ASA404 enters pivotal phase III trial in second-line lung cancer
London, UK, and Cambridge, MA – Antisoma plc (LSE:ASM; USOTC: ATSMY) announces that ‘ATTRACT-2’, a phase III trial testing ASA404 as a second-line treatment for non-small cell lung cancer (NSCLC), is now underway. This is a single pivotal study designed to support applications to market ASA404 for lung cancer patients who have received one previous round of treatment. A separate, ongoing pivotal trial, ATTRACT-1, is evaluating ASA404 in patients receiving their first treatment for NSCLC.
Glyn Edwards, Antisoma’s CEO, said: “We’re delighted that our partner Novartis has decided to explore the potential of ASA404 in previously treated as well as newly diagnosed lung cancer patients. This will help to ensure that a wide range of patients could benefit from the drug.”
About the ATTRACT-2 phase III trial
ATTRACT-2 (Anti-vascular Targeted Therapy: Researching ASA404 in Cancer Treatment-2) is a randomised, double-blind, placebo-controlled, multi-centre, multi-country phase III trial that will include approximately 900 patients receiving their second treatment for stage IIIb/IV NSCLC of either squamous or non-squamous histology. It is open to patients who previously received only chemotherapy and to patients who received chemotherapy plus bevacizumab or cetuximab as their first-line treatment. Patients will be randomly assigned to receive either ASA404 1800 mg/m2 plus docetaxel or a placebo plus docetaxel. The primary endpoint of the trial is overall survival. Before the final analysis there will be a single interim look, which is expected to occur during 2010. The study is expected to be completed in 2011.
Lung cancer is the number one cause of cancer death for both men and women worldwide, with 1.2 million new cases per year and around 920,000 deaths. Approximately 85-90% of all lung cancer cases are NSCLC.
ASA404 (DMXAA) is a small-molecule Tumour-Vascular Disrupting Agent (Tumour-VDA) which selectively 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.
About ASA404 in NSCLC
ASA404 improved survival by 5 months in patients with NSCLC when added to first-line carboplatin and paclitaxel chemotherapy in a randomised phase II trial. A second, single-arm, phase II trial also reported positive results with ASA404 in the same patient group. A pivotal phase III trial, ATTRACT-1, is evaluating ASA404 in combination with carboplatin and paclitaxel in the first-line treatment of NSCLC. The ATTRACT-2 phase III trial is the first study to investigate ASA404 as a second-line treatment for NSCLC. In this trial, ASA404 is combined with docetaxel, which, like paclitaxel, belongs to the taxane class of drugs, and which is widely used in the second-line treatment of NSCLC.
Antisoma is a London Stock Exchange-listed biopharmaceutical company that develops novel products for the treatment of cancer. The Company has operations in the UK and the US. Please visit www.antisoma.com for further information about Antisoma.
Except for the historical information presented, certain matters discussed in this statement are forward looking statements that are subject to a number of risks and uncertainties that could cause actual results to differ materially from results, performance or achievements expressed or implied by such statements. These risks and uncertainties may be associated with product discovery and development, including statements regarding the company’s clinical development programmes, the expected timing of clinical trials and regulatory filings. Such statements are based on management’s current expectations, but actual results may differ materially.
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