SCIB1 Trial-Higher Dose Allowed in Phase 1/2 Trial

RNS Number : 3085T

Scancell Holdings Plc

12 December 2012

 



12 December 2012

Scancell Holdings Plc

('Scancell')

 SCIB1 Trial Update - Higher Dose Allowed in Phase 1/2 Trial

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 dose an extra group of patients with a higher, 8 mg, dose of SCIB1, its DNA ImmunoBody® vaccine being developed for the treatment of melanoma.

The new cohort will recruit up to six more patients and will be recruited in parallel with the patients being recruited into Part 2 of the study.  Patients with metastatic tumour present may enter the new cohort so that their tumour response can be assessed, whereas patients who have had their tumours surgically removed may enter Part 2.  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 to this additional group of patients."

Scancell is planning to start treating patients with the 8mg dose in the new year.

This update follows the announcement made by Scancell on 6th December 2012, of preliminary results from Part 1 of the Phase 1/2 clinical trial of SCIB1 in patients with Stage III/IV malignant melanoma. In view of the encouraging results and minimal side effects seen with the 4mg dose, the Company stated that it intended to evaluate an 8mg dose in parallel with Part 2 of the Phase1/2 study

Part 2 of the study continues to be on track to be completed by the end of 2013. A successful outcome, if achieved, would confirm the potential of SCIB1 as a new cancer treatment as well as validating the Immunobody® platform technology.

Prof. Lindy Durrant, Joint CEO of Scancell, commented:

"This approval from GTAC and MHRA provides Scancell with the opportunity to determine whether a higher dose of SCIB1 would be even more effective in inducing immune response and clinical benefit in late stage melanoma patients."

The Directors of the issuer accept responsibility for this announcement.

-ENDS-

For Further Information:

Dr Richard Goodfellow, Joint CEO Professor Lindy Durrant, Joint CEO	Scancell Holdings Plc Scancell Holdings Plc	+ 44 (0) 74 2323 0497  + 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 positive 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.

 

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