LONDON — British Biotech plc announced last week that it will axe one of the 11 pivotal studies of its oral anticancer therapy, marimastat, prompting a fall of 5 pence in the share price, to 30 pence. The company, based in Oxford, dropped the European Phase III monotherapy trial in ovarian cancer following a review of the trials program, but stressed that the decision was not related to any problems of safety or efficacy. A trial of marimastat in combination with chemotherapy in ovarian cancer continues.
Katie Arber, spokeswoman for the company, told BioWorld International the trial was being discontinued because it was badly designed. "The trial was using an assessment of disease progression composed of three different measures as its primary endpoint," she said. "As a result of the review, we were advised that these measures are not sufficiently objective."
The monotherapy trial, on which British Biotech was to spend £1 million (US$1.6 million) was due to recruit 300 patients, who would have received either marimastat or placebo. Recruitment commenced in November 1997 and 64 patients had been recruited by December 1998.
Commenting on the decision, Peder Jensen, development director and chief medical officer, said that, during the review of the marimastat trial program, a question was raised about the monotherapy study in ovarian cancer. "We therefore undertook further separate discussions with the clinical and regulatory experts, before making a final decision," he said. "The consensus was that the design of this particular study was not sufficient to generate registerable data in ovarian cancer. For this reason, it makes sense to stop the study now and use the resources previously allocated to it elsewhere in the business."
Of the £1 million budgeted for the trial, £700,000 is unspent. Ten trials of marimastat in six tumor types are continuing. *