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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