PRINCETON, N.J.--(BUSINESS WIRE)--Derma Sciences, Inc. (Nasdaq: DSCI), a medical device and pharmaceutical company focused on advanced wound care, today announced that full results from its successful Phase 2 clinical trial with the investigational drug DSC127 in patients with diabetic foot ulcers will be published on July 5th in the July 2012 issue of Wound Repair and Regeneration. The article, entitled “NorLeu3-A(1–7) stimulation of diabetic foot ulcer healing: Results of a randomized, parallel-group, double-blind, placebo-controlled phase 2 clinical trial,” provides details on the efficacy and safety outcomes of the study and reviews the apparent mechanism of action of NorLeu3-A(1-7) (DSC127) in healing and includes information about prior preclinical work.
The authors conclude that the study provides preliminary evidence that DSC127, the clinical formulation of NorLeu3-A(1-7), is safe and effective in accelerating the healing of diabetic foot ulcers. The abstract is available at http://onlinelibrary.wiley.com/doi/10.1111/j.1524-475X.2012.00804.x/abstract in advance of publication of the full article.
“We are delighted that our Phase 2 study results have been published in such a prestigious, peer-reviewed medical journal,” said Edward J. Quilty, chief executive officer of Derma Sciences. “Publication validates the exceptional scientific approach our investigators undertook in conducting this trial, and we feel comfortable that this same rigor will be applied to our upcoming Phase 3 trials with DSC127 for the treatment of diabetic foot ulcers.”
The article’s authors include Peter P. Balingit, M.D. of Olive View-UCLA Medical Center; David G. Armstrong, M.D. of the Southern Arizona Limb Salvage Alliance at the University of Arizona; Alexander M. Reyzelman, DPM of the California School of Podiatric Medicine at Samuel Merritt University; Laura Bolton, Ph.D. of the Robert Wood Johnson University Medical School; Shelagh J. Verco, Ph.D. of U.S. Biotest; Kathleen E. Rodgers, Ph.D. of the Keck School of Medicine at the University of Southern California; Katherine A. Nigh, BS of U.S. Biotest; and Gere S. diZerega, M.D of the Keck School of Medicine at the University of Southern California. Drs. Rogers and diZerega are the inventors of DSC127.
Peter P. Balingit, M.D., Chief, Division of Hospital Medicine, Olive View - UCLA Medical Center and the study’s lead investigator said, “Wound repair in the DSC127 0.03% group exceeded results using the best standard of care in this diabetic foot ulcer Phase 2 study, improving all healing parameters measured for at least 20 weeks after the last treatment. It is the only agent I’ve seen that surpasses results of consistent moist healing and off-loading in non-healing diabetic foot ulcers. Importantly, there were no significant differences among the treatment groups in any of the safety parameters.”
About Diabetes and Diabetic Foot Ulcers
According to the National Institute of Diabetes and Digestive and Kidney Diseases of the National Institutes of Health, diabetes affects 25.8 million people of all ages, or 8.3% of the U.S. population, and nearly 2 million new cases are diagnosed yearly in people age 20 or older. More than 60% of nontraumatic lower-limb amputations occur in people with diabetes and in 2006, about 65,700 nontraumatic lower-limb amputations were performed in people with diabetes. About 80% of amputations were preceded by a foot ulcer. In 2007 the total direct and indirect cost attributed to diabetes was $174 billion in the U.S. alone and was the seventh leading cause of death. The International Diabetes Foundation estimates that 366 million people worldwide had diabetes in 2011 and that by 2030 this will rise to 552 million.
About DSC127
DSC127, a novel investigational angiotensin analog, has been shown to improve epithelialization, granulation and vascularization, accelerating wound healing in a variety of normal and diabetic animal models. These findings suggest that DSC127 produces different actions at the wound site during various stages of healing. Derma Sciences has advanced the DSC 127 development program through Phase 1 and Phase 2 clinical studies, where no safety concerns were identified. DSC127 is not approved for commercial distribution.
About Wound Repair and Regeneration
Wound Repair and Regeneration: The International Journal of Tissue Repair and Regeneration is the official publication of the Wound Healing Society, the European Tissue Repair Society, the Japanese Society for Wound Healing, and the Australian Wound Management Association. The Journal provides extensive international coverage of cellular and molecular biology, connective tissue, and biological mediator studies in the field of tissue repair and regeneration and serves a diverse audience of surgeons, plastic surgeons, dermatologists, biochemists, cell biologists, and others.
About Derma Sciences, Inc.
Derma Sciences is a medical technology company focused on three segments of the wound care marketplace: pharmaceutical wound care products, advanced wound care dressings and traditional dressings. Derma Sciences has successfully completed the Phase 2 clinical trial in diabetic foot ulcer healing with DSC127, an investigational pharmaceutical drug under development for accelerated wound healing and scar reduction, and is preparing to begin Phase 3 clinical trials. Its MEDIHONEY® product is the leading brand of honey-based dressings for the management of wounds and burns. The product has been shown to be effective in a variety of indications, and was the focus of a positive large-scale, randomized controlled trial involving 108 subjects with leg ulcers. Other novel products introduced into the $14 billion global wound care market include XTRASORB® for better management of wound exudate, BIOGUARD® for infection prevention and TCC-EZ™, a gold-standard treatment for diabetic foot ulcers.
For more information please visit www.dermasciences.com.
Forward-Looking Statements
Statements contained in this news release that are not statements of historical fact may be deemed to be forward-looking statements. Without limiting the generality of the foregoing, words such as "may," "will," "expect," "believe," "anticipate," "intend," "could," "estimate" or "continue" are intended to identify forward-looking statements. Readers are cautioned that certain important factors may affect the Company's actual results and could cause such results to differ materially from any forward-looking statements that may be made in this news release or that are otherwise made by or on behalf of the Company. Factors that may affect the Company's results include, but are not limited to, product demand, market acceptance, impact of competitive products and prices, product development, including clinical trial results, completion of an acquisition, commercialization or technological difficulties, the success or failure of negotiations and trade, legal, social and economic risks. Additional factors that could cause or contribute to differences between the Company's actual results and forward-looking statements include but are not limited to, those discussed in the Company's filings with the U.S. Securities and Exchange Commission.