Nestle, Phosphagenics to complete trial by mid-08

By Jess Halliday

- Last updated on GMT

Related tags: Metabolic syndrome, Nutrition, Attention-deficit hyperactivity disorder

A phase 2 clinical trial into the potential for using Phospha E in
foods to address metabolic syndrome is on schedule for completion
this summer, paving the way to commercialisation of the ingredient
in functional foods.

Nestle Nutrition and Phosphagenics entered into an agreement to licence Phospha E, a patented vitamin E phosphate, for use in nutritional products aimed at metabolic syndrome in January 2007 , following an option agreement the previous year. . The deadline for concluding the deal was subsequently extended last summer to give the Swiss food giant time to integrate newly-acquired Novartis Medical Nutrition into its operations. Phospha E has previously been used in dietary supplements and is under license in this market to NBTY as Ester E. But a commercialisation agreement for its use in foods is expected to follow the successful completion of the clinical trial. The trial is taking place across three research sites in Australia, but further details of its design have not been made public. The estimated completion date of mid-2008 is based on current recruitment rates of participants. The companies said today that they progressed to the phase 2 clinical trial after successful completion of two pre-clinical dose response trials completed in 2006. These studies were said to have conformed that orally administered Phospha E "significantly reduces many of the key biomarkers associated with metabolic syndrome"​ - that is, inflammation and cardiovascular disease. Metabolic syndrome is defined as a collection of health conditions, including fat around the waistline, high blood pressure, insulin resistance and low HDL cholesterol, which taken together, significantly increase the risk of type 2 diabetes and heart disease. An estimated 15 per cent of the European adult population already have this combination of obesity-related conditions, and figures on childhood obesity suggest that Europe could follow the US trend for rising metabolic syndrome among the younger generation. In the US, incidence of metabolic syndrome has risen dramatically in the past 10 years and now affects up to 32 per cent of adults, an estimated 50 million people. In 2006 Phosphagenics started construction of a new A$500,000 (c €294,000) new facility which it said at the time could help assure Nestle - and other licensees, current or future - that Phosphagenics is in a position to fulfill demand. The plant was tipped to have an annual capacity of tonnes of tocopheryl phosphates - with an estimated value of $25m (c €14.7m), and sends a clear message that the company has the capability to manufacture on a commercial scale for its licensing partners. Nestle Nutrition is involved in a number of research partnerships with ingredients innovators with a view to ultimately developing scientifically-backed functional and medical foods. Amongst these is a programme with Canada's Neptune Technologies and Bioressources to jointly research the benefits of krill oil. The companies have not disclosed the precise areas of benefit to be explored, beyond saying they will be on "exceptionally prevalent conditions affecting the worldwide adult population".​ But Neptune has previously reported positive results for studies looking at its potential in cognitive function, particularly adult Attention Deficit Hyperactivity Disorder (ADHD). The company claims that participants in a pilot study improved their ability to concentrate and their working capacity by an average of 60.2 percent over the course of the trial. It has also studied its ability to help reduce LDL 'bad' cholesterol. The procedure for a development and license agreement between Neptune and Nestle upon successful completion of the research is built into the firms' agreement.

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