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12:00 AM
 | 
Apr 05, 2010
 |  BioCentury  |  Product Development

No Regrets for Antisoma

Antisoma, Novartis carefully developed ASA404 for lung cancer, but still failed

The vagaries of drug development are such that even carefully thought out clinical programs can fail. Thus Antisoma plc says it has no regrets about the way it and partner Novartis AG have run development for ASA404, which failed last week in a Phase III trial in non-small cell lung cancer.

The partners halted the international Phase III ATTRACT-1 trial in 1,200 previously untreated NSCLC patients after an interim analysis showed there was "little or no prospect" that ASA404 plus carboplatin and Taxol paclitaxel would meet the primary endpoint of significantly improving overall survival (OS) vs. placebo plus chemotherapy.

"I think we felt we were following a pretty gold standard path for developing cancer drugs," said Daniel Elger, Antisoma's VP of marketing and communications.

ASA404 is a vascular disrupting agent (VDA) originally discovered at Auckland Cancer Center at the University of Auckland. The small molecule is meant to work by targeting the existing vasculature that supplies tumors with nutrients, as opposed to other anti-angiogenesis therapies like Avastin bevacizumab that prevent tumors from creating new blood vessels.

In 2001, Antisoma in-licensed the compound from Cancer Research Campaign (now Cancer Research UK). To that point ASA404 had been tested as monotherapy in two Phase I dose escalating trials.

The biotech then ran a third Phase I trial to better characterize the dose-dependent effects of ASA404, both on tumor blood vessels and on side effects. Although QTc prolongation and ophthalmic side effects had been seen at higher doses, the study showed these "weren't of significance at...

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