RegeneRx Cleared to Initiate Phase II Clinical Trial with TB4 for Epidermolysis Bullosa

       RegeneRx Biopharmaceuticals, Inc. (Bethesda, Md) announces it is clear to begin its third Phase II clinical trial to test its drug, Thymosin beta 4 (TB4), for the treatment of patients with epidermolysis bullosa (EB). “We are pleased we are able to proceed according to our clinical development plan,” said David Crockford, Head of Clinical and Regulatory Affairs for RegeneRx. “Epidermolysis bullosa represents a unique opportunity for RegeneRx, both from a scientific and business perspective. The ability of TB4 to up-regulate the expression of laminin-5, among other things, may be very important for these patients, since many are unable to effectively produce this adhesive protein. Further, as an orphan drug, we hope to be able to take advantage of a number of opportunities otherwise unavailable for large-market drugs, including funding of clinical trials by the US Food and Drug Administration’s (FDA) Office of Orphan Products Development.”
       The Phase II trial is a randomized, double-blind, placebo-controlled trial designed to test several dosages of TB4 in a limited number of patients with dystrophic and junctional EB at a number of medical centers in the United States. The drug will be topically administered to each patient every day over a period of several weeks.
       Under the Orphan Drug Act, grants to fund Phase II and Phase III clinical trials for orphan-designated products may be available from the FDA. RegeneRx has previously applied for such a grant and will await word from the agency before formally initiating the study.
       Visit http://www.regenerx.com for more information.

FDA Approves Ortec’s Diabetic Foot Ulcer Protocol and Gives Clearance to Initiate Diabetic Foot Ulcer Trial

       Ortec International Inc. (New York, NY) announces that the US Food and Drug Administration (FDA) has completed a review of the modified Diabetic Foot Ulcer (DFU) Protocol submitted to the FDA on January 6, 2005 and has given the company permission to initiate a pivotal trial evaluating OrCel® in the treatment of DFUs. The company expects to initiate patient enrollment shortly after receiving approval of its Premarket Approval (PMA) application for the use of the product in the treatment of venous leg ulcers (VLU) currently under FDA review. The DFU trial is expected to be conducted at up to 25 clinical centers and involve up to approximately 200 patients.
       The results of the multicentered, controlled, pilot study assessing the effectiveness of its product in treating DFUs was featured in the July 2003 issue of the peer-reviewed publication WOUNDS: A Compendium of Clinical Research and Practice. The article was entitled, “Effectiveness of Bilayered Cellular Matrix in Healing of Neuropathic Diabetic Foot Ulcers: Results of a Multicenter Pilot Trial.”
       The results of the trial, as described in the article, demonstrated that in hard-to-heal diabetic foot ulcers that were less than or equal to 6cm2 (approximately 70% of the ulcers in the trial were in that category), 47% of the patients treated with OrCel were completely healed compared to 23% in the control group. In addition to OrCel producing a greater percentage of patients with complete healing, the study also showed that the mean rate of reepithelization (wound closure) was significantly higher in the OrCel-treated groups.
       Visit http://www.ortecinternational.com for more information.