Business
CTA Approval for SCIB1
CTA Approval for SCIB1.
About this update from Scancell Holdings Plc
[{"type":"text","content":"\n \n5 May 2010\n\n GB00B39J5N63\n\n Scancell Holdings Plc \n\n (`Scancell' or the `Company') \n\n Clinical Trial Approval for SCIB1 melanoma vaccine study \n\nScancell Holdings Plc, (PLUS:SCLP), the developer of therapeutic cancer\nvaccines, is pleased to announce that its proposal to conduct a Phase I\nclinical trial on SCIB1, its DNA ImmunoBody® vaccine being developed for the\ntreatment of melanoma, has been approved by the Gene Therapy Advisory Committee\n(`GTAC') and by the Medicines and Healthcare products Regulatory Agency\n(`MHRA') Medicines Division. In addition, Scancell's partner Ichor Medical\nSystems (`Ichor') has obtained the required parallel approval from the MHRA\nDevices Division for the use of Ichor's TriGrid™ electroporation delivery\ndevice to administer SCIB1 to patients participating in the trial of SCIB1.\n\nRecruitment for the Phase I clinical trial of SCIB1 is expected to commence\nshortly at three leading UK hospital centres in Nottingham, Manchester and\nNewcastle.\n\nSCIB1 is a novel DNA ImmunoBody® vaccine being developed using Scancell's\npatented ImmunoBody® technology for the treatment of melanoma. ImmunoBody®\nvaccines generate the high-avidity T-cells that kill cancer cells, which may\novercome the current limitations of most cancer vaccines. In vivo\nelectroporation is widely regarded as an effective method of enhancing the\npotency of DNA vaccines by up to 100-fold compared to conventional methods of\ndelivery. Scancell is confident that TriGrid™ will provide the most effective\ndelivery system for its SCIB1 melanoma vaccine as it enters clinical trials.\n\nAdvanced melanoma currently has a very poor prognosis with late stage (stage\nIV) disease having a median survival of approximately six months. According to\nthe World Health Organisation, 132,000 melanoma skin cancers occur globally\neach year and the incidence is increasing, especially in the United States,\nEurope and Australia.\n\nDavid Evans, Chairman of Scancell, commented:\n\n\"With the approvals from GTAC and MHRA in place Scancell will commence the\nPhase I clinical trial of our first therapeutic cancer vaccine SCIB1 during\nthis second quarter which is exactly on track with our programme and marks a\nsignificant step for the Company. We look forward to updating shareholders\nagain in due course.\"\n\nA copy of this annou...