Point Biopharma12 Jan 2023 15:51
INDIANAPOLIS, Jan. 12, 2023 (GLOBE NEWSWIRE) -- POINT Biopharma Global Inc. (PNT) (the “Company” or “POINT”), a company accelerating the discovery, development, and global access to life-changing radiopharmaceuticals, today announced the completion of enrollment for the randomization phase in the pivotal phase 3 SPLASH trial, on schedule and meeting previous guidance. SPLASH is a multi-center, randomized, open label assessment of 177Lu-PNT2002 in participants with PSMA-expressing metastatic castration resistant prostate cancer who have progressed on androgen receptor pathway inhibitor therapy and refuse, or are not eligible for, chemotherapy.
Enrollment for randomization was completed on schedule with more than 390 participants randomized across 55 SPLASH trial sites in North America, Europe, and the United Kingdom.
“We are proud to have reached this important milestone for the PNT2002 program,” said Jessica Jensen, Executive Vice President, Clinical Development of POINT Biopharma. “Our incredibly talented cross-functional team collaborated tirelessly to ensure that, despite the extraordinary circumstances of a pandemic, POINT’s first phase 3 global trial remained on track. Our success is a testament to both the expertise of our team and the level of enthusiasm for radioligand therapy in the oncology community. We are grateful for patients who agreed to be screened for this study, the trial investigators and their hard-working staff, our research partners, and the POINT team for their passion and commitment to the program. We look forward to continuing to work diligently to advance novel treatment options for patients as we accelerate the discovery, clinical development, and manufacturing of radioligand therapies.”
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