In the State of the Cure 2014 report, Diabecell was identified as one of the eight Practical Cure solutions in human clinical trials.
Diabecell, based in Auckland, New Zealand, is an islet cell transplantation approach which utilizes encapsulated insulin-producing porcine islet cells. The project completed Phase I human trials several years ago to inconclusive results and is expected to start Phase II/III early next year.
We look forward to the results, which we hope are more conclusive, and will share those findings with our readers when they are released. In the meantime, here are details about the project directly from Dr. Andrea Grant, who is the CEO of Diatranz Otsuka Limited.
Cara Murphy: How did you and your team get involved in type 1 diabetes research?
Dr. Andrea Grant: DIABECELL’s genesis was in the research laboratories of Professor Bob Elliott way back in the ‘80s when he was working as a Professor of Pediatrics at Auckland Hospital. Many of the young people he treated were living with type I diabetes and seeing their struggle created a life long ambition to find a cure. Bob always believed that pig islet transplantation held the key. In the 1990s, Bob met David Collinson, a succesful entrepreneur who’s son had type 1. David convinced Bob to move his research into a commercial setting and Living Cell Technologies was born. By 2011, LCT was a world leader with the only pig cell islet transplant product in clinical development. Seeing this, Ostuka Pharmaceutical Factory invested in the company forming Diatranz Otsuka Limited, a joint venture with LCT. Now we have a team of 65 dedicated people working hard at our head office in New Zealand to bring Diabecell to patients. A few of the team have been working on this goal with Bob since the very early days in the 80’s. How’s that for passion!
CM: Please describe to us non-scientists what DIABECELL does.
AG: It is a very simple concept. Type 1 diabetes results in a loss of islets which secrete the hormone insulin to regulate blood sugar. Currently, people with Type 1 have to replace this insulin with injections. Our approach is to replace the islets instead, by using pig islets. We do this by taking the pig islets from newborn piglets and placing them into the abdomen of someone with Type 1. One trick we have to stop the immune system attacking the pig cells is to protect them in a jelly-like, microscopic, capsule. This capsule lets all the nutrients the islets need in, lets the insulin out, but stops the immune system attacking and killing the pig islet cells.
So, by replacing the lost islets, we hope to achieve normal blood glucose control using the natural biology and without the person having to consciously control their glucose and insulin intake.
CM: How many years have you been on this journey and what keeps you going?
AG: Please see our answer to Question 1 for our history. What keeps us all going is the passion to really make a difference to the lives of people living with Type 1 diabetes and their families.
CM: What are 3 things about your project that you want the type 1 diabetes community to know?
AG: Although the concept of the treatment is simple, getting it through from research into the clinic and onto the market has been a herculean effort. We’re pioneering a totally new approach to cell therapy, and when you’re the first, you’re also the first to learn where the wrong turns are and make the mistakes.
We’re hopefully in the final stage now, and are preparing for a Phase 2/3 trial that should enable us to launch, initially in NZ.
It’s an exciting time for people living with diabetes in the USA; as Otsuka Pharmaceutical Factory have taken a license to develop DIABECELL in the US. So the US program for development will accelerate from here-on.
CM: If successful, how will it change the lives of people living with T1D?
AG: Of course our ultimate goal is to enable people living with T1D to be free of managing their glucose, exercise and insulin to stay well. Initially though, we expect DIABECELL will have the most significant benefit with those people who can’t achieve “good” glucose control i.e the low HbA1c’s that physicians want to see, without experiencing multiple hypos, some of them severe. That’s pretty scary for a person with T1D and their family, and we’re seeing DIABECELL as a really promising treatment to dramatically reduce these unaware hypos, whilst maintaining low HbA1c and by doing so, restore a better quality of life for people living with Type 1 diabetes.
CM: In what stage of human trials is Diabecell? When can we expect to learn the next set of results?
AG: We’re building up to a Phase 2/3 trial in NZ, which we hope will enable us to obtain registration for the product in NZ.
CM: Are you still recruiting for the trial? If so, how can people get in touch with you?
AG: As the sponsor of the trial, we are not responsible for recruitment, so contacting us directly will not be fruitful. Instead, anyone who wishes to participate in any clinical trial should first review the website “clinicaltrials.gov” to see what trials in T1D are running in their country. They then should talk to their physician about their interest in participating in a trial, as their physician will be key in supporting and securing their participation. The physician will determine if the person is suitable candidate for the trial and will work with the principle investigators to see if the person can be recruited.
CM: What are the biggest obstacles your team faces?
AG: Please see first part of answer to Question 4.
CM: What can the type 1 diabetes community do to support your project?
AG: The type 1 diabetes community are amazing in the way they support research into their field, particularly through their philanthropic giving. For DOL and other research companies like us, I think the best thing that the community can do is continue to be willing to be pioneers themselves, by participating in the clinical trials. And be patient with us, know that whilst we’re probably not going as fast as you wish we would, we are all getting up every morning and working our best to bring you a treatment that will make a world of difference.