Atlanta, Georgia, and London, UK: 4 June 2006 Antisoma announces the successful completion of a phase I trial of R1550 (huHMFG1) and presentation of its results today at the ASCO meeting in Atlanta. The safety study in patients with metastatic (spreading) breast cancer showed that the drug was well tolerated at the maximum dose tested, clearing the way for further development in patients with less advanced disease. While analysis of efficacy was not a primary aim, a number of patients showed prolonged stabilisation of disease.
Antisoma has reached agreement with Roche to regain all rights to R1550, which will now be redesignated AS1402. Antisoma plans to move the drug rapidly into a phase IIa study in breast cancer patients awaiting surgery after initial diagnosis. State of the art microarray analyses will be used to examine the effects of the drug in these earlier stage patients, and data are expected during 2007.
Commenting on the developments, Antisoma's Chief Executive Officer, Glyn Edwards, said: "R1550 is clearly well tolerated and has shown some interesting signs of activity in patients with advanced breast cancer. We and Roche both feel that Antisoma is best placed to investigate these further and that a phase IIa study in pre-surgical breast cancer is the logical next step. This trial will allow us to assess the effect of R1550 in patients with earlier stage disease, where experience with other antibody drugs suggests there is greatest chance of seeing efficacy."
Dr Mark Pegram of the UCLA Jonsson Comprehensive Cancer Center, Los Angeles, an investigator in the study and its presenter at ASCO, said "Targeting MUC1 with R1550 is a promising approach and I look forward to seeing how the drug performs in less heavily pretreated patients and patients with earlier stage breast cancer."
Enquiries: Glyn Edwards, CEO Daniel Elger, Director of Communications +44 (0)7909 915 068
Antisoma plc Mark Court/Lisa Baderoon/Rebecca Skye +44 (0)20 7466 5000 Dietrich Buchanan Communications
Antisoma disclaimer 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 on R1550 (AS1402) and the phase I study The poster presentation on the R1550 phase I study is available at www.antisoma.co.uk. A webcast regarding Antisoma's presentations at ASCO is also available on the company's website.
R1550 is a humanised monoclonal antibody that targets MUC1, a protein found on the surface of many types of cancer cell. The drug has been shown to mediate ADCC (antibody dependent cell-mediated cytotoxicity) in experiments using donor immune cells and cancer cells from patients. R1550 was originally licensed by Antisoma from Imperial Cancer Research Technologies, the technology transfer group of ICRF, now incorporated into Cancer Research UK.
Background on Antisoma Based 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.co.uk for further information about Antisoma.
