Trial Results

RNS Number : 2656I

Provexis PLC

09 March 2010

 

Provexis PLC

("Provexis" or the "Company")

Completion of Aspirin Comparison Human Trial for Fruitflow^®

Provexis plc (PXS.L), which focuses on the discovery, development and licensing of scientifically-proven functional food, medical food and dietary supplement technologies, today announces the completion of the human trial comparing the effects of its Fruitflow^® anti-thrombotic technology with aspirin.

Fruitflow^® is a patented, scientifically-proven tomato extract which inhibits several pathways involved in platelet aggregation (a process which, if overstimulated can contribute to unwanted clot formation in the bloodstream), a known factor in cause of heart attack, stroke and venous thrombosis, and does so without any side effects.

Aspirin, an anti-inflammatory drug, primarily targets one specific platelet aggregation pathway, and is not recommended for use by the population at large for cardiovascular disease prevention, partly due to its well known side effects which include gastric ulceration and bleeding. In addition, a significant percentage of users show some resistance to its effects.

The trial was undertaken by Provexis at the Rowett Institute of Nutrition and Health, part of the University of Aberdeen, with independent statistical analysis by BIOSS, and is the tenth placebo controlled human trial undertaken with the Fruitflow extract. The trial compared the effects of Fruitflow^® and aspirin over a five hour time course. Interactions between Fruitflow^® and aspirin when consumed together were also studied. 43 healthy subjects completed the trial over a 7-month period and the results are statistically significant.

Fruitflow^® showed up to 30% reduction from baseline platelet aggregation in each of three different biological pathways, while a single dose of aspirin caused up to 60% reduction in a single pathway, with lesser effects on the other two. The broader antiplatelet effect of Fruitflow^® reflects the Company's aim to provide a daily dietary supplement with a significant effect on blood flow, but without suppressing platelet aggregation completely.

The study also showed no negative interactions between Fruitflow^® and aspirin when consumed together.

The findings are significant and serve to demonstrate the potential effectiveness of Fruitflow^® as a preventative measure in cardiovascular health through inhibiting platelet aggregation, with no side effects. This trial is an important milestone for the Company as it has worked to develop and patent the technology worldwide while submitting Fruitflow^® to rigorous scientific and regulatory testing to substantiate efficacy and safety.

Stephen Moon, CEO of Provexis, commented:

"We are delighted with the results of this latest human trial, which highlight the substantial effect that Fruitflow^® can have on platelet aggregation, without the associated side effects known to occur with aspirin.

"On 12^th February we announced intent to enter into an agreement with DSM Nutritional Products, the world's leading supplier of vitamins, carotenoids and other fine chemicals to the feed, food, pharmaceutical and personal care industries. Today's news provides further strength to the commercialisation plans for Fruitflow^® and in the planned alliance we anticipate developing multiple routes to market."

9 March 2010

Enquiries:

Provexis Plc    Stephen Moon, Chief Executive Ian Ford, Finance Director	Tel: [phone]
Evolution Securities Ltd Sam Plumptre/Bobbie Hilliam	Tel:  [phone]
Haggie Financial LLP Nicholas Nelson/Kathy Boate/Alex Parry	Tel: [phone] [e-mail]

Notes to Editors

About Fruitflow^®

Provexis' development of Fruitflow^®, a water-soluble tomato concentrate, is a breakthrough in anti-thrombotic food technology.  In human trials, consumption of the Fruitflow^® extract has been proven to reduce platelet aggregation in 97% of subjects. The effect takes place within three hours of consumption and lasts for up to eighteen hours, making it ideal for daily dosage in functional foods or dietary supplements.  Provexis has developed a syrup format for use in food & beverages and a concentrated powder format for tablets and capsules.

Fruitflow^® syrup is GRAS (Generally Regarded as Safe) by the US FDA and is not regarded as a Novel Food in the EU, clearing it for wide use in foods, beverages and supplements. In May 2009, the Fruitflow^® technology was the first to be substantiated by the European Food Safety Authority ("EFSA") under the new Article 13(5) for proprietary and emerging science. In December 2009 the European Commission authorised the health claim "Helps maintain normal platelet aggregation, which contributes to healthy blood flow", which was the first wording to be authorised under Article 13(5).

The technology has been granted patents in the EU, US, Australia, Canada and Mexico, with Japan pending. Further patents have been filed for the bioactive components of Fruitflow^® and for other developmental areas such as deep vein thrombosis and triglyceride lowering.

 

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