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Antisoma starts phase II trial of AS1411 in acute myeloid leukaemia |
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07 Aug 2007 |
Antisoma today announces that it has started a randomised phase II trial of AS1411 in AML (acute myeloid leukaemia)
LONDON, UK | August 6, 2007 | Cancer drug developer Antisoma plc (LSE: ASM; USOTC: ATSMY) today announces that it has started a randomised phase II trial of AS1411 in AML (acute myeloid leukaemia). Around 70 patients will be recruited at major cancer centres in the USA.
The trial tests AS1411 in patients with relapsed or refractory AML. It evaluates addition of AS1411 to the current standard therapy, cytarabine (Ara-C). Patients are being randomly assigned to one of three groups: cytarabine alone, cytarabine plus 10 mg/kg/day AS1411 or cytarabine plus 40 mg/kg/day AS1411. Efficacy and safety will be compared to see whether patients receiving a cytarabine-AS1411 combination do better than those receiving cytarabine alone and whether the two doses of AS1411 have different effects. Initial results are expected in 2008.
Dr Robert Stuart of the Medical University of South Carolina, an investigator in the trial and a collaborator in earlier experimental work on the drug, said: “AS1411 has shown real promise against AML in preclinical testing and there is a strong biological rationale for evaluating the drug in this disease, so we are very pleased to be testing AS1411 in our leukaemia patients.”
AS1411 was the first anti-cancer aptamer to start clinical trials and today becomes the first to progress to phase II. Preclinical data suggest that AS1411 has potential against various blood cancers and solid tumours. AML was selected as the lead blood-cancer indication because cancer cells from AML patients and AML cell lines show particularly high sensitivity to AS1411. There is also evidence for a synergistic effect when AS1411 is combined with cytarabine.
Phase I testing of AS1411 was conducted in solid tumours. This showed a favourable safety profile and evidence of anti-cancer activity in renal cancer. A phase II trial in renal cancer is expected to start shortly.
Antisoma’s CEO, Glyn Edwards, said: “We intend to explore the potential of AS1411 in a number of cancers where new treatment options are needed. Our robust, randomised trials should provide clear evidence of any benefit associated with AS1411 and therefore have the potential to add significantly to its value over the next couple of years.”
SOURCE: Antisoma plc |
