Source: Clarity Pharmaceuticals
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  • Clarity Pharmaceuticals (CU6) receives approval from the US Food and Drug Administration (FDA) of its investigational new drug (IND)
  • The approval will enable a Phase 2 imaging trial to detect prostate cancer in up to 50 prostate-specific membrane antigen (PSMA)-negative using its SAR-Bombesin product
  • The primary objectives of the trial is to investigate the safety and tolerability of copper-64 SAR-Bombesin and in addition, its ability to correctly detect the recurrence of prostate cancer
  • Further, the trial is developed in response to the strong demand from clinicians with prostate cancer patients whose cancer was not visible with currently approved PSMA diagnostic agents of conventional imaging
  • Shares in Clarity end the day 2.11 per cent in the red to close at 46.5 cents

Clarity Pharmaceuticals (CU6) has received approval from the US Food and Drug Administration (FDA) of its investigational new drug (IND).

The approval will enable a Phase 2 imaging trial to detect prostate cancer in up to 50 prostate-specific membrane antigen (PSMA)-negative using its SAR-Bombesin product.

Executive Chairman Dr Alan Taylor said the clearance is another “significant milestone” for the company.

“It shows our ability to develop cutting-edge theranostics from the lab, through preclinical studies and into clinical trials, with SAR-Bombesin being Clarity’s fourth IND across five products which are clear for investigation in the US,” he said.

SABRE derives from “copper-64 SAR-Bombesin in biochemical recurrence of prostate cancer trial”, is a multicenter, single arm, non-randomised, open-label trial in up to 50 PSMA-negative patients with known or suspected prostate cancer.

The primary objectives of the SABRE trial is to investigate the safety and tolerability of copper-64 SAR-Bombesin and in addition, its ability to correctly detect the recurrence of prostate cancer.

Further, the SABRE trial was developed in response to the strong demand from clinicians with prostate cancer patients whose cancer was not visible with currently approved PSMA diagnostic agents of conventional imaging like a CT scan or MRI.

This trial builds upon clinical data from the pilot trial assessment of copper-64 SAR-Bombesin in breast cancer led by Professor Louise Emmett of St Vincent’s Hospital Sydney.

The company said there is a significant unmet medical need for approximately 20 per cent of prostate cancers with BCR which are PSMA-PET negative.

These patients are most likely unable to respond to therapeutic PSMA-targeted products and have few treatment options available to them.

“Combined with the clinical, environmental and logistical benefits enabled by the copper isotope pairing, SAR-Bombesin has potential to provide this large patient population with accurate and precise detection and treatment of prostate cancer,” Dr Taylor added.

Shares in Clarity have ended the day 2.11 per cent in the red to close to 46.5 cents.

CU6 by the numbers
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