically measured due to too few patients with complete healing during the treatment period.

The company performed an ad hoc analysis of all patients in the study to determine any differences in acceleration of wound healing in each of the three active dose groups and in the placebo group. The results indicated that there appeared to be improvements in acceleration of wound healing in every dose group over placebo. The mid-dose (0.03%) provided the best results, which was similar to results seen in two previously reported phase 2 dermal wound healing trials in non-EB patients with venous stasis and pressure ulcers. The mid-dose mean (average) wound size decreased 57.3% from baseline after 14 days of treatment compared to the placebo decrease of 30.4% from baseline over the same period, or a difference of approximately 27%. Mean wound sizes in patients receiving placebo were similar to mean wound sizes in patients receiving RGN-137 by the end of the 56-day study.

In dermal wound healing clinical trials, patients receiving placebo (in this case the dermal gel without Tβ4) often respond positively to "good wound care," a treatment standard against which drug candidates are commonly compared.

"I am encouraged by these results as any modality that can enhance wound healing will have a clinically relevant impact in patients with inherited EB, since the presence of non-healing wounds on the skin increases the risk of secondary bacterial infections, is often associated with severe if not debilitating pain, is a source of blood and protein loss, and is believed to be an important contributing factor in the eventual development of potentially life-threatening squamous cell cancers in these patients," commented Dr. Jo-David Fine, the principal investigator of the study and Professor of Medicine (Dermatology) and Pediatrics, at Vanderbilt University School of Medicine, Nashville, Tennessee.

"These results are consistent in many respects with results of previous clinical trials treating patients with Tβ4 formulations for skin and eye disorders. Specifically, in addition to the strong safety profile of the drug candidate, it appears that Tβ4 is the key signaling molecule prompting the body to initiate and/or accelerate the wound healing process by reducing inflammation and stimulating cell migration and angiogenesis, the first critical steps in the wound healing cascade," according to Dr. Hynda Kleinman, Former Chief of the Cell Biology Section at the National Institute of Dental and Cranial Research, Bethesda, Maryland, and a consultant to RegeneRx.

About RegeneRx Biopharmaceuticals, Inc. ( )

RegeneRx is focused on the development of a novel therapeutic peptide, Thymosin beta 4, for tissue and organ protection, repair and regeneration. RegeneRx currently has three drug formulations in development for ophthalmic, cardiac, central nervous system and dermal indications, two strategic licensing agreements in China and the EU, and has an extensive worldwide patent portfolio covering its products.

About Epidermolysis Bullosa (EB)

EB is a group of genetic disorders characterized by exceptionally fragile skin and chronic, painful wounds and blisters caused by the slightest trauma, even normal day-to-day activities. EB is caused by missing or damaged proteins that cause a breakdown between skin layers, resulting in skin that can slip off as easily as that of a ripe peach. There is no treatment for EB other than "good wound care." The disease affects people of both genders and every ethnicity and can lead to infections, cancer and premature death. EB is an "orphan disorder," meaning the condition itself affects less than 200,000 Americans, most likely less than several thousand dystrophic and junctional subtypes, the most severe manifestations of EB.

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. Results of clinical trials may be subject to additional analysis that could offer different conclusions and/or not be reproducible in future clinical trials. Any 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. Please view these 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, 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. The Company specifically disclaims any obligation to update this information, as a result of future events or otherwise, except as required by applicable law.

RegeneRx Biopharmaceuticals, Inc.
Lori Smith, 301-208-9191

KEYWORDS:   United States  North America  Maryland


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