Antisoma's ASA404 programme to expand with new pivotal trial in lung cancer

ATTRACT-2 study will evaluate ASA404 as second-line treatment

21-Jul-2008

Antisoma plc ( announced that its Tumour-Vascular Disrupting Agent, ASA404, will enter a second pivotal phase III trial this year. The ATTRACT-2 (Anti-vascular Targeted Therapy: Researching ASA404 in Cancer Treatment-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.

Glyn Edwards, Antisoma's CEO, said: "We're very pleased to see Novartis expanding the ASA404 development programme 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."

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 randomised, 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.

ASA404 (DMXAA) is a small-molecule Tumour-Vascular Disrupting Agent (Tumour-VDA) which targets the blood vessels that nourish tumours. The drug was discovered by Professors 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 Ventures Limited (now Cancer Research Technology), the development and commercialisation company of the Cancer Research Campaign (now Cancer Research UK), in August 2001. Worldwide rights to the drug were licensed to Novartis AG in April 2007.

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