Clarity Pharmaceuticals Boosts Cu-64 Supply for Phase III Trials

Jun 14, 2023

Clarity Pharmaceuticals Limited (ASX: CU6), a clinical stage radiopharmaceutical company focused on advancing cancer treatment outcomes, has entered into a significant agreement with PETNET Solutions Inc, a leading manufacturer of radiopharmaceuticals for PET imaging in the US. The Master Service Agreement and Clinical Supply Agreement will facilitate the production of Clarity's 64Cu SAR-bisPSMA, a next-generation diagnostic radiopharmaceutical for prostate cancer imaging.

PETNET Solutions will manufacture the ready-to-use 64Cu SAR-bisPSMA in compliance with current Good Manufacturing Practice (cGMP) guidelines for Clarity's US-based clinical trials. This investigational PET agent is expected to commence a pivotal Phase III trial in the US by the end of FY2023 and potentially a second Phase III trial in FY2024. The collaboration between the companies also paves the way for streamlined technology transfer of other Cu-64 based imaging agents from Clarity to PETNET Solutions for current and future clinical trials in the US.

 

 

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