POINT Biopharma Announces Early Completion of enrollment and initial dosing in the Lead-In of its Phase 3 SPLASH study of PNT2002 for mCRPC
INDIANAPOLIS, Aug. 10, 2021 (GLOBE NEWSWIRE) -- POINT Biopharma Global Inc. (NASDAQ: PNT), a company accelerating the discovery, development, and global access to life changing radiopharmaceuticals, today announced the completion of enrollment and initial dosing of the 25-patient safety and dosimetry lead-in of the Company’s Phase 3 SPLASH study evaluating PNT2002 for the treatment of metastatic castration-resistant prostate cancer (mCRPC).
“Patient enrollment and initial dosing was completed significantly ahead of schedule,” said Dr. Joe McCann, Chief Executive Officer of POINT Biopharma. “I am incredibly proud of our team for this achievement, especially considering it occurred during an unprecedented global pandemic. I believe the speed of enrollment further highlights the caliber of POINT’s team, as well as the unmet need of patients and physicians for additional treatments for advanced prostate cancer.”
The open-label safety and dosimetry lead-in enrolled patients with PSMA-expressing mCRPC who have progressed on ARAT therapy and are ineligible or averse to chemotherapy. Data generated from the initial safety lead-in phase of the study will be analyzed before proceeding to the randomization phase, with site initiation in the United Kingdom and several European Union countries beginning shortly thereafter. Patient treatment and follow-up remain ongoing, and the Company expects to report data from this phase of the study at a future scientific conference.
“On behalf of the entire POINT Biopharma team, I would like to extend our gratitude to the patients, their families and treating physicians for their enthusiasm and support for our Phase 3 SPLASH study,” said Dr. Neil Fleshner, Chief Medical Officer of POINT Biopharma. “Completing the enrollment of the safety and dosimetry lead-in is an important step on our journey to offer a new treatment option to patients battling mCRPC, a highly aggressive form of cancer with few therapeutic options. We look forward to starting the randomization part of the trial phase globally.”
The Phase 3 SPLASH study (NCT04647526) is a multi-center, randomized, open label assessment of PNT2002 in patients with PSMA-expressing mCRPC who have progressed on ARAT therapy and refuse or not eligible for chemotherapy. The next phase of the study is expected to enroll approximately 400 patients across North America, Europe and the UK. Patients will be randomized 2:1 with patients in arm A receiving PNT2002 and patients in arm B receiving either Abiraterone or Enzalutamide. Patients in arm B who experience centrally assessed radiographic progression and meet protocol eligibility will have the option to crossover and receive PNT2002. Patients will be subject to follow-up for up to 5 years from first PNT2002 dose. The primary endpoint of the study is radiographic progression-free survival (rPFS). Key secondary endpoints include overall response rate (ORR), overall survival (OS), and pharmacokinetics (PK).
Additional information on the Phase 3 SPLASH study can be found at https://www.splashtrial.com.
About POINT Biopharma
POINT Biopharma Global Inc. is a globally focused radiopharmaceutical company building a platform for the clinical development and commercialization of radioligands that fight cancer. POINT Biopharma Global Inc. is combining a portfolio of best-in-class radiopharmaceutical assets, a seasoned management team, expertise in radioisotopes such as Actinium-225 (Ac-225) and Lutetium-177 (Lu-177), and industry-leading manufacturing capabilities and supply chain to revolutionize theragnostic drug development and radioligand commercialization. Learn more about POINT Biopharma Global Inc. at https://www.pointbiopharma.com. Information about POINT Biopharma Global Inc.’s Phase 3 SPLASH trial for metastatic castrate resistant prostate cancer (mCRPC) patients can be found at https://www.splashtrial.com.
Forward Looking Statements
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