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UK approval to start SCIB1 Phase 2 trial
UK approval to start SCIB1 Phase 2 trial.
About this update from Scancell Holdings Plc
[{"type":"text","content":"\n \nRNS Number : 0105X Scancell Holdings Plc 25 April 2019 \n\n25 April 2019\n \nScancell Holdings Plc\n(\"Scancell\" or the \"Company\")\n \nScancell announces UK regulatory approval to start SCIB1 Phase 2 trial in patients with advanced melanoma\n \nDosing in UK arm due to commence during this quarter, as planned \n \nScancell Holdings plc, the developer of novel immunotherapies for the treatment of cancer, is pleased to announce that it has received all of the UK regulatory, ethical and legal approvals required to initiate the Phase 2 clinical trial to assess the safety and efficacy of SCIB1 in metastatic melanoma patients also receiving the checkpoint inhibitor pembrolizumab (Keytruda). The UK arm of the study is therefore expected to start during the second quarter of this year, as planned.\n \nSCIB1 has completed a Phase 1/2 clinical trial in patients with Stage III/IV malignant melanoma. In this study SCIB1 was shown to have a favourable safety profile with no dose-limiting toxicities and no serious adverse events related to study drug or delivery device. Survival with SCIB1 treatment appears superior to historical survival rates, with 14 of 16 resected patients receiving 2-4 mg doses surviving for more than five years (as reported in February 2018).\n \nAlthough pembrolizumab is an approved checkpoint inhibitor therapy for advanced melanoma, response to treatment is limited to only a subset of patients (circa 30%). The Phase 2 study is therefore designed to assess whether the addition of SCIB1 treatment 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. SCIB1 will be administered using Ichor's TriGrid® v2.0 electroporation delivery system.\n \nDr Cliff Holloway, Chief Executive Officer of Scancell, commented:\n \n\"This is a major milestone in the clinical advancement of our SCIB1 programme and we look forward to initiating this important Phase 2 study. Our preclinical research has indicated that SCIB1 administration with an immune checkpoint inhibitor has the potential to offer even greater efficacy than when either agent is given alone and this new study is designed to evaluate the safety and efficacy of this appro...