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Medivir announces Phase II data

John Öhd

Phase II efficacy and safety data in patients with Mycosis Fungoides (MF) type early-stage Cutaneous T-cell Lymphoma (CTCL) demonstrated that remetinostat gel 1%, when applied topically twice daily, reduced the severity of CTCL skin lesions.

Remetinostat also caused a clinically significant reduction in the severity of pruritus (itching) in those patients with clinically significant pruritus at the start of the study, and was highly tolerable with no systemic adverse effects.

These data were contained in an abstract published at the European Organization for Research and Treatment of Cancer (EORTC) Cutaneous Lymphoma Task Force meeting being held in London on October 13-15th. The details of the study are scheduled to be presented at the meeting by Dr Madeleine Duvic, Professor of Internal Medicine and Dermatology at the MD Anderson Cancer Center in Houston, Texas.

The remetinostat phase II trial enrolled 60 patients with stage IA-IIA MF, the predominant variant of CTCL, across five different clinical sites in the USA. Patients were randomized to receive one of remetinostat gel 0.5% twice daily, remetinostat gel 1% once daily, or remetinostat gel 1% twice daily, for up to 12 months.

The primary end-point of the study was the proportion of patients with either a complete or partial confirmed response to therapy, assessed using the Composite Assessment of Index Lesion Severity. The study showed a dose response with patients in the remetinostat gel 1% twice daily arm having the highest proportion of confirmed responses including 1 complete response.

Remetinostat was generally well tolerated, with adverse events evenly distributed across the treatment arms. The most common adverse events were skin related and mostly grade 1-2. There were no signs of systemic adverse effects related to remetinostat treatment, including those associated with systemic HDAC inhibitors. Most patients remained on study for the maximum possible duration and the median treatment time was 350 days.

“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” said John Öhd, Chief Medical Officer at Medivir AB. “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.”

Based on the outcomes of the phase II study, Medivir expects to meet with regulatory authorities to discuss the design of a pivotal clinical program for remetinostat in MF-type CTCL.

Photo of John Öhd, CMO at Medivir