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RegeneRx:
J.J. Finkelstein
jjfnk@regenerx.com
301.280.1992
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RegeneRx Receives First Patent on Tβ4's Ability to Repair Lung Damage Resulting from Infections and Other Disorders RegeneRx Receives First Patent on Tβ4's Ability to Repair Lung Damage Resulting from Infections and Other Disorders
June 24, 2008 — Bethesda, Md
RegeneRx Biopharmaceuticals, Inc. (AMEX: RGN) (www.regenerx.com) announced today that it has received an Australian patent for the use of Tβ4, its derivatives, analogues and fragments, to repair pulmonary damage resulting from pulmonary microbial infections. The patent expires in 2023.
Tβ4 is a synthetic version of a biologically active, naturally occurring peptide that has been shown, in pre-clinical studies, to be effective in accelerating dermal, ophthalmic, and myocardial wound healing. Tβ4 may also be important in other areas of tissue and organ repair, as well as tissue protection. RegeneRx is currently sponsoring five clinical trials and expects to report data later this year on several of these studies.
"We are pleased to receive this patent as it expands our intellectual property portfolio by addressing potential disease indications beyond wound healing that may benefit from our drug candidates, in addition to creating a proprietary position through 2023," stated David Crockford, vice president for clinical and regulatory affairs.
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 Tβ4, a 43-amino acid, naturally occurring peptide, in part, under an exclusive world-wide license from the National Institutes of Health. RegeneRx holds over 60 world-wide patents and patent applications related to its technology and 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 (injectable) clinical trial supporting systemic delivery of RGN-352 for cardiovascular indications.
RegeneRx Technology Backgrounder
Tβ4 is a synthetic version of a naturally occurring peptide present in virtually all human cells. It is a first-in-class multi-faceted molecule that promotes endothelial cell differentiation, angiogenesis in dermal tissues, keratinocyte migration, collagen deposition, and down-regulates inflammation. RegeneRx has identified several molecular variations of Tβ4 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 Tβ4's in vitro and in vivo efficacy in accelerating wound healing and tissue protection under a variety of conditions. Abstracts of scientific papers related to Tβ4'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. Examples of such forward-looking statements include statements concerning the therapeutic potential of Tβ4 or patents related thereto. 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 although Tβ4 has demonstrated potential therapeutic benefit for wound healing and cardioprotection, the Company's product candidates may not demonstrate safety and/or efficacy in 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, and other filings the company makes with the SEC. 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.
SOURCE: RegeneRx Biopharmaceuticals, Inc.
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