CLR 131 Advances to Second Malignant Brain Tumor Cohort of Ongoing Pediatric Phase 1 Study

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FLORHAM PARK, N.J., Aug. 14, 2019 (GLOBE NEWSWIRE) -- , a clinical-stage biopharmaceutical company focused on the discovery, development and commercialization of drugs for the treatment of cancer, today announced it has successfully completed the first cohort of malignant brain tumor patients in its ongoing Phase 1 trial of CLR 131 in children and adolescents with select solid tumors, lymphoma, and malignant brain tumors, including relapsed or refractory neuroblastoma, rhabdomyosarcoma, Ewing’s sarcoma, and osteosarcoma. The independent Data Monitoring Committee determined the 15mCi/m bolus dose to be safe and tolerated and recommended the company progress to a second cohort utilizing a 30 mCi/m bolus dose of CLR 131.

“CLR 131 continues to advance through its Pediatric Phase 1 dose escalation study and we are encouraged by our pace of progress,” said James Caruso, President and CEO of Cellectar. “Pediatric patients with primary metastatic or relapsed solid tumors have very poor prognosis even with standard, highly toxic multimodality therapies and salvage regimens. We look forward to exploring the next dose and having additional safety data from this study later this year.”

The first cohort in malignant brain tumor patients received a 15mCi/m bolus dose of CLR 131 and based on results, the company is progressing to a second cohort of patients, who will receive a higher 30mCi/mbolus dose of CLR 131. The company will progress to additional cohorts at higher fractionated doses, if the dose in the second cohort is determined to be safe and tolerated. The multi-center study is being conducted at well-respected U.S. and international sites. Further details about the trial can be found at using the identifier number NCT03478462.

The company’s lead PDC therapeutic, CLR 131, is currently in three clinical studies – a Phase 2 study, and two Phase 1 studies. The Phase 2 clinical study (CLOVER-1) is in relapsed/refractory (R/R) B-cell malignancies, including multiple myeloma (MM), chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL), lymphoplasmacytic lymphoma (LPL), marginal zone lymphoma (MZL), mantle cell lymphoma (MCL), and diffuse large B-cell lymphoma (DLBCL). The company is also conducting a Phase 1 dose escalation study in patients with R/R multiple myeloma (MM) and a Phase 1 study in pediatric solid tumors and lymphoma.

The company’s product pipeline also includes one preclinical PDC chemotherapeutic program (CLR 1900) and several partnered PDC assets.

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Globe Newswire: 13:30 GMT Wednesday 14th August 2019

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