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news.Antisoma, a biopharmaceutical company, has started a randomised, controlled, multi-territory, Phase IIb trial of AS1411 in patients with acute myeloid leukaemia (AML).
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AS1411 belongs to a new type of drug called aptamers. These drugs are short pieces of DNA or RNA that fold into three-dimensional structures capable of targeting particular proteins. AS1411 is a DNA aptamer that targets nucleolin, a protein found on the surface of cancer cells..
The Phase IIb trial is enrolling patients with AML in first relapse or refractory to one prior treatment. Around 90 patients are being randomised to three treatment groups. A control group is receiving high-dose cytarabine, a standard chemotherapy treatment for the patient population.
The other two groups are receiving high-dose cytarabine combined with AS1411 at 40 or 80mg/kg/day. The trial is expected to compare the three treatment groups with respect to safety, response rates, period free of leukaemia and survival. Data are expected next year.
The Phase IIb trial follows a randomised Phase II trial in AML, which reported positive results at the 2009 Annual Meeting of the American Society of Clinical Oncology (ASCO).
Ursula Ney, chief operating officer of Antisoma, said: “This Phase IIb trial builds on earlier positive Phase II findings, and is designed to pave the way for a registration trial of AS1411 in AML.”