Date: 2018-06-18
Type of
information: Clinical trial authorisation
phase: 3
Announcement: clinical trial authorization
Company: Medivir (Sweden)
Product: remetinostat
Action
mechanism:
- HDAC inhibitor. Remetinostat is a topical, skin-directed inhibitor of histone deacetylases (HDACs). The compound was designed to effectively inhibit HDACs within cutaneous lesions, but to be rapidly broken down in the bloodstream, preventing the side effects associated with systemically administered HDAC inhibitors.
- Medivir has acquired this clinical stage oncology program from TetraLogic Pharmaceuticals in December 2016.
Disease: early-stage cutaneous T-cell lymphoma (CTCL).
Therapeutic
area: Cancer - Oncology
Country:
Trial
details:
Latest
news:
- • On June 18, 2018, Medivir announced that the board of directors have decided to continue the discussions with the FDA to agree on the design of the planned pivotal phase III clinical study of remetinostat for the treatment of early-stage cutaneous T-cell lymphoma (CTCL). The aim of the continued dialog with the FDA is to agree upon the design for a phase III study that could, if successfully completed, lead to the approval of the company’s most advanced candidate drug within oncology. The start of the study will not be possible earlier than 2019, and thus not in 2018 as previously communicated. Details of the phase III study design will be published at a future date when finalized.
Is
general: Yes
