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4d pharma gets approval tor drug trial

11 November 2015 07:46

4D pharma (AIM: DDDD), a pharmaceutical company focussing on the development of live biotherapeutics, has obtained regulatory and ethical approval for a phase 1 clinical trial in respect of Thetani, its programme for the treatment of Paediatric Crohn's Disease ("PCD"), and release of the drug product for the start of the trial.

PCD is a chronic inflammatory bowel disease that causes inflammation, or swelling, across the lining of the digestive tract.

The phase 1 trial of Thetanix is expected to begin before the end of the year. The trial will be conducted in two UK centres and, unusually for a phase I study, will only include PCD patients.

Dr Alex Stevenson, 4D's Chief Scientific Officer commented: "Obtaining regulatory and ethical approval and product release for the Thetanixâ„¢ trial are key milestones in the clinical trial process. We look forward to commencing the trial in line with our anticipated timeline, and assessing Thetanixâ„¢ and its effects in a clinical setting."

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