• Clarity Pharma doses first patient with two cycles of 67Cu-SAR-bisPSMA at 8GBq 
  • The patient achieved a complete response to treatment
  • This was part of Clarity’s theranostic SECuRE trial


Clarity Pharma (ASX:CU6) jumped +7% this morning after revealing that the first patient to be dosed with two cycles of 67Cu-SAR-bisPSMA at 8GBq achieved a complete response to treatment based on RECIST criteria.

The patient received the first cycle of 67Cu-SAR-bisPSMA as part of Cohort 2 of Clarity’s theranostic SECuRE trial, which is evaluating the drug in patients with mCRPC (metastatic castration-resistant prostate cancer).

Prior to receiving this drug, the patient had failed multiple lines of treatment, including hormone therapy, an investigational agent and chemotherapy.

Following the administration of the first cycle of 67Cu-SAR-bisPSMA, the patient showed a reduction of PSA (prostate-specific antigen) level of >99%.

The patient then received a second cycle of 67Cu-SAR-bisPSMA, which resulted in further reduction of his PSA to undetectable levels.

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

A complete response (absence of detectable cancer after treatment) was observed in all but one lesion, assessed by computed tomography (CT).

That one lesion showed a reduction in size from 27mm to 12mm, missing the complete response cut-off by only 2mm based on RECIST (response evaluation criteria in solid tumours) assessment.

Importantly, no PSMA uptake was observed in any of the lesions using 64Cu-SAR-bisPSMA following the second cycle of 67Cu-SAR-bisPSMA.

Clarity’s executive chairperson, Dr Alan Taylor, said he was very excited with this incredible response of the very first patient ever to be dosed twice at what would be considered a therapeutic dose.

“We hope to replicate this remarkable result in many patients, and confirm the favourable safety profile of this agent,” Taylor said.

For further reading on Clarity Pharma, read here: Radiopharmaceutical emerges as the hottest space in biotech; here’s what it means for Clarity Pharma


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