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NEWS
Cellectar Biosciences Provides Strategic Update on Clinical Development, Pipeline Programs and Corporate Restructuring
Tuesday, 10th December at 5:00 pm
Evaluating strategic options for iopofosine I 131 a late-stage clinical program with compelling Phase 2 data and a substantial market opportunity
Focusing on advancing radiotherapeutic assets including alpha- and Auger-emitting radioconjugates into Phase 1 solid tumor studies
Evaluating strategic options for iopofosine I 131 a late-stage clinical program with compelling Phase 2 data and a substantial market opportunity
Focusing on advancing radiotherapeutic assets including alpha- and Auger-emitting radioconjugates into Phase 1 solid tumor studies
FLORHAM PARK, N.J., Dec. 10, 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 announces a strategic update on its clinical development programs for its proprietary phospholipid ether drug conjugate platform that delivers a broad array of therapeutic modalities to target cancers.
Due to recent communications with the U.S. Food and Drug Administration (FDA, or the Agency) regarding a confirmatory study to support accelerated approval and the regulatory submission for iopofosine I 131, the Company has decided to pursue strategic options for the further development and commercialization of this product candidate.
The CLOVER-WaM study was conducted in accordance with earlier FDA communications from an end of Phase 2 meeting and from a meeting in early 2024, during which the Company was informed that positive results for major response rate (MRR) as the primary endpoint could be acceptable to support accelerated approval of iopofosine I 131 as a treatment for Waldenstrom's macroglobulinemia (WM).
Based upon a recent Type-C meeting with the FDA, the Company now believes that a submission seeking accelerated approval would need to be based on the MRR data from CLOVER-WaM and enrollment in a randomized, controlled confirmatory study that is designed to generate data on progression-free survival (PFS).
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Teo knows : I have few thousands of this i hope it jumps
Alan velasquez : Are these good news ?
Jaguar8 OP Alan velasquez : Yes
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Alan velasquez : Down?
Jaguar8 OP Alan velasquez : Yes
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