Antisoma plc (UK) - Phase II trial showing improved survival with ASA404 in lung cancer published in British Journal of Cancer
London, and Cambridge, MA: 16 December 2008 - Cancer drug developer Antisoma plc (LSE: ASM; USOTC: ATSMY) announces that the British Journal of Cancer has today published the results of a randomised phase II trial of ASA404 in non-small cell lung cancer (NSCLC). Positive data from this trial supported the progress of ASA404 into phase III development. ASA404 is a Tumour-Vascular Disrupting Agent (Tumour-VDA) that attacks tumours by selectively destroying the tumour blood vessels on which they depend to survive and grow.
In the trial published today, 73 patients receiving their first treatment for NSCLC were randomly assigned to receive either ASA404 plus standard chemotherapy or standard chemotherapy alone. Patients in the ASA404 group had a median survival of 14.0 months while those in the control group had a median survival of 8.8 months. Expressed another way, the risk of death in the ASA404 group was 27% lower. This is the first publication of these data in a peer-reviewed journal.
Commenting on the trial, Dr Mark McKeage of The University of Auckland, New Zealand, a leading investigator of ASA404, commented: "The survival advantage and supportive data on other endpoints in this phase II trial were most encouraging and provided a clear basis for progress into large-scale phase III trials of ASA404 in lung cancer."
A pivotal phase III trial (ATTRACT-1) is recruiting patients with previously untreated NSCLC like those who participated in the trial published today. A separate phase III study (ATTRACT-2) will start soon in patients with NSCLC that has relapsed after initial treatment. The phase III studies are designed to support applications to market the drug around the world, with filings to regulatory authorities expected in 2011. The phase III trials are being conducted by Novartis, with whom Antisoma signed a worldwide development and commercialisation deal for ASA404 in April 2007.
Glyn Edwards, Antisoma's CEO, said: "We're pleased that the positive findings from this phase II trial of ASA404 in lung cancer are now available in detail to the oncology community. If these findings are endorsed in the phase III studies, we will be able to offer a major improvement in treatment to lung cancer patients."
Glyn Edwards, CEO
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Daniel Elger, VP Marketing & Communications
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Mark Court/Lisa Baderoon/Rebecca Skye Dietrich
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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.
Notes for Editors:
About the randomised phase II trial of ASA404 in NSCLC The trial was a randomised, controlled trial that enrolled patients receiving first-line chemotherapy treatment for stage IIIb or IV NSCLC. Patients were randomly assigned to receive up to 6 cycles of standard therapy (carboplatin AUC 6 mg/mL*min and paclitaxel 175 mg/m2; n=36) or standard therapy plus ASA404 1200 mg/m2 (n=37). The trial was conducted at hospitals in France, Germany, Australia and New Zealand. Seventy patients were evaluable for efficacy, 34 of whom received ASA404 plus chemotherapy while 36 received chemotherapy alone.
Key results reported in the British Journal of Cancer publication are as follows:
* Patients who received ASA404 in addition to standard chemotherapy had a median survival 5.2 months longer (14.0 vs 8.8 months) than that of patients who received standard chemotherapy alone. Addition of ASA404 reduced the risk of death by 27% (hazard ratio of 0.73; 95% confidence intervals 0.39, 1.38).
* Patients who received ASA404 in addition to standard chemotherapy had a 23% increase in median time to tumour progression (5.4 vs 4.4 months) compared with patients on standard chemotherapy.
* Patients who received ASA404 plus standard chemotherapy had a tumour response rate (by independent assessment) of 31% compared with 22% for those who received chemotherapy alone.
* Safety profiles were similar and manageable in both groups, with most adverse effects attributed to standard chemotherapy. Sixteen of the patients receiving ASA404 experienced serious adverse events compared with 17 of the patients receiving chemotherapy alone.
About ASA404 ASA404 (formerly known as DMXAA and AS1404) 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 NSCLC Lung cancer is the biggest 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.
About Antisoma 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.
Posted: December 2008