21 Mar 2014 07:00

21 March 2014
Â
Scancell Holdings Plc
('Scancell' or the "Company")
Â
8mg Higher Dose SCIB1 Study On Track
Â
Â
Scancell Holdings Plc, (AIM:SCLP), the developer of novel immunotherapies for the treatment of cancer, is pleased to announce completion of patient dosing with 8mg of SCIB1 ImmunoBody® ('SCIB1') in Part 1 of its on-going Phase 1/2 clinical trial in patients with Stage III/IV melanoma.
Â
Following preliminary evidence from Part 1 of the study showing that a 4mg dose of SCIB1 produced an immune response that might be associated with clinical benefit in patients with malignant melanoma, regulatory approval was obtained for treating a cohort of up to six patients with a higher, 8mg dose of SCIB1. Five patients with metastatic tumour present have been recruited and dosed, with no reported drug or device-related serious adverse events. Immunology and clinical responses in this higher dose cohort of patients are currently being analysed and will be reported by the end of Q2 2014.
Â
Regulatory approval to expand Part 2 of the study to include up to 13 patients receiving the 8mg dose was obtained in October 2013. With the absence of any serious toxicity in the 8mg Part 1 cohort, enrolment into this cohort has now been closed and new patients will be now be recruited into the expanded 8mg Part 2 cohort. The first such patient was dosed with SCIB1 earlier this week.
Â
Richard Goodfellow, Joint CEO of Scancell, said: "Our higher dose 8mg SCIB1 study is progressing well. In view of the continued safety profile of SCIB1 at the higher dose, we are now recruiting for Part 2 of this cohort, which will assess the immune and clinical response to SCIB1 in a larger number of patients with Stage III/IV melanoma. We look forward to reporting the results from Part 1 of the study later this year."
Â
Â
For Further Information:
Â
Dr Richard Goodfellow, Joint CEO Professor Lindy Durrant, Joint CEO | Scancell Holdings Plc Scancell Holdings Plc | + 44 (0) 20 3727 1000 |
Camilla Hume/Stephen Keys | Cenkos Securities plc | + 44 (0) 20 7397 8900 |
Mo Noonan/Simon Conway | FTI Consulting | + 44 (0) 20 3727 1000 |
Â
Â
About Scancell
Â
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 being evaluated in a Phase 1/2 clinical trial. Data from the trial demonstrate that SCIB1 produced a melanoma-specific immune response and promising survival trend.
Â
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 T-lymphocyte or CTL response where immune system cells are primed to recognise and kill specific cells.
Â
Scancell has also identified and patented a series of modified epitopes that stimulate the production of killer CD4 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.
Â
Â