Life before 64Cu-Sar-bisPSMA!The video below, titled "Navigating...

Life before 64Cu-Sar-bisPSMA!

The video below, titled "Navigating the Complexities of PSMA PET in Prostate Cancer Management" is a useful and timely reminder of what Clarity's Clarity is going to bring to the arena! This is the motivation for the Life before 64Cu-Sar-bisPSMA title to this post. Listen to the discussion, and I think you will agree that if things go as we have seen, that statement may well become a reality!

I think the discussion should also help anyone who may be wondering why Clarity's 64Cu-Sar-bisPSMA got awarded FDA Fast Track Designation for both conditions that are targeted by this product (64Cu-Sar-bisPSMA), and for which Clarity applied for.

But before we get there, a few primers and reminders!

Early 64Cu-Sar-bisPSMA Trials: PROPELLER and COBRA!

• Here is something for those who are new to Clarity (and those who have been around who may have forgotten): Experts at two of the Medical Conferences where the data generated by trials of this product was presented in 2023 (PROPELLER) and in 2024, were clearly very pleased! To be rated BEST, out of hundreds of abstracts submitted, is a very big deal!
• These studies are the reason why 64Cu-Sar-bisPSMA got awarded FDA Fast Track Designation: A big deal in its own right!

Who gets FDA Fast Track Designation?

• Serious Condition & Unmet Need: The designation is granted to drugs that treat serious or life-threatening conditions and address an unmet medical need.
• Potential to Offer an Advantage: The drug must show potential to provide a significant advantage over existing therapies. This could be through improved efficacy, fewer side effects, or better convenience for patients.

Here is the summary (in a Table)!




Pivotal 64Cu-Sar-bisPSMA Clinical Trials! CLARIFY and AMPLIFY! Designed to lead to an application for FDA approval!

The State of CLARIFY?

We might find out sooner than we expect! Here is why!

1. A poster, "CLARIFY: Positron emission tomography using 64Cu-SAR-bisPSMA in patients with high-risk prostate cancer prior to radical prostatectomy — A phase 3 diagnostic performance study', will be presented at ASCO GU on the 13th of February 2025 (next week). This is a follow on presentation by the same group that presented a poster by the same title last year, at the same conference (ASCO GU 2024), where they described just the trial protocol (without results). That was fine then: One step at a time!
2. Although its still under the "Trials in Progress" session, in my opinion, there is simply no way that the same researchers would return once again, to the same conference, simply to inform those attending of how wonderful the idea is, or how they wish to investigate and prove out the hypotheses! I could be wrong , but I think there will be results this time! This is not investing advice!

A reminder: CLARIFY evaluates the performance of 64Cu-SAR-bisPSMA in patients with histologically confirmed high risk adenocarcinoma of the prostate, before they proceed to Radical Prostatectomy and pelvic lymph node dissection.



The State of AMPLIFY!
AMPLIFY is a Phase 3 Performance in Biochemical Prostate Cancer Recurrence (BCR). The trial is planned for launch in H1 2025.
Positive guidance from the U.S. FDA was received in 2024 (Ann. 14/10/2024)

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Here is the YouTube video: Navigating the Complexities of PSMA PET in Prostate Cancer Management



On this topic: A great time to be alive lies ahead - and is in sight!


REFERENCES

• Society of Nuclear Medicine and Molecular Imaging (SNMMI) 2023 Annual Meeting: Clarity’s PROPELLER Results Win Top Prize at prestigious nuclear medicine conference, 17 July 2023, https://www.claritypharmaceuticals.com/news/snmmi_prize_propeller/
• European Association of Nuclear Medicine (EANM) 2024 Congress: Clarity’s COBRA study selected as a Top-Rated Oral Presentation at prestigious industry Annual Meeting, 1 October 2024,https://www.claritypharmaceuticals.com/news/eanm24/
• 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/
• CLARIFY: Positron emission tomography using 64Cu-SAR-bisPSMA in patients with high-risk prostate cancer prior to radical prostatectomy, a Phase 3 diagnostic study; https://www.claritypharmaceuticals.com/wp-content/uploads/2024/07/ASCO-2024-CLARIFY-Final-scaled.jpg
• Clarity to present COBRA and CLARIFY abstracts at two world-leading conferences; https://www.claritypharmaceuticals.com/news/ascogu_aua/

The Trials

• PROPELLER: https://clinicaltrials.gov/study/NCT04839367
• COBRA: https://clinicaltrials.gov/study/NCT05249127
• CLARIFY: https://clinicaltrials.gov/study/NCT06056830
• AMPLIFY: Coming Up - TBA!

Best of Luck to All - Long Term Holders, Traders, FA and TA specialists!