Antisoma plc announced that the ATTRACT-1 phase-III trial of ASA404 in non-small cell lung cancer (NSCLC) has reached its enrolment target of 1,200 patients. The trial is the single pivotal registration study for the drug as a first-line treatment for squamous and non-squamous NSCLC, and is being conducted by Novartis, Antisoma's development and commercialisation partner for ASA404.
Glyn Edwards, Antisoma's CEO, said, "Novartis has done an excellent job in rapidly completing recruitment into this very large trial of ASA404 in lung cancer. We can now be even more confident that the results will be available in time to support potential marketing applications in 2011."
Primo N Lara, professor of Medicine at the University of California Davis Cancer Center and US Steering Committee Chair for the ATTRACT-1 study, said, "Lung cancer afflicts an enormous number of patients worldwide and there is a clear need for new and improved treatment options. Phase-II trials reported substantial benefits for lung cancer patients receiving ASA404, and I therefore look forward greatly to seeing the results of this large and important phase-III trial."
ASA404 is a Tumour-Vascular Disrupting Agent (Tumour-VDA) that selectively disrupts established tumour vasculature, inhibits tumour blood flow, and causes extensive tumour necrosis.
ATTRACT-1 is a pivotal study designed to support applications to market ASA404 in previously untreated, advanced NSCLC. It is a randomised, double-blind, placebo-controlled, multicentre phase III trial being conducted across the US, EU, Japan and other territories.
ASA404 (vadimezan, formerly known as DMXAA and AS1404) is a small-molecule Tumour-Vascular Disrupting Agent (Tumour-VDA) which targets the blood vessels that nourish tumours.
Antisoma is a London Stock Exchange-listed biopharmaceutical company that develops novel products for the treatment of cancer.