No more insulin injections?

Israeli drug maker Teva Pharmaceutical Industries and Clal Biotechnology Industries (CBI) have more than $40 million riding on an Israeli-innovated treatment for Type 1 diabetes now in advanced clinical trials in about 115 medical centers on five continents.

Teva owns the license and worldwide market rights to DiaPep277, a trademarked peptide first synthesized in 1994 by Prof. Irun Cohen at Israel’s Weizmann Institute of Science. This synthetic peptide – a chemical link extracted from a long protein chain – seems to halt the progression of this form of the disease, which used to be called “juvenile” diabetes.

Both Type 1 and Type 2 diabetes result from problems with insulin, a hormone produced by the pancreas to convert sugar, starches and other foods into energy for all the body’s functions. Type 1, accounting for about five percent of the estimated 220 million worldwide cases of diabetes, is caused by an abnormal immune response that kills the insulin-producing beta cells in the pancreas. Until now, nobody has found a way to address the root cause of this serious immune system foul-up, so patients must take daily injections of insulin.

“There have been many approaches to try to treat this disease, because it’s very complicated – partly genetic and partly environmental,” explains Shlomo Dagan, CEO of Andromeda Biotech, the Yavne-based company developing DiaPep277. “The immune system itself is very complicated and we still do not understand its full mechanism of action.”

DiaPep277 is derived from a human protein that modulates the immune system, says Dagan, who has a doctorate in immunology from Weizmann and formerly worked for several biotech companies in Israel and the United States.

Testing on four continents

Andromeda’s radically different approach to diabetes provides hope for children and adults at an early stage of Type 1 diabetes as well as people at high risk of developing it, or in whom the disease is progressing slowly. “The goal is preservation rather than treatment,” Dagan says. “If you still have some [insulin-producing] cells left functioning, we can preserve them with this substance.”

Diabetes patients aged 16 to 45 have been receiving DiaPep277 injections once every three months since 2005 in the first Phase III studies conducted at 40 medical centers in Europe, South Africa and Israel. The subjects are tested regularly over a two-year period to measure their ability to secrete insulin. This study will conclude in a few months.

Last year, Andromeda began the confirmatory Phase III trials concentrating on patients from ages 20 to 45 within six months of diagnosis. Dagan explains that two independent studies are necessary in order to win regulatory approval, and this second trial also will allow researchers to evaluate differences between results in teens and adults. The newer study is going on at hospitals in Israel, three Canadian provinces, many US states, and in Europe and Eastern Europe.

This is currently the largest and most advanced study ever involving Type 1 diabetes patients. Other potential treatments are far behind, in early stages of clinical development. “We are willing to continue with patients who want to try it for another two or three years,” says Dagan. The formal conclusion of the second study is targeted for early 2014.

The product is several years away from pharmacy shelves, but he expects that when it’s commercially available it would be administered the same way as in the testing period, once every three months by injection.

Betting on DiaPep277

Though Andromeda Biotech has fewer than 10 employees, the operation behind getting DiaPep277 into the marketplace involves hundreds of people, from the testing centers on up the ladder to CBI, which owns of 84% of the company it founded in 2007 to develop and commercialize the peptide. Teva holds the remaining 16% of Andromeda

The advanced study’s steering committee is composed of doctors Itamar Raz, Hadassah Medical Center, Jerusalem; Paolo Pozzilli, Università Campus Bio-Medico di Roma, Rome; Thomas Linn, Universitätsklinikum Giessen, Germany; Francois Bonnici, New Groote Schuur Hospital, Capetown; and Philip Raskin, University of Texas Southwestern Medical Center at Dallas.

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