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Scancell receives US regulatory green light

The US Food & Drug Administration has granted investigational new drug status to the firm's lead drug, SCIB1

Scancell Holdings PLC -

Scancell Holdings PLC (LON:SCLP) shares jumped higher on Monday after the firm said it will ramp up patient recruitment after receiving the green light to start a phase II clinical trial of its cancer treatment in the US.

This followed the granting of investigational new drug status for SCIB1 by the Food & Drug Administration (FDA) for use in people with late-stage melanoma.

The drug will be administered in combination with Keytruda, a Merck-developed treatment that helps the immune system fight the disease, and it will be delivered using an electroporation device developed by Ichor Therapeutics.

The phase II study is designed to assess whether using SCIB1 with Keytruda results in an improvement in the tumour response rate, progression-free survival and overall survival in 25 patients with skin cancer.

The parallel arm of the study is already underway in the UK.

Scancell chief executive Dr Cliff Holloway said he was “delighted” about receiving FDA sign-off.

“Approval will allow us to increase our overall patient recruitment rate and determine whether the addition of SCIB1 to current, standard of care treatment with pembrolizumab [Keytruda] increases the anti-cancer response rate in patients with metastatic melanoma," he added.

In late morning trade, shares in Scancell were 15% higher at 7.90p.

 -- Adds share price --

Quick facts: Scancell Holdings PLC

Price: 4.75 GBX

LSE:SCLP
Market: LSE
Market Cap: £22.1 m
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Morning Report: Scancell receives US approval for its SCIB1 skin cancer...

Headlines from the Proactive UK newsroom. Scancell (LON:SCLP) has received IND approval from the US FDA for its SCIB1 skin cancer treatment. the company will now start a US Phase 2 trial in combination with leading drug Keytruda to see if it reduces toxicity compared to other...

on 3/2/20

2 min read