Study publication - comparison with aspirin

RNS Number : 9166P

Provexis PLC

23 November 2016

 

23 November 2016

Provexis plc

Study publication - Fruitflow® comparison trial with aspirin - European Journal of Clinical Nutrition

Provexis plc ("Provexis" or the "Company"), the business that develops, licenses and sells the proprietary, scientifically-proven Fruitflow® heart-health functional food ingredient, is pleased to confirm the publication of an important study for Fruitflow® in the European Journal of Clinical Nutrition.

The study, titled 'A randomised controlled trial comparing a dietary antiplatelet, the water-soluble tomato extract Fruitflow®, with 75mg aspirin in healthy subjects' is expected to be a significant opportunity to promote Fruitflow® further across scientific, trade customer and consumer channels, and it demonstrates that Fruitflow® has the potential to play an import role across all major global markets in primary prevention of cardiovascular disease ('CVD').

The trial was undertaken by Provexis with independent statistical analysis by BIOSS, and it compared the effects of Fruitflow® and 75mg aspirin. Interactions between Fruitflow® and aspirin when consumed together were also studied. A total of 47 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 study showed no negative interactions between Fruitflow® and aspirin when consumed together.

The study findings are significant and serve to demonstrate the potential effectiveness of Fruitflow® as a dietary supplement with a significant effect on blood flow, suitable for daily use in primary prevention of CVD, and with no adverse side effects.

The World Health Organization reports that more people die annually from CVDs than from any other cause¹ and the global market for cardiovascular disease, to include dietary supplements, is estimated to be in excess of $10 billion per year.

The US FDA states that after carefully examining scientific data from major studies, it has concluded 'the data do not support the use of aspirin as a preventive medication by people who have not had a heart attack, stroke or cardiovascular problems, a use that is called 'primary prevention.' In such people, the benefit has not been established but risks - such as dangerous bleeding into the brain or stomach - are still present.' ²

Professor Asim Duttaroy, Group Leader of Chronic Disease at The University of Oslo's Faculty of Medicine and a member of the Company's Scientific Advisory Board was the original inventor of Fruitflow® and he 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.

This latest study really helps to put the platelet effects of Fruitflow® into context, by comparing them to a drug with known outcomes. The study focuses on potential use in primary prevention of CVD, and clearly shows the overly strong effects of aspirin on platelets, and the less strong - but still significant - effects of Fruitflow®. Simply put, whereas aspirin may be necessary for those with CVD, it is not a perfect or medically supported solution for healthy adults. But Fruitflow® has been proven suitable for maintaining health in all normal healthy adults".

This publication follows shortly behind another important study for Fruitflow® which was published in the European Journal of Nutrition in July 2016. The paper, titled 'Fruitflow®: the first European Food Safety Authority-approved natural cardio-protective functional ingredient' includes a scientific summary of the entire Fruitflow® project from its inception, to include a discussion of its mechanisms of action and uses, and it is available to view on the Company's website at www.provexis.org/wp-content/uploads/2016/07/Fruitflow%C2%AE-the-first-European-Food-Safety-Authority-approved-natural-cardio-protective-functional-ingredient-07-Jul-16.pdf

Fruitflow® is a patented, scientifically-proven tomato extract which inhibits platelet aggregation, a known cause of heart attack, stroke and venous thrombosis. It is a natural product classified as a food which is easy to digest.

In May 2009 Fruitflow® was the first technology 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'.

On 7 September 2016 the Company announced in its preliminary results for the year ended 31 March 2016 that more than 50 regional consumer healthcare brands containing Fruitflow® have now been launched by direct customers of DSM, with a number of further regional brands having been launched through DSM's distributor channels.

In June 2016 the Company announced the launch of its new Fruitflow® + Omega-3 dietary supplement product, which is exclusively available through the Company's new e-commerce website www.fruitflowplus.com, the product also has a Facebook page at www.facebook.com/FruitflowPlus

¹ World Health Organisation - CVDs - www.who.int/mediacentre/factsheets/fs317

² US FDA - www.fda.gov/ForConsumers/ConsumerUpdates/ucm390539.htm

Dawson Buck, Chairman of Provexis, commented:

"We are delighted to announce the publication of this important study which highlights the substantial effect that Fruitflow® can have on platelet aggregation, without the associated side effects known to occur with aspirin.

The study is expected to be a significant opportunity to promote Fruitflow® further across scientific, trade customer and consumer channels. and it demonstrates that Fruitflow® has the potential to play an import role across all major global markets in primary prevention of cardiovascular disease.

The Company and DSM are committed to a number of ongoing scientific and marketing initiatives for Fruitflow® and the Company's Fruitflow® + Omega-3 capsules, seeking to extend the reach of the existing science for Fruitflow® and give the products further global exposure. The Company and DSM are keen to secure greater medical advocacy for Fruitflow®.

The publication of this study is another strongly positive development for Fruitflow® and the Provexis business."

This announcement contains inside information.

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For further information please contact:

Provexis plc                                                     Tel:      [phone]

Dawson Buck, Chairman                                 [e-mail]

Ian Ford, Finance Director

Cenkos Securities plc                                      Tel:      [phone]

Bobbie Hilliam

Notes for editors

About Provexis plc

AIM-listed Provexis is focused on the development and licensing of its proprietary, scientifically-proven Fruitflow® heart-health functional food ingredient.

In May 2009, the Company's 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).

In June 2010 it was announced that the Company had entered into a long-term Alliance Agreement with DSM Nutritional Products to commercialise Fruitflow®, and in June 2015 the Company confirmed it had agreed significantly enhanced financial terms for its Alliance Agreement with DSM for Fruitflow®.

The Company's Alliance partner DSM Nutritional Products has developed the market actively for the Company's novel, patented Fruitflow® heart-health ingredient in all global markets, with over 50 regional consumer healthcare brands now having been launched by direct customers of DSM, and with a number of further regional brands having been launched through DSM's distributor channels.

An increasing number of further commercial projects have been initiated by DSM with prospective customers, including some prospective customers which are part of global businesses, with good prospects for these projects to be launched as consumer products. Interest in the technology exists in all major global markets.

In June 2016 the Company launched a high quality dietary supplement product containing Fruitflow® and Omega-3 which is being sold initially from a separate, dedicated website www.fruitflowplus.com on a mail order basis.

The Company conducted a Key Opinion Leaders' roundtable event for Fruitflow® in London on 29 September 2016, focussed on raising awareness of the importance of blood flow in cardiovascular health, and the effectiveness of dietary antiplatelets. The roundtable was attended by key scientists from Provexis and DSM, along with a number of interested health care professionals with close links to the media. The event was recorded with the intention of producing two further videos: a video for Fruitflow® targeting prospective trade customers, and a video for Fruitflow® + Omega-3 capsules targeting prospective consumers. The video for consumers can be seen here www.youtube.com/watch?v=P3HCSdyupEY&t=48s

Video content recorded at the event and subsequently will be used to promote Fruitflow® and the Company's Fruitflow® + Omega-3 capsules more widely across key digital and other mainstream media channels.

The Company and DSM are keen to secure greater medical advocacy for Fruitflow® and the roundtable event forms part of this strategy. The roundtable event is also being supported by a broader consumer PR campaign.

The Company is engaged in a two stage collaboration agreement with the University of Oslo ('the University') to undertake further research into the relationship between Fruitflow® and blood pressure regulation. The Company is very pleased with the encouraging results from the first stage of the collaboration with strong evidence that a standard dose of Fruitflow® has the potential to give a clinically relevant reduction in systolic blood pressure. The Company and the University expect to be able to complete a small clinical trial by way of a proof of principle study in Q4 2016 and the results of the proof of principle study will be announced as soon as possible thereafter.

Provexis was founded in 1999 and is headquartered in Reading, Berkshire.

Provexis shares are traded on the AIM market of the London Stock Exchange under the ticker symbol PXS.

For further information, please visit www.provexis.com

 

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