October 19, 2003

Nutrinia’s technology enables the industrial production of micro-encapsulated insulin that can be incorporated into an infant formula while maintaining a level of potency similar to that of the insulin present in natural mother’s milk.Nutrinia, a start-up Israeli company founded by a prominent Israeli-Arab physician, is developing infant formula containing insulin with the same bioavailability and potency as the insulin contained only in mother’s milk.

The idea for the company’s proprietary technology comes from a decade of clinical research work by Shehadeh, an Israeli-Arab physician. Shehadeh is a prominent pediatric diabetes researcher who also serves as the Head of the Pediatric Department at Rambam’s Meyer Children’s Hospital in Haifa.

Although scientists knew that human mother’s milk contains insulin, the reason for this phenomenon puzzled scientists for a long time. The insulin that is found in the bloodstream and cells has a clear role: it is used by the body for glucose regulation. However, because orally-administered insulin at PPM (Parts-Per-Million) levels is not easily digested or able to make its way into the bloodstream, it seemed unlikely that it would be present in mother’s milk for this reason.

Then a few years ago, scientists began solving the mystery. They found out not only why infants need insulin in their milk but also what happens if they don’t get it. Studies showed that insulin plays a crucial role in helping the small intestines to mature and develop properly. Insulin, it was observed, serves as a well-localized growth factor on highly specific receptors in the gastrointestinal tract (GI) and helps make the entire GI system mature in a much healthier manner.

An even more important clinical finding – currently observed in animal models but not yet validated in humans – suggests that mammals prone to Diabetes Type I (e.g. juvenile or Insulin-dependent Diabetes) and deprived of mother’s milk containing insulin have an increased risk of becoming sick in the disease.

About five years ago Shehadeh began to look for a way to introduce insulin into infant formulas. He did so realizing that insulin is a very sensitive protein that needs to be refrigerated and is highly perishable even under optimal storage conditions.

After years of research he came up with InsuMeal. The proprietary technology that Dr. Shehadeh devised, enables the industrial production of micro-encapsulated insulin that can be incorporated into an infant formula while maintaining a level of potency and bioavailability similar to that of the insulin present in natural mother’s milk.

After pre-clinical and clinical trials in Israel and the U.S. showed oral insulin feeding to be safe and effective, Shehadeh founded Nutrinia in June of this year. Nutrinia is part of the NGT (New Generation Technologies) Technological incubator in Nazareth, headed by Dr. Sharon Devir.

Together with CEO Amir Barzilay, the company’s management and Medical Advisory Board are preparing for a large-scale clinical trial slated to start at the beginning of 2004. The trial – still subject to health authorities approval – will involve about 64 pre-term infants at several medical centers in Israel. The researchers will measure the ability of the preterm infants to achieve more rapidly full entral feeding, as well improvement in a variety of metabolic and other physiological parameters.

Another important Nutrinia project suggests that the supplementation of insulin into milk replacement products can significantly benefit more than just human infants.

“Preliminary studies that we have carried out on agriculturally-important mammalian infants intensively raised for meat consumption, show that an insulin-fortified diet can lead to greater weight gains and a lower death rates during similar growth periods,” said Barzilay.

“As the profit margins in growing animals for meat consumption are under constant pressures, Nutrinia’s technologies and products have the potential of significantly expanding profit margins for those growers utilizing it.”

Nutrinia has to date obtained initial funding from the Office of the Chief Scientist, Maabarot Industries (the manufacturer of the Materna brand and Israel’s largest infant food company) as well as a private Israeli-Arab investor.

“We are currently looking internationally for strategic partners who are producers and distributors of infant formula products,” adds Devir, Chairman of Nutrinia.

(Reprinted from BioIsrael)

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Jason Harris

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