Living Cell Technologies: New Technologies and Clinical Trials




Episode Loading...




PharmaTelevision requires Javascript enabled and Adobe Flash Player to watch our programmes. If you do not have Flash installed, you can download it for free from the Adobe Flash homepage.

Improve your Internet experience and start watching exciting new video content.

Video title: Living Cell Technologies: New Technologies and Clinical Trials
Released on: January 20, 2010. © PharmaVentures Ltd
Share/save this page:
Email
Bookmark
Facebook
Twitter
LinkedIn
Follow us:
RSS
Twitter
  • Summary
  • Transcript
  • Participants
  • Company
In this episode of PharmaTelevision News Review, Fintan Walton talks with Dr Paul Tan, CEO of Living Cell Technologies.

Filmed at AusBiotech 2009, they discuss:

• The company’s origins and aims
• Pig islet transplantation to combat diabetes
• Results of Russian and New Zealand clinical trials
• Living Cell Technologies’ issues with clinical trials in Australia
• The company’s search for a clinical service partner
Living Cell Technologies's origins and aims
Fintan Walton:
Hello and welcome to PharmaTelevision news review here in Melbourne, Australia. On this show I have Paul Tan, who is CEO of a company called Living Cell Technologies. Welcome to the show.
Paul Tan:
Thank you for having us on your program.
Fintan Walton:
Paul, your company is a company that's involved in the area of diabetes in particular transplantation and the technology you've developed is pig-islets and the transplantation of those pig-islets into humans tell me how the company started and what it's specific aims are?
Paul Tan:
The company started with research that was done by Professor Bob Elliott at the University of Auckland and Bob together with David Collinson a business man started this company because David's son had insulin dependent Type I diabetes, so that research has developed over the years into a new treatment for Type I diabetes the aim of which is to control blood glucose and better control of diabetes overall.
Pig islet transplantation to combat diabetes
Fintan Walton:
So what is the fundamentals of the technology that allows you to take pig-islets and to put them into humans, what's behind the technology?
Paul Tan:
The technology takes advantage of a fact that a natural cell would produce insulin when blood glucose is high and will switch off insulin production when blood glucose returns to normal. Presently this problem is not solved no matter what kind of insulin pumps you have there are people with Type I diabetes will have great problems controlling the blood glucose with repeated injections of insulin everyday.
Fintan Walton:
So in order to take pig-islets did you is it important to get a specific type of pig breeding program was it how did you take that and then translate that into a effective therapy?
Paul Tan:
That's right, we would never have been allowed by international experts and reviewers who encourage the New Zealand government to give us permission to conduct you know human trials in New Zealand, we are in offer the fact that we have very special pigs, these pigs are the cleanest in the world, they were abandoned in the Auckland Islands these are Sub-Antarctic Islands 300 miles south of New Zealand closer to the South Pole abundant there 200-years ago. These were the days when ships from Melbourne and Sydney returned to England from the bottom of the world and they come across these Islands that are shrouded in fog and it is a graveyard for ships, pigs were left there and pigs abandoned for 200-years and kept away from all other pig herds are remarkably free of common viruses, bacteria and parasites that you see in other pig herds. So our pigs are very unique and very high health status and approvable for use as a sort of cells for human treatment.
Fintan Walton:
So the source of pigs is an important component to it?
Paul Tan:
Absolutely critical, you cannot develop a program for using pig cells unless the pigs are certified as safe by a number of you know international rules and regulations.
Results of Russian and New Zealand clinical trials
Fintan Walton:
So to do your clinical trials, you are doing these clinical trials currently in New Zealand, I think you are also doing in Russia as well?
Paul Tan:
Yes.
Fintan Walton:
The how you are doing those clinical trials? What sort of patients are you selecting, because obviously there is a procedure that's required to insert these cells?
Paul Tan:
The procedure is very simple, the cells are implanted into the abdomen and because the cells are foreign they are put first of all into little capsules and what the capsules do is that it protects the cells from rejection by the immune system so there is no need for immunosuppressive drugs.
Fintan Walton:
This is important, right.
Paul Tan:
The procedure itself is through a laparoscope and the capsules are implanted the procedure is about 15 minutes.
Fintan Walton:
So they don't actually have to insert themselves into the pancreas at all.
Paul Tan:
No.
Fintan Walton:
They can just be free in within the abdomen?
Paul Tan:
That's right, it's not floating free, these capsules get attached to the liver and to various organs and over several weeks blood vessels will grow on top of the capsules and this is important because what it does is the blood supply and oxygen allows the cells to survive a long time.
Fintan Walton:
So how many patients have been given this treatment and what sort of results are you getting?
Paul Tan:
Well the first study started in Russia about two-years ago and we have implanted eight patients and what the results they show is firstly that the procedure is safe that you can give more than one dose and then there is a clear clinical benefit. We have one patient with Type I diabetes who has been off insulin now since February or March this year.
Fintan Walton:
Right.
Paul Tan:
And this is still early days and the doses, the initial doses used in Russia were small doses, with the New Zealand trial we will be testing higher doses and therefore we expect even better results.
Fintan Walton:
So the one patient that's now is insulin free or lesser insulin dependent
Paul Tan:
Yes, yeah.
Fintan Walton:
From injections, was it just, is that � does that mean that the other seven wasn't so, so successful?
Paul Tan:
No the main concern of the regulators right now and this is a requirement for the New Zealand trial, the first concern is to make sure that blood glucose is normalized.
Fintan Walton:
Right.
Paul Tan:
And in seven out of those eight patients in Russia this is what we've seen, the blood test called HbA1c glycated haemoglobin is a reflection of good blood glucose control and in seven of eight patients we see a significant improvement in that test result. Now with the New Zealand study it goes without saying that we do want to see improvement of the HbA1c-1, but secondly what's more important is that the swings that one sees in blood glucose control is eliminated and that plays a reduction in those life threatening episodes of low blood glucose so called hypoglycemic and awareness.
Fintan Walton:
Sure.
Paul Tan:
That is a more significant concern of doctors and patients then a reduction of insulin. We will expect to see a reduction in insulin dose and in some patients it might be it will be possible for them to go often soon.
Living Cell Technologies issues with clinical trials in Australia
Fintan Walton:
Right. Now one of the things that, you are obviously doing clinical trials in Russia and New Zealand you started this trial in New Zealand which is important, you are obviously based in New Zealand you're originally incorporated in Melbourne and you are looking to do clinical trials here in Australia which obviously got a larger population, but you have a problem here, what's that problem?
Paul Tan:
Well there is a moratorium which was has been around now for about five-years preventing clinical trails with animal cells into humans, we know that there are others in Australia, there is an excellent group in Melbourne, an excellent group in Sydney doing research using animal cells like us but also using animal organs potentially for transplant. And as a group we would like to see this moratorium lifted, because the main concerns with the transfer of retroviruses, endogenous retroviruses from pigs to humans has largely been settled.
Fintan Walton:
And that's the issue that the original moratorium impose was the was presumably because of this threat so called threat.
Paul Tan:
Threat.
Fintan Walton:
Of viruses from pigs?
Paul Tan:
That's right and now it's been well internally scrutinized, multiple laboratories have taken these endogenous retroviruses and injected them into any number of animals including monkeys and shown that it does not cause disease. And what's important is that the pigs that we use do not secrete these viruses.
Fintan Walton:
So how can you change the government's moratorium on pig transplantation?
Paul Tan:
Our understanding is that the NHMRC and the experts advising government are looking forward to lifting this moratorium, we have been in communication as well as other groups and we would be surprised if the moratorium is not lifted.
The company's search for a clinical service partner
Fintan Walton:
Just going back to your company Living Cell Technologies obviously you are taking this technology forward, you are performing these clinical trails, what is your ultimate outcome do you want to be you want to get into partnership with other companies or are you just gonna do this totally on your own all the way through and become the main provider of this particular procedure?
Paul Tan:
We see ourselves essentially as people who as a company that will supply the product. There is no one else in the world that have got pigs like ours and so we have to be the company that breeds the pigs, no one knows how to prepare the cells and encapsulate the cells the way we have done it, so we will be responsible for manufacturing that product. When it comes to a business say in Russia or in the US or anywhere else we don't want to be in the business of running hospitals. So we'd like to have a clinical service partner that will look after that end of the business we are suppliers of the product.
Fintan Walton:
So what sort of company do you think would be a suitable partner?
Paul Tan:
Essentially those that provide clinical services, now this is not to say that a large pharmaceutical company were to come into this field that we would not be prepared to talk to them, but they will nevertheless you know need us to breed the pigs and transfer the technology for making the product.
Fintan Walton:
When do you think you will get your first approval?
Paul Tan:
The first approval for our commercial product, that's usually about three-years after the first trial.
Fintan Walton:
Right.
Paul Tan:
And for a market such as Russia it might be as soon as 2012. For Australia, New Zealand and the rest of the world it will have to be at least a year later.
Fintan Walton:
Okay.
Paul Tan:
That is if all goes smoothly and well.
Fintan Walton:
Paul Tan, thank you very much indeed for coming on the show.
Paul Tan:
Thank you for the opportunity.
Paul Tan
Chief Executive Officer
Dr Paul Tan has been an executive director since 23 February 2007 and was appointed as Chief Executive Officer of the Group on 23 December 2008. Paul joined the company in 2004 as the Managing Director of LCT's New Zealand operations. Prior to this he was Chief Executive Officer of CenTec Ltd and founding Deputy Director and Head of Health Division at Genesis Research & Development Corporation Limited. He has wide experience in all aspects of assessment and selection of products for commercialization, expansion of intellectual property, product development and managing critical paths, timelines and establishing and managing international partnerships. He has been a research fellow, associate professor in immunology and a physician rheumatologist. He is on the NZBio National Advisory Council and Committee of the NZBio Auckland.
Living Cell Technologies
Living Cell Technologies: Developing cell-based therapies for type 1 diabetes and neurological disorders. LCT is a New Zealand based biotechnology company focused on developing living cell products for the treatment of diabetes, neurological disease and haemophilia. We have collaborations in Melbourne, Sydney, Auckland, Germany, Italy, Russia and the US.