LONDON (ShareCast) - (Sharecast News) - Cancer immunotherapy developer Scancell Holdings has received all of the UK regulatory, ethical and legal approvals required to initiate the phase 2 clinical trial to assess the safety and efficacy of \'SCIB1\' in metastatic melanoma patients also receiving the checkpoint inhibitor pembrolizumab (Keytruda), it announced on Thursday.
The AIM-traded company said the UK arm of the study was thus expected to start during the second quarter of this year, as planned.

SCIB1 had already completed a phase 1 and 2 clinical trial in patients with stage III and IV malignant melanoma.

In that study, SCIB1 was shown to have a favourable safety profile with no dose-limiting toxicities, and no serious adverse events related to study drug or delivery device.

Survival with SCIB1 treatment appeared superior to historical survival rates, with 14 of 16 resected patients receiving doses between 2mg and 4mg surviving for more than five years.

Although pembrolizumab is an approved checkpoint inhibitor therapy for advanced melanoma, Scancell said response to treatment was limited to only a subset of patients equivalent to around 30%.

The phase 2 study was therefore designed to assess whether the addition of SCIB1 treatment would result in an improvement in the tumour response rate, progression-free survival and overall survival in 25 patients with advanced melanoma who were also eligible for treatment with pembrolizumab.

SCIB1 would be administered using Ichor\'s \'TriGrid\' v2.0 electroporation delivery system.

\"This is a major milestone in the clinical advancement of our SCIB1 programme and we look forward to initiating this important phase 2 study,\" said Scancell chief executive officer Dr Cliff Holloway.

\"Our preclinical research has indicated that SCIB1 administration with an immune checkpoint inhibitor has the potential to offer even greater efficacy than when either agent is given alone and this new study is designed to evaluate the safety and efficacy of this approach in patients with inoperable disease.

\"Discussions with the FDA are on-going and we continue to work with Ichor towards IND approval to open our US study centres.\"

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