Copper-67 SAR-bisPSMA updates
SYDNEY, Oct. 16, 2024 /PRNewswire/ -- HIGHLIGHTS Cohort 4 - SECuRE Trial * The third participant of cohort 4 (multi-dose) of the SECuRE trial1 has now completed the Dose Limiting Toxicity (DLT) period after a second dose of 12GBq of67Cu-SAR-bisPSMA, following on from the announcement dated 1...
Positive guidance from the U.S. FDA on 64Cu-SAR-bisPSMA Phase III trial in patients with recurrence of prostate cancer
Highlights * United States Food and Drug Administration (U.S. FDA) provided positive feedback on a pivotal Phase III trial for64Cu-SAR-bisPSMA diagnostic in prostate cancer patients with biochemical recurrence (BCR), AMPLIFY. * The positive results of the completed COBRA and PROPELLER trials,...
SECuRE trial advances: No dose limiting toxicities and strong preliminary efficacy data in first multi-dose cohort
Highlights * Cohort 4 of the SECuRE trial is the first to assess multiple cycles of 67 Cu-SAR-bisPSMA at the highest dose of 12GBq. * The Safety Review Committee (SRC) assessed early data from the first 3 participants in cohort 4 who received 2 doses of67Cu-SAR-bisPSMA. Two of these participa...
Clarity receives FDA Fast Track Designation for 64Cu-SAR-bisPSMA
SYDNEY, Aug. 22, 2024 /PRNewswire/ -- Clarity Pharmaceuticals (ASX: CU6) ("Clarity"), 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 ...
Additional COBRA results: SAR-bisPSMA detects lesions in the 2-millimetre range
Highlights * Clarity recently reported that in its diagnostic Phase 1/2 trial, COBRA, 64 Cu-SAR-bisPSMA was found to be safe and highly effective in detecting prostate cancer (PC) lesions in patients with biochemical recurrence (BCR). * In trial participants where standard of care (SOC) imagin...
Registrational Phase III CLARIFY trial in prostate cancer commences
SYDNEY, Nov. 30, 2023 /PRNewswire/ -- Clarity Pharmaceuticals (ASX: CU6) ("Clarity"), 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 r...
First patient with metastatic prostate cancer to receive 2 doses of Cu-67 SAR-bisPSMA achieves undetectable PSA level
HIGHLIGHTS * Undetectable levels of Prostate Specific Antigen (PSA) have been reported from the first patient with metastatic castrate-resistant prostate cancer (mCRPC) to ever receive two cycles of Clarity's67Cu-SAR-bisPSMA at the 8GBq dose level. PSA is a marker of tumour burden, clinical re...
Clarity's theranostic prostate cancer trial progresses at the highest dose level cohort
HIGHLIGHTS * Cohort 3 of the theranostic SECuRE trial investigating 64Cu/67 Cu-SAR-bisPSMA in metastatic castrate-resistant prostate cancer (mCRPC) has enrolled and treated 3 participants who received therapy with67Cu-SAR-bisPSMA at the highest dose level of 12GBq. * No dose limiting toxicit...
Recruitment target achieved for Phase II SAR-Bombesin prostate cancer trial
SYDNEY, Nov. 7, 2023 /PRNewswire/ -- Clarity Pharmaceuticals (ASX: CU6) ("Clarity"), 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 50 patients have no...
Clarity and PSI kick off SAR-bisPSMA Phase III
SYDNEY, Oct. 26, 2023 /PRNewswire/ -- Clarity Pharmaceuticals (ASX: CU6) ("Clarity"), a clinical stage radiopharmaceutical company with a mission to develop next-generation products that improve treatment outcomes for children and adults with cancer, and PSI CRO AG ("PSI"), a global contract rese...
First patient treated with Cu-67 SAR-Bombesin in theranostic prostate cancer trial
SYDNEY, Oct. 3, 2023 /PRNewswire/ -- Clarity Pharmaceuticals (ASX: CU6) ("Clarity"), 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 the dosing of the first ...
First participant treated at the highest dose level in Clarity's theranostic prostate cancer trial
Highlights * First participant of cohort 3 in the theranostic SECuRE trial investigating 64Cu/67Cu SAR-bisPSMA in metastatic castrate-resistant prostate cancer (mCRPC) has been treated at the highest dose level of 12GBq. * Cohort 2 was recently completed in 3 participants who received therapy...
Clarity's theranostic prostate cancer trial advances to highest dose level
Highlights * Cohort 2 of the theranostic SECuRE trial investigating 64Cu/67Cu SAR-bisPSMA in metastatic castrate-resistant prostate cancer (mCRPC) has been completed in 3 participants who received therapy with67Cu SAR-bisPSMA at the dose level of 8GBq. * No dose limiting toxicities (DLTs) ha...
Clarity reaches 50% recruitment milestone for Phase II SABRE prostate cancer trial
SYDNEY, July 24, 2023 /PRNewswire/ -- 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 the Phas...
Positive guidance from US FDA on Cu-64 SAR-bisPSMA Phase III trial in prostate cancer
Highlights * FDA agreement for a pivotal Phase III trial for 64Cu SAR-bisPSMA diagnostic in prostate cancer * Phase III trial design based on 64Cu SAR-bisPSMA data package, including positive results from the completed PROPELLER trial * A total of 383 prostate cancer patients to take part ...
Clarity establishes a US Center of Excellence for Targeted Copper Theranostics
SYDNEY, June 28, 2023 /PRNewswire/ -- Clarity Pharmaceuticals (ASX: CU6) ("Clarity"), 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 the establishment of a ...
Clarity commences COMBAT theranostic prostate cancer trial in the US
SYDNEY, June 20, 2023 /PRNewswire/ -- Clarity Pharmaceuticals (ASX: CU6) ("Clarity"), 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 its64C...
Clarity's theranostic prostate cancer trial advances to cohort 2
Highlights * Cohort 1 of the SECuRE trial has been completed in 6 participants with metastatic castrate-resistant prostate cancer (mCRPC) who received therapy with 67Cu SAR-bisPSMA at the lowest dose level of 4GBq. * No dose limiting toxicities (DLTs) have been reported in cohort 1. * The Sa...
US based COBRA diagnostic prostate cancer trial reaches recruitment target
SYDNEY, Feb. 9, 2023 /PRNewswire/ -- Clarity Pharmaceuticals (ASX: CU6) ("Clarity"), 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 its diagnostic 64Cu SAR-...
IND approval from the US FDA for theranostic SAR-Bombesin trial in prostate cancer
SYDNEY, Nov. 21, 2022 /PRNewswire/ -- Highlights * Clarity's fifth successful Investigational New Drug (IND) application with theUnited States Food and Drug Administration (US FDA), opening up therapeutic applications for SAR-Bombesin * A total of six products with both the diagnostic and t...
