Provexis plantain medical food

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Provexis kicks-off Crohn's Disease clinical trial
11 August 2009

Provexis, the life-science business, is about to kick-off a clinical trial for its NSP#3G plantain medical food for Crohn’s disease patients. A two-centre trial on Crohn’s disease patients in remission will commence on 18 August 2009. The trial will last for approximately 18 months, with 72 patients taking part.

Crohn’s disease is an inflammatory disease of the gastrointestinal tract causing a wide variety of symptoms. It affects between 400,000 and 600,000 in North America and estimates of incidence in Northern Europe range from 27 to 48 per 100,000 people. There is no known pharmaceutical or surgical cure for Crohn’s disease and treatment is restricted to controlling symptoms, maintaining remission and preventing relapse.

Stephen Moon, Chief Executive Officer of Provexis plc, commented:

'Our new technology addresses an important patient need for a debilitating disease where no effective medical food products for maintaining remission are available currently. Laboratory and human trial work to date has been very promising and we look forward to successful clinical data from this important trial.'

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Provexis to launch trial of NSP#3G plantain medical food in patients with Crohn's disease

Published in M2Europharma on Tuesday, 11 August 2009 at 15:31 GMT

11 August 2009 - Provexis plc (AIM: PXS), developing scientifically proven functional food, medical food and dietary supplement technologies, announced today the initiation of a clinical trial for its NSP#3G plantain medical food for Crohn's disease patients.

The results announcement of 9 June 2009 updated the Clinical Trials Authorisation received from the Medicines & Healthcare products Regulatory Agency. Provexis has since successfully completed the necessary pre-trial processes and can now announce a two-centre trial on Crohn's disease patients in remission will commence on 18 August 2009. The trial will run for approximately 18 months, with 72 patients taking part.

Crohn's disease is an inflammatory disease of the gastrointestinal tract causing a wide variety of symptoms. It affects between 400,000 and 600,000 in North America and estimates of incidence in Northern Europe range from 27 to 48 per 100,000 people. There is no known pharmaceutical or surgical cure for Crohn's disease and treatment is restricted to controlling symptoms, maintaining remission and preventing relapse. Provexis believes that its medical food technology will successfully maintain remission. The market for Crohn's disease treatments is estimated at USD1.7bn (EUR1.203bn) annually.

With the trial now starting and combined with recently obtained healthy human data, Provexis will start looking for potential global license or co-development partners to address this substantial market opportunity.

Stephen Moon, Provexis CEO, said that following the company's recent industry-first European Article 13(5) health claim

approval for its Fruitflow anti-thrombotic technology, this further underpins Provexis' capability in developing high quality and scientifically-proven intellectual property. The new technology addresses an important patient need for a debilitating disease where no effective medical food products for maintaining remission are available currently. Laboratory and human trial work to date has been very promising and Provexis looks forward to successful clinical data from this important trial, Moon explained.