Friday 26th August 2016
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Australasian biotech company Living Cell Technologies plans to treat patients for Parkinson’s disease under a “medical tourism” model if its clinical trial under way in Auckland succeeds next year.
The phase 11b clinical trial of 18 patients is underway at the University of Auckland and Mercy Hospital on its regenerative cell therapy NTCELL, which would be the world’s first disease-modifying treatment for Parkinson’s.
Results are expected mid-next year from the escalating dosage clinical trial which is being carried out in three legs and requires consent from the Data Safety Monitoring board at the end of each 26-week period after the cells are implanted.
Living Cell chief executive Ken Taylor said if the second trial proves successful, the company will apply for provisional consent that would speed up approval for treatments for severe illnesses that speed up approval to treat paying patients in New Zealand next year, including patients brought in from other countries.
Medical centres of excellence that attract paying patients from other countries are common overseas, he said.
“It would be quite good when launching it to keep tight management on it to make sure implementation is being done properly,” Taylor said.
The next step on from medical tourism under its business strategy is scaling up the GMP manufacturing process, developing NTCELL for other central nervous system diseases such as Huntington’s and Alzheimer's, and expanding its use worldwide.
Living Cells’ operations are based in New Zealand and it’s listed on the ASX and US stock exchanges.
It reported a narrowed annual loss this week of A$3 million for the year ended June 30 from A$7 million the prior year.
It was founded in New Zealand in 1999 to develop a regenerative cell therapy that involves transplanting cells from Auckland Island pigs into humans. The initial target was type 1 diabetes, which is now being pursued by its joint venture company, Diatranz Otsuka Ltd (DOL).
In 2014 DOL licensed Living Cell’s other 50 percent partner, Japanese-based Otsuka Pharmaceutical Factory, to use DIABCELL in the US and Japan and last year DOL decided to carry out research in the US in order to meet strict Food and Drug Administration (FDA) rules, rather than in New Zealand. It is now consulting with seven full and part-time employees about closing its Invercargill pig facility and with the Southern Heirloom Breeds Trust about rehoming the 30 pigs.
DOL has completed Phase 1 and 2 trials of DIABCELL in New Zealand, Russia, and Argentina and general manager Shaun Wynyard said it is still some years away before the product will be brought to market.
As part of its commercialisation plans, Living Cell secured supply of its lead product NTCELL by paying A$580,000 for plant and equipment and pathogen-free pigs now held at a North Island pig breeding facility. Taylor said it has sufficient supply of NTCELL as Parkinson’s requires fewer cells than the diabetes treatment.
Living Cell’s smaller loss was mainly due to a markedly reduced share of joint venture losses as the carrying value of the investment has been reduced to zero. The company’s share of unrecognised losses through the joint venture is A$3.5 million.
It still has plenty of cash in hand - A$5.3 million compared to A$5.1 million the year before, following a A$3.7 million fund-raising through private placements and a share purchase plan, partially offset by clinical trial and operating costs.
Research and development costs increased to A$2.36 million from A$1.77 million the prior year after completion of the first clinical trial and the start of the second, along with maintaining the pig herd.
Grant income more than doubled during the year to A$592,000 from A$228,000 after gaining a three-year Callaghan Innovation research and development grant.
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