NTCELL (alginate-encapsulated neonatal porcine choroid plexus cells) / Algorae Pharmaceuticals - LARVOL DELTA

Living Cell Technologies (ASX:LCT) launches $2.5 million cap raise for Parkinson’s treatment (The Market Herald) - "Biotech company Living Cell Technologies (LCT) has launched a $2.5 million capital raise with Alignment Capital to develop its NTCELL project. Three distinct funding initiatives are part of the raise: a placement for $750,000, a non-renounceable rights issue entitlement offer and a shortfall offer by way of prospectus for $1.2 million, and a post-rights issue over-allotment offer to raise an additional $562,500....LCT plans to use the funds to further develop its NTCELL project and conduct a third clinical trial for Parkinson’s disease, to fund assessments of corporate development opportunities regarding additional projects, and to provide for general working capital."

Financing • CNS Disorders • Parkinson's Disease

December Quarterly Activities Report and Appendix 4C Cash Flow Statement (Irasia) - "During the quarter, the Company continued to progress its third clinical trial to assess NTCELL in people with Parkinson's disease in collaboration with Nzeno, a New Zealand-based biotech company that supports xenotransplantation. Nzeno breeds and maintains a unique herd of designated pathogen-free pigs from Auckland Island that are harvested for tissues compatible for human transplantation. The focus of LCT continues to be optimisation of the NTCELL manufacturing process, using choroid plexus tissue harvested by Nzeno. LCT employs a sophisticated protocol, developed during the first two clinical trials, to manufacture NTCELL. Once production of NTCELL has been optimised, it will be manufactured at scale at a Good Manufacturing Practice (GMP) facility for use in the Company's third clinical trial of NTCELL. The board is considering a range of initiatives to expand and improve upon the NTCELL R&D program."

Commercial • Licensing / partnership • CNS Disorders • Parkinson's Disease

Living Cell Technologies (ASX:LCT) completes stage one of NTCELL manufacture (The Market Herald) - "Living Cell Technologies (LCT) has completed stage one of its use of artificial intelligence in the planned manufacturing of NTCELL in Sydney....The company is using AI to optimise and select high quality encapsulated cells (NTCELL) for implantation into the brains of people with Parkinson’s disease, as a potential treatment for the disease that affects millions of people globally...With this stage now complete, OptiCellAI is working to progress to the second stage of assembling the necessary software and providing a prototype to LCT for trials. The research is expected to result in the development of two prototype machines....The news follows LCT receiving its first shipment of choroid plexus tissue sent from New Zealand to Sydney in August as part of its third clinical trial. Once production of NTCELL has been optimised at the University of Technology Sydney, it will be manufactured at a Good Manufacturing Practice (GMP) facility."

Commercial • CNS Disorders • Parkinson's Disease

Living Cell Technologies (ASX:LCT) raises $1.28m for NTCELL (The Market Herald) - "Biotech company Living Cell Technologies (LCT) has raised $1.285 million through a private placement to boost its research into Parkinson’s Disease. The company issued 257 million new fully-paid ordinary shares to professional and sophisticated investors of advisory firm Alignment Capital at 0.5 cents. LCT said it would use the money to support its research to fight Parkinson’s disease, with its NTCELL product advancing to a third clinical trial. The aim of this trial is to determine whether NTCELL provides neuroprotection to pause or delay the natural progression of Parkinson’s."

Financing • CNS Disorders • Parkinson's Disease

NTCELL to be produced in Australia under UTS research agreement (The National Tribune Australia) - "Living Cell Technologies...says it has advanced plans for a third clinical trial of NTCELL in Parkinson’s disease. The company said this follows the signing of a research agreement with the University of Technology Sydney (UTS) and the Australian Foundation for Diabetes Research (AFDR). The agreement will allow university facilities to be used to optimise the production of NTCELL in Australia for the first time, prior to the third clinical trial."

Licensing / partnership • CNS Disorders • Parkinson's Disease

A long-term follow-up of safety and clinical efficacy of NTCELL® [Immunoprotected (Alginate-encapsulated) porcine choroid plexus cells for xenotransplantation] in patients with Parkinson's disease. (PubMed, Parkinsonism Relat Disord) - "Un-blinded, long-duration follow-up to week 104 post-implantation showed no evidence that putaminal NTCELL® administration produces significant clinical benefit in patients with moderately advanced Parkinson's disease."

Journal • CNS Disorders • Movement Disorders • Parkinson's Disease • Transplantation

Open-label Investigation of the Safety and Clinical Effects of NTCELL in Patients With Parkinson's Disease (clinicaltrials.gov) - P1/2; N=4; Completed; Sponsor: Living Cell Technologies; Trial completion date: Mar 2020 ➔ Jun 2020

Clinical • Trial completion date • CNS Disorders • Gene Therapies • Movement Disorders • Ophthalmology • Parkinson's Disease • Transplantation

LCT collaborates to develop novel neurological treatments (SCOOP) - "Living Cell Technologies Limited has formed a collaboration with the Centre for Brain Research (CBR). The research collaboration will identify additional neurodegenerative disease targets for clinical studies of LCT’s lead product NTCELL®."

Licensing / partnership • Parkinson's Disease

Appendix 4C quarterly cash flow report 30 September 2017 (Irasia) - "Chief executive Dr Ken Taylor said that the company is eagerly awaiting the unblinding of results in the Phase IIb clinical trial of NTCELL® for Parkinson's disease in November. The Phase IIb trial aims 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. If the trial is successful, the company plans to apply for provisional consent with a view to treating paying patients in New Zealand in 2018."

P2b data • CNS Disorders • Parkinson's Disease

DSMB reviews safety data from Phase I/IIa clinical trial of NTCELL for Parkinson’s disease (News Medical) - "Living Cell Technologies...announced that the independent data safety monitoring board (DSMB) has reviewed the safety data from the initial patient in the Phase I/IIa clinical trial of NTCELL and advised that implants for the additional three patients in the trial can proceed. We are very pleased that the DSMB has given approval for us to proceed with implants for the remaining three patients in this Phase I/IIa trial."

DSMB • Parkinson's Disease

A phase IIb, randomised, double-blind, placebo-controlled, dose-ranging investigation of the safety and efficacy of NTCELL [immunoprotected (alginate-encapsulated) porcine choroid plexus cells for xenotransplantation] in patients with Parkinson's disease. (PubMed, Parkinsonism Relat Disord) - "The study did not meet its primary efficacy end-point of a change in UPDRS at 26 weeks post-intervention compared with baseline. Stereotactic NTCELL implantation was safe and well tolerated."

Journal • P2b data

Open-label Investigation of the Safety and Clinical Effects of NTCELL in Patients With Parkinson's Disease (clinicaltrials.gov) - P1/2; N=4; Active, not recruiting; Sponsor: Living Cell Technologies; Trial completion date: Nov 2019 ➔ Mar 2020

Clinical • Trial completion date

Open-label Investigation of the Safety and Clinical Effects of NTCELL in Patients With Parkinson's Disease (clinicaltrials.gov) - P1/2; N=4; Active, not recruiting; Sponsor: Living Cell Technologies; Trial completion date: Apr 2019 ➔ Nov 2019

Clinical • Trial completion date

Investigation of the Safety and Efficacy of NTCELL® [Immunoprotected (Alginate-Encapsulated) Porcine Choroid Plexus Cells for Xenotransplantation] in Patients With Parkinson's Disease (clinicaltrials.gov) - P2b; N=18; Completed; Sponsor: Living Cell Technologies; Active, not recruiting ➔ Completed

Trial completion

NTCELL Parkinson's trial - Patient data 2 years after implantation (Irasia) - P2b, N=18; NCT02683629; Sponsor: Living Cell Technologies; "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)....Recipients of 40 capsules showed no difference from placebo. We are seeking advice...to help interpret the data further."

P2b data

NTCELL phase I/IIa Parkinson's trial update (Irasia) - P1/2, N=4; "LCT has the data from the 4 year follow up of the three remaining patients in the Phase I/IIa study of NTCELL® for Parkinson's disease...Four patients with advanced Parkinson's disease who were not responding to symptomatic treatment and were listed for DBS treatment, received implants of 40 NTCELL capsules unilaterally in the putamen...Patient 1, four years after implantation continues to show a clinically significant improvement in Parkinson's disease symptoms as measured by UPDRS and the motor subscale...Efficacy data from the Phase IIb NTCELL clinical study 2 years after implantation should be complete in all the treatment groups and available in May 2019."

P2b data