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ALGORAE PHARMACEUTICALS LIMITED — Board/Management Information 2021
Dec 12, 2021
64249_rns_2021-12-12_40866db4-cb5a-4592-ae6f-3708d6643cf0.pdf
Board/Management Information
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Living Cell Technologies Limited
ACN: 104 028 042 ASX: LCT OTCQB: LVCLY
ASX ANNOUNCEMENT
LCT Appoints COO to Establish NTCELL Trial
Sydney, Australia & Auckland, New Zealand - 13 December 2021 – Living Cell Technologies (LCT) has appointed Dr Belinda Di Bartolo as Chief Operating Officer. Dr Di Bartolo will lead the planning and preparations for the third clinical trial of NTCELL in Parkinson’s disease.
Dr Di Bartolo has 18 years’ experience in health and medical research. She has a clear understanding of the translational pathway of research as well as knowledge of the regulatory processes, with experience in ethics and governance committees. Dr Di Bartolo, who is based in Sydney, has outstanding leadership and relationship skills and a fundamental passion for medical research.
Prior to joining LCT, Dr Di Bartolo was a research fellow at the Kolling Institute at the University of Sydney, NSW. She previously held research roles at SAHMRI, The Heart Research Institute and the University of New South Wales, NSW. She holds a Bachelor of Medical Science (Hons) and a PhD from the University of Sydney.
LCT Executive Chairman, Professor Bernie Tuch, says the board was impressed by Dr Di Bartolo’s research experience, ability to secure funding and understanding of the regulatory requirements involved in clinical trials.
“Dr Di Bartolo brings a breadth of expertise and connections that will be invaluable as LCT puts in place the infrastructure needed for the third clinical trial with NTCELL.
“The timing couldn’t be better as we near completion of commercial discussions with NZeno as a source of pig tissue for the trial,” says Professor Tuch.
Initial preparations including trial protocols and dry runs of pig tissue between Invercargill in New Zealand and Sydney will take around two years to complete. In parallel, LCT will seek regulatory approval for the trial. The first trial participants are expected to receive treatment in 2024.
Authorised for release by the Board of Living Cell Technologies Limited.
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For further information: www.lctglobal.com
| At the Company: | At the Company: |
|---|---|
| Bernie Tuch | Mark Licciardo |
| Chief Executive | Mertons Corporate Services Pty Ltd |
| Mobile:+61 411 461 604 | P: +61 03 8689 9997 |
| [email protected] | [email protected] |
About Living Cell Technologies
Living Cell Technologies Limited (ASX: LCT) is an Australasian biotechnology company that has focused on discovering and developing novel treatments for debilitating conditions such as diabetes and Parkinson’s disease. LCT has secured initial funding for a third clinical with NTCELL (alginate coated capsule containing clusters of neonatal porcine choroid plexus cells) after completing Phase IIa and IIb clinical studies in Parkinson’s disease. In a Phase IIb trial of NTCELL, there was not a statistically significant difference between the groups who received NTCELL and the placebo group at the 26-week study endpoint. However, at 24 months post-implant a clinically relevant effect was observed (<-6.45 points from baseline) in two of the three treatment groups. In the third clinical trial LCT will seek to alter the rate of disease progression in early-to-mid stage Parkinson’s disease.
LCT has out-licensed DIABECELL (alginate coated capsule containing neonatal porcine pancreatic cells) to Diatranz Otsuka Limited to continue the development of a cell therapy for type 1 diabetes in return for a royalty arrangement. LCT continues to seek new product project opportunities and also interactions that leverage its financial assets. LCT is listed on the Australian (ASX: LCT) and US (OTCQB: LVCLY) stock exchanges. The company is incorporated in Australia, with its operations based in Australia and 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.