Living Cell Technologies Limited has implanted the first two patients taking part in a Phase II DIABECELL® clinical trial in Buenos Aires, Argentina.
This is the third jurisdiction to date where LCT, the world leader in xenotransplantation (animal to human implants), has conducted clinical trials. LCT is the only company in the world in clinical trials using this technology. Up to eight adult patients with Type 1 diabetes, including those with unstable diabetes and severe hypoglycaemia, will each receive two implants of DIABECELL, three months apart.
“The great news is that our earlier clinical trials have validated this treatment and shown it can greatly benefit patients suffering from unstable diabetes who don’t have any awareness when their blood glucose levels are low which puts their life at serious risk,” says LCT medical director and acting CEO Bob Elliott.
“We have a treatment that works. However, during this next stage of our clinical trial we will use fewer insulin producing cells, implanted on two occasions and also utilise a different implantation technique to determine if we can provide patients with even greater benefit. The cells were produced by an improved technique that can also be more readily upscaled.”
Phase II clinical trials are typically used by physicians to determine the most effective dosage of any treatment before moving onto Phase III trials which look at the benefit of that treatment and dosage over a much larger group of patients. Earlier clinical trial results of DIABECELL showed that lower dosages had greater benefit than larger dosages.
“We hope to see the effect of these even lower and repeated doses. We are looking for most effective combination before we enter into our final stages of commercialisation,” says Elliott.
LCT will also employ a new variation of the company’s patented IMMUPEL® cell encapsulation technique. The new process avoids a source of capsule imperfection that may affect function. IMMUPEL is used to encapsulate the porcine insulin producing cells to prevent rejection by the recipient.
The Argentinean trial follows a positive assessment from the New Zealand Data Safety and Monitoring Board of the first twelve patients to receive DIABECELL implants in its Phase II trial in New Zealand, as well as favourable two-year follow up data from its Phase I/IIa clinical trial in Russia. LCT recently announced plans for collaborative development of DIABECELL in Asia following the strategic investments made in LCT by ASK in China and Otsuka in Japan.
DIABECELL is LCT’s treatment designed to normalise the lives of people with insulin-dependent diabetes. DIABECELL comprises encapsulated porcine insulin-producing cells (islets) that are implanted into the abdomen of patients using a simple laparoscopic procedure, and work by self-regulating and efficiently secreting insulin in the patient’s body. LCT's breakthrough proprietary encapsulation technology, IMMUPEL™, means that patients receiving DIABECELL treatment do not require immunosuppression after implantation.