PRINCETON, N.J.--(BUSINESS WIRE)--Derma Sciences, Inc. (Nasdaq: DSCI), a medical device and pharmaceutical company focused on advanced wound care, today announced that it has discussed the results of the Company’s Phase 2 clinical study of the investigational drug DSC127 for the treatment of diabetic foot ulcers with the U.S. Food and Drug Administration (FDA), and that the FDA has agreed that the drug’s development program to date supports the initiation of Phase 3 pivotal clinical studies. Derma Sciences has received guidance from the FDA on the design of Phase 3 trials and other clinical activities, which will allow the Company to adjust the sequence of planned studies, including toxicology studies, for potentially more cost-effective and efficient Phase 3 trials than had previously been contemplated. Initiation of the Phase 3 clinical trials is expected in the second half of 2012.
“We had an extremely productive meeting with the FDA and are looking forward to beginning our Phase 3 clinical trials,” said Edward J. Quilty, president and chief executive officer of Derma Sciences. “In the coming weeks we plan to have further discussion with the FDA to finalize the protocols for these studies. In addition, we will begin manufacturing the product candidate to support both the pivotal trials and the requisite pharmacokinetic studies. Patient recruitment for the Phase 3 studies is expected to begin in the second half of this year, and we intend to continue discussions with the FDA to develop all of the information required to support a New Drug Application, as planned. I am extremely proud of the progress our internal and external teams have made on the development of DSC127,” Quilty added.
About Diabetes and Diabetic Foot Ulcers
According to 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 percent of the U.S. population and nearly 2 million new cases are diagnosed yearly in people age 20 or older. More than 60 percent 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 cost, both direct and indirect 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 have risen 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.
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. 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
Under U.S. law, a new drug cannot be marketed until it has been investigated in clinical trials and approved by the FDA as being safe and effective for the intended use. Statements contained in this news release that are not statements of historical fact may be deemed to be “forward-looking statements” within the meaning of the “safe harbor” provisions of the Private Securities Litigation Reform Act of 1995. 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, our failure to successfully commercialize our product candidates; costs and delays in the development and/or FDA approval, or the failure of our products to obtain such approval; uncertainties or differences in interpretation of clinical trial results; our inability to maintain or enter into, and the risks resulting from, our dependence upon, collaboration or contractual arrangements necessary for the development, manufacture, commercialization, marketing, sales and distribution of any products; our inability to protect our patents or proprietary rights and obtain necessary rights to third party patents and intellectual property to operate our business; our inability to operate our business without infringing the patents and proprietary rights of others; 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; trade, legal, social and economic risks; our inability to obtain any additional required financing; government regulation; changes in industry practice and one-time events. 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. We do not intend to update any of these factors or to publicly announce the results of any revisions to these forward-looking statements.