Full Press Release Details
to Second Malignant Brain Tumor Cohort of Ongoing Pediatric Phase 1 Study
Data Monitoring Committee recommends the study continue to higher dose after first dose deemed safe and tolerated
N.J., Aug. 14, 2019 -- 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 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/m2 bolus dose
to be safe and tolerated and recommended the company progress to a second cohort utilizing a 30 mCi/m2 bolus dose of
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."
About the Phase 1 Pediatric Study
The Phase 1 pediatric
study is an open-label, sequential-group, dose-escalation study designed to evaluate the safety and tolerability, toxicity, pharmacokinetics,
biodistribution and efficacy of single and fractionated intravenous administrations of CLR 131 in up to 30 children and adolescents
with select solid tumors, lymphoma, and malignant brain tumors, including relapsed or refractory malignant brain cancer, neuroblastoma,
rhabdomyosarcoma, Ewing's sarcoma, and osteosarcoma. Secondary objectives of the study are to identify doses at which preliminary
anti-tumor activity occurs and to assess drug accumulation within the different tumor types.
in malignant brain tumor patients received a 15mCi/m2 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/m2 bolus 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 clinicaltrials.gov using the identifier number NCT03478462.
granted Rare Pediatric Drug Designation (RPDD) for four separate pediatric disease indications: neuroblastoma, rhabdomyosarcoma,
osteosarcoma and Ewing's sarcoma. Should CLR 131 be approved by the FDA in any one of these indications, the RPDD may enable
Cellectar to receive a priority review voucher. Priority review vouchers can be used by the sponsor to receive priority review
designation for a future NDA or BLA submission, which could reduce the FDA review time from twelve months to eight months. Currently
these vouchers can also be transferred or sold to another entity. Since 2017, six priority review vouchers were sold for between
$80 and $150 million each.
CLR 131 is a small-molecule, cancer-targeting
radiotherapeutic PDC designed to deliver cytotoxic radiation directly and selectively to cancer cells and cancer stem cells. CLR
131 is the company's lead therapeutic PDC product candidate and is currently being evaluated in both Phase 2 and Phase 1
clinical studies. The FDA granted orphan drug designation for CLR 131 for the treatment of multiple myeloma as well as orphan drug
and rare pediatric disease designations for CLR 131 for the treatment of neuroblastoma, rhabdomyosarcoma, Ewing's sarcoma
and osteosarcoma. In addition to the ongoing Phase 1 dose-escalation study and the Phase 2 CLOVER-1 trial, the company recently
initiated a Phase 1 open-label, dose-escalating study in pediatric solid tumors and lymphoma to evaluate the safety and tolerability
of a single intravenous administration of CLR 131 in up to 30 children and adolescents with cancers including neuroblastoma, sarcomas,
lymphomas (including Hodgkin's lymphoma) and malignant brain tumors.
Cellectar Biosciences
is focused on the discovery, development, and commercialization of drugs for the treatment of cancer. The company is developing
proprietary drugs independently and through research and development (R&D) collaborations. The company's core objective
is to leverage its proprietary PDC delivery platform to develop PDCs that specifically target cancer cells, delivering improved
efficacy and better safety as a result of fewer off-target effects. Our PDC platform possesses the potential for the discovery
and development of the next-generation of cancer-targeting treatments, and we plan to develop PDCs independently and through research
and development collaborations.
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.
product pipeline also includes one preclinical PDC chemotherapeutic program (CLR 1900) and several partnered PDC assets.
For more information,
please visit www.cellectar.com.
Forward-Looking Statement Disclaimer
contains forward-looking statements. You can identify these statements by our use of words such as "may", "expect",
"believe", "anticipate", "intend", "could", "estimate", "continue",
"plans", or their negatives or cognates. These statements are only estimates and predictions and are subject to known
and unknown risks and uncertainties that may cause actual future experience and results to differ materially from the statements
made. These statements are based on our current beliefs and expectations as to such future outcomes. Drug discovery and development
involve a high degree of risk. Factors that might cause such a material difference include, among others, uncertainties related
to the ability to raise additional capital, uncertainties related to the disruptions at our sole source supplier of CLR 131, the
ability to attract and retain partners for our technologies, the identification of lead compounds, the successful preclinical development
thereof, the completion of clinical trials, the FDA review process and other government regulation, the volatile market for priority
review vouchers, our pharmaceutical collaborators' ability to successfully develop and commercialize drug candidates, competition
from other pharmaceutical companies, product pricing and third-party reimbursement. A complete description of risks and uncertainties
related to our business is contained in our periodic reports filed with the Securities and Exchange Commission including our Form
10-K for the year ended December 31, 2018 and Form 10-Q for the quarters ended March 31, 2019 and June 30, 2019. These forward-looking
statements are made only as of the date hereof, and we disclaim any obligation to update any such forward-looking statements.