Antisoma has announced that its tumor-vascular disrupting agent, ASA404, will enter a second pivotal Phase III trial in 2008.
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The Attract-2 trial will be conducted by Antisoma’s partner, Novartis, and will evaluate ASA404 as a second-line treatment for non-small cell lung cancer (NSCLC). A separate, ongoing phase III trial (Attract -1) is testing ASA404 as a first-line treatment for NSCLC.
Attract-2 has been designed to support potential applications to market ASA404 for the second-line treatment of NSCLC. The primary endpoint of the trial will be overall survival. There will be a single interim look before the final analysis.
Attract-2 will be a randomized, double-blind, placebo-controlled, multi-centre, multi-country phase III trial including approximately 900 patients receiving their second treatment for stage IIIb/IV NSCLC. Patients will be randomly assigned to receive either ASA404 1800 mg/m2 plus docetaxel or a placebo plus docetaxel.
Glyn Edwards, Antisoma’s CEO, said: “We’re very pleased to see Novartis expanding the ASA404 development program to explore the drug’s potential to benefit second-line as well as first-line lung cancer patients. Since there is a clear need for improved treatment options in the second-line setting, we believe this represents a substantial additional opportunity for ASA404.”
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