British Biotech plc received regulatory approval in the U.K. toresume batimastat studies, which were put on hold in Februarybecause of side effects attributed to a new manufacturing process.
The drug, a metalloproteases (MMP) inhibitor, will be tested inPhase II trials for malignant ascites and malignant pleural effusions,both tumors involving fluid accumulation. A pivotal Phase III trial ofbatimastat was put on hold after 16 malignant ascites patients wererecruited. When two-thirds of those in the treatment arm experiencedpain and discomfort, the trial was halted. (See BioWorld Today, Feb.20, 1995, p. 1.)
The company, in scaling up its manufacturing facility between PhaseII and III studies, changed from water to an organic solvent in themanufacturing's last step. The unexpected side effects were attributedto that change.
British Biotech, of Oxford, England, will restart its malignant ascitestrials with dose-ranging studies expected to take six to nine months,said Katie Arber, the company's head of corporate communications."We have reversed the manufacturing process to the original process,but on a scaled-up basis," she said.
"We're very pleased," Arber said. "The commitment we made [inFebruary] was to get regulatory approval in June, and that's exactlywhat we did. The study we intend to conduct is exactly what we hadhoped, so we're very much back on track with this program."
In addition to the U.K. dose-ranging studies in malignant ascites,British Biotech's Phase II studies of batimastat for pleural effusionsare expected to begin in the U.K. and U.S. in the third quarter. Newlymanufactured product will be used for all the studies.
BB-2516, an orally available MMP inhibitor, is being tested in theU.K. and U.S. in various cancers, and replaced batimastat as thecompany's lead drug for solid tumors. Batimastat's use is expected tobe limited to the ascites and pleural effusions indications.
British Biotech's stock fell 17 percent to 491 pence on the LondonStock Exchange the day the trial suspension was announced inFebruary. It gained 2 pence in a down market Monday, closing at 492pence. n
-- Jim Shrine
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