On June 14, 2021 POINT Biopharma Inc. (POINT), a global radiopharmaceutical company dedicated to successfully delivering precision radioligand therapy to cancer patients, reported that it has successfully dosed multiple patients in its Phase 3 SPLASH study evaluating the efficacy of PNT2002, the Company’s investigational 177Lu-PSMA targeted radioligand therapy for patients with PSMA expressing metastatic castration resistant prostate cancer (mCRPC) who are not eligible for chemotherapy (Press release, Point Biopharma, JUN 4, 2021, View Source [SID1234583586]).
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The Phase 3 SPLASH study is a multi-center, randomized, open label assessment of PNT2002 in patients with mCRPC who have progressed on ARAT therapy and refuse or not eligible for chemotherapy. The study will commence with a single-arm dosimetry lead-in and expects to enroll a total of approximately 450 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. 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).
"We are pleased to announce dosing of patients in our Phase 3 SPLASH study, which represents a significant milestone for POINT. I am very proud of the work our clinical and CMC teams have done to bring us to this stage and believe that this study holds the potential to demonstrate an improvement against the current standard of care for patients with little to no current therapeutic options," said Joe McCann, Chief Executive Officer of POINT Biopharma. "It is exciting to be working on PSMA targeted radiopharmaceuticals, a technology which will likely continue to gain interest as results from studies like the VISION trial are published. We appreciate the collaboration and engagement from our trial investigators as well as the guidance from global key opinion leaders in the field."
The first patients in the trial were dosed last month by Dr. Luke Nordquist, Urologic Medical Oncologist, Urology Cancer Center & GU Research Network, Omaha, Nebraska, and Dr. Ebrahim Delpassand, Nuclear Medicine Physician, Excel Diagnostics and Nuclear Oncology Center, Houston, Texas. "There is a significant unmet need for therapeutic alternatives with a novel mechanism of action for patients with PSMA expressing mCRPC, particularly in advance of chemotherapy. The current standard of care is not sufficient for patients with this aggressive form of cancer," said Dr. Nordquist. "As a nuclear medicine physician with special interest in nuclear Oncology, I have seen an increasing demand and appreciation for this therapeutic modality and believe it holds much promise as the future of precision medicine," added Dr. Delpassand.
Additional information on the Phase 3 SPLASH study can be found at View Source
POINT Biopharma has entered into a definitive merger agreement with Research Alliance Corp. I (Nasdaq: RACA). Upon closing, the combined company is expected to be listed on Nasdaq under the ticker symbol "PNT". A full description of the terms of the business combination can be found in registration statement on Form S-4 filed with the SEC by RACA.