• Clarity Pharma gives update on first patient dosed in SECuRE trial 
  • The patient’s PSA level dropped to undetectable levels following 2 cycles of 8GBq of 67Cu-SAR-bisPSMA
  • Clarity has also commenced its registrational Phase III 64Cu-SAR-bisPSMA diagnostic trial


Clarity Pharmaceuticals (ASX:CU6) rose 8% this morning after an update from its theranostic trial, SECuRE, evaluating 64Cu/67Cu-SAR-bisPSMA in patients with mCRPC (metastatic castration-resistant prostate cancer).

Results showed that the first prostate cancer patient ever to be dosed with two cycles of 8GBq of 67Cu-SAR-bisPSMA has had a drop in PSA to undetectable levels.

PSA is a known marker of tumour burden, clinical response to treatment, and an indicator of the recurrence of disease for prostate cancer.

The patient also had undetectable lesions using PET post-treatment, with two lesions showing a complete response (absence of all detectable cancer), and one lesion showing a partial response, missing the complete response criteria by just 2 millimetres.

The patient had been heavily pre-treated with multiple lines of therapy, including androgen deprivation therapy, ARPI, chemotherapy and a PARP inhibitor, and had failed all previous treatments.

The patient then received the two cycles of 8GBq 67Cu-SAR-bisPSMA with the initial cycle provided under the SECuRE trial protocol, and the second cycle provided under the US FDA’s Expanded Access Program (EAP). The patient experienced three adverse events, most mildly, and all have been resolved.

Meanwhile, no dose limiting toxicities (DLTs) were reported in any of the 12 patients treated in the SECuRE trial to date, and recruitment is ongoing for cohort 3 at the highest single dose level of 12GBq.

Clarity’s executive chairperson, Dr Alan Taylor, said that although the study is still progressing through the dose-escalation phase of the trial, the near complete response and undetectable PSA results were very encouraging.

“The favourable safety profile of the product, in a patient with this level of response, is a very welcome reward for the hard work and dedication of our team and collaborators that has led to this early success,” said Dr Taylor.


Clarity also commences CLARIFY Phase 3 trial

Separately, Clarity announced that it has has commenced its registrational Phase III 64Cu-SAR-bisPSMA diagnostic trial in prostate cancer, CLARIFY, with the initiation of the first clinical site at the Urology Cancer Center/XCancer in Omaha.

The aim of the CLARIFY study is to assess the diagnostic performance of 64Cu-SAR-bisPSMA to detect regional nodal metastasis in participants with high-risk prostate cancer prior to radical prostatectomy.

The study expects to recruit 383 participants at multiple clinical sites across the US and Australia.

Evaluation will take place over two imaging timepoints, day one (day of administration) and day two (approximately 24 hours post administration). CLARIFY is expected to image the first participant in late 2023.

As a registrational trial, the final study results are intended to provide sufficient evidence to support an application to the US FDA for approval of 64CuSAR-bisPSMA as a new diagnostic imaging agent in prostate cancer.

“The prostate cancer market is a key focus area for Clarity as there is a high unmet need for diagnostics and therapy,” said Dr Taylor.

“And we believe our theranostic SAR-bisPSMA product has the potential to improve diagnosis, therapy and ultimately change patients’ lives.”


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