New Zealand Living Cell-Otsuka Partnership Implants Pig Cells Into Parkinson’s Patient
This article was originally published in The Pink Sheet Daily
Executive Summary
New Zealand’s Living Cell Technologies has taken a key clinical step in regenerative and replacement branded cell therapy work focused on Parkinson’s disease and type 1 diabetes that has drawn investment from Japan’s Otsuka.
MELBOURNE – Living Cell Technologies Ltd. implanted branded cells harvested from a pathogen-free pig herd into the brain of a patient with Parkinson’s disease, a world first, as part of a Phase I clinical trial supported through a partnership with Japan’s Otsuka Pharmaceutical Co. Ltd.
Living Cell Managing Director Andrea Grant presented the work on the NTCELL therapy at the Australia Biotech Invest Conference organized by AusBiotech Oct. 28-29 in Melbourne, saying the first patient was treated at Auckland City Hospital and is being monitored for two months to judge safety, marking a milestone in a long road to use the cells in treatment (Also see "New Zealand's Living Cell Technologies Closer To Getting Pigs To Market" - Scrip, 17 Jun, 2010.).
In 2011, Otsuka invested $25 million in a joint venture with Living Cell to use pig cell transplants from a free-range herd living on an island off Auckland to treat diabetes. The product has been successful in diabetes trials, and the company is now proceeding to work on a separate Parkinson's disease treatment program (Also see "Otsuka Rescues Living Cell Of N. Zealand With $25 Million" - Scrip, 19 Oct, 2011.).
If the New Zealand Data Safety Monitoring Board grants approval after the two-month period, three more Parkinson’s disease patients with late-stage disease will receive NTCELL implants.
Grant has worked for Incyte Corp., GlaxoSmithKline PLC, Galapagos NV and Roche, and discussed details of the implant process in an interview during the Australian conference.
“During the neurosurgical NTCELL implant procedure, a very small drill hole is placed in the skull and a catheter is placed down the hole to the brain. Instead of electrodes in the catheter, which is the traditional way used in deep brain stimulation treatment for Parkinson’s disease, we insert 40 porous capsules of NTCELL cells.”
Regenerative Focus
She said that NTCELL works by encouraging the survival and regrowth of different neurons damaged by the disease. The implant contains choroid plexus cells, naturally occurring support cells for the brain, which release growth factors, anti-oxidants and protective enzymes. These aid nerve health and cause damaged neurons to regrow.
“The implant is injected under guidance by neuroimaging into the areas of the brain where death of neurons and other cells has occurred, and they appear to trigger regeneration,” Grant said.
Research data from using NTCELL in treating Rhesus monkeys with Parkinson’s disease symptoms, revealed that the cell therapy could regenerate damaged brain tissue, potentially delaying or preventing the effects of Parkinson’s disease.
Otsuka and other Japanese drug companies have shown sharp interest in research into regenerative medicine with the government also seeing it as a possible cornerstone of biotech development (Also see "Japan Mulls Two Bills To Spur Local Regenerative-Medicine Industry" - Scrip, 31 Oct, 2013.).
LCT is listed in Australia and the United States and has worked with Otsuka for the clinical development of its two lead products, NTCELL for Parkinson’s disease and DIABECELL for type 1 diabetes.
Clinical trials of DIABACELL conducted in type 1 diabetes patients in New Zealand and Argentina showed reduced hypoglycemia, improved glucose control and reduced injected insulin required by patients. DIABACELL contains porcine insulin-producing cells and when transplanted into a patient’s body, secretes insulin when the patient’s glucose rises, according to Grant.
A $50 million DIABECELL partnership was formed in 2011 under Diatranz Otsuka Ltd. and was transferred into the joint venture and was followed by the NTCELL partnership in 2012 to co-develop NTCELL to treat Parkinson’s disease. Otsuka is now funding the current Phase I Parkinson’s disease trial in New Zealand.
Grant said that if the present Phase I trial is completed and successful, LCT plans to transfer NTCELL into the joint venture and Otsuka would provide a further AU$20 million to fund more clinical development and look at other degenerative diseases such as Huntington’s disease, hearing loss and Alzheimer’s disease.
[Editor’s note: This story was contributed by PharmAsia News
, which provides in-depth coverage of Asian business and regulatory developments.]