This was posted last January here on Imetechat....
viewtopic.php?f=1&t=1260
"Two IMpress-ive Physicians with Pathways to follow?" Tue January 18, 2022 -Kmall
....Australia – Dr. Steven Lane
https://www.qimrberghofer.edu.au/people/steven-lane/
https://metronorth.health.qld.gov.au/rb ... teven-lane
Dr. Steven Lane Publications and Review Articles with Imetelstat/Telomerase/Geron:
1. (2014) – ASH 2014 Analyst & Investor Event December 8, 2014
John A. Scarlett, M.D. President & CEO, Geron Corporation
Steven Lane, M.D., Ph.D. Queensland Institute of Medical Research
https://www.geron.com/file.cfm/53/docs/ ... -Event.pdf
2. (2014) - Telomerase Inhibition Effectively Targets Mouse and Human AML Stem Cells and Delays Relapse following Chemotherapy
Claudia Bruedigam, Frederik O. Bagger, Florian H. Heidel, Scott A. Armstrong, David A. Williams, Steven W. Lane
https://www.cell.com/cell-stem-cell/ful ... 14)00522-0
3. (2016) – The preclinical efficacy of a novel telomerase inhibitor, imetelstat, in AML: A randomized trial in patient-derived xenografts
Claudia Bruedigam, Ph.D Gordon and Jessie Gilmour Leukaemia Research Laboratory
Headed by A/Professor Steven Lane
https://www.geron.com/file.cfm/53/docs/ ... H-2016.pdf
4. (2016) Telomerase in hematologic malignancies
Claudia Bruedigam 1, Steven W Lane
https://pubmed.ncbi.nlm.nih.gov/27213497/
5. (2016) Analysis of telomerase target gene expression effects from murine models in patient cohorts by homology translation and random survival forest modeling
Bagger, Frederik Otzen, Bruedigam, Claudia, and Lane, Steven W.
https://espace.library.uq.edu.au/view/UQ:380922
As of now, there has been no mention of who the additional Physicians involved in the P1 IMpress Clinical Trial will be. For now, this is just speculation on my part. However, given the locations and their past associations with Imetelstat and Geron, I believe taking a further look at these two prestigious Hematologists is warranted.
Since France and Germany are members of the EU, the EMA, as we all know, would be the Regulatory Agency involved with the Approval process of Imetelstat in that region.
Australia however, is seemingly new territory for Imetelstat and Geron. This past year, under the IMpact P3 Clinical Trial, Geron and Imetelstat have several Clinical Trial locations open in Australia and Tasmania. One of which (*) – Royal Brisbane Women’s Hospital in Queensland, Australia - has an association with Dr. Steven Lane.
Australia, New South Wales
Royal North Shore Hospital
St Leonards, New South Wales, Australia
Australia, Queensland
Royal Brisbane and Women's Hospital*
Herston, Queensland, Australia
Australia, Tasmania
Royal Hobart Hospital
Hobart, Tasmania, Australia
Australia, Victoria
Epworth Healthcare
Richmond, Victoria, Australia
For those interested, Australia’s Regulatory Agency (TGA), has a similar structure to that of the UK with expedited pathways for approval in novel, rare disease, unmet needs, and promising new medicines in which “the benefit of early availability of the medicine outweighs the risk inherent in the fact that additional data are still required.” (see below – Provisional Approval Pathway)
Australia’s Regulatory Agency: Therapeutic Goods Administration (TGA)
https://www.tga.gov.au/australian-regul ... l-products
has a process similar to that of the EMA and FDA, including Registration, Application for Approvals, Data Submission, Orphan Drug Designation, as well as a Priority review pathway and Provisional approval pathway through the Australian Regulatory Guidelines for Prescription Medicines (ARGPM)
https://www.tga.gov.au/publication/aust ... ines-argpm
Priority review pathway: The priority pathway provides a formal mechanism for faster assessment of vital and life-saving prescription medicines. The target timeframe of 150 working days is up to three months shorter than the standard prescription medicines registration process.
https://www.tga.gov.au/priority-review- ... -medicines
Sounds familiar to the UK ILAP Innovation Passport which Imetelstat was granted on 10/25/2021:
https://ir.geron.com/investors/press-re ... fault.aspx
Provisional approval: The provisional approval pathway allows sponsors to apply for time-limited provisional registration on the Australian Register of Therapeutic Goods (ARTG). It provides access to certain promising new medicines where we assess that the benefit of early availability of the medicine outweighs the risk inherent in the fact that additional data are still required.
Provisional registration of prescription medicines under this pathway is limited to a maximum of six years. Registration will automatically lapse at the end of a specified period unless sponsors are able to demonstrate that they have met the conditions imposed on the provisional registration. Sponsors may apply for full registration when sufficient clinical data to confirm the safety and efficacy of the medicine are available.
The Provisional approval pathway consists of five steps as outlined in the Provisional approval diagram [see right]: provisional determination, pre-market registration, the provisional registration period, extension of provisional registration and transition to full registration.
https://www.tga.gov.au/provisional-appr ... -medicines
At this time Geron has not applied for either of these pathways or an application through the TGA – to the best of my knowledge. These links are provided for information and dialog purpose only. -Kmall
