First European Union Patient Dosed With 177Lu-PNT2002 in the Phase 3 SPLASH Trial
POINT Biopharma Global Inc. recently announced the first patient in the European Union (EU) has been dosed in the Phase 3 SPLASH trial (NCT04647526). The SPLASH trial is investigating the use of 177Lu-PNT2002, a PSMA-targeted radioligand, in pre-chemotherapy metastatic castration-resistant prostate cancer (mCRPC), with entry criteria including a positive PSMA-PET scan with either 68Ga-PSMA-11 or 18F-DCFPyL.
The SPLASH trial began randomization in North America in September 2021, and a total of 37 trial sites across North America and Europe are currently enrolling patients. Site activations in remaining jurisdictions continue to further accelerate trial recruitment. The company continues to expect to report top line data from SPLASH mid-2023.
“I’m pleased with our team’s consistent execution of the SPLASH trial,” said Dr. Joe McCann, CEO of POINT Biopharma. “In 2 years, we’ve gone from a pre-IND meeting with the FDA to dosing patients in multiple countries, and I’m proud of our team for realizing this achievement. We remain on track to complete recruitment by the end of this year, and to disclose efficacy and safety data from the 27-patient lead-in in the second half of 2022.”
In February 2022, the company announced publication of the first data from the SPLASH trial, dosimetry results from the lead-in cohort. The findings presented by Dr. Jean-Mathieu Beauregard concluded that “PNT2002 has a favorable and safe dosimetry profile in the patient population and dose regimen being studied.” To provide additional context on interpreting dosimetry, the company also hosted an investor education event titled Introduction to Dosimetry for Radiopharmaceuticals shortly after the release of the data. The 30-minute educational webinar was led by Dr. Ana Kiess, MD, PhD, Assistant Professor of Radiation Oncology and Molecular Radiation Sciences at Johns Hopkins Hospital, and provides more context into interpreting dosimetry results. A replay of the webinar and the slides are available to download at https://hub.pointbiopharma.com/dosimetry.
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 is transforming precision medicine by combining a portfolio of best-in-class radiopharmaceutical assets, a seasoned management team, an industry-leading pipeline, in-house manufacturing capabilities, and secured supply for rare medical isotopes like actinium-225 and lutetium-177. For more information, visit 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/.
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