British Biotech's Oral MMPI Clears Phase I Trials

British Biotech's oral matrix metalloproteinase inhibitor for the treatment of cancer, BB-2516, has successfully navigated Phase I studies in healthy volunteers. Results of the studies were presented at the American Association of Cancer Research annual meeting in Toronto, Canada, last week.

The studies show that BB-2516 was well-tolerated and well-absorbed by the volunteers. The first study involved giving single doses of the drug (25mg-800mg) to 13 patients, while a second study involved 18 patients who were given placebo or the drug twice a day for one week at doses of 50mg, 100mg or 200mg. "Good absorption and prolonged half-life indicate that a potentially therapeutic drug level could be maintained with low doses of BB-2516 twice a day," said the company.

On the basis of these results, British Biotech is planning to begin shortly a series of studies with BB-2516 in patients with a variety of solid tumors. In the USA, an Investigational New Drug application has been approved and the first study will start "imminently" in ovarian cancer patients. In the UK, Clinical Trial Exemption certificate (CTX) applications have been submitted for studies to begin in ovarian and colorectal cancer patients. Subject to regulatory approval, these UK Phase II studies should begin in second quarter of 1995, said the company.