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8mg Higher Dose SCIB1 Study On Track

21st March 2014

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.

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. 

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.

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.”

 

For Further Information:

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

About Scancell

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. 

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.

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.

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