Diabetes patients face many inconveniences in their daily lives, including a dependence on insulin injections. Betalin Therapeutics aims to change the paradigm - to find a cure instead of a temporary treatment, using tissue engineering.

The idea behind the new solution was born in the labs of Prof. Eduardo Mitrani at the Hebrew University of Jerusalem. VP of Operations Moni Heuser explains: "There are two types of diabetes. Type 1, known as juvenile diabetes, is an autoimmune disease, meaning that the immune system attacks the beta cells in the pancreas, which make insulin. That insulin moves glucose from the bloodstream into the cells, to create energy. Type 2 diabetes is also a resistance to insulin, caused by excessive use of the insulin-creating cells, mostly due to the modern Western lifestyle. In both cases, patients require an external source of insulin - regular injections."

Heuser compared this type of treatment to putting a band-aid on a wound instead of treating the cause. He said, "Prof. Mitrani, who specializes in developmental biology, looked into an existing protocol to transplant beta cells, searched for a way to improve it, and found one."

Meanwhile, on the other side of the world Prof. James Shapiro - from the Medicine and Surgical Oncology Department at the University of Alberta, Canada - developed a new method to implant beta cells in patients suffering from debilitating diabetes and required a pancreas transplant because they could not balance their insulin levels.

Shapiro’s treatment - the "Edmonton protocol" - allowed doctors to transplant cells from the new pancreas to the patient’s liver, in the hope they would create insulin there. "But these cells undergo trauma, meaning this is not a comprehensive solution," said Heuser, "After five years the patient goes back to needing the injections. Essentially, from the moment of the procedure, 80% of the cells don’t make it, meaning we would need the donations of three pancreases from three different donors to treat one patient. That solution costs close to $200,000."

And that is where Betalin’s solution fits in. Prof. Mitrani’s development takes into consideration the environment of the cells - to make them feel at home. "He started out with the assumption that no cell is an island. They are always in a pile that creates tissue, and that creates an organ," said Heuser.

While Prof. Shapiro’s protocol was an impressive advance, it did not take the cell’s environment into consideration. "What he developed was basically a micro-environment, into which the beta cells are injected instead of the liver. That micro-environment is built to provide them the same familiar conditions as the pancreas. To that end, we use natural tissue taken from a donor, which we cut into microscopic slices, and only then implant the beta cells into them."

That tissue is then transplanted into the patient, and then it is absorbed. "The process of creating new cells begins 48 hours after the transplant," Heuser explained, "The transplant tries to connect, and then the beta cells receive an indication of the glucose level and know to release insulin."

According to Heuser, the process was proven, and Prof. Mitrani was able to observe a controlled release of insulin in thousands of trials conducted at the lab. Furthermore, an even greater breakthrough was the ability to maintain those cells outside of the body.

"In Prof. Shapiro’s protocol, there was a three-day window of opportunity to find a donor. Prof. Mitrani managed to hold them outside the body for 90 days, and that capability is an indication that the pancreas will continue to survive inside the body. That’s also what caught the eye of Prof. Shapiro. When he heard about Prof. Mitrani’s research, they created a strategic connection and coordination in their research."

Betalin’s solution sets itself apart because of how it manufactures the micro-tissue. "It undergoes a process in which the living cells are extracted, leaving behind the tissue scaffolding, into which the beta cells are inserted. Now the need is for only one donor," emphasized Heuser. "The technology was licensed under an exclusive world-wide agreement with Yissum, the technology transfer company of the Hebrew University."

Betalin is currently in the pre-clinical stage and awaiting results. "In the Israeli trials, all the rats survived, while in the control group, which did not receive the treatment, all died," said Heuser, "The moment the tissue, the micro-pancreas, was removed, they returned to being diabetic."

The company is currently in the midst of a financing round, seeking $2.5 million to support clinical trials. As Heuser explains, the next stage is "a first transplant in humans - that will happen in a year and a half or two years from now."

Published by Globes [online], Israel business news - www.globes-online.com - on December 8, 2015

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