LCT gets green light from Russia for Type 1 diabetes treatment Diabecell

Living Cell Technologies (LCT) announced today that Russia has become the first country in the world to approve the use and sale of its Diabecell porcine implant for Type 1 diabetics.

“This is a major step toward global commercialisation of this important advancement in the treatment of diabetes, providing us with the necessary authority to commercialise DIABECELL in Russia,” said LCT CEO Dr Ross Macdonald.

Read more about xenotransplantation.

The world’s first approved human xenotransplantation as well as the first registered porcine cell implant therapy, Diabecell has been proven to safely reduce the amount of insulin required by Type 1 diabetics. What’s more, the product is gaining awareness as a mean of eliminating life threatening episodes of hypoglycaemic unawareness, a potentially fatal condition whereby diabetics are unaware when their blood sugar levels reach dangerously low levels.

The Russian registration has been granted to LCT’s recently formed Russian subsidiary LCT Biomedical Limited.

Clinical trials of Diabecell began in Russia in 2007 at the Sklifosovsky Research Institute in Moscow. Eight patients with insulin-dependent diabetes each received between one and three implants of Diabecell with no major adverse product-related events.

Participants received a blood test after a year, all of which turned up negative for the transmission of diseases between pigs and humans. Six of the eight showed a marked long-term improvement in blood glucose control indicated by the reduction in glycated haemoglobin (HbA1c %) levels, while the required daily dose of insulin injections also fell. Two patients were able to do without any insulin injections at all for around eight months.

The Russian registration of Diabecell is the first commercially significant milestone for the product, permitting its sale and use for the treatment of Type 1 diabetes in the country. LCT is currently conducting Phase II trials in New Zealand on patients with unstable diabetes, with Phase III trials to start in the country next year.

Diabecell is made up of encapsulated porcine insulin producing cells (islets) that are implanted into the abdomen of patients where they self-regulate the efficient secretion of insulin throughout the body.

The announcement of Diabecell’s registration in Russia drove LCT’s shares to close today up almost 26 percent to $0.17.