4SC (Frankfurt, Prime Standard: VSC), a drug discovery and development company focused on autoimmune and cancer indications, today announced that initial safety and efficacy data from its ongoing Phase II Study with resminostat, a pan-Histone Deacetylase (HDAC) Inhibitor, in relapsed/refractory Hodgkin Lymphoma (HL) patients after high dose chemotherapy and autologous hematopoietic stem cell transplantation will be presented at the 52nd Annual Meeting of the American Society of Hematology (ASH) in Orlando, Florida, USA.
The data presented include the safety and efficacy results from the first 18 patients from this single-arm, Simon two-stage-design study, that were included in the 1st Simon stage cohort of this trial. These patients received a once daily oral dose of 600 mg resminostat, administered in two week cycles, each consisting of five consecutive therapy days and a nine day treatment free period. Clinical activity was measured through PET/CT, the combination of computer tomography (CT) and positron-emission tomography (PET).
Based on this disease assessment, 10 patients out of those 18 included in this 1st Simon stage cohort benefited from treatment with resminostat. Two of those 10 patients were assessed as partial responders (PR, i.e. more than 50% reduction in size of tumour lesions) and eight patients with stabilization of disease (SD). The PET analysis also revealed that almost all of the patients showed a diminished metabolic activity of their disease lesions, with the majority being evaluated as partial metabolic responders (PMR), i.e., more than 25% decrease in PET activity.
The study treatment with resminostat was well tolerated with primarily mild to moderate gastrointestinal and haematological side effects. Based on these data, the study has recently entered into the 2nd Simon stage recruitment phase and will now also include an optional increase of the daily dose of resminostat from 600 mg to 800 mg.
The study tumour assessments are conducted after cycle 3 and cycle 6, and thereafter every 4th cycle during an optional follow-up treatment period, in which patients may remain on treatment until disease progression or occurrence of intolerance to protocol therapy. The primary endpoint of the study is the estimation of overall objective response rate (OOR), secondary endpoints include time to response (TTR), duration of response (DOR), safety and tolerability and the analysis of drug regulated biomarkers.
Overtreatment of older men with prostate cancer raises concerns