Medivir has positive data from basal cell carcinoma study

Swedish Medivir said Monday that positive data from the investigator-initiated study of remetinostat in basal cell carcinoma (BCC) patients has shown that remetinostat gel offers a potentially effective and well-tolerated, non-surgical intervention for treatment of localized BCCs.

Medivir said that the patients enrolled had at least one BCC of any subtype between 5 and 25 mm in size. Participants applied remetinostat gel 1% 3 times daily under bandage occlusion to BCC(s) for 6 weeks prior to undergoing surgical excision. The primary outcome was overall response rate (ORR) and secondary objectives include safety and tolerability.

The study has shown the ORR, at least a 30% decrease in longest diameter, was 64% (9/14).

Furthermore, the average decrease in tumor area is 70% (n=14), while the average decrease in longest diameter is 62% (n=14). 43% (6/14) of tumors were fully cleared.

Medivir note that no systemic toxicities have been observed, and that 2 of 14 subjects had their study drug temporarily discontinued (for 1-3 days) due to adverse events. The reaction improves within 2-4 weeks of discontinuing medication.

Grade 2 eczematous local site reactions occurred in 71% (10/14) tumors treated with topical remetinostat under bandage occlusion.

Dr Uli Hacksell, Medivir’s Chief Executive Officer, said: “Remetinostat has already demonstrated efficacy in treating MF-CTCL and we are excited about the potential opportunity to develop remetinostat for multiple indications.”

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