Scancell Holdings plc, ("Scancell" or the "Company") the developer of novel immunotherapies for the treatment of cancer, was informed on 11 July 2013 that one of the three patients recruited into the higher 8mg dose study of SCIB1 will no longer be eligible for evaluation due to delivery of an incomplete dose of SCIB1 following a fault with the electroporation device for that patient. Scancell will recruit a replacement patient as soon as possible in order to complete the initial phase of the 8mg study which is to assess the safety and immune response produced by the 8mg dose prior to expanding the study to include a further ten patients as planned. The initial part of the study is now expected to be completed early next year.
The higher 8mg dose SCIB1 study has been implemented for two reasons:
- Firstly, one of the goals of Part 1 of the Phase 1/2 study was to establish a "maximally tolerated dose" of SCIB1 for use in Part 2. As there were no drug related side effects observed at 4mg, a maximally tolerated dose was not reached and a higher dose could improve the immune response even further.
- Secondly, we were pleased to see a significant effect on tumour burden in one late stage patient in the Part 1 study. The Part 2 study, however, is primarily designed to assess immune response in resected Stage 3 patients and although we will be monitoring the time to disease progression, we will not be able to measure an effect on tumour size. The extended study using the 8mg dose will be in patients with tumour load and will therefore provide the opportunity to assess whether we can reproduce the valuable data reported from Part 1 in an additional group of patients and at a higher dose.
Richard Goodfellow, Joint CEO of Scancell, said:
“With the higher dose study underway, we are now looking to recruit a new patient to ensure adequate safety and immune response data ahead of the extended trial of SCIB1 in patients with tumour load. We firmly believe that the data we gain from this additional trial will add further value to SCIB1 and the ImmunoBody® platform and look forward to reporting the results in due course.”
For Further Information:
Scancell Holdings Plc: + 44 (0) 74 2323 0 497
Dr Richard Goodfellow, Joint CEO
Professor Lindy Durrant, Joint CEO
Cenkos Securities: +44 (0) 20 7397 8900
FTI Consulting: +44 (0) 20 7831 3113
Scancell is developing novel immunotherapies for the treatment of cancer based on its ImmunoBody® and Moditope™ technology platforms. Scancell‟s first ImmunoBody®, SCIB1 is being developed for the treatment of melanoma and is in Phase 1/2 clinical trials. Preliminary evidence from Part 1 of the study showing that SCIB1 produced an immune response which might be associated with clinical benefit in patients with malignant melanoma was released in December 2012.
Scancell's ImmunoBody® vaccines target dendritic cells and stimulate both parts of the cellular immune system; the helper cell system where inflammation is stimulated at the tumour site; and the cytotoxic Tlymphocyte or CTL response where immune system cells are primed to recognise and kill specific cells.
Scancell has also identified and patented a series of modified epitopes that stimulate the production of killer CD4 T cells that destroy tumours without toxicity. The Directors believe that the Moditope™ platform could play a major role in the development of safe and effective cancer immunotherapies in the future.