Antisoma announces start of phase III lung cancer trial of ASA404
LONDON, UK--(Marketwire - April 11, 2008) -
Initiation triggers USD 25 million milestone payment from Novartis
London, UK, and Princeton, NJ, 11 April 2008 - Cancer drug developer Antisoma plc (LSE: ASM; US OTC: ATSMY) announces that its partner Novartis has started the pivotal phase III trial of ASA404 combined with first-line chemotherapy in non-small cell lung cancer (NSCLC). The study, called ATTRACT-1, is designed to support applications for marketing authorisations in the US, Europe and other territories. Its initiation triggers a USD 25 million milestone payment to Antisoma.
Glyn Edwards, Antisoma's CEO, said: "We're delighted that the phase III trial in lung cancer is underway, putting ASA404 on a clear path towards potential marketing applications. Lung cancer is an indication with substantial unmet clinical need and blockbuster sales potential, and Novartis' trial is optimally designed to seek confirmation of the positive results seen in our two phase II lung cancer studies."
Two webcasts/conference calls will be held today at 9:30am BST / 4:30am EST and at 2pm BST / 9am EST. The webcasts can be accessed via Antisoma's website at http://www.antisoma.com/ and the calls by dialling +44 (0)20 8609 1435 (UK toll-free 0808 109 1498; US toll-free 1866 793 4279) and using the participant PIN code 816385#. Recordings will also be available afterwards on the Antisoma website.
About the phase III trial
The ATTRACT-1 trial is a randomised, double-blind, placebo-controlled, multicentre phase III trial being conducted across the US, EU and other territories. With 1200 patients, it will be amongst the largest trials conducted in NSCLC. ATTRACT-1 is open to patients with all histologies, or types, of NSCLC, including squamous and non-squamous cancers. Patients are being randomised 1:1 to receive either ASA404 1800 mg/m2 plus chemotherapy (carboplatin/paclitaxel) or a placebo plus chemotherapy (carboplatin/paclitaxel) as a control. The primary endpoint of the ATTRACT-1 trial is overall survival. Key secondary endpoints are survival in the squamous and non-squamous patient subgroups.
If the trial results are positive, applications for marketing authorisations are anticipated in 2011. There will be a single scheduled interim look during the trial, expected in mid-late 2009.
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 921,000 deaths. Around 85-90% of all lung cancer cases are NSCLC.
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.
About ASA404 in NSCLC
ASA404 has shown a substantial survival benefit in patients with non-small cell lung cancer when added to paclitaxel-based chemotherapy in a randomised phase II study. A second, single-arm, phase II study of ASA404 in non-small cell lung cancer has also reported positive results.
Headquartered in London, UK, Antisoma is a biopharmaceutical company that develops novel products for the treatment of cancer. Antisoma fills its development pipeline by acquiring promising new product candidates from internationally recognised academic or cancer research institutions. Its core activity is the preclinical and clinical development of these drug candidates. Please visit www.antisoma.com for further information about Antisoma.
Glyn Edwards, CEO
Daniel Elger, Director of CommunicationsÂ Â Â Â Â Â Â Â Â +44 (0)7909 915 068
Mark Court/Lisa Baderoon/Rebecca SkyeÂ Â Â Â Â Â Â Â Â Â Â Â +44 (0)20 7466 5000
Brian KorbÂ Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â +1 646 378 2923
The Trout Group
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.