ASX Health Stocks: Clarity Pharma, Island Pharma set to embark on next steps of clinical trials

Clarity Pharma says 50 patients have been imaged at SABRE trial
Island Pharma granted human research ethics approval for ISLA-101

Clarity Pharma imaged 50 patients

Clarity Pharmaceuticals (ASX:CU6) announced that 50 patients have now been imaged with 64Cu-SAR-Bombesin in its US-based diagnostic trial, SABRE, for participants with PSMA-negative prostate cancer.

SABRE, which derives from “Copper-64 SAR-BisPSMA in Biochemical Recurrence of prostate cancer” is a Phase II Positron Emission Tomography (PET) imaging trial of participants with PSMA-negative biochemical recurrence (BCR) of prostate cancer following definitive therapy.

The primary objectives of the trial are to investigate the safety and tolerability of the product, as well as its ability to correctly detect recurrence of prostate cancer.

Andrei Iagaru, the Lead Principal Investigator for the trial, said that being able to visualise the gastrin-releasing peptide receptor (GRPr) expressing lesions with SAR-Bombesin has the potential to change the entire treatment paradigm for patients.

“With more tools to detect prostate cancer that may not be visible with other imaging agents, we may be able to better diagnose and offer more effective treatment for their disease,” he said.

Unique to Clarity’s SAR Technology is the ability to image patients at later timepoints due to the optimal half-life of 64Cu.

“As such, 64Cu-SAR-Bombesin enables imaging not only on the day of product administration, but also at later timepoints, which may add utility to the diagnosis of cancerous lesions,” Iagaru added.

Island Pharma granted ethics approval

Meanwhile, Island Pharmaceuticals (ASX:ILA) has just been granted human research ethics approval to commence its ISLA-101 Single Ascending Dose study, to be performed at Scientia Clinical Research’s trial facilities in Sydney.

The Human Research Ethics Committee (HREC) approval was given to commence the dosing of ISLA-101, a drug candidate being repurposed for the prevention and treatment of dengue and other mosquito (or vector) borne diseases.

The study will be a dose escalation study, in which three cohorts of healthy subjects will receive escalating doses of ISLA-101.

The aim is to ensure that administered doses could safely achieve blood concentrations of ISLA-101 that are predicted to be effective against the dengue virus.

Recruitment and dosing will commence imminently, with the data readout expected in early 2024.

“If all runs smoothly, our aim is to have final data by early 2024 and then rapidly transition to the Phase 2 PEACH study soon thereafter,” said Island CEO, Dr David Foster.