Curative Technologies Inc. said Tuesday that it has gotten thego-ahead from the FDA to resume clinical trials of its CT-102compound to treat diabetic patients with chronic non-healingwounds.
CT-102 is a topical solution containing growth factors extractedfrom human platelets. After the East Setauket, N.Y., companycompleted Phase II trials last year, the FDA asked Curative notto go forward until certain product characterization and clinicalprotocol issues were resolved, said Russell Whitman, chairman,president and chief executive.
Curative will begin another Phase II dose ranging study, whichis designed to be a pivotal study, within a few weeks, Whitmansaid.
"Our strategy is to combine this trial with a European trial,which is just starting, and hope the two trials will constitutetwo pivotal studies that the FDA will accept," Whitman said. Heestimated that the two Phase II trials will take about a year. "Ifthe FDA wants a Phase III, that would add another year."
The stock (NASDAQ:CURE) rose 75 cents to $10.75. -- KB
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