4SC commences treatment in its resminostat Phase II trial for HL

Jan 12 2010

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.

The primary endpoint of the study is to determine the ORR (objective overall response rate) of resminostat in patients who are refractory to first line treatment or have relapsed after responding to first line therapy. The secondary endpoints include assessment of PFS (progression free survival), TTP (time to progression), DOR (duration of response) and OS (overall survival), as well as the analysis of safety and tolerability of the treatment.

Dr Bernd Hentsch, Chief Development Officer of 4SC, commented: 'We are very pleased to have commenced this Phase II trial with our HDAC inhibitor resminostat in relapsed or refractory Hodgkin's Lymphoma. HDAC inhibitors have recently shown particularly promising efficacy in lymphoma indications and we look forward to the results resminostat will deliver in this proof of concept study. We have now delivered the second strategic development goal for resminostat by starting this Proof-of-Concept trial in an haematological tumour indication, having already initiated a Phase II study in hepatocellular carcinoma. We continue to evaluate further tumour indications and potential combinations of resminostat with standard chemotherapeutic agents and plan to commence a further clinical study later this year.'