ACN: 104 028 042
ASX: LCT
OTCQX: LVCLY
13 May 2019 - Sydney, Australia & Auckland, New Zealand - LCT has the data from the 24 month follow up of the 18 patients in the Phase IIb study of NTCELL® for Parkinson's disease.
At 24 months post implant the 4 people with Parkinson's disease who received 80 capsules continue to show a benefit as measured by the change in the Unified Parkinson's Disease Rating Scale (UPDRS Part III in the off state).
This was greater than the 2 placebo group in that section of the Trial, but not when compared to all the 6 placebo patients (4 from the other groups) in whom responses were quite varied. Recipients of 40 capsules showed no difference from placebo.
We are seeking advice from both our statistician and a panel of internationally recognized experts on clinical studies in Parkinson's disease to help interpret the data further.
Earlier trials
The Phase I/IIa clinical trial of NTCELL for the treatment of Parkinson's disease, in New Zealand, met the primary endpoint of safety and halted the progression of the disease three years after implant. Results from this trial were used to design this larger Phase IIb trial to confirm the most effective dose of NTCELL, define any placebo component of the response and further identify the initial target Parkinson's disease patient sub group.
The 26 week results of this Phase IIb trial met safety endpoints but not efficacy endpoints. Patients were then monitored in accordance with the study extension protocol.
At 12 and 18 months follow up there were indications of efficacy.
The Phase IIb study was designed to confirm the most effective dose of NTCELL, define any placebo component of the response and further identify the initial target Parkinson's disease patient sub group. The study consisted of three groups of six patients. Two patients from each group had sham surgery with no NTCELL implanted, to act as a control. Group 1 received 40 microcapsules of NTCELL implanted on each side of the brain; group 2 received 80; and group 3 received 120.
The future for NTCELL
Dr Ken Taylor, CEO of LCT, says the company will confirm its future strategy once it has the in-depth analysis of the data.
"We anticipate that the input of our expert advisors in the coming weeks will shape our plans for the future of NTCELL," says Dr Taylor.
For further information: www.lctglobal.com
| At the Company: | Media Contact: |
| Ken Taylor | Rachael Joel |
| Chief Executive | Botica Butler Raudon Partners |
| Mobile: +64 21 796 000 | Tel: +64 9 303 3862 |
| ktaylor@lctglobal.com | Mobile: +64 21 403 504 |
| rachaelj@botica.co.nz |
About NTCELL®
NTCELL is an alginate coated capsule containing clusters of neonatal porcine choroid plexus cells that are sourced from a unique herd of designated pathogen-free pigs bred from stock originally discovered in the remote sub-Antarctic Auckland Islands. Choroid plexus cells are naturally occurring "support" cells for the brain and secrete cerebrospinal fluid (CSF), which contains a range of factors that support nerve cell functions and protective enzymes that are crucial for nerve growth and healthy functioning. In NTCELL, the porcine choroid plexus cells are coated with LCT's propriety technology IMMUPEL™ to protect them from attack by the immune system. Therefore, no immunosuppressive regimen is required for treatment.
Following implantation into a damaged site within the brain, NTCELL functions as a neurochemical factory producing CSF and secreting multiple nerve growth factors that promote new central nervous system (CNS) growth and repair disease-induced nerve degeneration while potentially removing waste products such as amyloids and proteins.
About Parkinson's disease
Current treatments for Parkinson's disease are symptomatic and do not reverse or slow the degeneration of neurons in the brain. Most existing pharmaceutical treatment options focus on restoring the balance of dopamine and other neurotransmitters. The effectiveness of dopamine replacement therapy declines as the disease progresses. When dopamine treatments are no longer useful, some patients are treated with Deep Brain Stimulation (DBS), in which a medical device is surgically implanted in the brain in order to send electrical impulses to regions of the brain involved in the control of movement. While DBS leads to short-term symptomatic improvement, it does not impact disease progression and is not curative or neuroprotective.
About Living Cell Technologies
Living Cell Technologies Limited (LCT) is an Australasian biotechnology company improving the wellbeing of people with serious diseases worldwide by discovering, developing and commercialising regenerative treatments which restore function using naturally occurring cells.
As well as its lead product, NTCELL, LCT is also advancing research collaborations with the University of Auckland to identify products that are candidates for out licensing to global pharmaceutical companies. Projects that have been initiated target obesity and migraine where the lead product candidates utilise patented novel peptide synthetic chemistry technology.
LCT is listed on the Australian (ASX: LCT) and US (OTCQX: LVCLY) stock exchanges. The company is incorporated in Australia, with its operations based in New Zealand.
For more information visit www.lctglobal.com or follow @lctglobal on Twitter.
Forward-looking statements
This document may contain certain forward-looking statements, relating to LCT's business, which can be identified by the use of forward-looking terminology such as "promising," "probable", "plans,"
"anticipated," "will," "project," "believe," "forecast," "expected," "estimated," "targeting," "aiming," "set to," "potential," "seeking to," "goal," "could provide," "intends," "is being developed," "could be," "on track," or similar expressions, or by express or implied discussions regarding potential filings or marketing approvals, or potential future sales of product candidates. Such forward-looking statements involve known and unknown risks, uncertainties and other factors that may cause actual results to be materially different from any future results, performance or achievements expressed or implied by such statements. There can be no assurance that any existing or future regulatory filings will satisfy the FDA's and other health authorities' requirements regarding any one or more product candidates nor can there be any assurance that such product candidates will be approved by any health authorities for sale in any market or that they will reach any particular level of sales. In particular, management's expectations regarding the approval and commercialisation of the product candidates could be affected by, among other things, unexpected clinical trial results, including additional analysis of existing clinical data, and new clinical data; unexpected regulatory actions or delays, or government regulation generally; our ability to obtain or maintain patent or other proprietary intellectual property protection; competition in general; government, industry, and general public pricing pressures; and additional factors that involve significant risks and uncertainties about our products, product candidates, financial results and business prospects. Should one or more of these risks or uncertainties materialise, or should underlying assumptions prove incorrect, actual results may vary materially from those described herein as anticipated, believed, estimated or expected. LCT is providing this information and does not assume any obligation to update any forward-looking statements contained in this document as a result of new information, future events or developments or otherwise.
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