Medivir has positive data from basal cell carcinoma study

Medivir has positive data from basal cell carcinoma study

May 13, 2019 Off By Dino Mustafić

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.”