The industrial backblocks of suburban Auckland may seem an unlikely setting for an international biotechnology company, but that’s where you will find Living Cell Technology’s New Zealand cell-processing GMP premises.
Formerly known as Diatranz, LCT’s Managing Director Dr Paul Tan describes the firm as “one of the leading companies in the world when it comes to cell-based insulin treatment”.
Its small overheads mean LCT is able to invest more money in expanding on its current site, new staff, updating equipment, and its GMP cell production plant.
“We are a cell-based company, and see cell therapy as something ready for the market,” Dr Tan says.
One of the projects LCT has been working on involves placing insulin producing cells, called islets, into the body to treat diabetes. Islets are natural aggregates of cells that produce insulin as well as glucagons. Islets comprise beta, alpha and delta cells. LCT’s product encapsulates not only beta cells, which produce insulin, but alpha and delta cells.
Collected from a unique herd of disease-free Auckland Island pigs, these cells have the specific requirements for responding to the body’s demand for insulin.
“You can’t better the sophistication that nature has assembled in the intricate regulating mechanisms within a cell.”
The islets are protected from the body’s immune system by being enclosed in gel capsules, and LCT’s products do not require toxic immunosuppressing drugs normally used with transplantation. “We are leading the charge for cell replacement without immunosuppression.”
Fears about the possibility of transferring pig viruses to humans have so far proven to be exaggerated, with the November 2004 issue of the Journal of Clinical Microbiology publishing an article co-authored by Diatranz on the long term follow-up of human patients who received pig islet xenotransplants.
Eighteen patients were monitored for up to nine years for potentially xenotic pig viruses. The study reported no evidence of viral infection. There is also recent information indicating earlier observations on the in-vivo transmission of pig endogenous retroviruses (PERV) are faulty and due to pseudotyping of the viruses (Yang et al, J Clin Invest 2004; 114: 695-700).
The first phase of Singapore-based trials involving diabetic monkeys that have received LCT’s DiaBCell diabetes product (the insulin producing cell transplant) is expected to be completed in early 2005. With everything going to plan, human trials could begin by the end of the year.
One unknown is how long the treatment will last, once it has been administered. Some individual variation is expected, in the number of years the transplant remains functional, but the company knows that more than one transplant is safe and feasible, Dr Tan says.
New Zealand’s current regulatory environment means the trials will be conducted by LCT BioPharma Inc, an LCT subsidiary in Rhode Island, USA. Despite considerable interest from China and Italy, the company is committed to gaining FDA approval first. Once secured, Dr Tan expects more activity and growth in the US firm.
“Of course it would be nice to do trials in your own country. We’d want the benefits of our research to be realised here.”
With a personnel list resembling a United Nations line up, LCT’s management believes the company must be international to be successful.
“For any biotech company to do well it must outgrow New Zealand. We can’t capture all the necessary expertise from one country.”
Having a presence in other countries has certainly been useful, with the US office assisting in gaining regulatory approvals, and the Italian research team, led by Professor Riccardo Calafiore, being the origin of LCT’s gel encapsulation technology and the first place in the world to implant encapsulated human islets.
Other projects LCT is working on include treatments for Huntington’s disease (NeurotrophinCell) and haemophilia. The company has deliberately targeted diseases that have no current treatment and that can be fast-tracked into clinical trials. Having already completed trials of a Huntington’s therapy in rat models, primate studies will begin in 2005 in Rhode Island.
Following a spectacular debut on the Australian Stock Market last September, LCT went on to raise an additional A$4.8 million in October by placing 12 million shares with Australian and US investors. Money the company said at the time would be used primarily for its Huntington’s research programme.
The applications for LCT’s technologies span some of our most elusive diseases, or as Dr Tan puts it: “This technology is particularly good for diseases where cells are lost, for example; Huntington’s, Parkinson’s, Alzheimer’s, stroke, brain and spinal damage.”
NZBio Report, Feb/March 2005