OTHER NEAR-TERM MILESTONES THAT I AM LOOKING FORWARD TO (this H1 of 2025)
1) CLARIFY Diagnostic Trial: 64Cu-SAR-bisPSMA in Participants With High-risk Prostate Cancer Prior to Radical Prostatectomy (Phase 3)
- Started 30/11/2023
- Estimatedcompletion in Feb 2025
This is a pivotal Phase 3 registrational trial! There will be a visit to the FDA for an important discussion! Who knows what's gonna come out of it!!
And, yes, the results should be just as we have seen before in PROPELLER! Best in class is the word.
# The FDA like what they have seen: Fast Track Designation granted, meaning that this product offers an advantage to existing therapies!
# The secret is truly not a secret!2) AMPLIFY Diagnostic Trial: 64Cu-SAR-bisPSMA in patients with biochemical recurrence BCR of prostate cancer (Phase 3)
- This trial is being planned. It will be Clarity's 2nd pivotal Phase 3 registrational trial!
- The FDA has given positive guidance! We need to recruit 220 prostate cancer patients!
- Recruitment expected tocommence in early 2025!
NEXT:FIRST patient dosed announcement (or will it be ethics approval gained, or sites activated, etc?)
# And, yes, the results should be just as we have seen before in COBRA!
# Its the same product that the FDA have liked: FDA’s Fast Track Designation granted!3) The CLICK CHEMISTRY Trial: PET Imaging Using 64Cu-Tz-SarAr and hu5B1-TCO in Peoplewith Pancreatic, Bladder or Colorectal Cancer or Solid Tumors with ElevatedCA19.9 Levels
- A Phase 1 trial, with a target of 22 patients. https://clinicaltrials.gov/study/NCT05737615
- Estimated Completion - Feb 2025
There has been radio silence on this one since the first announcement (unless I missed something), but I think it will be something special coz the science is exceptional: the inventors were awarded the Nobel Prize in Chemistry in 2022!
REFERENCES- 64Cu-SAR-bisPSMA - Next-generation diagnostic for patients with prostate cancer; https://www.claritypharmaceuticals.com/pipeline/sar-bispsma/64cu-sar-bispsma/
- Positron Emission Tomography Using 64Cu-SAR-bisPSMA in Participants With High-risk Prostate Cancer Prior to Radical Prostatectomy (CLARIFY); https://clinicaltrials.gov/study/NCT06056830?cond=PROSTATE%20CANCER&term=CLARIFY&rank=1
- Positive guidance from the U.S. FDA on 64Cu-SAR-bisPSMA Phase III trial in patients with recurrence of prostate cancer; https://www.claritypharmaceuticals.com/news/fda_amplify/
- Clarity receives FDA Fast Track Designation for 64Cu-SAR-bisPSMA; https://www.claritypharmaceuticals.com/news/fast-track/
- Clarity bolsters antibody pre-targeting with IP from leading global cancer center; https://www.claritypharmaceuticals.com/news/pre-targeting/
(20min delay)