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Scancell Gets US FDA Approval For SCIB1 Drug Application

3rd Feb 2020 10:44

(Alliance News) - Scancell Holdings PLC on Monday said it has secured approval from the US Food & Drug Administration for the investigational new drug application for cancer treatment SCIB1.

The drug developer added that it will now commence US arm of the Phase Two clinical trial of SCIB1 in patients with metastatic melanoma also receiving the checkpoint inhibitor pembrolizumab, following the regulatory approval. Melanoma is a type of skin cancer and when it spreads to other parts of a human body it is called metastatic melanoma.

Scancell said the Phase Two study will assess whether the addition of SCIB1 to pembrolizumab will result in an improvement in the tumour response rate, progression-free survival and overall survival in 25 patients with advanced melanoma, who are also eligible for treatment with pembrolizumab.

Shares in Scancell were up 19% at 8.18 pence each in London on Monday morning.

By Tapan Panchal; [email protected]

Copyright 2020 Alliance News Limited. All Rights Reserved.


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