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The US Food and Drug Administration (FDA) has given a positive nod for a pivotal Phase III trial for 64Cu SAR-bisPSMA diagnostic in prostate cancer, with 383 patients to participate in a single-arm, open-label, multi-center trial projected to start in late 2023.
Upon successful completion, results from the trial will assist in submitting an application to the FDA for approval of 64Cu SAR-bisPSMA as a new diagnostic imaging agent for prostate cancer.
Dr. Alan Taylor, Executive Chairperson at Clarity, expressed the company's eagerness to advance to Phase III clinical trials, highlighting that the endeavor is backed by convincing preclinical and clinical data, scientific collaborators, participating patients and Clarity's devoted team.
Clarity Pharmaceuticals is setting up a Center of Excellence at the Idaho Accelerator Center (IAC) for advanced research and development of Targeted Copper Theranostics (TCTs).
The investment will allow Clarity to efficiently execute key projects, support readiness of products in clinical development, and expand TCTs as a platform for large global markets in the radiopharmaceutical sector.
According to the Executive Chairman of Clarity, Dr. Alan Taylor, the establishment of the center is a vital next step that will strengthen Clarity's industry-academia collaboration, maintain its competitive advantage, and ultimately improve cancer treatment outcomes for children and adults.
Clarity Pharmaceuticals and PETNET Solutions have entered into a Master Service Agreement and Clinical Supply Agreement for the production of 64Cu SAR-bisPSMA, a diagnostic radiopharmaceutical for prostate cancer imaging.
PETNET Solutions will manufacture 64Cu SAR-bisPSMA for Clarity's US-based Phase III clinical trials, anticipated to begin before the end of 2023 and potentially another in 2024.
The partnership aims to enhance lesion detection and improve treatment outcomes for prostate cancer patients with this next-generation PSMA-PET diagnostic.