UK GTAC, MHRA approve Scancell's Phase I clinical trial of SCIB1 DNA ImmunoBody vaccine

May 5 2010

Scancell Holdings Plc, (PLUS:SCLP), the developer of therapeutic cancer vaccines, today announced at BIO2010 in Chicago that its proposal to conduct a Phase I clinical trial on SCIB1, its DNA ImmunoBody® vaccine being developed for the treatment of melanoma, has been approved in the UK by the Gene Therapy Advisory Committee ('GTAC') and by the Medicines and Healthcare products Regulatory Agency ('MHRA') Medicines Division. In addition, Scancell's US 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 to patients participating in the trial of SCIB1.

Recruitment for the Phase I clinical trial of SCIB1 is expected to commence shortly at three leading UK hospital centres in Nottingham, Manchester and Newcastle.

SCIB1 is a novel DNA ImmunoBody® vaccine being developed using Scancell's patented ImmunoBody® technology for the treatment of melanoma. ImmunoBody® vaccines generate the high-avidity T-cells that kill cancer cells, which may overcome the current limitations of most cancer vaccines. In vivo electroporation is widely regarded as an effective method of enhancing the potency of DNA vaccines by up to 100-fold compared to conventional methods of delivery. Scancell is confident that TriGrid™ will provide the most effective delivery system for its SCIB1 melanoma vaccine as it enters clinical trials.

Advanced melanoma currently has a very poor prognosis with late stage (stage IV) disease having a median survival of approximately six months. According to the World Health Organisation, 132,000 melanoma skin cancers occur globally each year and the incidence is increasing, especially in the United States, Europe and Australia.

David Evans, Chairman of Scancell, commented:

"With the approvals from GTAC and MHRA in place Scancell will commence the Phase I clinical trial of our first therapeutic cancer vaccine SCIB1 during this second quarter which is exactly on track with our programme and marks a significant step for the Company. We look forward to updating shareholders again in due course."

SOURCE Scancell Holdings Plc,