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ImmuPharma spells out plans for phase III clinical trial

Last updated: 06:54 04 Nov 2015 EST, First published: 02:58 04 Nov 2015 EST

biotech
ImmuPharma and its partner are gearing up for landmark clinical study.

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ImmuPharma (LON:IMM) is gearing up to recruit 200 patients to its pivotal phase III clinical trial of Lupuzor, its potential breakthrough drug for the life-threatening autoimmune disease, Lupus.

The study, being carried out with the help of clinical research firm Simbec-Orion, will take place at 45 different sites – 10 in the US, 35 in Europe.

In all 270 people will be screened in order to recruit the required 200 to the programme.

In the States the trial has been approved by a Central Institutional Review Board, while in Europe the study is progressing through the centralised Voluntary Harmonisation Procedure (VHP). 

The VHP application was submitted on October 28 and has up to a 60 day review window. 

“I am confident that given the dedication and expertise of the ImmuPharma team combined with the experience of Simbec-Orion, the study will progress as planned with the anticipation of completing the study by the end of 2017," said newly appointed ImmuPharma chairman, Tim McCarthy.

Lupuzor has fast-track status with the US Food & Drug Administration, which will reduce development costs significantly.

The company signed a term sheet for a proposed US$14mln finance package in July to fund the clinical development of the treatment.

The first sites in the US are expected to be “fully initiated” in late November, or early December, with European sites expected to follow in January, said Panmure Gordon analyst, Dr Mike Mitchell.

“We consider the progress provides evidence of momentum within the programme – completion expected by the end of 2017 – and look forward to further updates in due course,” he said, repeating his ‘buy’ advice and 150p a share price target.

The shares added 10% in morning trade to change hands for 27.25p.

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on 06/27/2023