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Cellectar Biosciences Announces Enrollment of the First Patient in Pediatric High-Grade Gliomas Phase 1b Clinical Study
Study of Iopofosine I 131 Supported by $2 Million Grant from the National Institute of Health’s National Cancer Institute (NCI) FLORHAM PARK, N.J., Jan. 30,
About this update from Cellectar Biosciences, Inc.
[{"type":"text","content":"Study of Iopofosine I 131 Supported by $2 Million Grant from the National Institute of Health’s National Cancer Institute (NCI)\nFLORHAM PARK, N.J., Jan. 30, 2024 (GLOBE NEWSWIRE) -- Cellectar Biosciences, Inc. (NASDAQ: CLRB), a late-stage clinical biopharmaceutical company focused on the discovery, development and commercialization of drugs for the treatment of cancer, today announced the first patient has been enrolled in its Phase 1b clinical trial evaluating iopofosine I 131, a novel phospholipid radiotherapeutic conjugate, in pediatric patients with relapsed or refractory malignant high-grade gliomas (pHGG). “Treatment of pediatric patients with relapsed and refractory high-grade glioma and ependymoma is extremely challenging. There are limited treatment options and high unmet clinical need for patients suffering from this aggressive cancer,” said Dr. Sameer Farouk Sait, pediatric hematologist-oncologist and assistant attending at Memorial Sloan Kettering Cancer Center. “Iopofosine I-131’s recently reported complete central nervous system clearance in a relapsed, refractory Bing-Neel Syndrome patient and demonstrated clinical activity across the blood-brain barrier in other hematologic malignancies, which included a complete response in a relapsed/refractory primary CNS lymphoma patient, is highly encouraging. The novel MOA is exciting, and we look forward to evaluating iopofosine’s efficacy and safety with the goal of providing a meaningful treatment to pediatric patients and hope to their families.” The open-label study (NCT05610891) will assess two dosing regimens to identify the optimal iopofosine I 131 Phase 2 recommended dose and schedule in pHGG patients and evaluate safety and tolerability. The study is supported by a $2 million Fast Track SBIR grant from the National Institute of Health’s National Cancer Institute (NCI), which was awarded based in part on the promising Phase 1a trial data. “We understand the profound impact pediatric high-grade gliomas have on the lives of young patients and their families,” commented James Caruso, president and CEO of Cellectar. “There exists an urgent need for more effective, targeted therapies for this vulnerable population and we are rapidly advancing further evaluation of our lead phospholipid radioconjugate therapy in this important indication. Iopofosine I 131 showed great p...