(a) In March 2021, Cyclotek CMO, Dr Rob Ware together with co-applicants AANMS submit the final health economics and assessment of the PET/CT PSMA imaging application into MSAC.
(b) Cyclotek’s Group Operations Manager, Rebecca Dodgson executes MasterControl at our Queensland facility. MasterControl is a document management program that when fully deployed across the group will contain our entire documentation management system for better functionality and performance.
(c) Collaboration between researchers at Monash Institute of Pharmaceutical Science and Cyclotek’s product development team have been successful with a novel 18F labelling of a drug used in Prostate Cancer to which may provide a better patient management tool for prognostic assessment.
(d) Cyclotek in New Zealand validate 18F FBB (Florbetaben) at our Wellington facility for use in clinical trials and clinical diagnostics. Contracts with Pacific Radiology and Ascot Radiology have been activated with first in-country supply scheduled for 5 July 2021.2021
(a) Cyclotek NSW Pty Ltd acquires the business from Cyclopet Pty Ltd (a subsidiary of Cyclopharm Ltd) the cyclotron facility at Macquarie University.
(b) Cyclotek (Aust) Pty Ltd signed a technology transfer agreement with Bristol Myers Squibb for their immunotherapy tracer. The development is being translated onto a GE Fastlab 2 synthesis with dual pHPLC systems.
(c) Completion of the validation for 18F FP-CIT a radiopharmaceutical used to image dopamine transporter. This radiopharmaceutical has been found to be clinically useful, as Parkinson Disease is neurodegenerative because of the loss of dopaminergic nerve terminals along the nigrostriatal pathway.
(d) The Prostate Specific Radiopharmaceutical, 18F-DCFPyL has now been validated at our Lucas Heights facility. This now adds to our sites in Queensland and Victoria enabling supply through-out the East Coast, Tasmania, Adelaide and New Zealand.
(e) Cyclotek’s CMO, Dr Rob Ware submitted an application into the Medical Services Advisory Committee for MBS funding of PET/CT PSMA imaging. Currently PSMA PET/CT imaging services are being widely used and men with Prostate Cancer are paying for this service as an out of pocket cost.2020
(a) Cyclotek NSW Pty Ltd purchase of the Pettech Solutions Pty Ltd FDG business. The Cyclotek Group now comprise five facilities stretched across the Australian eastern seaboard and New Zealand.
(b) Establishment of Applied Molecular Therapies Pty Ltd. This new entity will spearhead our launch into radionuclide therapies – Molecular Targeted Therapeutics
(c) Life Molecular Imaging approves the Technology Transfer of their Tau PET agent PI2620 for manufacture within Australia. Cyclotek has undertaken a GMP manufacture validation of this exciting new tracer to enable it’s use in clinical trials within Australia and New Zealand.
(d) The 18F FP-CIT tracer for Parkinson Disease has undergone a technology transfer process. We now have a manufacturing methodology for the GE Fastlab synthesis unit and will progress to a GMP manufacturing validation in Q1-2020.
(e) The research team have worked solidly this year with RMIT and Cell Therapies on a complex radiolabelling method incorporating a Superparamagnetic Iron Oxide Nanoparticle (SPION) with Cu64 and then loading onto CAR-T cells for a first into human trial.2019
(a) Cyclotek Melbourne Pty Ltd is issued with a Licence to Manufacture Therapeutic Goods by the TGA – Feb 2018 and commenced operations in April 2018.
(b) Cyclotek Queensland Pty Ltd validates the fluorinated DCFPyL, PSMA agent for Prostate Imaging. To be used within our Clinical Trial. Radiologists and Nuclear Medicine Physicians have requested access via the Special Access Scheme.
(c) Cyclotek Queensland Pty Ltd validates 18F Florbetaben to support pharmaceutical sponsored clinical trials as a bio-market for therapeutic trials and supporting local researchers with their respective Investigator Sponsored Studies.
(d) Cyclotek NSW Pty Ltd acquires the business of PETTECH Solutions Pty Ltd with a commencement date of 2 January 2019. This acquisition enables the business to further develop PET Radiopharmaceuticals into the NSW marketplace.
(e) Cyclotek (Aust) Pty Ltd validates 18F F-AraG on behalf of Telix Pharmaceuticals Ltd. 18F F-AraG hones in on and images activated T cells that are critical to any immune modulated therapy.2018
(1) Cyclotek New Zealand undertakes a technology transfer for the manufacture of 18F-DCFPyL a Prostate Specific Radiopharmaceutical. Supply commenced in June 17;
(2) ASAN Medical Center and Duchembio Co. Ltd. announce Strategic Partnership with Cyclotek for Exclusive Licensing of [18F]FP-CIT in Australia and New Zealand. 18F DATscan for imaging of patients being evaluated for uncertain Parkinsonian syndrome – differentiating patients suffering from PD and non-PD related tremor;
(3) At the request of Peter MacCallum and Genentech, Cyclotek undertakes a technology transfer for 18F FES for use in breast cancer monitoring;
(4) Cyclotek appoints Mr Doug Cubbin as an independent Director;
(5) Cyclotek, in conjunction with GE Healthcare and Macquarie University, has been awarded funding under the Commonwealth’s Cooperative Research Centres – Project (CRC-P) to conduct a clinical trial to evaluate 18F DCFPyL in comparison to WB Bone Scans and CT;
(6) Research Manufacturing and/or Supply Agreements have been signed with Telix Pharmaceuticals Ltd, Monash University, Queensland Institute of Medical Research, The Prince Charles Hospital Foundation, Melbourne Health and inviCRO, LLC (Institute of Neurodegerative Disorders).2017
(1) Cyclotek QLD – Site validation completed, building certifier approved, QLD Health and TGA approval achieved by May 2016. Commenced commercial supply of FDG on 30 May 2016.
(2) 18F-DCFPyL in-licence agreement finalised with Johns Hopkins University for use of the F18 PSMA tracer for Prostate cancer for Australia and New Zealand.
(3) Cyclotek undertakes a development plan for the GMP manufacture of 18F-DCFPyL (Prostate Specific Radiopharmaceutical)
Procure, Install and Commission of a GE PETTrace cyclotron with its support equipment together with Comecer hotcels and GE FASTlabs synthesis units into the new Victorian Comprehensive Cancer Centre2015 - VCCC
(1) Cyclotek commenced site preparation work at the Princess Alexandra Hospital, building 39;
(2) Construction of the vault and laboratories with procurement of a GE self shielded PETTrace cyclotron with support equipment and supplies;
(3) Installation and commission of GE self shielded PETTrace cyclotron and support equipment and infrastructure.2015 - PAH
(1) On request from clinicians, Cyclotek validates the GMP production of FCH;
(2) GE Healthcare and Cyclotek sign Statement of Work for the evaluation of stability of the Nb targets for the MINItrace at 70µA;
(3) Increase capacity of PETtrace cyclotron from 100µA to130µA.
On request from clinicians, Cyclotek validates the GMP production of FLT;2013
Cyclotek completes seven year participation in the CRC for Biomedical Imaging Development Ltd.2012
(1) On request from clinicians, Cyclotek validates the GMP production of NaF;
(2) GE Healthcare and Cyclotek sign Statement of Work for the evaluation of Niobium (Nb) targets for the MINItrace.
(1) On request from clinicians, Cyclotek validates the GMP production of FET;
(2) Cyclotek participates in clinical trial of PET tracer MEL050, for CRC for Biomedical Imaging Development. The purpose of this study is to investigate the safety and potential effectiveness of MEL050 for metastatic melanoma.
(1) Cyclotek, along with our JV partners (Pacific Radiology Group), established Cyclotek Pharmaceuticals Ltd (CPL) company in New Zealand. GE Healthcare was again selected to supply, install and commission a PETtrace 10Ci cyclotron, our third cyclotron into the group;
(2) Cyclotek is engaged by Pharma to manufacture Amyloid PET tracers under contract for clinical trials.2009
Increase capacity of PETtrace cyclotron from 70µA to 100µA.2008
Installation of second cyclotron in the Bundoora facility, a GE MINItrace.2006
Develop and lead the establishment of CRC for Biomedical Imaging Development comprising Peter MacCallum Cancer Centre, Australian Nuclear Science and Technology Organisation, Monash University, Garvan Institute, GE Healthcare, Berthold Australia, Cyclotek and the Australian Government’s CRC program.2005-2012
Initiate research project for the automation of FET synthesis in collabaration with Peter MacCallum Cancer Centre.2004
Site design, build and commissioning of Cyclotek’s first PET Radiopharmaceutical facility, with a GE PETtrace 6Ci cyclotron with support infrastructure and equipment. Supply FDG into Australian marketplace.2002
Business case for the establishment of Australia’s first commercial medical cyclotron.1999-2001