StockMarketWire.com - Immunotherapy treatment for cancer developer Scancell said it had withdrawn a regulatory application in the US to allow the UK arm of a clinical trial to proceed.

The company was planning to conduct a SCIB1 Phase 2 trial in patients with metastatic melanoma, in both the UK and US.

In April, it received the necessary regulatory and ethical approvals to initiate the UK arm of the trial.

However, the US Food and Drug Administration had requested additional information from Ichor Medical Systems on the TriGrid 2.0 electroporation delivery system.

'Whilst there has been extensive dialogue between Ichor and the FDA, a timely resolution to the device-specific questions has yet to be agreed,' Scancell said.

'In order to initiate patient recruitment in the UK under the Investigational New Drug (IND) application submitted to the FDA, prior approval of the IND is required.'

'Having considered the ethical issues related to patients awaiting enrolment into the UK sites, Scancell has decided to withdraw its IND application in the US to allow the UK arm of the trial to proceed.'

Scancell said it would resubmit the IND at a later date with the intent to initiate clinical sites in the US, following further clarification from the Agency regarding Ichor's TriGrid 2.0 delivery device.



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