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Investigator-initiated phase II clinical study of remetinostat started in patients with squamous cell carcinoma

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Stockholm, Sweden — Medivir AB (Nasdaq Stockholm: MVIR) today announces that the first patient has been enrolled and is being dosed with remetinostat gel 1% in an investigator-initiated phase II clinical study in patients with squamous cell carcinoma (SCC). This clinical study is conducted at the Stanford University School of Medicine in California, USA under the leadership of the principal investigator, Dr Kavita Sarin. Medivir is providing remetinostat drug supply for this study, and has full access to, and the rights to use, all clinical data after the study is complete.

The primary objective of the study is to assess the effects of topical remetinostat on biopsy-proven SCC and SCC in situ tumors and could establish that remetinostat has the potential for use in other skin-associated cancers in addition to MF-CTCL. Further details of the study can be found at www.clinicaltrials.gov, reference number NCT03875859.

“This study together with the ongoing study in basal cell carcinoma explore the potential of remetinostat to be used in multiple conditions beyond cutaneous T-cell lymphoma” said Dr. Uli Hacksell, CEO of Medivir. He continues, “We are eagerly looking forward to the results from these studies.”

For more information please contact:
Uli Hacksell, CEO, Medivir AB, phone: +46 8-5468 3100.

About squamous cell carcinoma

Squamous cell carcinoma (SCC) is the second most common form of cancer in humans occurring in the skin. Surgery is standard of care and there are currently no marketed products approved for the treatment of SCC. There is a need for efficacious and safe treatments when surgery is impractical, e.g. multiple lesions and/or difficult treatment sites.

About remetinostat
Remetinostat is a histone deacetylase (HDAC) inhibitor. The unique design of remetinostat enables topical application, making it active only in the skin. As soon as it reaches the blood stream, it is degraded, avoiding the side effects associated with orally administered HDAC inhibitors. The effect of remetinostat on basal cell carcinoma is investigated in an ongoing phase II study.

About Medivir
Medivir develops innovative drugs with a focus on cancer where the unmet medical needs are high. The drug candidates are directed toward indication areas where available therapies are limited or missing and there are great opportunities to offer significant improvements to patients. Collaborations and partnerships are important parts of Medivir's business model and the drug development is conducted either by Medivir or in partnership. Medivir's share (ticker: MVIR) is listed on Nasdaq Stockholm's Small Cap list. www.medivir.com.



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