My decision to go all in was here11 Jun 2018 14:39
19 June 2012
Scancell Holdings Plc
('Scancell' or the 'Company')
SCIB1 Trial Update - Approval to dose patients for up to 5 years
Scancell Holdings Plc, (AIMSCLP), the developer of therapeutic cancer vaccines, is pleased to announce that the Gene Therapy Advisory Committee ('GTAC') and the Medicines and Healthcare Products Regulatory Agency ('MHRA') Medicines Division have given their approval to increase the maximum treatment period from 6 months up to a further 5 years in its Phase I/II clinical trial of SCIB1, its DNA ImmunoBody� vaccine being developed for the treatment of melanoma. The continuation option will be available for patients with stable disease. Approval was also granted to further broaden the study inclusion criteria. In addition, Scancell's partner Ichor Medical Systems ('Ichor') has obtained the required parallel approval from the MHRA Devices Division for the use of Ichor's TriGrid� electroporation delivery device to administer SCIB1 for this extended period.
The clinical trial of SCIB1 is being conducted at five leading UK hospital centres in Nottingham, Manchester, Newcastle, Leeds and Southampton.
Prof. Lindy Durrant, Joint CEO of Scancell, commented:
"This approval from GTAC and MHRA provides our Investigators with the opportunity to continue dosing patients whose disease has not progressed whilst receiving the SCIB1 vaccine and will allow the Company to gather longer term data on late stage melanoma patients for whom the prognosis is poor."
A copy of this announcement is available for download on the Company's website at http://www.scancell.co.uk/