Living Cell aims to be on US market in three years

Living Cell Technologies (ASX:LCT) has announced preliminary animal results after 12 weeks of a six-month study evaluating the safety and tolerability of its pig islet cell product, Diabcell.

Sixteen diabetic monkeys were implanted with the islet cells, which regulate blood-sugar levels by producing insulin, whilst remaining protected from immune reaction by a porous alginate capsule. The primates demonstrated a reduction in insulin need in comparison to an unchanged or increased need for insulin in the untreated control group.

Australian authorities last year placed a five-year moratorium on therapies which involve the transfer of animal cells into humans, known as xenotransplantation. The Bioethics Council of New Zealand is gearing up for a series of dialogues on xenotransplantation to be held between March and May this year. The US Food and Drug Administration has approved a number of xenotransplantation clinical studies. Companies working in the area include Circe Biomedical and Cytotherapeutics.

Bob Elliott, LCT's co-founder and medical director, explained that the moratorium was prompted by a perceived risk of infection of transplant recipients by endogenous pig retroviruses. He said that studies had not been conclusive, and it was difficult to tell whether results were caused by experimental design or accident.

He said that a factor 8 product given to haemophiliacs which contained pig retrovirus had been on the market in the US since 1984, and there had been no evidence of infection.

"The bottom line is that someone raised a question that we've never been able to answer. They've never been able to demonstrate there is a problem - but the converse is also true -- there is no proof of safety," said Alfred Vasconcellos, CEO of the company's US arm, LCT BioPharma.

After more than six painstaking years, the company has achieved a fully-characterised production process for its alginate-encapsulated cells, and has a GMP-accredited facility for manufacturing the cells. It is currently putting together an IND application for the US Food and Drug Administration to begin safety and tolerability studies of Diabcell in humans with Type I diabetes. The primate study data is one of the final component's of the company's IND.

Vasconcellos estimates that -- all going well -- LCT could run the full gamut of clinical trials in no more than three and a half years, meaning that the Diabcell therapy could reach the market in the US before the Australian moratorium is lifted.

The cells are transplanted under local anaesthetic by a laproscopic procedure, and would need to be renewed around every three months.