�Regenerx Biopharmaceuticals, Inc. (Amex:Rgn) (www.regenerx.com) proclaimed today that it has been awarded an extra $136,245 from the U.S. Food and Drug Administration's (FDA's) Office of Orphan Products Development for continued development of its T?4 dose candidate (RGN-137) for intervention of patients with Epidermolysis Bullosa (EB), a rare and debilitating skin hot disorder.
"We are very pleased to receive this award from the FDA. Their supporting provides welcomed additional resources to help develop RGN-137 for patients with EB. Currently, thither are no drugs approved to speed up wound healing in EB patients and it is our goal to address this penury. We apprise the FDA's diligence in working with us as we proceed clinical evolution and look forward to completing this phase II clinical trial in 2009," commented David Crockford, principal investigator under the cary Grant and RegeneRx's vice prexy for clinical and regulatory affairs.
About Epidermolysis Bullosa Epidermolysis bullosa is a rare, and often crushing, genetic disease that has been designated an orphan indication by the U.S. FDA. It is estimated that 'tween 20,000 and 50,000 people in the U.S. are affected with some type of EB, with a similar number in Europe. EB is characterized by the presence of extremely fragile peel and perennial blister constitution resulting from minor mechanically skillful friction or trauma often associated with routine everyday activity. These blisters potty develop into chronic, raw wounds that may likewise occur in the eye, mouth, and internal variety meat and tissues. In its most severe form EB is painful, debilitating, and requires constant care. The disorder occurs in every racial and ethnic group throughout the world and affects both sexes evenly. Patients with the most severe form of EB produce less laminin-5, a protein that induces both adhesion and migration in a wide variety of cell types. Laminin-5 plays a key role in maintaining the structural integrity of the skin and is a vital protein needed for proper healing of wounds. In addition to accelerating wound healing, T?4 has been shown to step-up the product of laminin-5 in animal models.
About RegeneRx Biopharmaceuticals, Inc. RegeneRx is focused on the discovery and development of novel molecules to speed tissue and organ resort. 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 T?4, a 43-amino acid, naturally occurring peptide, in role, under an exclusive world-wide license from the National Institutes of Health. RegeneRx holds over 60 worldwide patents and patent applications related to its engineering and is currently sponsoring three Phase II continuing dermal wound healing clinical trials, a Phase II ophthalmic wound healing clinical trial, and a Phase I parenteral (injectable) clinical trial encouraging systemic delivery of RGN-352 for cardiovascular and other indications.
RegeneRx Technology Background T?4 is a celluloid 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 dermic tissues, keratinocyte migration, collagen deposition, and down-regulates rubor. RegeneRx has identified several molecular variations of T?4 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 passim the U.S., have promulgated numerous scientific articles indicating T?4's in vitro and in vivo efficacy in accelerating wound healing and tissue protection under a variety of conditions. Scientific papers related to T?4's mechanisms of action are listed on RegeneRx's web page: hTTP://www.regenerx.com.
Forward-Looking Statements This release contains certain modern statements that involve risks and uncertainties that could cause actual results to be materially different from historical results or from any future results explicit or implied by such forward-looking statements. Examples of such modern statements include statements concerning the healing potential of T?4 for epidermolysis bullosa or patents related thereto. Factors that may cause actual results to dissent materially from any next results uttered or implied by whatever forward-looking statements include the risk that although T?4 has demonstrated potential therapeutic benefit for wound healing and cardioprotection, the Company's product candidates may non demonstrate safe and/or efficacy in clinical trials, the risk that encouraging results from early research, preclinical studies or clinical trials may non be confirmed upon farther analysis of the detailed results of such research, preclinical subject area or clinical trial, the risk that additional data relating to the safety device, efficacy or tolerability of our product candidates crataegus laevigata be observed upon further analysis of preclinical or clinical trial data, the risk that the company's or its collaborators will not prevail approval to market the company's product candidates, the risks associated with reliance on extraneous financing to meet capital requirements, the risks associated with trust 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, address only as of the date made. The Company undertakes no obligation to publicly update any modern statements, whether as a result of new information, future events or otherwise.
Regenerx Biopharmaceuticals, Inc.
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