Scancell Holdings Plc, (PLUS:SCLP), the parent company of Scancell Limited (‘Scancell’), the developer of innovative therapeutic cancer vaccines, is pleased to announce that it expects to commence its Phase I/II clinical trial with SCIB in the first half of 2010. PharmaNet Development Group (PharmaNet), a top-ten clinical research organization, has been selected for the conduct and management of the study.
Scancell’s SCIB1 is a DNA ImmunoBody® vaccine for the treatment of melanoma. SCIB1 was developed using Scancell’s patented ImmunoBody® technology. ImmunoBody® vaccines generate the high-avidity T-cells that kill cancer cells, overcoming the current limitations of most cancer vaccines. 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.
PharmaNet has extensive oncology experience from more than 200 studies, at over 9600 investigative sites with over 50,000 patients.
David Evans, Chairman of Scancell, commented:
“We are delighted to have selected PharmaNet to manage Scancell’s Phase I/II clinical trial programme with SCIB1. PharmaNet’s extensive experience, particularly in the management of early stage oncology clinical trials, will be of critical importance to Scancell as SCIB1 moves into clinical development.”
Jeffrey McMullen, President and Chief Executive Officer, PharmaNet Development Group, commented:
"This is our first project with Scancell. We are thrilled to work on Scancell’s innovative therapeutic cancer vaccine, SCIB1, and are very pleased that they have entrusted PharmaNet with their study.”
The Directors of the issuer accept responsibility for this announcement.
For further information contact:
Professor Lindy Durrant - Scancell Holdings Plc - +44 207 245 1100
Adam Reynolds/Vikki Krause - Hansard Group - +44 7515 922906
Ross Andrews - Zeus Capital - +44 (0)161 831 1512
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 will enter clinical trials in early 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 DNA vaccine encoding 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 can effectively target dendritic cells via their Fc receptors, allowing efficient stimulation of high avidity and high frequency 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.
About PharmaNet Development Group, Inc.
PharmaNet Development Group, Inc., a global drug development services company, provides a comprehensive range of services to the pharmaceutical, biotechnology, generic drug and medical device industries. The Company offers early and late stage consulting, Phase I clinical studies and bioanalytical analyses, and Phase II, III and IV clinical development programs. With approximately 2,300 employees and 40 facilities throughout the world, PharmaNet is a recognized leader in outsourced clinical development. For more information, please visit www.pharmanet.com.