Full Press Release Details
Grants Exemption to Import Alert for Cellectar's CLR 131 in Pediatric and Adolescent Patients
Phase 1 study in pediatric and adolescent patients with select relapsed or
refractory solid tumors, lymphomas and malignant brain
N.J., Mar. 19, 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 that the U.S. Food and
Drug Administration (FDA) has granted an exemption to the Import Alert placed on the Centre for Probe Development and Commercialization
(CPDC) for the use of CLR 131 in connection with the company's pediatric IND. This exemption will allow Cellectar to immediately
begin enrolling patients in its Phase 1 pediatric study for the treatment of select relapsed or refractory solid tumors including
neuroblastoma, lymphomas and malignant brain tumors.
Cellectar is already
enrolling patients in its Phase 1 and Phase 2 multiple myeloma and select B-cell lymphoma studies of CLR 131 after having received
FDA exemption to the CPDC Import Alert in November 2018 for its hematology IND.
grateful that the FDA has granted this additional exemption for CLR 131, which allows us to immediately initiate our pediatric
clinical study in children battling life-threatening cancers," said James Caruso, president and CEO of Cellectar. "These
patients have a very poor prognosis and low rates of survival as a result of limited effective treatment options. Based on our
preclinical and ongoing clinical studies, we are optimistic that CLR 131 has the potential to provide a meaningful treatment
option for children suffering from cancers with high unmet medical needs."
1 Pediatric Study of CLR 131
The Phase 1 pediatric
study will be an open-label, sequential-group, dose-escalation study 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. Secondary objectives of the study are to identify the recommended Phase 2
dose of CLR 131 and to determine preliminary antitumor activity (treatment response) of CLR 131 in children and adolescents. We
plan to initiate this Phase 1 study at 5-7 pediatric cancer centers, within and possibly outside the US.
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 our lead therapeutic PDC product candidate and is currently being evaluated in both Phase 2 and Phase 1 clinical studies.
In December 2014, the FDA granted orphan drug designation for CLR 131 for the treatment of multiple myeloma. In 2018, the FDA granted
orphan drug and rare pediatric disease designations for CLR 131 for the treatment of neuroblastoma, rhabdomyosarcoma, Ewing's
sarcoma and osteosarcoma. The FDA previously accepted our IND application for a Phase 1 open-label, dose-escalating study 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.
About Cellectar Biosciences,
Cellectar Biosciences
is focused on the discovery, development, and commercialization of drugs for the treatment of cancer. The company plans to develop
proprietary drugs independently and through research and development (R&D) collaborations. The core drug development strategy
is to leverage our PDC platform to develop therapeutics that specifically target treatment to cancer cells. Through R&D collaborations,
the company's strategy is to generate near-term capital, supplement internal resources, gain access to novel molecules or
payloads, accelerate product candidate development and to broaden our proprietary and partnered product pipelines.
lead PDC therapeutic, CLR 131, is in a Phase 2 clinical study 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 is initiating a Phase 1 study with CLR 131 in pediatric solid tumors and lymphoma.
product pipeline also includes one preclinical PDC chemotherapeutic program (CLR 1900) and several partnered PDC assets.
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Forward-Looking Statement Disclaimer
This news release 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. These forward-looking statements are made only as of the date hereof, and we disclaim
any obligation to update any such forward-looking statements.