• Clarity says initial data from Phase 1/2 trial is positive
  • Opthea completes enrolment of all patients in the COAST Phase 3 trial
  • ProMedicus locks in record half


Clarity’s Phase 1/2 trial shows positive initial results

Clarity Pharmaceuticals (ASX:CU6) says that initial data from its Phase 1/2 trial has confirmed that 64Cu-SAR-bisPSMA is safe and highly effective in detecting prostate cancer (PC) lesions in patients with biochemical recurrence (BCR).

64Cu- SAR-bisPSMA is a copper-based imaging agent. It contains copper-64 (64Cu), and is used to visualise tumors that express the PSMA protein using a positron emission tomography (PET) scanner.

The Phase 1/2 trial, also called COBRA, is studying PC lesions in patients with BCR where standard of care imaging was unable to detect any lesions.

Initial data suggests that, when 64Cu-SAR-bisPSMA is used, up to approximately 60% had lesions identified by same-day 64Cu-SAR-bisPSMA imaging, and up to 80% on next- day imaging, with high specificity on both days.

The next day imaging increases detections from a median number of 80 lesions on Day 0, to up to 153 lesions on Day 1.

Clarity describes the almost doubling of the number of lesions with next-day imaging as remarkable, and brings to light the issues of current standard of care imaging.

“Current standard of care imaging fails to do this for a large percentage of men who eventually experience BCR of their PC,” said Clarity’s executive chair, Dr Alan Taylor.

“As such, there is an immediate opportunity for bisPSMA to address the entire market of PSMA imaging as we move closer to our ultimate goal of improving treatment outcomes of people with cancer.”

Following the results from 64Cu-SAR-bisPSMA PET imaging, investigators of the trial indicated that they would change the treatment plan of approximately half of the patients (48%) to use 64Cu-SAR-bisPSMA.

Initial results from the COBRA trial will be presented at leading international oncology and nuclear medicine conferences.


Opthea completes Phase 3 enrolment

Opthea (ASX:OPT) has completed enrolment of all patients in the COAST Phase 3 pivotal clinical trial investigating sozinibercept (OPT-302), in combination with aflibercept, a well known therapy for wet Age-related Macular Degeneration (wet AMD).

OPT-302 is Opthea’s novel recombinant “trap” fusion protein, which inhibits vascular endothelial growth factor (VEGF)-C and VEGF-D – two factors demonstrated to be important in the molecular pathogenesis of tumour growth associated with several blinding eye diseases.

The sozinibercept clinical program includes two Phase 3 pivotal trials, COAST and ShORe. Enrolment in ShORe is expected to be completed in calendar Q2 this year.

Earlier, Phase 2b study of sozinibercept when combined with ranibizumamet had met its pre-specified primary efficacy endpoint.


ProMedicus locks in record half

ProMedicus (ASX:PME) announced a half-year net profit of $36.3 million for the six months to the end of December, 33.3% higher than the pcp.

This was on the back of revenue of $74.1 million, up 30.3% on pcp.

This was a record half for the company in terms of revenue and net profit, as well as new sales.

ProMedicus announced a fully-franked interim dividend of 18c per share.

The company remains debt-free, and says its pipeline is strong across all sectors of the market.

ProMedicus is a leading healthcare informatics company. Its medical imaging software are used in hospitals and imaging centres worldwide.


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