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news.Australian biotechnology company Cytopia has obtained regulatory approval to proceed with a Phase II clinical study assessing its lead anticancer drug in up to 24 multiple myeloma patients. The company said that patient enrollment will soon commence.
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This Phase II study is the first in a number of further clinical studies planned for the anticancer vascular-disrupting agent CYT997 and will be conducted at the Alfred Hospital in Melbourne, Australia. It will investigate the activity of CYT997 in patients with relapsed or refractory multiple myeloma.
To be eligible for the study, patients must have failed at least one previous line of approved therapy. The trial is a single-arm, two-stage design with an interim analysis after 14 patients and maximum enrollment of 24 subjects. The company anticipates releasing interim data for this study in the third quarter of 2008.
Andrew Macdonald, CEO of Cytopia, said: “We are keen to unlock the potential of CYT997 as a next-generation cancer drug, particularly in indications with unmet medical need. This study is the first of Cytopia’s planned suite of Phase II studies for CYT997 and is a substantial value-adding milestone for the company.”