Phase III registration study of topsalysin in localized prostate cancer.
Phase of Trial: Phase III
Latest Information Update: 02 Dec 2018
At a glance
- Drugs Topsalysin (Primary)
- Indications Prostate cancer
- Focus Registrational; Therapeutic Use
- Sponsors Sophiris Bio
- 02 Dec 2018 According to a Sophiris Bio media release, the Company believes that the data generated in the single-administration portion of the Phase 2b prostate cancer study supports the advancement of the program into this single Phase 3 pivotal trial.
- 13 Nov 2018 According to a Sophiris Bio media release, the Company is in the process of preparing information for regulatory guidance meetings with the U.S. Food and Drug Administration and the European Medicines Agency which are expected to take place in the first half of 2019, after which the Company will provide an update on the Phase 3 trial design
- 11 Jun 2018 New trial record