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news.The FDA has approved UK-based biopharmaceutical firm Antisoma's investigational new drug application to evaluate AS1404 in prostate cancer and has released preclinical data showing that AS1404 plus taxane drugs had significantly better efficacy than the taxanes alone.
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The FDA has now approved an investigational new drug (IND) application for a phase II study of AS1404 in hormone-refractory prostate cancer. This study, in which AS1404 will be combined with the taxane docetaxel, will start shortly.
A phase II study in recurrent ovarian cancer, where AS1404 will be combined with carboplatin and the taxane paclitaxel, is also close to initiation in Europe, Australia and New Zealand.
The phase II program began last year with a study of AS1404 with paclitaxel in non-small cell lung cancer. Recruitment into this study is ongoing in Australia and New Zealand, and the first efficacy findings are expected this year.
AS1404 is among the leading small-molecule vascular disrupting agents, a class of drugs that attack tumors by targeting established tumor blood vessels supplying nutrients, in clinical trials.
Antisoma’s share price has risen by more than 2% following news of the approval.