Scancell Holdings Regulatory News (SCLP)

 17 April 2012

Scancell Holdings Plc

('Scancell Holdings' or the 'Company')

SCIB1 Clinical Trial: Recruitment for Phase I completed. Approval to start Phase II

Scancell Holdings Plc, (AIM: SCLP), the developer of therapeutic cancer vaccines, is pleased to announce the completion of recruitment to the Phase I clinical trial of SCIB1, its DNA ImmunoBody® vaccine being developed for the treatment of melanoma. The trial is being conducted in five UK centres in patients with Stage III/IV disease, and it is anticipated that Phase II trials will commence in the next few weeks.

Scancell has obtained approval from the Cohort Review Committee to commence the Phase II study using the 4mg dose, the highest dose used in the Phase I part of the study. The approval is based upon safety data collected after all patients have been treated for 6 weeks. The Phase I patients will continue to be treated and followed up for a total of 6 months.

Professor Lindy Durrant, Joint CEO of Scancell Holdings and Professor of Cancer Immunotherapy at Nottingham University, commented:

"The recruitment of patients to early stage cancer studies can be very challenging and it is a tribute to both the dedicated Scancell team and the efforts of our clinical investigators that we have now completed recruitment for the Phase I part of the study. We expect recruitment for Phase II to be substantially faster than for Phase I and hope to treat the first patient in this part of the study within the next few weeks."

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About Scancell

Scancell is developing novel therapeutic vaccines for the treatment of cancer and infectious diseases based on its groundbreaking ImmunoBody® technology platform. Scancell's first cancer vaccine SCIB1 is being developed for the treatment of melanoma and entered clinical trials in 2010.

Treating cancer by vaccination allows small non-toxic doses of a vaccine to be administered to a patient, stimulating an immune response. Effective cancer vaccines need to target dendritic cells to stimulate both parts of the cellular immune system; the helper cell system where inflammation is stimulated at the tumour site; and the cytotoxic T-lymphocyte or CTL response where immune system cells are primed to recognise and kill specific cells.

A limitation of many cancer vaccines currently in development is that they cannot specifically target dendritic cells in vivo. Several groups have demonstrated successful vaccination by growing dendritic cells ex vivo, pulsing them with tumour antigens and re-infusing them. However, this procedure is patient specific, time consuming and expensive. Scancell has developed its breakthrough patent protected ImmunoBody® technology to overcome these limitations.

An ImmunoBody® is a human antibody or fusion protein engineered to express helper cell and CTL epitopes from tumour antigens over-expressed by cancer cells. Antibodies are ideal vectors for carrying T cell epitopes from tumour antigens as they have long half-lives and can effectively target dendritic cells via their Fc receptors, allowing efficient stimulation of both helper and CTL responses.

The Immunobody® technology can be adapted to provide the basis for treating any tumour type and may also be of potential utility in the development of vaccines against hepatitis, HIV and other chronic infectious diseases.