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."
Source: Derma Sciences, Inc.