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news.Insert Therapeutics, a majority owned subsidiary of Arrowhead Research, has filed with the FDA to initiate a Phase II clinical trial evaluating the safety and efficacy of its drug candidate IT-101 in patients with ovarian cancer.
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The Phase II study utilizes a unique design intended to demonstrate prolonged time until disease progression in patients who achieved a response or stabilization in their disease following a second line course of platinum-based chemotherapy. Patients will begin the experimental therapy shortly after chemotherapy is completed.
The study will enroll 150 patients in the US and Eastern Europe, and will be led by Jonathan Berek, professor and chair, department of obstetrics and gynecology, Stanford University School of Medicine and the Stanford Cancer Center.
Mr Berek, said: “An effective treatment should not only slow progression, but should also minimize the side-effects caused by traditional chemotherapy and preserve the patient’s quality of life.”