Beta-O2 announced today that it has received a $500K grant from JDRF. The grant will be used to help fund a $1M pilot human study of Beta-O2's ßAir bio-artificial pancreas, in development as a treatment and potential cure for type 1 diabetes (T1D). The two-year study, which will enroll eight participants at Uppsala University Hospital in Sweden, will evaluate the safety, survival and function of implanted human islets of Langerhans in the system. Islets of Langerhans, also known as pancreatic endocrine cells, control the insulin production in the body. Insulin is a hormone that is needed to convert sugar, starches and other food into energy needed for daily life. In type 1 diabetes, the body does not produce insulin. Approximately 3 million people have T1D in the U.S.
As stated on the JDRF website, "The dream for everyone with type 1 diabetes (T1D) is to permanently restore their body's lost ability to produce insulin… JDRF is partnering with Beta-O2 in order to speed up the testing of ßAir, an implantable macroencapsulation system composed of an immune protection unit (about two and a half inches across) connected to ports through which oxygen can be periodically injected to support the survival of the enclosed beta cells or islets. Ensuring an adequate oxygen supply for encapsulated cells remains one of the biggest challenges for macroencapsulation devices. Balancing the need for immune protection with the need for an adequate oxygen supply is a tall order for most encapsulation device designs. The Beta-O2 approach may represent an ingenious solution."
Extensive pre-clinical studies demonstrated significantly strong results. ßAir has also experienced early success in the clinic. A 63-year-old patient in Europe with (T1D) received the implant and was followed for 10 months. Persistent graft function in the device was demonstrated, with regulated insulin secretion and preservation of islet morphology and function without any immunosuppressive therapy.
Dr. Dan Gelvan, chairman of the board of Beta-O2 and managing director of life sciences at Aurum Ventures said, "Imagine if those with type 1 diabetes no longer had to worry about insulin injections or glucose levels. They could eat what they wanted, exercise as they wished and need not measure every step they took. This is the future that Beta-O2 envisions ßAir will help to create."
Dr. Gelvan continued, "There are two key factors that make ßAir different from other bio-artificial pancreases in development. ßAir provides very effective protection from the host immune system, thus eliminating the need for immunosuppressive therapy and preventing what could otherwise be a fatal immune response of the patient to the transplanted cells. ßAir is also the only system that actively supplies oxygen and in more than sufficient quantities to the islet cells, one of the biggest consumers of oxygen in the body. Once every 24 hours, those with the implant are required to refill the air in the tiny device using a replenishing system which includes a dedicated injector. In addition, ßAir is able to support any type of cell source, which widens treatment possibilities."
Beta 02 Technologies Ltd.