RegeneRx Awarded Additional $136,000 From FDA Office Of Orphan Products For Phase II Epidermolysis Bullosa Trial

Main Category: Dermatology
Also Included In: Clinical Trials / Drug Trials;  Regulatory Affairs / Drug Approvals
Article Date: 02 Aug 2008 - 3:00 PDT

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Regenerx Biopharmaceuticals, Inc. (Amex:Rgn) (www.regenerx.com) announced today that it has been awarded an additional $136,245 from the U.S. Food and Drug Administration's (FDA's) Office of Orphan Products Development for continued development of its Tβ4 drug candidate (RGN-137) for treatment of patients with Epidermolysis Bullosa (EB), a rare and debilitating skin blistering disorder.

"We are very pleased to receive this award from the FDA. Their support provides welcomed additional resources to help develop RGN-137 for patients with EB. Currently, there are no drugs approved to accelerate wound healing in EB patients and it is our goal to address this need. We appreciate the FDA's diligence in working with us as we continue clinical development and look forward to completing this phase II clinical trial in 2009," commented David Crockford, principal investigator under the grant and RegeneRx's vice president for clinical and regulatory affairs.

About Epidermolysis Bullosa

Epidermolysis bullosa is a rare, and often devastating, genetic disease that has been designated an orphan indication by the U.S. FDA. It is estimated that between 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 skin and recurrent blister formation resulting from minor mechanical friction or trauma often associated with routine daily activity. These blisters can develop into chronic, raw wounds that may also occur in the eye, mouth, and internal organs 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 equally. 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, Tβ4 has been shown to increase the production of laminin-5 in animal models.

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 I parenteral (injectable) clinical trial supporting systemic delivery of RGN-352 for cardiovascular and other indications.

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. Scientific papers related to Tβ4's mechanisms of action are listed on RegeneRx's web page: http://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 for epidermolysis bullosa 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.

Regenerx Biopharmaceuticals, Inc.