Clarity enters a Clinical Manufacturing Agreement for Cu-64 SAR-bisPSMA with SpectronRx
Reno, Nevada (UroToday.com) Clarity Pharmaceuticals (ASX: CU6) (“Clarity”, “the Company”), a clinical-stage radiopharmaceutical company with a mission to develop next-generation products that improve treatment outcomes for children and adults with cancer, is pleased to announce it has entered into a Clinical Manufacturing Agreement with SpectronRx for the production of the diagnostic 64Cu-SAR-bisPSMA product for its Phase III trials. This agreement builds on the earlier Master Services Agreement and Supply Agreement for the production of the 64Cu isotope, now allowing for a streamlined manufacturing process of both the isotope and the 64Cu-SAR-bisPSMA product at the same facility.
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Clarity receives FDA Fast Track Designation for 64Cu-SAR- bisPSMA
Reno, Nevada (UroToday.com) -- Clarity Pharmaceuticals (ASX: CU6) (“Clarity”, “the Company”), a clinical stage radiopharmaceutical company with a mission to develop next-generation products that improve treatment outcomes for children and adults with cancer, is pleased to announce that the U.S. Food and Drug Administration (FDA) has granted Fast Track Designation for 64Cu-SAR-bisPSMA for positron emission tomography (PET) imaging of prostate-specific membrane antigen (PSMA) positive prostate cancer lesions with suspected metastasis who are candidates for initial definitive therapy.
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Registrational Phase III CLARIFY Trial in Prostate Cancer Commences
Reno, Nevada (UroToday.com) -- Clarity Pharmaceuticals (ASX: CU6) (“Clarity”, “the Company”), a clinical stage radiopharmaceutical company with a mission to develop next-generation products that improve treatment outcomes for children and adults with cancer, is pleased to announce it has commenced its registrational Phase III
64Cu-SAR-bisPSMA diagnostic trial in prostate cancer, CLARIFY (NCT06056830)
1, with the initiation of the first clinical site at the Urology Cancer Center / XCancer Omaha, NE.
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