StockMarketWire.com - Scancell Holdings said the Food and Drug Administration had requested extra information before it can start a trial of a cancer treatment with partner Ichor Medical Systems.

The international Phase 2 clinical study was test Scancell's ImmunoBody SCIB1 treatment in combination with Keytruda in patients with advanced melanoma.

The FDA requesting information in particular with respect to Ichor's new electroporation delivery system and its use in combination with SCIB1.

Scancell and Ichor were working with the FDA to provide the necessary information to enable initiation of the trial.

In parallel, Scancell said it was continuing to work on the operational activities required to initiate clinical sites in the US and UK.

Scancell said it expected patient enrolment would commence in the first half of 2019, subject to the necessary regulatory approvals.

'We are working closely with Ichor and the FDA to address the questions they have raised and we are confident we can respond to these in timely manner,' chief executive Cliff Holloway said.

'We continue to advance the operational processes and procedures to ensure a rapid start to the study once approval is obtained.'


At 8:20am: [LON:SCLP] Scancell Holdings PLC share price was -2p at 8.25p



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