25 patients to be enrolled for safety, response duration and disease-free survival
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Arno Therapeutics has initiated dosing of the first patient in a phase II clinical study of AR-67 in adult patients with myelodysplastic syndrome (MDS), who have failed prior therapies.
The phase II, open-label, single-arm study is designed to evaluate the efficacy of AR- 67, dosed intravenously for five days over four cycles or approximately 16 weeks.
About 25 patients are expected to be enrolled in the clinical trial. The primary objective of the phase II study is to determine the response rate of AR-67 in patients with MDS. Secondary objectives include evaluation of the safety, response duration and disease-free survival of patients with MDS treated with AR-67.
Arie Belldegrun, chairman of Arno Therapeutics, said: “Based upon the encouraging clinical activity, safety profile and pharmacokinetic characteristics observed in the phase I trial of AR-67, we are pleased to advance AR- 67 into this Phase II trial in MDS, which represents a significant milestone for Arno.”
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