Singapore: Medivir has announced the completion of phase II clinical study of the topical, skin-directed histone deacetylase (HDAC) inhibitor, remetinostat, in patients with early stage CTCL.

CTCL is a chronic, orphan hematologic cancer that presents in the skin. According to the National Cancer Institute, the most common CTCL is the mycosis fungoides (MF) variant of CTCL. MF affects an estimated 15,000 to 20,000 people in the United States, with an estimated 1,500 new cases annually, and around 75 percent of these have early-stage disease. Patients remain at this stage for extended periods and require long-term topical treatments for their disease, which causes substantial reductions in patients' quality of life. A small proportion of patients go on to develop cutaneous tumors or systemic disease, and these patients then require systemic anti-cancer therapy.

"The results of this study confirm and extend the previously published interim analysis of the phase II study, and show that remetinostat has the potential to be a safe and effective new treatment for patients with early-stage CTCL" said Dr Richard Bethell, Medivir's Chief Scientific Officer. "There are few drugs available for the treatment of the disease, and those currently available have generally poor tolerability. As a result, CTCL patients and their physicians require safe and effective new treatment options. Remetinostat 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. Based on the efficacy and safety data from this Phase II study, we believe that remetinostat is capable of meeting a very important unmet need in patients with this chronic and poorly treated orphan disease."