Business
Update on the SCIB1 Phase 2 clinical trial
Update on the SCIB1 Phase 2 clinical trial.
About this update from Scancell Holdings Plc
[{"type":"text","content":"\n \nRNS Number : 4101J Scancell Holdings Plc 19 August 2019 \n\n19 August 2019\n \nScancell Holdings plc\n(\"Scancell\" or the \"Company\")\n \nUpdate on the SCIB1 Phase 2 clinical trial in patients with advanced melanoma \n \nInitiation of patient enrolment into UK sites\n \nScancell, the developer of novel immunotherapies for the treatment of cancer, today announces the initiation of and further updates on the SCIB1 Phase 2 trial in patients with metastatic melanoma also receiving the checkpoint inhibitor pembrolizumab (Keytruda).\n \nAs reported in April, the Company has received the necessary regulatory and ethical approvals to initiate the UK arm of the SCIB1 clinical trial. Operational activities for clinical centre initiation in the UK have now been completed. In the US, the Food and Drug Administration (\"FDA\" or the \"Agency\") requested additional information from Ichor Medical Systems (\"Ichor\") on the TriGrid® 2.0 electroporation delivery system. Whilst there has been extensive dialogue between Ichor and the Agency, a timely resolution to the device-specific questions has yet to be agreed. \n \nIn order to initiate patient recruitment in the UK under the Investigational New Drug (IND) application submitted to the Agency, prior approval of the IND is required. Having considered the ethical issues related to patients awaiting enrolment into the UK sites, Scancell has decided to withdraw its IND application in the US to allow the UK arm of the trial to proceed. \n \nScancell will resubmit the IND at a later date with the intent to initiate clinical sites in the US, following further clarification from the Agency regarding Ichor's TriGrid® 2.0 delivery device.\n \nThe Phase 2 study is designed to assess whether the addition of SCIB1 to pembrolizumab will result in an improvement in the tumour response rate, progression-free survival and overall survival in 25 patients with advanced melanoma, who are also eligible for treatment with pembrolizumab. Professor Poulam Patel, Chief Investigator for the SCIB1 Phase 1/2 clinical trial and Professor of Clinical Oncology at the University of Nottingham, will now be the Chief Investigator for the Phase 2 study. Patient enrolment into the UK arm of the study will commence immediately.\n \nDr Cliff Holloway, Chief Executive Offic...