|Derma Sciences Initiates Enrollment in DSC127 Phase 3 Trial for Healing Diabetic Foot Ulcers|
Company expects both pivotal studies to be enrolling patients by end
Both trials will evaluate a 0.03% formulation of DSC127 against a
topical vehicle, while one will include an additional arm of patients
treated with a standard of care hydrogel. This second trial is expected
to begin enrolling patients by the end of
“Non-healing foot ulcers are a tragic outcome of the rapidly growing
diabetes epidemic and are an enormous burden on the healthcare system in
the U.S. and around the world. Sadly, diabetic foot ulcers result in
amputation or even death for far too many people,” said Peter P.
Balingit, M.D., FACP, chief of the division of hospital medicine at
Recent laboratory studies indicate that DSC127 may facilitate recruitment of stem cells to the site of tissue injury. It is theorized that this action may help to re-set the trajectory of healing. In the Phase 2 study, 54% of wounds treated with DSC127 0.03% were healed at 12 weeks, compared with 33% in the vehicle control group. The difference between the two groups continued to expand out to 24 weeks, the last time wounds were assessed, with 65% in the arm treated with DSC127 0.03% healed compared with 38% in the vehicle control group.
“In commencing our Phase 3 trials we draw closer to potentially
providing a safe and efficacious, much-needed pharmaceutical option for
diabetics with non-healing ulcers,” said
“In the meantime,” Mr. Quilty added, “we continue to execute on our vision to provide a full armamentarium of treatments to address diabetic foot ulcers and other chronic and hard-to-heal wounds, from dressings to casting systems, marketed by a specialized sales force in the U.S. and select countries, and globally by a network of quality distribution partners. We maintain our guidance for at least 30% annual sales growth in 2013 for this part of our business, which is consistent with our estimate for organic sales growth in 2012.”
About the DSC127 Phase 3 Clinical Trials
Patients will receive drug, vehicle or placebo hydrogel once daily for four weeks, and will receive standard of care for up to six additional weeks. The primary endpoint of the Phase 3 trials is the proportion of ulcers healed at 10 weeks, which is defined as 100% epithelialized with no drainage, with a confirmation of healing two weeks after the first instance of complete closure. Secondary endpoints include rate of healing and safety.
In addition, a chronic use safety study of up to 200 patients will be conducted, and will include patients randomized into the pivotal trials as well as those enrolled but not randomized. This study will assess the safety of DSC127 dosed for a longer duration than in the pivotal studies, up to 12 weeks. Additionally, safety after repeat applications will be assessed on those patients whose ulcers either recur or who develop additional diabetic foot ulcers after their initial treatment has concluded.
Further information may be found at www.clinicaltrials.gov.
DSC127 is a novel angiotensin analog formulated as a topical gel
discovered by researchers at the
About Diabetic Foot Ulcers
According to the 2011 National Diabetes Fact Sheet, an estimated 25.8
million Americans – or approximately 10% of the population – are living
with diabetes and nearly 1.6 million new cases of diabetes are diagnosed
in people age 20 and older each year. The number of Americans with
diabetes could triple by 2050, according to the
According to the
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