@fourdollarsDear FourDollars! What a name, especially with the sp now at about $2!
I share your concerns as well. Another one that I was bothered by due to radio silence and info mismatch is the DISCO trial - I know we have since got a little glimpse of the results packaged with the last patient assessment completed announcement as well as the last quarterly!
Below are some extracts from my email to Clarity as well as the reply from Alan (6th of Jan 2025);
They do reply pretty quickly! That's good.
SABRE is coming back to focus this year, so we will hear more. When? I hope soon. But I am concerned overall for biotech so I am not sure if good results will help us, especially with the talk about a need to raise in the next 12 to 18 months! Where is Telix when you need them!
Anyhow, here is a bit about the DISCO trial (which I like very much) - as well as the SARTATE strategy (as I read them)!
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DISCO TRIAL: Positron Emission Tomography Imaging of Participants With Known or Suspected Neuroendocrine Tumours Using 64Cu SARTATE: A Multi-Centre, Single Arm, Non-Randomised, Blinded-Review, Phase II Study- Completed recruitment in November 2024 (Last patient assessment announcement 28 Nov 2024).
- Planned number of participants: 63.
- Number recruited: 45
Comment:
1) The discordance level between imaging with 64Cu-SARTATE and SOC 68Ga-DOTATATE was higher than expected (64Cu-SARTATE was better than previously thought to be). The image lesion-to-liver ratios were higher for SARTATE at 1, 4, and 24 hours.
2) The results have still not been shared in an explicit way, although a table was included (below). Clarity have results, and they are good!
Anyway: Clarity Last Updated the ClinicalTrials.Gov record for DISCO on
25/03/2025. No idea what the update was about (around the same date, they updated Clarify, plus made an extension application for uploading of results for SABRE)!
Clarity did tell us that the final results from the DISCO study expected in
H1 of 2025 (which should be Q2 2025). Lets hope they keep their word!
RESULTS INTERPRETATION: The differences are very impressive: In money terms, if I buy Cu6 for $3.92 (fourdollars), end ride this horse to $16.69, I will be very happy! Thats how much the image lesion-liver differential (improvement) you get when you compare a 68Ga-DOTA image versus imaging next day using 64Cu-SARTATE!
The following is KEY - I think!SARTATE DUAL STRATEGY for SARTATE: (As per Announcement on Nov 28th, 2024)
- INITIAL FOCUS: 'Theranostic development of 64/67Cu-SARTATE for neuroblastoma in children with the CL04 trial currently running (for which Clarity have two Rare Pediatric Disease Designations (RPDD) and two Orphan Drug Designations (ODD)'. (He highlighted the two tradeable Priority Review Vouchers (PRVs) valued at around US$158 million each - that might be whats influencing the who goes first). This is the trial that updated recently - where there was a DLT in a child with brain lesions who received Cu67. The trial is now in Cohort 5 (per last report).
- SECOND STRATEGY: 'Diagnostic development of 64Cu-SARTATE in a larger market of NETs and other diseases that express the somatostatin receptor 2 (SSTR2) target, followed by therapy in these same indications'. Actually - this is DISCO 2.0!
IF I am getting this right: This means that, the results of DISCO will not immediately lead to the expected follow on: A Phase 3 in NETS! Rather, CL04 (Neuroblastoma trial), which is in dose determination stage (an earlier stage), will be prioritised!
I am a little disappointed with that one, but I can sort of see the logic.
[THE FOLLOWING IS MY SPECULATIVE BRAIN AT WORK:
I think Clarity is deliberately developing a multitude of assets and moving them from preclinical to Phase 2 and 3 ready - and then waiting for something they won't Telix anyone about, to happen!]
Good Luck To All!
(20min delay)