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Encouraging Interim Data from Phase 2 Clinical Study of Depsipeptide in Prostate Cancer

Strategic Insights

— 1 min read

In a significant development in the treatment of prostate cancer, Gloucester Pharmaceuticals, Inc. announced encouraging interim data from its phase 2 clinical study investigating the use of depsipeptide in treating patients with metastatic hormone refractory prostate cancer (HRPC). The data were presented at the American Society of Clinical Oncology (ASCO) 2006 Prostate Cancer Symposium. Among the 24 patients enrolled in the study, 17 had radiological responses evaluated, and 18 had prostate-specific antigen (PSA) responses evaluated. The study showed promising results, with one patient achieving a partial response for six months, and two patients achieving stable disease for six months. Additionally, five patients displayed evidence of disease stabilization, but had not yet reached six months. The study also showed significant reductions in PSA levels in three patients.

Key Takeaways:

  • The interim data from the phase 2 clinical study investigating depsipeptide in HRPC show promising results, with one patient achieving a partial response for six months and two patients achieving stable disease for six months.
  • Of the patients evaluated for radiological response, an additional five patients have shown evidence of disease stabilization, but have not yet reached six months.
  • The study showed significant reductions in PSA levels in three patients, with two patients achieving a 50% or greater decrease in PSA and one patient achieving a 40% fall in PSA.
  • Dr. Johann S. de Bono, principal investigator of the clinical trial, stated that the data from the study so far is very promising and believes that depsipeptide is the first histone deacetylase inhibitor (HDAC) to show clinical activity in prostate cancer.
  • The drug has been well tolerated, and accrual in the study is ongoing.

Statistics:

  • 17 patients had radiological responses evaluated.
  • 18 patients had prostate-specific antigen (PSA) responses evaluated.
  • 1 patient achieved a partial response for six months.
  • 2 patients achieved stable disease for six months.
  • 5 patients showed evidence of disease stabilization, but had not yet reached six months.
  • 3 patients showed significant reductions in PSA levels, with 2 patients achieving a 50% or greater decrease in PSA and 1 patient achieving a 40% fall in PSA.

Sources:

  • Gloucester Pharmaceuticals, Inc., "Gloucester Pharmaceuticals Announces Promising Interim Data from Phase 2 Clinical Study of Depsipeptide in Prostate Cancer"
  • American Society of Clinical Oncology (ASCO) 2006 Prostate Cancer Symposium
  • De Bono, J.S., "Phase II study of depsipeptide (FK228) in patients with metastatic hormone refractory prostate cancer," poster presentation at the ASCO 2006 Prostate Cancer Symposium.

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