Update on patient recruitment in the ongoing SCIB1 clinical trial

Scancell Holdings Plc, (AIM:SCLP), the developer of therapeutic cancer vaccines, today announces the recruitment and treatment of the final patient in the second part of its Phase 1/2 clinical trial of SCIB1, its DNA ImmunoBody® vaccine being developed for the treatment of melanoma. This part of the trial is being conducted in five UK centres in  patients with Stage III/IV disease to further assess the safety of treatment and to assess the cellular immune response induced by SCIB1. Patients  are being treated with a 4mg dose of SCIB1 on five occasions over a period of 6 months.  

In December 2012, Scancell released 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. Also in December 2012, Scancellannounced that the Gene Therapy Advisory Committee ('GTAC') and the Medicines and Healthcare products Regulatory Agency ('MHRA') Medicines Division had given their approval to dose an extra group of patients with a higher, 8 mg, dose of SCIB1. Scancell is planning to start treating patients with the 8mg dose shortly.

 Professor Lindy Durrant, Joint CEO of Scancell Holdings and Professor of Cancer Immunotherapy at Nottingham University, commented:

 "As expected, the recruitment of patients in the second part of the trial proceeded faster than recruitment for the first part of the trial, as we were not constrained by the cohort study design requiring sequential dose escalation, and there were more patients available with earlier stage disease. The recruitment and dosing of the final patient in Part 2 gives us confidence that this phase of the study will be completed by the end of 2013, consistent with previous expectations."

Dr Richard Goodfellow, Joint CEO  of Scancell Holdings, commented:

 "The SCIB1 clinical programme is progressing on schedule and, as previously announced, we expect the results for Part 2 of the study to be available by the end of 2013. 

The Directors of the issuer accept responsibility for this announcement.  


For Further Information: 

Dr Richard Goodfellow, Joint CEO Scancell Holdings Plc + 44 (0) 74 2323 0497 
Professor Lindy Durrant, Joint CEO Scancell Holdings Plc + 44 (0) 74 2323 0497 
Annie Cheng, CFA Visible Value LLP + 44 (0) 74 2323 0497 
Camilla Hume/Stephen Keys Cenkos + 44 (0) 20 7397 8900

The design  of the Phase 1/2 study

Part 1 of this Phase1/2 clinical trial was conducted in five UK centres in 11 patients with Stage III/IV malignant melanoma.  Patients were to be  given five doses of 0.4mg, 2mg or 4mg of SCIB1, delivered using the Ichor Medical Systems' TriGrid™ electroporation delivery device, over a period of six months at the start of the trial, as well as at three weeks, six weeks, three months, and six months after the initial dose.

As this was the first human trial of SCIB1, safety of each dose was assessed before patients were given a higher dose.

In view of the encouraging results and minimal side effects seen with the 4mg dose the Company intends to evaluate an 8mg dose in parallel with Part 2 of the Phase1/2 study.

Part 2 of the study is being conducted in 13 patients with resected Stage III/IV disease and is designed to further assess  the cellular immune response, safety and tolerability of the 4mg dose when given over a period of 6 months.

About Scancell

Scancell is developing therapeutic vaccines for the treatment of cancer and infectious diseases based on its ImmunoBody® and Moditope™ technology platforms. Scancell's first cancer vaccine 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.

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.

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 have a profound effect on the way that cancer vaccines are developed.