World News: 13:30 GMT Wednesday 15th May 2019. [Cellectar Biosciences via Globe Newswire via SPi World News]
FLORHAM PARK, N.J., May 15, 2019 (GLOBE NEWSWIRE) -- Cellectar Biosciences, Inc. (NASDAQ: CLRB), a clinical-stage biopharmaceutical company focused on the discovery, development and commercialization of drugs for the treatment of cancer, today announced initial results from Cohort 6 in the Company’s ongoing Phase 1 clinical study with CLR 131 in Relapsed or Refractory Multiple Myeloma (R/R MM). The 37.5mCi/m fractionated dose was determined to be safe and tolerable by the independent Data Monitoring Committee (DMC). Following the determination, the Company has initiated a Cohort 7 utilizing a 40mCi/m fractionated dose (20mCi/m dose on day 1 and day 8).
Data from Cohort 6 showed improved efficacy and a clear dose response compared to prior cohorts, including a 50% partial response rate, a 50% minimal response rate and 100% disease control rate. The International Myeloma Working Group defines a partial response as a 50% to 89.9% reduction in the marker of disease and minimal response as 25% to 49.9% reduction in the marker of disease. One patient achieving a minimal response with a 48% reduction in their marker is still on study and continues to be evaluated.
“We are very pleased to see continued positive safety and tolerability data in addition to enhanced efficacy from our ongoing Phase 1 dose escalation study for CLR 131,” said James Caruso, president and CEO of Cellectar. “We are observing a clear dose response with greater and more prolonged median reductions in surrogate efficacy markers throughout the study safety evaluation period as compared to prior cohorts, along with an improved overall drug profile with our fractionated dosing regimen. The Data Monitoring Committee unanimously agreed the study should progress to a Cohort 7 with a higher 40mCi/m fractionated dose. This cohort has been initiated with data expected in Q4 2019.”
The company’s lead PDC therapeutic, CLR 131, is in a Phase 2 clinical study (CLOVER-1) in R/R MM and select B-cell malignancies, as well as a dose escalation Phase 1 study in patients with R/R MM. The company has initiated a Phase 1 study with CLR 131 in pediatric solid tumors and lymphoma.
Cellectar’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 15th May 2019
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