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Exisulind Cell Pathways.

G J Griffiths1

  • 1University of Manchester, Department of Biological Sciences, Stopford Building, Manchester, M20 9PT, UK. ggrifit@fs1.scg.man.ac.uk

Current Opinion in Investigational Drugs (London, England : 2000)
|March 16, 2001
PubMed
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Exisulind, an oral apoptosis modulator, showed promise in reducing polyp formation for familial adenomatous polyposis (FAP). However, the FDA issued a non-approvable letter due to unsatisfactory phase III data, requiring further review.

Area of Science:

  • Oncology
  • Pharmacology
  • Gastroenterology

Background:

  • Exisulind (Aptosyn) is an oral apoptosis modulator and cGMP phosphodiesterase inhibitor developed by Cell Pathways.
  • It was investigated for multiple oncologic indications, including precancerous conditions and cancer recurrence prevention.

Purpose of the Study:

  • To evaluate the efficacy and safety of exisulind for treating precancerous adenomatous polyposis coli (APC), also known as familial adenomatous polyposis (FAP).
  • To assess exisulind's potential in preventing tumor recurrence in prostate and breast cancer.

Main Methods:

  • Submission of a New Drug Application (NDA) to the US FDA for APC treatment, supported by data from multiple clinical trials.
  • Phase III trials for APC, and ongoing phase II/III trials for prostate and breast cancer recurrence.

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  • Analysis of data from three additional trials, including open-label and double-blind, placebo-controlled studies, to support the NDA.

    • Main Results:

    • Patients treated with exisulind showed significant reductions in polyp formation compared to placebo.
    • In one trial, patients previously on placebo experienced a 50% reduction in polyp formation after switching to exisulind.
    • Exisulind was generally well-tolerated, with patients in long-term studies showing sustained reductions in polyp rates.

    Conclusions:

    • Despite promising efficacy data in reducing polyp formation, the FDA issued a non-approvable letter for exisulind for FAP treatment.
    • Cell Pathways intended to amend the NDA and request a meeting with the FDA to address deficiencies.
    • Patents covering exisulind's mechanism of action were allowed in Europe and Japan, indicating ongoing interest in its therapeutic potential.