Full Press Release Details
After Much Anticipation, Cellectar Biosciences
Initiates NCI-Supported Phase II Trial of CLR 131 in Multiple Myeloma and Other Blood Cancers
Madison, Wis. (March 30,
2017) -- Cellectar Biosciences, Inc. (Nasdaq: CLRB), an oncology-focused clinical stage biotechnology
company, today announces the initiation of a Phase II clinical study of its lead phospholipid drug
conjugate (PDC) CLR 131 in patients with multiple myeloma and other hematologic malignancies.
The study will be conducted in up to 15 centers
in the United States for patients with a variety of orphan-designated relapse or refractory hematologic cancers. The study's
primary endpoint is objective response rate (ORR), with additional endpoints of progression free survival (PFS), median overall
survival (OS) and other markers of efficacy following a single 25.0 mCi/m2 dose of CLR 131, with the option for a second
25.0 mCi/m2 dose approximately 75-180 days later. Cellectar will receive approximately $2 million in a non-dilutive
grant to help fund the trial from the National Cancer Institute and initial efficacy data are expected as early as the second half
"I would like to thank the
entire team at Cellectar whose diligent efforts enabled the company to initiate the Phase II trial a full quarter ahead of our
original guidance. The prospect of extending patient survival with a one or two-dose treatment continues
to drive a high sense of urgency for all involved in this study as we continue to focus on providing clinical benefit to patients
who suffer from these difficult to treat conditions," said Jim Caruso, president and CEO of Cellectar Biosciences. "Given
the results from our Phase I trial of CLR 131 in multiple myeloma, we are enthusiastic about the potential outcomes of this Phase
II trial, and look forward to reporting results as they become available."
The hematologic cancers to be studied include
multiple myeloma (MM), chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL), lymphoplasmacytic lymphoma (LPL), marginal
zone lymphoma (MZL), mantle cell lymphoma (MCL), and potentially diffuse large B-cell lymphoma (DLBCL).
In addition to the CLR 131 infusion(s), MM patients will receive
40 mg oral dexamethasone weekly for up to 12 weeks. Efficacy responses will be determined by the latest International Multiple
Myeloma Working Group criteria. Efficacy for all lymphoma patients will be determined according to Lugano criteria. More information
about the trial, including eligibility requirements, can be found at www.clinicaltrials.gov, reference NCT02952508.
CLR 131 is an investigational compound under development for
a range of hematologic malignancies. It is currently being evaluated as a single-dose treatment in a Phase I clinical trial in
patients with relapse or refractory (R/R) multiple myeloma as well as in a Phase II clinical trial for R/R MM and select R/R lymphomas
with either a one- or two-dose treatment. Based upon preclinical and interim Phase I study data, treatment with CLR 131 provides
a novel approach to treating hematological diseases and may provide patients with therapeutic benefits, including overall survival,
an improvement in progression-free survival, surrogate efficacy marker response rate, and overall quality of life. CLR 131 utilizes
the company's patented PDC tumor targeting delivery platform to deliver a cytotoxic radioisotope, iodine-131, directly to tumor
cells. The FDA has granted Cellectar an orphan drug designation for CLR 131 in the treatment of multiple myeloma.
About Phospholipid Drug Conjugates (PDCs)
Cellectar's product candidates are built upon its patented cancer cell-targeting delivery and retention platform of optimized
phospholipid ether-drug conjugates (PDCs). The company deliberately designed its phospholipid ether (PLE) carrier platform to
be coupled with a variety of payloads to facilitate both therapeutic and diagnostic applications. The basis for selective tumor
targeting of our PDC compounds lies in the differences between the plasma membranes of cancer cells compared to those of normal
cells. Cancer cell membranes are highly enriched in lipid rafts, which are glycolipoprotein microdomains of the plasma membrane
of cells that contain high concentrations of cholesterol and sphingolipids, and serve to organize cell surface and intracellular
signaling molecules. PDCs have been tested in more than 80 different xenograft models of cancer.
About Cellectar Biosciences, Inc.
Cellectar Biosciences is developing phospholipid drug conjugates (PDCs) designed to provide cancer-targeted delivery of diverse
oncologic payloads to a broad range of cancers and cancer stem cells. Cellectar's PDC platform is based on the company's proprietary
phospholipid ether analogs. These novel small-molecules have demonstrated highly selective uptake and retention in a broad range
of cancers. Cellectar's PDC pipeline includes product candidates for cancer therapy and cancer diagnostic imaging. The company's
lead therapeutic PDC, CLR 131, utilizes iodine-131, a cytotoxic radioisotope, as its payload. CLR 131 is currently being evaluated
under an orphan drug designated Phase I clinical study in patients with relapsed or refractory multiple myeloma, as well as a
Phase II clinical study to assess efficacy in a range of B-cell malignancies. The company is also developing PDCs for targeted
delivery of chemotherapeutics such as paclitaxel (CLR 1603-PTX), a preclinical-stage product candidate, and plans to expand its
PDC chemotherapeutic pipeline through both in-house and collaborative R&D efforts. For more information please visit www.cellectar.com.
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 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, 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, 2016. These forward-looking statements are made only as of the date hereof, and we disclaim any obligation to
update any such forward-looking statements.