It used to be called “juvenile” diabetes. Today, it’s called Type 1 diabetes. And though it accounts for only a fraction of the estimated 220 million worldwide cases of this chronic disease, an effective treatment or cure would improve the lives of millions.
This is why a unique solution pioneered in Israel is being watched with great interest as it goes through advanced stages of Phase III clinical testing in about 115 medical centers in North and South America, Europe and Israel.
Andromeda Biotech CEO Shlomo Dagan says 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.
The substance under investigation is a synthetic peptide – a chemical link extracted from a long protein chain – that seems to halt the progression of the disease.
An alternative to insulin injections
Diabetes is a result of problems regulating insulin, a hormone produced by the pancreas. Insulin is responsible for the crucial job of converting sugar, starches and other foods into energy for all the body’s functions.
In Type 1 diabetes, a haywire immune response actually kills the insulin-producing beta cells in the pancreas. Without any way to stop this destruction, the only treatment is 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 Dagan, who has a doctorate in immunology from Israel’s Weizmann Institute of Science and worked for several biotech companies in Israel and the US. “The immune system itself is very complicated and we still do not understand its full mechanism of action.”
Andromeda’s trademarked DiaPep277 is a synthetic peptide derived from a human protein that modulates the immune system. This radically different approach to diabetes is meant for patients at an early stage of the disease.
“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.”
In the first Phase III studies being conducted at 40 medical centers in Europe, South Africa and Israel, diabetes patients aged 16 to 45 have been receiving DiaPep277 injections once every three months. The study began in 2005 and is ending late this year.
In the confirmatory Phase III study, running from 2010 through early 2014, Andromeda is concentrating on patients from ages 20 to 45 within six months of diagnosis, so that researchers may differentiate between results in teens and adults. This trial is being carried out at hospitals in Israel, three Canadian provinces, 16 US states (plus the District of Columbia) and a dozen European countries.
To verify whether the peptide is working its magic, throughout the clinical trial period the subjects are tested to measure their ability to secrete insulin.
Marketing mechanism in place
Dagan explains that the two independent studies are necessary in order to win regulatory approval – a goal awaited eagerly by Teva Pharmaceutical Industries, the major Israeli corporation that owns the license and worldwide market rights to the product.
So far, more than $40 million funding for this large operation is coming from Teva and from Clal Biotechnology Industries (CBI), founder of Andromeda and owner of 84 percent of the company. Teva holds the remaining 16%.
Based in the Israeli city of Yavne south of Tel Aviv, Andromeda Biotech was founded in 2007 to develop and commercialize DiaPep277 – a peptide first synthesized in 1994 by Prof. Irun Cohen at Weizmann. The company set up around it was bought by German company DeveloGen, which eventually sold its assets to CBI.
Aside from newly diagnosed adult patients, the potential target population for DiaPep277 also includes Type 1 diabetic children, people with a high risk of developing Type 1 diabetes, and people in whom the disease is progressing slowly.