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news.Calando Pharmaceuticals, a majority owned subsidiary of Arrowhead Research, has started a Phase II clinical trial in the US evaluating the safety and efficacy of its drug candidate, IT-101, in patients with platinum-sensitive ovarian cancer. The study is open for enrollment.
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This Phase II study is designed to determine if IT-101 treatment initiated after a standard second line course of platinum chemotherapy in patients who have stable disease, a partial response or a complete response can delay disease progression. The study is expected to enroll 150 patients in the US.
A team of experts from Dana Farber, Sloan Kettering, Columbia University, and MD Anderson comprise the data safety monitoring committee.
According to the company, IT-101, a conjugate of camptothecin and Insert’s proprietary cyclodextrin polymer nanoparticle, Cyclosert, has demonstrated a highly favorable toxicity profile and pharmacokinetic characteristics.
Previous work with IT-101 suggests that twice monthly ‘maintenance doses’ of IT-101 given after the patient’s standard chemotherapy may have minimal side effects, allowing for improved quality of life, and improved progression free survival.