In the State of the Cure 2014 report, BO2 was identified as one of the eight Practical Cure solutions in human clinical trials.
BO2, a Tel-Aviv based company, is entering human trials in Sweden with a unique encapsulation approach that prioritizes oxygen delivery to the cells. First results for their phase I trial are expected in early 2015. We spoke with Dr. Dan Gelvan, Ph.D., Managing Director, Life Sciences, Aurum Ventures MKI to learn more.
Cara Murphy: How did you and your team get involved in type 1 diabetes research?
Dan Gelvan: We wanted to improve the world of islet transplantation and deal with the shortcomings of the method. We looked at it from an engineering perspective to problem solve what we needed and then how to get there.
CM: Please describe to us non-scientists what BO2 does.
DG: Type 1 diabetes is the loss of most of your beta cells, which means glucose monitoring and insulin management in the body has been lost. People must manually act like their pancreases. One of the best solutions developed was to transplant islets of Langerhans that contain beta cells. I’m sure you’ve heard of the Edmonton Protocol. However, there are 2 major shortfalls with this procedure. Number one, you must be on immunosuppressants for the rest of your life. This is significant risk and not a good quality of life. And number two, it does not supply enough oxygen to the islets. Islet cells consume 80% of oxygen used by the pancreas, even though they weigh only 2 grams out of the total 100 grams of the pancreas.
The Insulin Bioreactor, ßAir, transplants islets without immunosuppressants and ensures that they have enough oxygen to secrete insulin. This replaces lost functionality of the pancreas. It is a small implantable device that encapsulates transplanted islet cells with a core oxygen reservoir. Each port allows the patient to inject oxygen to replenish the device. One port is a backup, you only really need one. Right now, we are transplanting 200,000 islet cells into the device. It is designed for a high density of cells to actively provide enough oxygen. It remains to the demonstrated how often the islets will need to be replenished.
CM: How many years have you been on this journey and what keeps you going?
DG: The team has been on the journey for 10 years. They started in 2004, worked on the concept from 2004-2008, and have been working on the idea to inject oxygen into the device since 2008. We are a bit masochistic to have taken on such a big project, but we firmly believe that we have solved the biggest problem in islet transplantation. We have a better product than our competition. The early success in our 1st patient gives us confidence.
CM: What are 3 things about your project you want the type 1 diabetes community to know?
DG: Number one, we are working on a cure. Our goal is to cure the disease. Number two, we are the real thing. From an engineering perspective we can put enough cells to restore full beta cell functionality. And number three, we are democratizing islet transplantation. There are no immunosuppressants and we are working on the possibility of stem cells and other ways to make this available to all patients. We are actively pursuing noncadaveric cells.
CM: If successful, how will it change the lives of people living with T1D?
DG: It will be a cure.
CM: In what stage of human trials is ßAir? When can we expect to learn the next set of results?
DG: We began Phase I, IIA in Uppsala Hospital in Sweden and we expect our first results in Q1 of 2015.
CM: Are you still recruiting for the trial? If so, how can people get in touch with you?
DG: Yes, we are still recruiting for the trial, but only among the patients of the center in Uppsala.
CM: What are the biggest obstacles your team faces?
DG: Apart from resources, the biggest challenge will be to have patients for future clinical trials so we can move on from safety phases.
CM: What can the type 1 diabetes community do to support your project?
DG: As clinical trials open up, they can volunteer for the trial. For more information they can visit our website: http://beta-o2.com/