Derma Sciences To Complete Enrollment In DSC127 Phase 2 Wound Healing Trial This Month

Derma Sciences, Inc. (Nasdaq:DSCI), a medical device and pharmaceutical company focused on advanced wound care, announced that patient screening in its DSC127 Phase 2 trial in diabetic foot ulcer healing will be completed tomorrow, and that enrollment in the trial will conclude on September 30. This randomized, double-blind, placebo controlled study of up to 75 patients will look at the percentage of diabetic ulcers completely healed over a 12-week period, among other outcomes. Top-line efficacy results are expected to be made public in late December 2010 or early January 2011.


Derma Sciences Chairman and Chief Executive Officer Edward J. Quilty said, "Should the DSC127 trial generate positive outcomes, we believe we will be able to attract several potential partners to handle further clinical testing of this drug and ultimately bring another treatment option to market for the millions of diabetics with chronic, non-healing foot ulcers. Given the 2.4 million diabetic foot ulcers and more than 60,000 diabetes-related amputations each year in the United States, the commercial potential of this drug is significant."


About DSC127


Skin represents one of the few human tissues with a high turnover rate. Upon injury the expression of receptors in injured skin is upregulated, and subsequently down regulates as the skin heals. In human skin, angiotensin II type 1 (AT1) and angiotensin II type 2 (AT2) receptors are found in the epidermis and in dermal vessel walls. DSC127, a novel angiotensin analog, has been shown to accelerate skin healing in a variety of animal models including wound repair after full-thickness excision in normal rats, in adriamycin or steroid-treated rats, in diabetic mice, after partial thickness thermal injuries in guinea pigs and after random flap injuries in rats.


DSC127 upregulates a cassette of genes at the site of skin healing. These genes are involved in energy metabolism (glycolysis and electron transport), oxidative stress and production of cytoskeletal proteins, all of which could be involved in the growth of new skin during wound healing. This finding suggests that DSC127 produces different actions at the wound site during various stages of healing. DSC127 appears to stimulate production of dermal adult progenitor cells, including mesenchymal stem cells, following injury.


Acute and chronic administration of DSC127 in rodents and dogs failed to demonstrate any meaningful toxicity to major organ systems. No mutagenic effects of DSC127 were observed in standard test panels. Preclinical and human Phase 1 studies of DSC127 have demonstrated safety.