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Marimastat (BB2516): current status of development.

W P Steward1

  • 1Department of Oncology, Leicester Royal Infirmary, UK. wsteward@lri.org.uk

Cancer Chemotherapy and Pharmacology
|June 5, 1999
PubMed
Summary

Marimastat, a matrix metalloproteinase inhibitor, shows promise in oncology trials. Lower doses reduce side effects, and it demonstrates a dose-dependent biological effect on tumor markers, potentially improving survival in cancer patients.

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Area of Science:

  • Oncology
  • Pharmacology
  • Cancer Research

Background:

  • Marimastat (BB-2516) is a novel matrix metalloproteinase inhibitor.
  • It is the first in its class to enter clinical oncology trials.
  • The drug exhibits excellent bioavailability.

Purpose of the Study:

  • To evaluate the safety and efficacy of Marimastat in cancer patients.
  • To assess the impact of Marimastat on tumor markers as surrogate indicators of antitumor activity.
  • To explore the potential of Marimastat in combination with chemotherapy.

Main Methods:

  • Phase I studies in healthy volunteers to assess tolerability.
  • Phase II studies in colorectal, ovarian, prostate, pancreatic, and gastric cancers using serum tumor markers.
  • Dose-ranging studies to identify optimal and tolerable dosages.
  • Evaluation of Marimastat in combination with cytotoxic chemotherapy.

Main Results:

  • Phase I studies showed Marimastat was well tolerated at lower doses.
  • Higher doses (>50 mg bid) caused debilitating joint and muscle pain in over 60% of patients, reversible upon discontinuation.
  • Reduced incidence of side effects observed at 10 mg bid.
  • Pooled Phase II analyses demonstrated a dose-dependent biological effect on tumor markers, with 58% response at doses >50 mg bid.
  • Tumor marker effects correlated with increased survival.
  • Demonstrated safety of combining Marimastat with cytotoxic chemotherapy.

Conclusions:

  • Marimastat is a well-tolerated matrix metalloproteinase inhibitor with demonstrated biological activity in various cancers.
  • Optimized dosing (10 mg bid) mitigates debilitating side effects.
  • Marimastat shows potential as an anticancer agent, particularly when combined with chemotherapy, warranting further investigation in Phase III trials.

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