Jerusalem-based Betalin Therapeutics, that includes two Nobel laureates in chemistry, announce they may have found ‘the cure’ with their CEO, Dr. Nikolai Kunicher saying, “The patient should never have to inject insulin into his body again.”
A team of Jerusalem-based researchers and entrepreneurs claim they have a cure for diabetes that could hit the market as early as within the next few years.
Betalin Therapeutics has developed the first bio-artificial pancreas, composed of pig’s lung tissue and insulin secreting cells. The artificial pancreas would be implanted into the patient and connect with his or her blood vessels and then be able to measure the body’s sugar level and secrete an optimal amount of insulin needed to balance blood sugar.
“This is a new way to treat diabetes,” said CEO Dr. Nikolai Kunicher. “Today, you only have ways to manage the disease. This is a cure. The diabetic pancreas has lost the function of secreting insulin and we give it back. The patient should never have to inject insulin into his body again.”
Kunicher and his team have completed animal trials. Human clinical trials are slated to launch within a year. But animal trials don’t always translate to humans because of species differences, he cautions.
Betalin has raised $3.5 million and is looking to raise another $5m. before human clinical trials begin. It is expected that the biological pancreas will cost around $50,000 per patient.
According to the World Health Organization, 500-million people worldwide suffer from Type I or Type II diabetes. Some 160 million are insulin dependent, according to Kunicher.
Numerous treatments for diabetes are available and vary depending on an individual patient’s needs. Insulin-dependent diabetics generally take insulin by injection or by using a pump. There are also oral diabetes medications.
Anyone who uses insulin would be eligible for the Betalin cure.
Among those who suffer from diabetes is Prof. Sidney Altman, a Betalin advisory board member who won the Nobel Prize in 1989 for chemistry. Altman, considered one of the world’s best molecular biologists, told The Jerusalem Post that he and his mother both suffer from Type II diabetes. His brother died of the disease, he added.
“This is a new approach,” Altman said, noting he believes it will have global impact.
The company was founded in 2015 based on a decade of research by Prof. Eduardo Miterani of the Faculty of Science at the Hebrew University of Jerusalem, who examined how cells contact supportive tissue that stimulates the extracellular environment in the human body.
“The pancreas is unique in that it functions as a complete autonomous organ, not as single cells, and can therefore be located anywhere in the body,” Miterani explained.
Prof. Aryeh Warshel, who won the Nobel Prize in 2013 in chemistry, also sits on the Betalin board.
Today, Dr. Avi Treves, founder and CEO of Hadasit Ltd. and Gamida-Cell Ltd., heads Betalin’s research and development. He said that the technology represents the next phase of what is known in the scientific community as the Edmonton Protocol, through which doctors are already implanting pancreatic islets into patients.
“Doctors take a suspension of islets from a donor and implant them into a patient,” he explained. “This can cure patients for a long time. But it is a complicated procedure and has many disadvantages, such as that the tissue dies over time, and patients have to be immunosuppressed because you are implanting a foreign tissue.”
In contrast, he said, Betalin’s artificial pancreas microstructure enables cells to function better and for a longer time.
Currently Betalin is collaborating with clinics in Germany, Britain, the US, China and Italy which are doing islet transplantation to test the technology. It was recently awarded a bi-national collaboration grant by Israel’s Innovation Authority and the Italian government, together with Prof. Lorenzo Piemonti, as a world-renowned transplant researcher.
Betalin also won the “Best Innovative Pharma Start-up” award from the Mixiii Biomed 2017 Conference, the largest event of Israel’s life science industry.
Treves said he believes the company is hoping to complete its Phase I trial in about two years. It will then be able to fast track to approval by proving efficacy.
“We are already building a regulatory file with local experts so everyone is prepared in parallel, and will be ready once we have culminated our study,” he said.
Treves said he envisions the artificial pancreas being gradually rolled out to a limited number of diabetic patients, though ultimately he believes it will serve all insulin-dependent individuals. He said that the next phase would be to apply the technology to treat other diseases that result from hormonal dysfunction.
Companies in the US are working on this with many more people and huge budgets,” Treves told The Post. “We are a small company with a small budget but we have excellent people who know how to do the work.
“The basic tech is ingenious,” he continued. “It will work.”
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NOTICE: Human clinical trials are slated to be launched within a year.
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