British Biotech's Marimastat Goes Into Phase III

British Biotech has started the first pivotal Phase III trial with its new matrix metalloproteinase inhibitor marimastat, in patients with advanced pancreatic cancer. The trial is an international study and patients are being recruited in the USA and the UK; initial patients have already commenced treatment. Phase II study results with marimastat were announced at the American Society of Clinical Oncology meeting earlier this year (Marketletter May 27), which met with significant enthusiasm from both the medical community and investors.

The marimastat trial will involve 400 patients and compare each of three doses of the drug with the recently-approved cytotoxic therapy gemcitabine, which is the best currently-available treatment for pancreatic cancer. Patients receiving marimastat will be given doses of 5mg, 10mg and 25mg twice a day, and will be dosed on a long-term basis. Gemcitabine will be administered on the currently-approved basis of cycles of treatment. The primary end-point of the trial is mortality, with secondary end-points being clinical progression and quality of life.

According to British Biotech, the US Food and Drug Administration has now confirmed that this study is regarded as a definitive pivotal trial which, if successful, can form the basis of a New Drug Application. Further Phase III studies in other forms of cancer are being planned, and at least one further pivotal trial is expected to commence later this year.