The UK nutraceutical company, whose flagship ingredient is based on compounds contained in the clear fraction of tomatoes that inhibit blood platelet aggregation, entered into a 12-month exclusivity agreement with an undisclosed major food company in July to develop a second generation version.
The first generation, used the demonstration product Sirco already on the UK market, is a thick sugary syrup. By making the bioactive into a powder that is 35 per cent more concentrated, the aim it to make it suitable for several more application areas, including dairy and other foods.
However in November, Provexis said that it is continuing to work on the platform, and discussions with the food company would extend into 2007. In its interim report for the six months ended September 30, released in late December, the company said it can realistically expect "significant licensing revenues" by the end of summer 2007 - but that it requires further funds to bridge the intervening period.
"The company has the support of key existing investors and is working with these parties and potential new investors to raise further working capital," said CEO Stephen Moon.
The level of funding it is seeking was not disclosed in the report. However the company views such funding as preferable to utilising a previously secured £3m (€4.45m at present exchange rates) Standby Equity Distribution Agreement, due to low trading volumes.
Twelve months ago Provexis launched its Sirco beverage in the UK, now sold in some 1,800 outlets throughout the country. Revenues for the six-month period were £428,000 (c €636,180) - in line with expectations.
But administration expenses totalled £1.88m (€2.79m), and operating loss before interest, taxation, share option expense and amortisation of goodwill came in at £1.37m (€2.03m). As at September 30, Provexis had £1.0m (€1.48m) cash in the bank.
Provexis is aiming for its Fruitflow technology to be used in a broader range of food products. As well as providing licensing revenues, tweaking the technology will open it up for use in a broader spectrum of platforms, such as over-the-counter medicines, dietary supplements and medical foods.
In 2006, it shored up the science behind the efficacy of Fruitflow with two studies published in the American Journal of Clinical Nutrition. In one, it examined the antiplatelet activity of the tomato components in vitro, and sought to establish their ex vivo efficacy in healthy humans. It concluded that the ingestion of tomato components with in vitro antiplatelet activity "significantly affects ex vivo platelet function".
In the second, involving 90 human subjects with normal platelet function, the researchers evaluated the extract's suitability for use as a dietary supplement to prevent platelet aggregation. Changes from baseline hemostatic function were measured 3 hours after consumption of extract-enriched or control supplements, and significant reductions in ex vivo platelet aggregation induced by ADP and collagen were observed.
The company says it has also identified the mode of action for reducing the risk of deep vein thrombosis, and has filed international patents in this area.
Another facet of conducting thorough scientific research is health claims approvals. With the entry into force of the new European health claims regulation in December, bioactives developers are striving to put their products in the best possible position to receive claims - preferably on the list of established claims but if not, reviewed approved swiftly by EFSA.
"We have made significant progress in meeting this new legislation, and furnishing the supporting data and as such believe that Fruitflow is in a strong position," said Moon.
He added that a submission has been made to the Food and Drug Administration in the US for the technology to be generally regarded as safe (GRAS), and that the company hopes to have clearance early in 2007. Study references: American Journal of Clinical Nutrition Sep 2006; 84: 561 - 569 "Effects of tomato extract on platelet function: a double-blinded crossover study in healthy humans" Authors: Niamh O'Kennedy, Lynn Crosbie, Stuart Whelan, Vanessa Luther, Graham Horgan, John I Broom, David J Webb, and Asim K Duttaroy
American Journal of Clinical Nutrition Sep 2006; 84: 570 - 579 "Effects of antiplatelet components of tomato extract on platelet function in vitro and ex vivo: a time-course cannulation study in healthy humans Authors: Niamh O'Kennedy, Lynn Crosbie, Machteld van Lieshout, John I Broom, David J Webb, and Asim K Duttaroy