PRINCETON, NJ, USA I June 18, 2015 I Derma Sciences, Inc. (Nasdaq:DSCI), a tissue regeneration company focused on advanced wound and burn care, announces that the required two-year animal carcinogenicity study for aclerastide has produced “clean results” related to safety findings and, in particular, carcinogenicity. This was the final study agreed to with the FDA for toxicological assessment.
Edward J. Quilty, Chairman and Chief Executive Officer of Derma Sciences, commented, “We are pleased to see components of our pharmaceutical program coming together with such encouraging results. These findings will certainly help define the overall safety of this potentially important drug for patients suffering from diabetic foot ulcers.”
Dr. Jay Albretsen, DVM, PhD, DABT, DABVT, Senior Study Director at MPI, the research facility that conducted the study for Derma Sciences, stated, “The 104-Week dermal oncogenicity study in mice had few notable findings, which is unusual for a study of this nature. Consequently, the results were easy to interpret and the conclusion was clear and clean.”
John Caminis, M.D., chief medical officer of Derma Sciences, said, “These are reassuring results that together with the existing clinical and nonclinical data package continue to support the safety profile of aclerastide. With the vast majority of preclinical activities now concluded, we continue to sharpen our focus towards completing recruitment of our pivotal registration program by the end of the second quarter of 2016.
The two-year toxicology study supplements safety data of aclerastide in preclinical animal models that include several weeks of dermal and subcutaneous dosing studies, and fertility and embryonic studies. There were no adverse findings in any of the toxicology studies. Systemic toxicity was evaluated by the subcutaneous route of administration in rats and mice for up to 13 weeks. A 39-week minipig study also showed no consistently notable local effects on the skin and no evidence of systemic toxicity. Genetic toxicology studies showed no mutagenic effects in a battery of studies. A fertility study and teratology studies in rats and rabbits showed no effects of the drug on reproductive processes. In all non-clinical studies and the clinical pharmacokinetic (PK) study, circulating levels of aclerastide were below the quantitation limit, indicating potentially negligible systemic exposure to aclerastide following daily topical administration to the skin. In addition, in PK and toxicokinetic studies in multiple species where aclerastide was administered subcutaneously, showed that the drug is removed from systemic circulation rapidly.
About Derma Sciences, Inc.
Derma Sciences is a tissue regeneration company focused on advanced wound and burn care. It offers a line of products with patented technologies to help better manage chronic and hard-to-heal wounds, many of which result from diabetes and poor vascular functioning. The Company sells AMNIOEXCEL® amniotic allograft membrane and AMNIOMATRIX® amniotic allograft suspension into the $500 million market for skin substitute products. Derma Sciences’ MEDIHONEY® product line is the leading brand of honey-based dressings for the management of wounds and burns. The product has been shown in clinical studies to be effective in a variety of indications. TCC-EZ® is a gold-standard total contact casting system for diabetic foot ulcers. Other novel products introduced into the $14 billion global wound care market include XTRASORB® for better management of wound exudate, and BIOGUARD® for barrier protection against microbes and other contaminants. Its pharmaceutical product in development, aclerastide (a patented peptide analog of angiotensin), is currently in Phase 3 and 3b clinical trials for the closure of diabetic foot ulcers. Aclerastide is also in pre-clinical development for the prevention and reduction of scarring after surgical incision and wound closure. Aclerastide is also part of a BARDA grant program for the mitigation and treatment of skin damage associated with exposure to ionizing radiation. The Company also offers a full product line of traditional dressings.
SOURCE: Derma Sciences
