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Cellectar Biosciences’ CLR 131 Demonstrates Preliminary Activity in Phase I Study for Pediatric Brain and Solid Tumors
CLR 131 crosses blood brain barrier delivering drug directly to brain tumors FLORHAM PARK, N.J., Nov. 05, 2020 (GLOBE NEWSWIRE) -- Cellectar Biosciences, Inc.
About this update from Cellectar Biosciences, Inc.
[{"type":"text","content":"CLR 131 crosses blood brain barrier delivering drug directly to brain tumors\nFLORHAM PARK, N.J., Nov. 05, 2020 (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 CLR 131 has demonstrated preliminary activity in inoperable brain tumors in a Phase 1 study. The study is an international, open-label, dose escalation, safety study of CLR 131 in children and adolescents with relapsed or refractory cancers, specifically high grade gliomas (HGGs), high risk neuroblastomas and select soft tissue sarcomas.\n Highlights from the study: Four dose levels (15, 30, 45 and 60mCi/m2 ) have been evaluated to date with all deemed safe and tolerated by the independent Data Monitoring Committee; patients are currently being evaluated at the 75mCi/m2 dose levelInitial activity was expected to occur at doses of 60mCi/m2 and higher; activity has been noted at lower dose levelsCLR 131 has been measured in tumors, confirming that systemic administration of CLR 131 crosses the blood brain barrier and is delivered into tumors Disease control has been exhibited in heavily pretreated patients with ependymomas “CLR 131’s ability to cross the blood brain barrier along with the initial responses in pediatric brain tumors are most encouraging. CLR 131 may provide an attractive new treatment option for these patients beyond the current paradigms of external beam radiation and/or systemic targeted radiation as standards of care,” said Dr. John Friend, CMO of Cellectar. “These ultra-orphan pediatric indications align with the development and regulatory strategy that we have successfully employed with our lead program in heme-oncology. We look forward to providing feedback from our recent FDA Guidance meeting, outlining the registrational pathway for our priority adult hematology indications and planned initiation of our pivotal trial later in the fourth quarter.” Similar to previous CLR 131 studies in adults, this study demonstrated that 20-40% of the infused CLR 131 is delivered to the tumors. Additionally, the study demonstrated that systemic administration of CLR 131 results in a sufficient proportion of infused drug crossing the blood brain barrier and is delivered to different types of m...