Swedish pharmaceutical firm Medivir has reported positive safety and efficacy results from a Phase II clinical trial of remetinostat in patients with mycosis fungoides (MF) type early-stage cutaneous T-cell lymphoma (CTCL).

Remetinostat is a histone deacetylase (HDAC) inhibitor being developed to be effective in the skin and degrade quickly in the bloodstream to avoid the adverse effects caused due to systemic administration.

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The results showed that 1% remetinostat gel minimised the severity of CTCL skin lesions when applied twice a day.

In 60 subjects with stage IA-IIA MF CTCL, the Phase II trial evaluated 0.5% two times a day, 1% once-daily and 1% twice-daily remetinostat gel for a duration of around 12 months.

The trial’s primary endpoint was the proportion of subjects with either a complete or partial confirmed response to the treatment.

It was observed that 40% of patients treated with 1% twice-daily remetinostat gel achieved a confirmed response, while it was 25% with 0.5% twice-daily and 20% in case of 1% once-daily gel.

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"Patients with early-stage CTCL are in need of new treatment options that effectively control the symptoms of the disease and that are safe to use over long periods of time."

Medivir chief medical officer John Öhd said: “The beneficial effects of remetinostat on both CTCL lesions and the pruritus associated with early-stage CTCL that were observed in this clinical trial are highly encouraging, as was its safety profile.

“Given the chronic nature of this cancer and the limited availability of safe, effective and convenient treatments, patients with early-stage CTCL are in need of new treatment options that effectively control the symptoms of the disease and that are safe to use over long periods of time.”

Remetinostat gel 1% twice daily also demonstrated clinically significant decrease in pruritus from baseline in the highest proportion of patients (80%).

The investigational candidate was found to be well-tolerated with the most common adverse events being skin related under grade 1-2.