-- U.S. IND granted for phase II study in prostate cancer
-- AACR presentations on Antisoma's AS1404: promising prostate and ovarian cancer data support trial plans
LONDON, April 19, 2005 (PRIMEZONE) -- American Association of Cancer Research Meeting, Anaheim, Calif. -- Cancer drug developer Antisoma plc (LSE:ASM) yesterday presented preclinical data showing that combinations of its phase II drug AS1404 with the taxane drugs used to treat prostate and ovarian cancers had significantly better efficacy than the taxanes alone. The data support plans for forthcoming clinical trials in these two cancers.
The U.S. Food and Drug Administration has now approved an Investigational New Drug (IND) application for a phase II study of AS1404 in hormone-refractory prostate cancer. This study, in which AS1404 will be combined with the taxane docetaxel, will start shortly. A phase II study in recurrent ovarian cancer, where AS1404 will be combined with carboplatin and the taxane paclitaxel, is also close to initiation in Europe, Australia and New Zealand. The phase II program began last year with a study of AS1404 with paclitaxel in non-small cell lung cancer. Recruitment into this study is ongoing in Australia and New Zealand, and the first efficacy findings are expected this year.
In a further AACR presentation tomorrow, Dr. Lesley McPhail of St George's Hospital, London, U.K., will show the correlation between reduced tumour blood flow and necrosis (death) of tumours in rats given doses of AS1404 equivalent to those currently being tested in clinical trials.
Glyn Edwards, CEO of Antisoma, said: "The data presented at AACR show the broad potential of AS1404 against different types of tumour and support our plans to trial AS1404-taxane combinations in prostate and ovarian cancers. We look forward to starting these studies and to the first phase II results from our lung cancer trial, which we expect during the second half of this year."
Note
The first presentation of Antisoma's phase I trial of AS1404 (DART) will be made at the forthcoming ASCO meeting (May 13-17, Orlando, Florida). Also to be presented at ASCO are results from the phase I study of Antisoma's aptamer drug AS1411 (formerly AGRO100).
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 programs, 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/Notes to Editors AS1404 is a "vascular disrupting agent" that attacks tumors by targeting established tumor blood vessels that supply nutrients and support further growth. Drugs in this class are distinct from angiogenesis inhibitors, which block the growth of new tumor vessels. AS1404 is among the leading small-molecule vascular disrupting agents in clinical trials. The data presented at AACR are consistent with many others in showing that the most effective use of vascular disrupting agents is in combination approaches with other cancer treatments.
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 commercialize products from Antisoma's pipeline. AS1404 is one of the products included in this alliance. Please visit www.Antisoma.com for further information about Antisoma.