4SC AG (Frankfurt, Prime Standard: VSC), a drug discovery and
development company focused on autoimmune and cancer indications, today
announced the treatment of the first patient in a Phase II study
evaluating resminostat (4SC-201), an oral pan-histone-deacetylase (HDAC)
inhibitor in relapsed or refractory Hodgkin's Lymphoma (HL) patients.
In this open-label, single-arm, Simon-design two-stage Phase II study
entitled 'SAPHIRE', resminostat will be given orally at a dose of 600mg
daily for five consecutive days, followed by a nine day treatment free
period ('5+9' dosing schedule). In the main phase of the trial, patients
will receive treatment for six cycles (12 weeks). Disease assessments
will be performed after treatment cycles three and six by computed
tomography in combination with positron emission tomography (PET/CT), as
recommended by the International Working Group (IWG) criteria for the
evaluation of HL. Patients showing response or stable disease at the end
of the main treatment phase may continue to the follow-up phase and can
remain on medication for up to one year. The trial will conclude when
the last patient remaining will have completed one year of therapy,
develops progressive disease or discontinues treatment for other
reasons. The study is expected to enrol 33 patients across 10 sites in
Poland, Romania and the Czech Republic.