Contact:
RegeneRx:
J.J. Finkelstein
jjfnk@regenerx.com
301.280.1992
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RegeneRx Receives Australian Patent for Treating Eye Disorders with Tβ4 RegeneRx Receives Australian Patent for Treating Eye Disorders with Tβ4
May 4, 2009 — Bethesda, Md
RegeneRx Biopharmaceuticals, Inc. (NYSE AMEX:RGN)(the “Company” or “RegeneRx”) announced today that it received a patent for treating disorders of the eye with Tβ4, including treatment for corneal vacuolization (cell debris), corneal stromal edema (tissue swelling), and healing associated with eye surgery including LASIK and PRK. The patent was issued in Australia, covers Tβ4, its analogues, isoforms and other derivatives and expires in 2022.
About RegeneRx Biopharmaceuticals, Inc.
RegeneRx is focused on the discovery and development of novel peptides 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 tissue repair, respectively. RegeneRx is also developing RGN-457 for use in pulmonary indications such as cystic fibrosis. These product candidates are based on Tβ4, a synthetic copy of 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 novel peptides and is currently sponsoring three Phase II chronic dermal wound healing clinical trials (two of which were recently completed), a Phase II ophthalmic wound healing clinical trial (which RegeneRx is in the process of closing), and a Phase I parenteral (injectable) clinical trial supporting systemic delivery of RGN-352 for acute cardiovascular indications, which recently completed subject enrollment and dosing.
RegeneRx Technology Background
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 press 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 Company’s intellectual property as described herein. 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 the Company may not be able to successfully develop its product candidates, may not demonstrate safety and/or efficacy in clinical trials, the risk that the Company or its collaborators will not obtain approval to market the Company’s product candidates in the U.S. or abroad, the risks associated with the Company’s need for additional financing to meet capital requirements necessary for the further development and commercialization activities relating to its product candidates, the risks associated with protecting the Company’s intellectual property, or that the Company will not be able to obtain continued patent protection, or that its issued patents will be infringed, and such other risks described in the Company’s annual report on Form 10-K for the year ended December 31, 2008, and other filings it 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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