Derma Sciences, Inc. (Nasdaq: DSCI), a medical device and pharmaceutical company focused on advanced wound care, today announced that five scientific abstracts based on commercial and development-stage products in the Company’s line of wound dressings were presented at the annual Diabetic Foot Global Conference (DFCON), held in Los Angeles March 24-26. For complete information on all five abstracts, please visit the DFCON website at www.dfcon.com. About the DSC127 Poster Presentation The development-stage drug DSC127 is a patented, topically applied novel angiotensin analog that targets receptors that are up-regulated upon injury to tissue. Potential indications of the drug range from chronic ulcers to burns to scar prevention. With regard to the Phase II study on the initial indication of diabetic foot ulcers, both the initial 12-week treatment phase and the follow-on 12-week durability phase have been completed. While the full data set results are expected to be released in June, only the topline efficacy results from the initial 12-week treatment phase were presented in the poster at DFCON. Randomized Trial: Novel Angiotensin Analogue Effects on Diabetic Foot Ulcer Healing; by Peter Balingit, MD; Alex Reyzelman, DPM; David G. Armstrong, DPM, MD, PhD; Kathleen Rodgers, PhD; Shelagh Verco, PhD; Laura Bolton, PhD; Gere diZerega, MD, Olive View – UCLA Medical Center, Department of Medicine The purpose of this study was to explore the safety and efficacy of an Angiotensin II analogue, NorLeu3-A(1-7) (DSC127) in a randomized, double-blind, placebo-controlled multicenter Phase II clinical trial. The initial topline results found that at 12 weeks, 0.03% DSC127-treated subjects were 2.3 times as likely to heal as vehicle-treated placebo subjects. Additionally, the rate of ulcer healing with regard to ulcer depth was found to be significantly improved in the 0.03% arm (p=0.05 vs. placebo). About the MEDIHONEY® Poster Presentations MEDIHONEY®, the leading global brand of honey-based wound care, is a line of wound and burn dressings containing active Manuka (Leptospermum) honey from New Zealand. This unique species of medical-grade honey has been shown in several large-scale, randomized controlled clinical studies to possess unique qualities that help to initiate healing in stalled wounds, and assist with fast debridement of non-viable tissue.
The Clinical Use of Leptospermum Honey on Neuropathic Forefoot Ulcerations in Patients with Diabetes Mellitus; by Steven Kavros, DPM, Mayo Clinic, Rochester, MNThe purpose of this study was to evaluate the healing of forefoot ulcerations with the use of MEDIHONEY® in the setting of diabetic neuropathy. The study found that the MEDIHONEY® group healed at a significantly faster rate than the control group; the mean healing time was 77 days (95% CI, 73.1 – 80.89 days) versus 96 days (95% CI, 91.3 – 100.89 days) for the control group. There was a significant healing rate with the use of MEDIHONEY® versus control (p< 0.0001). The Use of Active Leptospermum Honey Dressings on Challenging Patients in an Indigent Wound Clinic; by LaVerne Graves, RN, BSW, CWS; Diane Maggio, RN, BSN, CRRN, CWON, Atlanticare Regional Medical Center; Princeton, NJ Also presented was data collected from case reports chronicling MEDIHONEY® dressing usage in an indigent clinic on patients with the co-morbidities of HIV and highly exudating venous ulcers. The study concluded that the outcomes of MEDIHONEY® usage in these cases were successful closure of wounds that restored quality of life to patients and cost savings with decreased healing times. About the XTRASORB® Poster Presentations XTRASORB® is a line of novel super-absorbent wound dressings. The core super-absorbent polymer technologies dramatically improve the capabilities of the dressings versus conventional moist wound dressings. Whereas other absorbent dressings (including foams, absorbent pads, and other cellulose-based dressings) rely on spaces within the dressings to fill with fluid, XTRASORB®’s super-absorbent polymers bind fluid and convert it to a gel. This dramatically increases the absorptive capability of the dressings, while also helping to reduce the risk of maceration and exposure to the harmful components within wound fluid (such as bacteria and proteases). Protease Modification by Super Absorbent Polymer Dressings Marcy Turkos, PT, DPT, CWS; Kimberly Stallo, BS, RN, CWOCN, Derma Sciences, Princeton, NJ The purpose of this study was to assess the capability of a variety of dressings to modulate known wound inhibiting matrix metalloproteinases. In this experiment a series of five tests using gelatin zympography were performed on two new super absorbent polymer (SAP) dressings; along with two control dressings and three commercially available dressings in order to determine if the gels in the new SAP wound dressings might be able to exert a clinical effect modulating this protease activity. At completion of the study, the SAP dressing’s ionic gels were shown to inhibit proteolysis by MMP‐9 whereas the controls and other commercially available dressings had no inhibitory effect.
Evaluation of a New Super Absorbent Foam to Manage Exudate Management Capabilities; by Kim Peters, RN, CWS; Paul Ligori, MD; Jolene Bowers, RN, Whittier Rehab Hospital, Princeton, NJThe purpose of this study was to evaluate the exudate management capabilities of XTRASORB® on a venous leg ulcer patient with multiple co-morbidities. The evaluation found that XTRASORB® proved to be an effective wound management tool and yielded added benefits, including cost effectiveness and reduction of wound surface area along with the patient satisfaction and enhanced of quality of life. The study indicated XTRASORB® may be an excellent treatment choice over standard foam and traditional absorbent dressings and could prove useful in wound center and homecare protocols. 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 treatment phase of a Phase 2 clinical trial in diabetic foot ulcer healing with DSC127, a novel pharmaceutical drug under development for accelerated wound healing and scar reduction. 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, and BIOGUARD® for infection prevention. 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, 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.