Health & Fitness
Health and Fitness
Health and Fitness 
Mon, December 22, 2008
RegeneRx Updates Schedule for Release of Clinical Trial Information
BETHESDA, Md.--([ BUSINESS WIRE ])--REGENERX BIOPHARMACEUTICALS, INC. (AMEX:RGN) today announced an updated schedule for the release of information related to certain of its ongoing clinical trials. RegeneRx currently estimates that it will report on its Phase II pressure ulcer trial evaluating RGN-137 by mid-January 2009; on its Phase II venous stasis ulcer trial, also evaluating RGN-137, in February 2009; and on its Phase I parenteral trial evaluating RGN-352 in March 2009. RGN-137 is a topical gel formulation of Tβ4 being developed for dermal wound healing and RGN-352 is an injectable formulation of Tβ4 being developed for internal indications such as acute myocardial infarction ("heart attack").
About RegeneRx Biopharmaceuticals, Inc.
RegeneRx is focused on the discovery and development of proprietary peptides to accelerate tissue and organ repair. RegeneRx is currently developing three product candidates, RGN-137, RGN-259 and RGN-352, for dermal, ophthalmic, and cardiovascular tissue repair, respectively. The Company 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, a Phase II ophthalmic wound healing clinical trial, and a Phase I parenteral (injectable) clinical trial supporting systemic delivery of RGN-352 for acute cardiovascular indications.
RegeneRx Technology Background
Tβ4 is a synthetic version of a naturally occurring peptide present in virtually all human cells. It is a 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 candidates as active ingredients in pharmaceutical and consumer products. Researchers at the National Institutes of Health, and at other U.S. academic institutions, have published scientific articles indicating Tβ4's in vitro and invivo 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 regarding RegeneRx's estimated schedule for the release of data related to its ongoing Phase II pressure ulcer trial evaluating RGN-137, its ongoing Phase II venous stasis ulcer trial, also evaluating RGN-137, and its ongoing Phase I parenteral trial evaluating RGN-352; and statements concerning the therapeutic potential of Tβ4 for dermal, ophthalmic and cardiovascular wounds, pulmonary indications, or cancer, or its use in other pharmaceutical or consumer products. 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 reporting of data in connection with any or all of RegeneRx's ongoing clinical trials is delayed (such delays could be the result of any number of factors, including, without limitation, delays in assembling or analyzing relevant data and, in the cases of the parenteral trial, delays in completing enrollment or dosing); the risk that RegeneRx's product candidates may not demonstrate safety and/or efficacy in its ongoing or future clinical trials and other development efforts, including its trials and/or other development efforts related to RGN-137, RGN-259, RGN-352 and RGN-457, the risk that RegeneRx or its collaborators will not obtain approval to market RegeneRx's product candidates in the U.S. or abroad, the risks associated with RegeneRx's need for additional financing to meet capital requirements necessary for the further development and commercialization activities relating to RegeneRx's product candidates, the risks associated with protecting RegeneRx's intellectual property, or that RegeneRx will not be able to obtain patent protection, or that its issued patents will be infringed, and such other risks described in RegeneRx's quarterly report on Form 10-Q for the period ended September 30, 2008, and other filings RegeneRx 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.