Topical remetinostat 1% gel can significantly reduce the severity of skin lesions and itching in mycosis fungoides (MF) patients without systemic adverse events, data from a Phase 2 trial show.
The trial results were presented at the European Organization for Research and Treatment of Cancer (EORTC) Cutaneous Lymphoma Task Force meeting held in London, Oct. 13-15.
The poster, “A Randomized Phase 2 Study to Evaluate Three Dosing Schedules of Remetinostat (SHAPE), a Histone Deacetylase Inhibitor, in Patients with Stage IA- IIA Cutaneous T-Cell Lymphoma,”was presented by Madeleine Duvic, professor of internal medicine and dermatology at the MD Anderson Cancer Center in Houston, Texas.
The study of Medivir’s remetinostat found that it caused skin lesions and itching to drop in patients with MF, a common variant of cutaneous T-cell lymphoma (CTCL).
Remetinostat, formerly known as SHAPE, is a gel applied to the skin of the affected area. It is a histone deacetylase (HDAC) inhibitor. HDAC is a protein that affects the activity of certain genes.
Remetinostat is designed to break down quickly in the bloodstream before it can cause the adverse effects that HDAC inhibitors cause when administered in the entire body.
The Phase 2 trial (NCT02213861) included 60 patients with stages IA, IB and IIA MF. Stage IA involves 10% or less of skin; stage IB involves more than 10% of skin; and stage IIA has stage IA or B skin involvement with additional limited involvement of lymph nodes, which are small organs of the immune and lymphatic systems located throughout the body.
The participants were divided into three groups of 20 that were given either 0.5% gel twice daily, 1% gel once daily, or 1% gel twice daily for up to 12 months.
The Composite Assessment of Index Lesion Severity, a measure of the affected area’s size and the severity of lesions, was used to evaluate decreases in the severity of skin lesions. The group that received the 1% gel twice daily had the highest response rate at 40%, or eight patients.
The amount of itching was measured using a visual analogue scale (VAS) commonly used to measure the severity of itching. Itching was reduced in 80% of the patients receiving the 1% gel twice daily. The rate was lower in the other two groups.
The number of adverse events was similar in the three groups, and common events were mostly limited to the skin and were mild to moderate.
Based on these promising data, Medivir plans to conduct a pivotal trial to confirm the results.
“The beneficial effects of remetinostat on both CTCL lesions and the pruritus [itching] associated with early-stage CTCL that were observed in this clinical trial are highly encouraging, as was its safety profile” John Öhd, chief medical officer at Medivir AB, said in a press release.
“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 for time. The results of the phase II study support the progression of remetinostat into a pivotal clinical program,” Öhd added.
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