Business
Cellectar Provides a Research and Development Program Summary
Waldenstrom’s macroglobulinemia pivotal trial top-line data now expected second half of 2023; pediatric high-grade glioma trial to initiate in Q3 Phospholipid
About this update from Cellectar Biosciences, Inc.
[{"type":"text","content":"Waldenstrom’s macroglobulinemia pivotal trial top-line data now expected second half of 2023; pediatric high-grade glioma trial to initiate in Q3 Phospholipid drug conjugate platform validation with alpha-emitting radioisotopes, small molecules, peptides and oligos FLORHAM PARK, N.J., June 12, 2023 (GLOBE NEWSWIRE) -- Cellectar Biosciences, Inc. (NASDAQ: CLRB), a late-stage biopharmaceutical company focused on the discovery, development, and commercialization of targeted treatments for cancer, today provided an update for its iopofosine I 131 clinical program and guidance related to its Waldenstrom’s macroglobulinemia (WM) CLOVER-WaM pivotal trial, as well as preclinical advancements to its proprietary phospholipid ether drug conjugate platform. WM CLOVER-WaM pivotal trialThe company now expects to release top-line data from the WM CLOVER-WaM trial in the second half of 2023 and assuming NDA approval, remains on target for a 2024 product launch. Cellectar experienced delays with trial start-up activities, such as site contracting and country regulatory responses, which slowed the initial pace of site initiations resulting in lower-than-expected patient enrollment. The company now has all 49 sites up and running and patient enrollment rates have accelerated. As has been previously reported, and in agreement with the FDA, WM CLOVER-WaM is a single arm, open label trial with a target enrollment of 50 patients. “Although we are disappointed with the delay in the study’s completion, our ongoing commercial preparations have compressed timelines and support a 2024 launch. Trial activations at high patient volume sites over recent quarters have increased the enrollment trend giving us confidence in our ability to complete the WM CLOVER-WaM study in the second half of 2023,” said Dr. Andrei Shustov, Cellectar’s senior vice president, medical. “Iopofosine I 131 demonstrated a 100% overall response rate, an 83.3% major response rate and a 16.7% complete response rate in our Phase 2a study of six WM relapsed/refractory patients. In addition to these impressive response rates, iopofosine I 131’s fixed, short-duration therapy removes the need for the indefinite or prolonged maintenance treatment that is currently required for other therapies.” Phase 1b study in pediatric high-grade gliomasWith the support of a $2 million grant from the Nation...