Business
Update on SCIB1 Phase 2 Clinical Study
Update on SCIB1 Phase 2 Clinical Study.
About this update from Scancell Holdings Plc
[{"type":"text","content":"\n \nRNS Number : 9581E Scancell Holdings Plc 24 October 2018 \n\n24 October 2018\n \nScancell Holdings Plc\n \nScancell and Ichor provide update on SCIB1 Phase 2 clinical study\nin patients with advanced melanoma\n \nScancell Holdings plc (\"Scancell\"), the developer of novel immunotherapies for the treatment of cancer, and Ichor Medical Systems, Inc. (\"Ichor\"), today provide an update on the proposed international Phase 2 clinical study of Scancell's lead ImmunoBody®, SCIB1, in combination with Keytruda (pembrolizumab), in patients with advanced melanoma. \n \nFollowing the submission of an Investigational New Drug (IND) application for the clinical study to the US Food and Drug Administration (FDA), the FDA has responded requesting additional information, in particular with respect to Ichor's new TriGrid® 2.0 electroporation delivery system and its use in combination with SCIB1.\n \nIchor's TriGrid® 2.0 is an electroporation delivery system which is designed to support eventual commercial deployment and will be used to deliver the SCIB1 vaccine to patients in the proposed Phase 2 study. Scancell has previously used Ichor's TriGrid® 1.0 delivery system in the SCIB1 Phase 1/2 clinical study in patients with Stage III/IV malignant melanoma. In this study SCIB1 was shown to have a favorable safety profile with no dose-limiting toxicities and no serious adverse events related to study drug or the delivery device.\n \nScancell and Ichor are working with the FDA to provide the necessary information to enable initiation of the trial. In parallel, Scancell is continuing to work on the operational activities required to initiate clinical sites in the US and UK. Scancell anticipates that patient enrolment into this trial will commence in the first half of 2019, subject to the necessary regulatory approvals. \n \nCliff Holloway, CEO of Scancell, said:\n \n\"We are working closely with Ichor and the FDA to address the questions they have raised and we are confident we can respond to these in timely manner. We continue to advance the operational processes and procedures to ensure a rapid start to the study once approval is obtained.\"\n \nRobert Bernard, President & CEO of Ichor, added:\n \n\"We have taken on board the comments from the FDA and are confi...