Derma Sciences, Inc. Announces Publication In Advances In Wound Care

PRINCETON, N.J.--(BUSINESS WIRE)--Derma Sciences, Inc. (Nasdaq: DSCI), a tissue regeneration company focused on advanced wound and burn care, announces the publication of a review of the current clinical development program for aclerastide (DSC127), a patented peptide analog of angiotensin, as a potential treatment for the closure of diabetic foot ulcers (DFUs) in an article titled, “NorLeu³-Angiotensin (1-7) [DSC127] as a Therapy for the Healing of Diabetic Foot Ulcers,” in the peer-reviewed journal, Advances in Wound Care. The full article can be accessed here or on the Company’s website at www.dermasciences.com.

“DSC127 and its active ingredient, NorLeu3-A(1-7), are potent stimulators of tissue repair and possibly regeneration leading to increased proportions of complete full-thickness wound healing. To date, DSC127 has been shown to be well tolerated in both preclinical and clinical studies.”

Aclerastide, also known as NorLeu³-A(1-7), is an analog of the active member of the RAS, A(1-7). The peptide accelerates and normalizes the healing/closure of dermal injuries in multiple animal models. In Phase I and II human clinical studies, aclerastide increased the incidence of full closure of DFUs.

The review cited the article by Balingit et al Wound Rep Reg 2012 stating, “The efficacy of this product was seen as early as 4 weeks with a reduction in wound volume. This observation is consistent with that observed in preclinical studies where normal granulation tissue was rapidly deposited. By week 12, there was an absolute increase in full wound closure in the Phase II trial of 27%. The benefit continued over the durability phase of the trial where at 24 weeks after initiation of treatment (20 weeks since the last exposure), the absolute increase in complete wound closure was 27–33% (52% of PP [per protocol] placebo subjects or 85% of 0.03% DSC127 PP subjects healed; 46% of ITT [intent-to-treat] placebo subjects or 73% of 0.03% DSC127 ITT subjects healed) even in the face of less rigorous clinical oversight and off-loading requirements after the first 12 weeks of study participation.”

Lead study author, Kathleen E. Rodgers, Ph.D., School of Pharmacy, University of Southern California, Los Angeles, noted that, “DSC127 and its active ingredient, NorLeu³-A(1-7), are potent stimulators of tissue repair and possibly regeneration leading to increased proportions of complete full-thickness wound healing. To date, DSC127 has been shown to be well tolerated in both preclinical and clinical studies.”

“We are very pleased to have these important data from studies with aclerastide summarized in this peer-reviewed journal article. We are encouraged by the fact that the journal editors considered this information important and timely, such that they invited the lead author to write this review, particularly since aclerastide is the only drug in late stage development with the goal of demonstrating an increased incidence of closure of DFUs. We look forward to the publication of additional articles on the clinical merits of this unique mechanism of action as we deploy our rigorous publication strategy,” noted John Caminis, M.D., chief medical officer of Derma Sciences.

“We are beyond the half way mark with the enrollment into our Phase III study of aclerastide for the accelerated healing of diabetic foot ulcers and expect that the encouraging data presented in this journal article will bring attention to this Phase III study and could enhance enrollment. We very excited about aclerastide’s potential as a new therapeutic option for the up to 1.5 million people in the U.S. suffering from diabetic foot ulcers. With no approved robust pharmaceutical solution for treating these chronic wounds that often lead to amputations, we believe this program offers tremendous opportunity in a multibillion-dollar market with significant unmet medical need,” commented Edward J. Quilty, Derma Sciences’ chairman and chief executive officer.

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 preclinical 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.

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 development and commercialization of aclerastide (DSC127), product demand, market acceptance, impact of competitive products and prices, product development, completion of an acquisition, 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.