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Clinical Trial Approval for SCIB1 melanoma vaccine study

05th May 2010

Scancell Holdings Plc, (PLUS:SCLP), the developer of therapeutic cancer vaccines, is pleased to announce that its proposal to conduct a Phase I clinical trial on SCIB1, its DNA ImmunoBody® vaccine being developed for the treatment of melanoma, has been approved by the Gene Therapy Advisory Committee (‘GTAC’) and by the Medicines and Healthcare products Regulatory Agency (‘MHRA’) Medicines Division. In addition, Scancell’s partner Ichor Medical Systems (‘Ichor’) has obtained the required parallel approval from the MHRA Devices Division for the use of Ichor’s TriGrid™ electroporation delivery device to administer SCIB1 to patients participating in the trial of SCIB1.

Recruitment for the Phase I clinical trial of SCIB1 is expected to commence shortly at three leading UK hospital centres in Nottingham, Manchester and Newcastle.

SCIB1 is a novel DNA ImmunoBody® vaccine being developed using Scancell’s patented ImmunoBody® technology for the treatment of melanoma. ImmunoBody® vaccines generate the high-avidity T-cells that kill cancer cells, which may overcome the current limitations of most cancer vaccines. In vivo electroporation is widely regarded as an effective method of enhancing the potency of DNA vaccines by up to 100-fold compared to conventional methods of delivery. Scancell is confident that TriGrid™ will provide the most effective delivery system for its SCIB1 melanoma vaccine as it enters clinical trials.

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.

David Evans, Chairman of Scancell, commented:

“With the approvals from GTAC and MHRA in place Scancell will commence the Phase I clinical trial of our first therapeutic cancer vaccine SCIB1 during this second quarter which is exactly on track with our programme and marks a significant step for the Company. We look forward to updating shareholders again in due course.”

The Directors of the issuer accept responsibility for this announcement.

For further information contact:

Professor Lindy Durrant  -  Scancell Holdings Plc  -  +44 (0)207 245 1100

John Bick/Kirsty  -  Hansard Communications  -  +44 (0)207 245 1100
Corcoran                                                             +44 (0)7872 061 007

Ross Andrews/Tom  -  Zeus Capital  -  +44 (0)161 831 1512
Rowley

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 will enter 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 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 Ichor

Ichor Medical Systems’ TriGrid™ Delivery System is the first integrated and fully automated system for electroporation-mediated DNA administration. Ichor, a privately-held biotech company based in San Diego, CA, is collaborating with partners on three continents in a wide range of studies to test the TriGrid™ as an enabling platform for delivery of DNA drugs and vaccines to treat diseases such as pandemic flu, hepatitis, HIV, melanoma, multiple sclerosis, and others. The TriGrid™ is also being tested by the U.S. military as an efficient means of delivering anti-bioterrorism agents.

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