Tuesday January 25, 7:14 am Eastern Time
Company Press Release
British Biotech plc Announces Results of Marimastat
Study 193 in Advanced Pancreatic Cancer
OXFORD, England--(BUSINESS WIRE)--Jan. 25, 2000--British Biotech (NASDAQ: BBIOY - news) today announced
the results of Study 193, a multi-center, pivotal Phase III ---- clinical trial of the oral matrix metalloproteinase (MMP) inhibitor,
marimastat. This study was designed to investigate the effect of marimastat on patients with advanced pancreatic cancer
receiving standard therapy with gemcitabine.
Study design and objectives
Study 193 was a randomized, double-blind, placebo-controlled study of 239 patients with advanced pancreatic cancer,
conducted in 37 centers across North America and Europe. Patients with histological or cytological confirmation of pancreatic
cancer treated with 1000mg/m2 of gemcitabine, given by a standard schedule, were, in addition, randomly allocated to receive
treatment with either 10mg of marimastat or placebo, orally, twice daily. The pre-defined clinical cut off of the study was when
90 per cent mortality was first recorded in one of the treatment groups.
The primary end-point was survival.
Study results
The combination of marimastat and gemcitabine failed to show a significant improvement in survival. Moreover, analyses of
secondary end-points did not reveal significant benefits attributable to marimastat. There was no difference in overall safety or
of the quality of life in the two treatment groups. A comparison of baseline characteristics showed that the two treatment arms
were well balanced. Consistent with the results in earlier marimastat studies, there was a trend indicating that patients with less
extensive disease responded better to marimastat.
Future marimastat studies
Based on results of studies with marimastat, and consistent with its mode of action, it appears that patients with earlier disease
are more likely to benefit from marimastat. Of the four marimastat studies scheduled to report in 2000, the patient population in
two monotherapy small cell lung cancer studies best fits this criterion of earlier disease. The other two marimastat trials
scheduled to report in 2000 are a monotherapy study in patients with glioblastoma, a form of malignant brain cancer, and a
combination study of marimastat and carboplatin in patients with ovarian cancer.
Elliot Goldstein, British Biotech's Chief Executive Officer, commented ''The results from this trial show that marimastat does
not add to the benefit of gemcitabine in advanced pancreatic cancer. The results appear to support previous data that patients
with less extensive disease are more likely to respond to marimastat. While it is impossible to predict any trial results, of the four
studies scheduled to report this year, the small cell lung cancer trials best conform to this setting. The results reported today are
the first to be announced since we entered into the collaboration with Schering-Plough Corporation to develop MMPIs for
cancer. The collaboration is progressing well and these results, although negative in the setting of advanced pancreatic cancer,
do not alter Schering-Plough's overall interest in and support of the program.''
This news release contains forward-looking statements which reflect the Company's current expectation regarding future
events. Forward-looking statements involve risks and uncertainties. Actual events could differ materially from those projected
herein and depend on a number of factors including the success of the Company's research strategy, the applicability of the
discoveries made therein, the successful and timely completion of clinical studies and the uncertainties related to the regulatory
process.
Contact:
British Biotech plc
Tony Weir, 011-44-1865-781166
or
G.A. Kraut Company
Gerard Coffey, 212/696-5600 |
