BioWorld International Correspondent

LONDON - Antisoma plc announced positive survival data from a second Phase II trial of ASA404 as an adjunctive treatment in lung cancer, showing median time to tumor progression of 5.5 months and median survival of 14.9 months. That supports the findings of the previous trial, which produced one of the largest increases in median survival ever reported in advanced lung cancer.

"These are huge results, which have to be viewed in the context of the previous random study," Glyn Edwards, CEO, told BioWorld International. "Treating 30 more patients at a higher dose, we have seen comparable median survival, confirming the huge advance on any other treatment recorded in that study."

The data, presented last week at the World Conference on Lung Cancer in Seoul, South Korea, showed a tumor response rate of 37.9 percent and that addition of ASA404 to chemotherapy was well tolerated. The single-arm trial evaluated an 1800 mg/m2 dose of ASA404 in combination with carboplatin and paclitaxel chemotherapy in patients with non-small-cell lung cancer.

"These data add considerably to the strength of the evidence supporting ASA404 in its lead indication and give us extra confidence as the drug proceeds into Phase III," Edwards said.

AS404, a vascular disrupting agent, was partnered with Novartis AG in April this year, in a deal with a headline value of $100 million. Novartis is planning to start enrollment of patients into a phase III trial in non-small-cell lung cancer in early 2008.

Edwards said that while those Phase II results added to the weight of evidence in favor of AS404, the outlines of the Phase III trial have been set out already. The trial will have two treatment arms at two doses, compared to standard treatment.

London-based Antisoma has handed over all responsibility for AS404 apart from one analysis of a Phase II trial in prostate cancer. Novartis, of Basel, Switzerland, will complete a Phase III in the indication also, but the plan for that study depends on data still to come out.

ASA404 was discovered by Bruce Baguley and William Denny and their teams at the Auckland Cancer Society Research Centre, University of Auckland, New Zealand. It was in-licensed by Antisoma from Cancer Research Technology Ltd., the development and commercialization company of Cancer Research UK, in August 2001.