Clarity Pharmaceuticals Ltd

The first cycle of 67Cu-SAR-bisPSMA was administered under the SECuRE trial protocol, and the second cycle under the US Food and Drug Administration’s (FDA) Expanded Access Program (EAP).

Preliminary data from mCRPC patients who received multiple doses of 67Cu-SAR-bisPSMA through the Food and Drug Administration Expanded Access Program show encouraging efficacy signals with a favorable safety profile.

Expanded Access Program (EAP) update: Multi-dose 67Cu-SAR-bisPSMA - Complete response with 2 doses of 8GBq of 67Cu-SAR-bisPSMA - A patient who had failed several lines of therapy and achieved a complete response following 2 doses of 8GBq of 67Cu-SAR-bisPSMA (first dose through the SECuRE trial and second dose through the EAP) remains with undetectable PSA for almost 13 months. - Durable response with multiple doses of 67Cu-SAR-bisPSMA - A patient from cohort 1 who had a reduction in PSA of 94.4% following the administration of 4 doses of 4GBq of 67Cu-SAR-bisPSMA (first dose through the SECuRE trial and 3 doses under the EAP) has received an additional dose (8GBq) following a recent rise in PSA.

Additional therapy cycles of 67Cu SAR-bisPSMA have been requested by clinicians under the United States Food and Drug Administration (US FDA) Expanded Access Program (EAP).

Additional therapy cycles of 67Cu SAR-bisPSMA have been requested by clinicians under the US Food and Drug Administration (FDA) Expanded Access Program (EAP).