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R1549 Fails To Meet Primary Endpoint in Phase 3 Study in Ovarian Cancer

BASEL, Switzerland and LONDON, April 26 /PRNewswire/ -- Roche and Antisoma announced today that they have completed SMART (Study of Monoclonal Antibody RadioimmunoTherapy), a phase III study of R1549 in ovarian cancer. The outcomes for R1549-treated patients appeared no better than those of patients in the comparative arm of the trial. Given these findings, it is unlikely that development of R1549 will continue. A more detailed analysis of the data from SMART will be completed. The trial provides an extensive clinical database which may be of interest for future research into ovarian cancer.

William M. Burns, Head of Roche's Pharmaceuticals Division, said "Drug development is a high-risk endeavour and such results are not unexpected in the development of novel treatment modalities. The outcome of this study will have no impact on our growth outlook and we remain committed to our long-term relationship with Antisoma, which is based upon multiple products. Commercially more important, Roche also announced today highly significant phase III data on Tarceva in non-small cell lung cancer which will be the next regulatory submission of a major product contribution to the treatment of cancer. The Roche group will be in the unparalleled position of having five cancer medicines with a proven survival benefit - Herceptin, MabThera, Xeloda, most recently Avastin and now Tarceva."

Commenting on the result, Glyn Edwards, CEO of Antisoma said "We're obviously disappointed by the R1549 result, but will now have the opportunity to focus all our efforts on the strong, diverse and rapidly advancing pipeline of other drugs we have in development. We're also confident that we will add further to our clinical portfolio by the end of this year.'

Antisoma and Roche are co-developing a number of drugs under the broad strategic alliance formed in November 2002. These include R1550, a humanised monoclonal antibody in phase I trials for breast cancer, and AS1404, a small-molecule vascular targeting agent, that is expected to start a phase II programme of combination studies later this year.

About the SMART study

SMART (Study of Monoclonal Antibody RadioimmunoTherapy) is a phase III randomised, single-blinded parallel group trial that began in 1998. The trial included more than 420 women with ovarian cancer in seventeen countries and compares patients who received standard care plus R1549 with patients who received standard care alone. Women receiving R1549 were given a single dose of the drug via a catheter into the abdomen (intraperitoneal administration) after surgery and chemotherapy.

R1549

R1549 is a monoclonal antibody linked to the radioactive isotope yttrium-90 using a chelating agent (linker) CITC-DTPA. The antibody component binds to a protein (MUC1) found on the surface of ovarian cancer cells.R1549 was originally developed at the Imperial Cancer Research Fund (now Cancer Research UK) in London. Antisoma licensed the drug from Imperial Cancer Research Technologies (now Cancer Research Technologies) in 1996.

Source: Roche and Antisoma

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