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Remetinostat shows promise for early-stage cutaneous T-cell lymphoma
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A phase 2 study designed to evaluate remetinostat in patients with early-stage cutaneous T-cell lymphoma yielded positive efficacy data, according to the agent’s manufacturer.
Remetinostat (Medivir) also appeared well tolerated.
“There are few drugs available for the treatment of the disease, and those currently available have generally poor tolerability,” Richard Bethell, chief scientific officer at Medivir, said in a company-issued press release. “As a result, cutaneous T-cell lymphoma patients and their physicians require safe and effective new treatment options.”
Remetinostat — a topical agent — is designed to effectively inhibit histone deacetylases within cutaneous lesions. It also is designed to be broken drown rapidly in the bloodstream, which helps to prevent side effects associated with systemically administered histone deacetylase inhibitors, Bethell said.
The trial included 60 patients with the mycosis fungoides variant of cutaneous T-cell lymphoma.
Researchers randomly assigned them to receive 0.5% remetinostat gel twice daily, 1% remetinostat gel once daily, or 1% remetinostat gel twice daily. Treatment continued for 6 to 12 months.
Overall response rate served as the primary endpoint.
Forty percent of patients who received 1% remetinostat gel twice daily achieved confirmed responses, followed by 25% of those who received 0.5% remetinostat gel twice daily and 20% of those who received 1% remetinostat gel once daily arm.
Investigators reported no signs of systemic adverse events.
Full data from the trial likely will be presented at scientific meetings in the second half of this year.
“The results of this study confirm and extend the previously published interim analysis of the phase 2 study, and show that remetinostat has the potential to be a safe and effective new treatment for patients with early-stage cutaneous T-cell lymphoma,” Bethell said. “Based on the efficacy and safety data from this phase 2 study, we believe that remetinostat is capable of meeting a very important unmet need in patients with this chronic and poorly treated orphan disease.”
Medivir officials expect to initiate discussions with regulatory authorities, with the hope of initiating a phase 3 trial later this year.