Osiris Takes A Big Leap On Diabetic Foot Ulcer Study Results

(RTTNews) - Osiris Therapeutics Inc. (OSIR) said Tuesday that its biosurgery product Grafix demonstrated overwhelming efficacy in a diabetic foot ulcer study - closing three times as many wounds as standard of care.

About 25% of all diabetics develop diabetic foot ulcers. According to the American Diabetes Association, the standard treatment for a diabetic foot ulcer involves debridement (removing dead tissue from the wound), offloading (having patients use a wheelchair or crutches to completely halt weight bearing on the affected foot) and infection control with suitable antibiotics.

In the landmark stem cell study for the treatment of diabetic foot ulcers, 62% of patients receiving Grafix had complete wound closure compared to only 21% in the placebo arm. Grafix also demonstrated faster wound closure and a reduction in the number of treatments needed to achieve wound closure.

In the crossover phase of the trial, patients whose wounds failed to close after 12 weeks of standard of care had an 80% closure rate when switched to Grafix. Importantly, patients randomized to receive standard of care were 74% more likely to experience an adverse event than those receiving Grafix, said Osiris.

Grafix, which is marketed by Osiris currently for wound and tissue repair, is a product regulated for use in the U.S. by the FDA as a Human Cellular and Tissue Based Product.

OSIR closed Tuesday's trading at $10.66. In premarket trading, the stock is up 40% to $15.