British Biotech and ImmunoGen, Inc announce initiation of second Phase I study of BB-10901
08 August 2002
New study explores more intensive dosing regimen
British Biotech plc (LSE: BBG, Nasdaq: BBIOY) and ImmunoGen, Inc. (Nasdaq: IMGN) announced today that patient treatment has begun in the planned second Phase I study of BB-10901, a novel anti-cancer agent targeted at small cell lung cancer that uses a humanised monoclonal antibody to deliver a highly potent chemotherapeutic agent specifically to the site of the tumour.
The study is assessing daily dosing of the product and complements a weekly dosing Phase I study currently under way in the United States. It is being conducted at the Christie Hospital in Manchester, under the direction Dr Paul Lorigan and Dr Malcolm Ranson of the Department of Medical Oncology, and at Nottingham City Hospital, under the direction of leading cancer expert Professor James Carmichael and Dr Penella Woll.
The open-label, dose-escalation study will assess the safety, tolerability, and pharmacokinetics of increasing doses of BB-10901; evidence of biological activity will also be determined. The drug will be administered daily for three successive days followed by an 18-day follow-up period. As in the US Phase I study, eligible patients have relapsed or refractory small cell lung cancer, or other tumours that express the CD56 antigen targeted by the drug's antibody component. Dosage will be increased in each new cohort of patients until dose-limiting toxicity occurs and the maximum tolerated dose is established.
The study is expected to be completed by mid-2003, with results available later that year, although timing is dependent on the rate of patient recruitment and the extent of dose escalation.
Commenting on the study, Dr Elliot Goldstein, Chief Executive of British Biotech, said: "We have made good progress in the US with our trial of this novel agent. In this study we aim to find out whether a more frequent dosing regimen can be safely employed. We expect that the data from these two Phase I studies will provide the information needed to select the optimum dosing regimen to take forward into Phase II antitumour efficacy studies".
Mitchel Sayare, PhD., Chairman and Chief Executive Officer of ImmunoGen, said: "We are pleased with the progress being made by British Biotech. The data from the US Phase I study with BB-10901 are encouraging and, combined with the data this study is expected to yield, should establish the appropriate dosing schedule for future studies with the product. This study also marks the first clinical trial to be conducted with an ImmunoGen Tumour-Activated Prodrug product in Europe."
British Biotech acquired rights to develop and commercialise BB-10901 for Europe and Japan under a May 2000 agreement with ImmunoGen Inc., of Cambridge, Massachusetts. ImmunoGen retained commercialisation rights for the US and the rest of the world.
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