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A Phase III Registration Study of Topsalysin in Patients with Intermediate Risk Localized Prostate Cancer

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Trial Profile

A Phase III Registration Study of Topsalysin in Patients with Intermediate Risk Localized Prostate Cancer

Status: Planning
Phase of Trial: Phase III

Latest Information Update: 23 Oct 2019

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At a glance

  • Drugs Topsalysin (Primary)
  • Indications Prostate cancer
  • Focus Registrational; Therapeutic Use
  • Sponsors Sophiris Bio

    • Most Recent Events

    • 21 Oct 2019 According to a Sophiris Bio media release, if the proposed study were positive and the safety profile were to continue as observed in clinical trials to date, this single study has the potential to provide the clinical data to support regulatory approval in both the US and Europe.
    • 21 Oct 2019 According to a Sophiris Bio media release, the Phase 3 study design agreed upon with the FDA is consistent with the design previously agreed upon with the European Medicines Agency, as reported in June of this year.In addition, the FDA has indicated that in order to receive approval, Sophiris will evaluate all patients that progress to alternative treatments for an additional 12 months, for a total of 24 months of data, post the administration of study drug.
    • 21 Oct 2019 According to a Sophiris Bio media release, following an End of Phase 2/ Pre-Phase 3 meeting with the United States Food and Drug Administration (FDA), there is agreement regarding the design of a single Phase 3 clinical trial to evaluate the potential of topsalysin as a targeted focal therapy to treat patients with intermediate risk localized prostate cancer.
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