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Results are expected by the end of the month in an efficacy study on a new drug that promises to improve diabetic wound care. Derma Sciences is wrapping up work on a phase 2 trial of DSC127, a drug already shown to speed up healing in animal tests.
According to Barry Wolfenson, executive vice president of global business development and marketing for the company, the study's last patient came aboard September 27, and the trial was set to wrap by the end of December 2010. After crunching the numbers, the company will be able to say how many patients' wounds were completely healed by the end of the 12-week study period.
"Should the DSC127 trial generate positive outcomes, we believe we will be able to attract several potential partners to handle further clinical testing of this drug and ultimately bring another treatment option to market for the millions of diabetics with chronic, non-healing foot ulcers," said company chairman and CEO Edward Quilty.
How does DSC127 work? Skin contains receptors for a natural peptide called angiotensin, and DSC127 is an analog of that peptide. In other words, it's a near-duplicate of what our own bodies produce--with one important difference. In its natural form, angiotensin raises blood pressure. According to Derma Sciencies, DSC127 does not. When applied to a wound, the drug appears to speed the growth of new skin without side effects.
Derma Sciences' phase 2 study includes a 12-week measure of durability. While early results should come out this month, that means that the study technically ends on March 27, Wolfenson said. More number crunching and and submission of a report to the FDA will take place afterward.
In November, the Princeton, NJ-based medical company received a $244,479 research and development grant for its work on DSC127 as part of the US healthcare reform bill. One billion dollars in the legislation was set aside for projects that address unmet needs or chronic conditions or could cut healthcare costs.
"Not only does this grant represent a non-dilutive source of financing, but we also are pleased that the US government has recognized the potential for DSC127 to make a significant difference in patient care," Quilty said.
Derma Sciences sells wound care products that focus on three areas: traditional dressings, advanced dressings, and pharmaceutical wound care products. Its treatments include Medihoney, which is a honey-based wound dressing, Xtrasorb, and Biogard.
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