LONDON, June 7, 2005 (PRIMEZONE) -- Cancer drug developer Antisoma (LSE:ASM) announces that it has started a phase II trial of its vascular disrupting agent AS1404 in recurrent ovarian cancer. This is the third and final trial in a series evaluating AS1404 in combination with chemotherapy drugs. Phase II studies in lung and prostate cancers are ongoing, with the first efficacy data expected from the lung study during the second half of this year.
The ovarian study is a randomized, controlled trial that will include around 70 patients from Europe, Australia and New Zealand. Half the patients are receiving standard chemotherapy treatment while the other half are receiving the same treatment plus AS1404. Response rates, time to tumour progression and survival will be compared to see whether patients on the combination of chemotherapy with AS1404 do better than those on chemotherapy alone.
The standard chemotherapy regime for these ovarian cancer patients is carboplatin and paclitaxel, the same as in the ongoing lung cancer study. Initiation of the ovarian cancer trial confirms the preliminary safety and good tolerability of the AS1404-carboplatin-paclitaxel combination in the lung patients treated to date. Preclinical experiments have demonstrated much improved efficacy when AS1404 is used alongside paclitaxel.
Dr. Keith Blundy of Cancer Research Technology, the company that licensed the drug to Antisoma in 2001, said: "Following the initial clinical trials supported by Cancer Research U.K., we are delighted to see Antisoma testing AS1404 in a phase II programme covering three different cancers, and we look forward to seeing the first findings from the trials later this year."
Antisoma's CEO Glyn Edwards said: "There is now considerable support for the idea of attacking cancer on two fronts, directly using chemotherapy and indirectly by cutting off the blood supply to the tumour. Our phase II trials in ovarian, lung and prostate cancers examine whether outcomes of patients receiving chemotherapy can be improved if they also receive AS1404 to disrupt tumour blood vessels. We look forward to results from this programme of studies, starting with the first lung data during the second half of this year."
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.
Background on AS1404
AS1404 (DMXAA) is a small-molecule vascular disrupting agent. 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 Limited) in August 2001. Three phase I monotherapy trials including around 120 patients have been reported, the last at ASCO 2005.
Background on Antisoma
Based in London, U.K., 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. In 2002, Antisoma formed a broad strategic alliance with Roche to develop and commercialise products from Antisoma's pipeline. AS1404 is included within the Roche alliance. Please visit www.Antisoma.com for further information about Antisoma.
Background on Cancer Research Technology Limited
Cancer Research Technology Limited (CRT) is a specialist technology transfer company which aims to develop new discoveries in cancer research for the benefit of cancer patients. CRT is wholly owned by Cancer Research U.K., the largest independent funder of cancer research in the world. CRT works closely with leading international cancer scientists and their institutes to protect intellectual property arising from their research and to establish links with commercial partners. CRT facilitates the discovery, development and marketing of new cancer therapeutics, vaccines, diagnostics and enabling technologies. Further information about CRT can be found at www.cancertechnology.com.
Background on Cancer Research U.K.
Cancer Research U.K. is Europe's leading cancer charity, dedicated to research into the causes, prevention and treatment of cancer. The charity supports the work of 3,000 scientists, doctors and nurses in over 80 academic centres across the UK, with an annual scientific spend of more than 213 million. Further information about Cancer Research U.K. can be found at www.cancerresearchuk.org.