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news.CardioVascular BioTherapeutics has received the green light from the FDA to commence its phase I clinical trial in diabetic patients who have foot ulcers and/or open leg wounds.
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The company is planning on testing two doses of its wound healing agent, Cardio Vascu-Grow, for topical application. The principal purpose of this first study is to test the safety and tolerability of the compound in the target patient population.
Earlier animal studies by CardioVascular BioTherapeutics (CVBT) in diabetic mice showed that Cardio Vascu-Grow significantly improved the healing rate of the wounds when compared to control animals.
The annual treatment costs for diabetic wound healing and the healing of bed sores is in the $5-$7 billion range, and it is estimated by the US Healthcare Finance Administration that approximately three million patients a year suffer from wound healing problems.
“I believe therapeutic wound healing will be one of the largest medical segments in which Cardio Vascu-Grow may be utilized,” commented Daniel Montano, president of CVBT. “This is a significant and growing healthcare problem as the world population ages, and I believe our wound healing candidate will prove superior to current treatments for wound healing.”
The new approval will mark the third investigational new drug application that has been allowed by the FDA for Cardio Vascu-Grow. The first two clinical studies involved the use of Cardio Vascu-Grow as a treatment for no-option heart patients and those studies are currently ongoing.