Business
SCIB1 IND Application Approved
SCIB1 IND Application Approved.
About this update from Scancell Holdings Plc
[{"type":"text","content":"\n \nRNS Number : 6596B Scancell Holdings Plc 03 February 2020 \n\n3 February 2020\n \nScancell Holdings plc\n(\"Scancell\" or the \"Company\")\n \nSCIB1 Investigational New Drug (IND) application approved\n \nPhase 2 clinical trial to commence in the US\n \nScancell, the developer of novel immunotherapies for the treatment of cancer, is pleased to announce that the Investigational New Drug (IND) application to the Food and Drug Administration (FDA) for SCIB1 has been approved. As a result, Scancell will initiate the US arm of the Phase 2 clinical trial of SCIB1 in patients with metastatic melanoma also receiving the checkpoint inhibitor pembrolizumab (Keytruda), using Ichor's TriGrid® 2.0 electroporation 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. Patient screening was initiated in the UK, with Professor Poulam Patel, Professor of Clinical Oncology at the University of Nottingham as the Chief Investigator for the global study. US site initiation activities and patient enrolment will commence alongside clinical site expansion in the UK. \n \nDr Keith Flaherty, Professor of Medicine at Harvard Medical School and Director of Clinical Research at Massachusetts General Hospital Cancer Center, and clinical advisor to Scancell commented: \n \n\"Although checkpoint inhibitor combinations have improved outcomes for patients with melanoma, the toxicity of combinations such as ipilimumab plus nivolumab means that there remains a need to develop combinations with other investigational agents such as SCIB1, which have the potential to improve response rates without increasing toxicity.\"\n \nDr Cliff Holloway, Chief Executive Officer, Scancell, commented:\n \n\"We are delighted that our IND is now open, allowing us to progress our SCIB1 Phase 2 trial in the US as well as the UK. Approval will allow us to increase our overall patient recruitment rate and determine whether the addition of SCIB1 to current, standard of care treatment with pembrolizumab increases the anti-cancer response rate in patients with metastatic melanoma.\"\n&...