4SC AG, has announced data from the ongoing oral resminostat Phase II SHELTER trial in hepatocellular carcinoma (HCC) and from the ongoing Phase I/II SHORE trial in KRAS-mutant colorectal carcinoma (CRC) during two poster presentation sessions at the ESMO 13th World Congress on Gastrointestinal Cancer in Barcelona, Spain, from 22-25 June, 2011.
The poster titled “Clinical update on the Phase I/II trial of HDAC Inhibitor Resminostat in Patients with Sorafenib-Resistant Hepatocellular Carcinoma (HCC) - the SHELTER Study” includes new interim data from the Phase I/II SHELTER study in HCC. The data confirm previously reported trends with regard to clinical activity.
The trial is evaluating up to 70HCC patients, which must show a radiologically proven progression of their disease under first line therapy with sorafenib (Nexavar) prior to entry into the study. After 6 weeks of study therapy, eleven out of eighteen (61%) patients assessed to date show confirmed tumor stabilization.
After 12 weeks of study therapy, eight out of 16 (50%) patients assessed displayed continuous stable disease either on sorafenib and resminostat or resminostat alone. The study medication continues to be safe and well tolerated. This study is expected to report Phase II results in 2011.
The poster titled “SHORE: a Phase I/II Study of Resminostat, an Oral Histone Deacetylase Inhibitor (HDACi), in Combination with FOLFIRI as Second-Line Treatment in KRAS Mutated Colorectal Cancer (CRC) Patients”, includes data from the study in which resminostat is applied in combination with the colon cancer chemotherapy regimen FOLFIRI in 80 patients.
The first dose level of 200mg, one of four dose levels planned, was successfully completed in the dose escalation portion of the trial. No dose-limiting toxicities were observed when 200 mg of resminostat and the standard dose of the FOLFIRI regimen were administered in combination.
The dose escalation continues according to the study protocol. The Phase I/II, dose-ranging part of the study is expected to conclude in 2012.
"We are very pleased with the new, positive data we have been able to present on our lead oncology compound resminostat today. As SHELTER and SHORE are open-label studies, we are able to gain updates from the trials as we evaluate the compound in various doses and in combination with established standard treatments,” said Ulrich Dauer, CEO of 4SC.
Dauer continued, ”Resminostat is already being evaluated in three cancer indications, and we are expecting to report Phase II results for both, the treatment of hepatocelluar cancer and Hodgkin's lymphoma, this year."