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Pin to quick picksScancell Holdings Regulatory News (SCLP)

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Re: SCIB1 Clinical Trial Patient Recruitment

28 Jan 2011 07:00

28 January 2011 Scancell Holdings Plc (`Scancell Holdings' or the `Company') Re: SCIB1 Clinical Trial Patient Recruitment

Scancell Holdings Plc, (AIM: SCLP), the developer of therapeutic cancer vaccines, is pleased to provide shareholders with an update on patient recruitment for its Phase I clinical trial of SCIB1, its DNA ImmunoBody® vaccine being developed for the treatment of melanoma. The trial has to date been conducted in three UK centres with Stage IV or inoperable Stage III melanoma patients.

Scancell has now obtained approval from the Gene Therapy Advisory Committee (`GTAC') and the Medicines and Healthcare products Regulatory Agency (`MHRA') Medicines Division to open a fourth UK site in Leeds. In addition, approval has been granted by GTAC and the MHRA to expand the patient population in the Phase I part of the study to include all patients with Stage III and Stage IV malignant melanoma.

As noted in the AGM Statement on 14 December 2010, patient recruitment has been slightly slower than originally anticipated. The Company sought approval to open a fourth centre and to be able to treat earlier stage patients in order to increase the rate of patient recruitment. In addition, it is hoped that the earlier stage patients might show a better immune response to SCIB1.

Professor Lindy Durrant, CEO of Scancell Holdings and Professor of Cancer Immunotherapy at Nottingham University, commented: "The approval to open a fourth centre in Leeds and to start recruiting patients with earlier stage disease is excellent news for Scancell. The Board remains confident that the Phase I/II clinical trial is on track to be completed by the end of 2012."

For further information contact:

Scancell Holdings Plc + 44 (0)207 245 1100 Professor Lindy Durrant Hansard Communications + 44 (0)207 245 1100 Kirsty Corcoran/Adam Reynolds

Zeus Capital - Nominated Adviser/Joint + 44 (0)161 831 1512 Broker

Ross Andrews/Tom Rowley

Matrix Corporate Capital LLP - Joint Broker +44 (0)20 3206 7340

Robert Naylor/Stephen Waterman

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.

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