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SCIB1: Safety Review and Dose Escalation

17 Aug 2011 07:00

17 August 2011 Scancell Holdings Plc (`Scancell Holdings' or the `Company') SCIB1: Safety Review and Dose Escalation

Scancell Holdings Plc, (AIM: SCLP), the developer of therapeutic cancer vaccines, is pleased to announce that the second group of patients receiving the 2mg dose of SCIB1 (its DNA ImmunoBody® vaccine being developed for the treatment of melanoma) in the Phase I clinical trial has been evaluated by the Cohort Review Committee.

Following review of the safety data from this mid-dose level group of three patients, the Cohort Review Committee has approved further escalation of the dose to 4mg and recruitment of the final group of patients as planned.

The trial, which commenced in June 2010, is designed to evaluate the safety and tolerability of SCIB1 in patients with late stage melanoma and also to gather data on the effects of SCIB1 on tumour growth and cellular immune response.

Professor Lindy Durrant, Joint CEO of Scancell Holdings and Professor of Cancer Immunotherapy at Nottingham University, commented: "We are pleased that the Cohort Review Committee has given us the go-ahead to escalate the dose of SCIB1 to the highest dose level. This data, combined with the recent recruitment of a fifth trial centre at Southampton demonstrates that we are continuing to make good progress in our Phase 1 study. We expect to commence the Phase 2 study in late 2011/early 2012 as planned."

For further information contact:

Scancell Holdings Plc + 44 (0)207 245 1100 Professor Lindy Durrant/Dr Richard Goodfellow Hansard Communications + 44 (0)207 245 1100 Adam Reynolds/Guy McDougall Zeus Capital - Nominated Adviser + 44 (0)161 831 1512 Ross Andrews/Tom Rowley XCAP Securities Plc - Broker +44 (0) 207 101 7070 Jon Belliss/Parimal Kumar 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, which entered clinical trials in 2010, is being developed for the treatment of melanoma.

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.

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