Healthcare Industry News: Tβ4
News Release - January 29, 2008
RegeneRx Names Drug Products Under Clinical DevelopmentBETHESDA, Md.--(HSMN NewsFeed)--RegeneRx Biopharmaceuticals, Inc. (AMEX:RGN ) (www.regenerx.com) said today that it is implementing numeric naming for its current drug products to differentiate between formulations and create a unique identity for each product. Effective immediately, RegeneRx’s topical gel will be known as RGN-137; its ophthalmic eye drop as RGN-259; and its parenteral (injectable) formulation as RGN-352. The active pharmaceutical ingredient in each of these formulations will be referred to as Tß4 peptide.
“Uniquely naming each of our drug products in clinical trials is intended to facilitate discussions with prospective partners and investors, and better differentiate RegeneRx drug products in scientific publications. This effort will help to more clearly define our product pipeline and highlight new products as they enter development,” stated David Crockford, vice president of clinical and regulatory affairs.
Future references in publications, SEC filings, investment and web site materials, and strategic discussions will utilize this new nomenclature. Commercial brand names, if applicable, will be announced at a later date.
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 drug products, RGN-137, RGN-259 and RGN 352 for dermal, ophthalmic, and cardiovascular wound healing, respectively. These drug products 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 drug products 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 I parenteral clinical trial in support of systemic administration of Tß4 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 drug 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.
Safe Harbor Statement
The information in this press release may include certain forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. These statements concern the Company's current expectations regarding future events, including the ongoing and prospective development of Tß4 and possible future benefits to the Company, its shareholders, and patients. Due to the nature of product development and the regulatory approval process, the forward-looking statements are subject to risks and uncertainties, including those reflected in the Company's filings with the Securities and Exchange Commission, particularly its most recent Annual Report on Form 10-K. 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 assumes no obligation to update or revise any forward-looking statements made herein or any other forward-looking statements made by the Company.
Source: RegeneRx Biopharmaceuticals
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