Scancell Holdings Plc, (AIM:SCLP), the developer of therapeutic cancer vaccines, is pleased to announce that the Gene Therapy Advisory Committee (‘GTAC’) and the Medicines and Healthcare products Regulatory Agency (‘MHRA’) Medicines Division have given their approval to increase the maximum treatment period from 6 months up to a further 5 years in its Phase I/II clinical trial of SCIB1, its DNA ImmunoBody® vaccine being developed for the treatment of melanoma. The continuation option will be available for patients with stable disease. Approval was also granted to further broaden the study inclusion criteria. 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 for this extended period.
The clinical trial of SCIB1 is being conducted at five leading UK hospital centres in Nottingham, Manchester, Newcastle, Leeds and Southampton.
Prof. Lindy Durrant, Joint CEO of Scancell, commented:
“This approval from GTAC and MHRA provides our Investigators with the opportunity to continue dosing patients whose disease has not progressed whilst receiving the SCIB1 vaccine and will allow the Company to gather longer term data on late stage melanoma patients for whom the prognosis is poor.”
A copy of this announcement is available for download on the Company’s website at www.scancell.co.uk
For further information contact:
|Professor Lindy Durrant/Dr Richard Goodfellow
||Scancell Holdings Plc
||+ 44 (0)207 653 9850
|Graham Herring/ Heather Armstrong
||+ 44 (0)207 653 9850
|Ross Andrews/Tom Rowley
||+ 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 is in Phase II clinical trials.
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 Medical Systems
Ichor Medical Systems’ TriGrid™ Delivery System (TriGrid) i s the first integrated and fully automated device for electroporation-mediated DNA administration in humans. Ichor, a privately-held biotech company based in San Diego, CA, is collaborating with partners on four continents to provide its enabling TriGrid platform as a means for delivery of DNA drugs and vaccines in disease indications such as melanoma, malaria, hepatitis B virus (HBV) infection, human immunodeficiency virus (HIV) infection, melanoma, Alzheimer’s disease, and others. For further info visit www.ichorms.com.