RegeneRx Receives Clinical Study Report for Phase 2 Dry Eye Trial

ROCKVILLE, Md.--(BUSINESS WIRE)--Jan 5, 2012 - RegeneRx Biopharmaceuticals, Inc. (OTC Bulletin Board: RGRX) (“the Company” or “RegeneRx”) announced today that it has received the clinical study report for its recently completed Phase 2 clinical trial evaluating RGN-259 for the treatment of dry eye syndrome. The following conclusions were highlighted in the report's summary:

 

  • “The efficacy of RGN-259 for the topical treatment of the primary signs and symptoms of dry eye was proven with this study by its protective effects to adverse stimuli as well as its enhanced repair at 24-hour recovery after CAE [controlled adverse environment] challenge.”
  • “RGN-259 was shown to be safe and very well tolerated.”
  • “In this exploratory study with only 35 subjects per group, RGN-259 was shown to have clinically significant effects on dry eye, albeit not in the chosen pre-determined primary endpoints.”
  • “The significant protective effect that RGN-259 was shown to have on ocular discomfort and corneal staining in response to adverse stimuli indicate that changes in response to the CAE challenge are effective new endpoints for future clinical trials.”
  • “The ability of RGN-259 after one month of treatment to protect the eye from adverse stimuli has obvious clinical significance in the treatment of dry eye. Acceleration in wound repair is the probable mechanism of action behind the significant 24-hour recovery from damage ensued during CAE challenge with regard to central fluorescein corneal staining.”
  • “Protection from adverse stimuli, indicated by the dampening of response from baseline to CAE challenge after 28 days of treatment, was also proven in this pilot study. RGN-259 caused significant lowering of scores in ocular discomfort and superior and peripheral corneal staining compared to placebo treatment. These exciting findings have newly defined important primary endpoints for future studies.”

“We are pleased the study report confirmed preliminary findings that RGN-259 was safe, well tolerated, and had a clinically relevant and statistically significant effect on the treatment of the primary signs and symptoms of dry eye. In our next study with RGN-259, we intend to specifically focus on these results as we seek to move forward toward developing a novel and effective treatment for dry eye syndrome,” stated David Crockford, RegeneRx's vice president for clinical and regulatory affairs.

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 patients with 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. We believe the positive results of this Phase 2 exploratory trial reflect RGN-259's reported mechanisms of action and provide RegeneRx with FDA-approvable endpoints to be targeted in future clinical trials.

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. 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. Forward-looking statements in this press release include statements concerning the Company's efforts to complete a partnering transaction involving continue the development of RGN-259 and other statements that include the words “believe,” “goal,” “intend,” “will,” ”may,” “potential” or the negative of those words or other similar expressions. 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 potential commercial partners may be unwilling to enter into a strategic partnership with us involving RGN-259 or on terms acceptable to us or at all, the risk that our product candidates, including RGN-259, do not demonstrate safety and/or efficacy in current clinical trials or future non-clinical or clinical trials; risks related to our ability to obtain financing to support our operations on commercially reasonable terms and the ability to retain the services of critical Company personnel while seeking such financing; 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 quarterly reports 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.

 

Contact: For RegeneRx:
Lori Smith, 301-208-9191
las@regenerx.com

 

Posted: January 2012

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