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RegeneRx Receives Ophthalmic Patent in Hong Kong
Tuesday, April 22, 2008
Bethesda, MD -- RegeneRx Biopharmaceuticals, Inc. (AMEX: RGN) (www.regenerx.com) announced today that it has received official notice from the Hong Kong Intellectual Property Department granting a patent using Tß4, analogues, isoforms and derivatives to accelerate corneal wound healing and reverse or inhibit eye degeneration. The patent claims are based on a significant body of data supporting the use of Tß4 for wound healing of the cornea and other areas in and around the eye.
Tß4’s corneal wound healing properties are being tested in a RegeneRx-sponsored Phase II clinical trial using an ophthalmic formulation, RGN-259, in diabetic vitrectomy patients, where a portion of the outer layer of the cornea is sometimes removed in order for surgeons to perform the procedure. Due to their diabetes, these patients often have problems healing quickly or at all.
About RegeneRx Biopharmaceuticals, Inc.
RegeneRx is focused on the discovery and development of novel molecules to accelerate tissue and organ repair. Currently, RegeneRx is developing three product candidates, RGN-137, RGN-259 and RGN-352 for dermal, ophthalmic, and cardiovascular wound healing, respectively. These product candidates are based on Tß4, a 43-amino acid peptide, in part, under an exclusive world-wide license from the National Institutes of Health. Preliminary research suggests that Tß4 may prove efficacious for multiple indications; therefore, RegeneRx is developing several product candidates as part of a broad therapeutic platform. RegeneRx holds over 60 world-wide patents and patent applications related to dermal, ocular, and internal wounds and tissue repair, cardiac and neurological protection and injuries, septic shock and several consumer product areas. RegeneRx is currently sponsoring three Phase II chronic dermal wound healing clinical trials, a Phase II ophthalmic wound healing clinical trial, and a Phase Ia parenteral clinical trial in support of systemic administration of RGN-352 for its cardiovascular clinical development program.
The RegeneRx Technology Platform
Tß4 is a synthetic version of a naturally occurring peptide present in virtually all human cells. It is a first-in-class product candidate that promotes endothelial cell differentiation, angiogenesis in dermal tissues, keratinocyte migration, collagen deposition, and down-regulates inflammation. One of Tß4's key mechanisms of action is its ability to regulate the cell-building protein, actin, a vital component of cell structure and movement. Of the thousands of proteins in cells, actin represents up to 10% of the total protein and, thus, plays a major role in the physiology of the cell. RegeneRx has identified several molecular variations of Tß4 that may affect the aging of skin, among other properties, and could be important candidates as active ingredients in pharmaceutical and consumer products. Researchers at the National Institutes of Health, and at other academic institutions throughout the U.S., have published numerous scientific articles indicating that Tß4 is effective in accelerating dermal and corneal wound healing in several animal models, under a variety of conditions. In two articles published in the scientific journal, Nature, researchers found that Tß4 protects heart tissue following a myocardial infarction and can regenerate coronary vessels in laboratory animals. A recent abstract presented at an American Heart Association meeting showed that in a porcine model Tß4 is cardio-protective after reperfusion following ischemic injury. Abstracts of scientific papers related to Tß4's mechanisms of action may be viewed at RegeneRx's web page: www.regenerx.com.
Forward-Looking Statements
This release contains certain forward-looking statements that 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. Factors that may cause actual results to differ materially from any future results expressed or implied by any forward-looking statements include the risk that product candidates that appeared promising in early research, preclinical studies or clinical trials do not demonstrate safety and/or efficacy in subsequent clinical trials, the risk that encouraging results from early research, preclinical studies or clinical trials may not be confirmed upon further analysis of the detailed results of such research, preclinical study or clinical trial, the risk that additional information relating to the safety, efficacy or tolerability of our product candidates may be discovered upon further analysis of preclinical or clinical trial data, the risk that the company’s or its collaborators will not obtain approval to market the company’s product candidates, the risks associated with reliance on outside financing to meet capital requirements, the risks associated with reliance on collaborators for the funding or conduct of further development and commercialization activities relating to the company’s product candidates, and such other risks described in the company’s annual report on Form 10-K for the year ended December 31, 2007, and other filings the company makes with the SEC. You are urged to consider statements that include the words "ongoing", "prospects," "forward," "may", "will", "would", "could", "should", "believes", "estimates", "projects", "potential", "expects", "suggests", "plans", "targeted," "anticipates", "intends", "continues", "forecast", "designed", "goal", or the negative of those words or other comparable words to be uncertain and forward-looking.
Any forward-looking statements are made pursuant to Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended, and, as such, speak only as of the date made. The company undertakes no obligation to publicly update any forward-looking statements, whether as a result of new information, future events or otherwise.
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