Full Press Release Details
Cellectar Biosciences Announces Results
From the First Two Cohorts of Its CLR 131 Phase 1 Trial: Demonstrates Excellent Efficacy, Overall Survival Benefit, and Progression
Free Survival Similar to or Better than Recently Approved Therapies
WI (December 1, 2016) -- Cellectar Biosciences, Inc. (Nasdaq: CLRB) (the "company"),
an oncology-focused, clinical stage biotechnology company, today provides a data update on the first
two cohorts of the company's Phase I clinical study of CLR 131 in patients with relapsed or refractory multiple myeloma.
clinical benefit rate for this study is 80 percent despite patients receiving an average of four prior treatments, including stem
cell transplant and triple drug combinations. The patients in Cohort 1 received a single 12.5 mCi/m2 dose and patients
in Cohort 2 received a single 18.75 mCi/m2 dose. At this time, Cohort 1 and Cohort 2 patients have demonstrated post
treatment median survival of 11.9 months and 4.9 months, respectively. The median survival for all evaluable patients in both
cohorts continues to increase and will be followed to determine overall survival benefit. Currently, the median overall survival
(mOS) for each cohort is not yet evaluable. All evaluable patients in the clinical study experienced progression free survival
(PFS). In Cohort 1, patients averaged 88.5 days of PFS. While patients in Cohort 2 have already achieved an average PFS of 127
days, the average PFS in Cohort 2 continues to increase as one of the four patients is still experiencing PFS. It is important
to note that overall survival of 11.9 months and PFS of 127 days in this heavily pretreated patient population is better than
or equivalent to that reported by several recently approved multiple myeloma drugs.
efficacy observed with CLR 131 at the 12.5 and 18.75 mCi/m2
single dose compares favorably to drugs recently approved for relapsed or refractory
multiple myeloma. We believe that the 18.75 mCi/m2 dose
could represent an acceptable single dose or multi-dose regimen for future studies," said Jim Caruso, president and
CEO of Cellectar Biosciences. "Combined with its clean safety profile, we are optimistic regarding the potential of CLR
131 and look forward to seeing results from our recently initiated Cohort 3 at a single 25mCi/m2
An evaluation of adverse events between Cohort 1 and Cohort 2 reveal a similar profile. Patients
in Cohort 1 experienced an average of 4.75 adverse events per patient while patients in Cohort 2 experienced an average of 4.25
events per patient. The median severity grade of the adverse events in both cohorts was 2.0 (mild to moderate), as
graded by the National Cancer Institute's Common Terminology Criteria for Adverse Events (NCI-CTCAE).
In the multi-center,
open label Phase I dose escalation study, CLR 131 was administered as a single dose, 30-minute intravenous infusion on Day 1 with
40 mg dexamethasone orally weekly for 12 weeks. The primary study objective is to characterize the safety and tolerability of CLR
131 with and without dexamethasone in patients with relapsed and/or refractory multiple myeloma. Secondary study objectives include
establishment of a recommended Phase II dose, both with and without dexamethasone, as well as an assessment of therapeutic activity,
including progression-free survival (PFS) and additional efficacy endpoints.
Dose-escalation in this study uses
a minimally modified, standard 3+3 schema with dose-limiting toxicities (DLTs) assessed through day 85 post-infusion. Each cohort
consisted of four evaluable patients (three men, one woman in Cohort 1 and two men, two women in Cohort 2). Patients in both cohorts
received an average of 4 prior treatments. All patients received and were relapsed or refractory to proteasome inhibitors and immunomodulatory
drugs prior to enrollment, and all patients had received triple combination therapy as a single line of therapy at least once.
One patient in Cohort 1 and three in Cohort 2 received autologous stem cell transplantation and three Cohort 1 patients and one
Cohort 2 patient each received the latest approved drugs for multiple myeloma prior to enrollment. Patient's ages range between
55-76 (Cohort 1) and 55-85 (Cohort 2) and averages were essentially identical at 68 and 69 years of age, respectively.
The company is currently enrolling patients into the
study's third cohort at a single 25 mCi/m2 dose and plans to provide an additional data update in the first half
131 is an investigational compound under development for a range of hematologic malignancies. It is currently being evaluated
in a Phase I clinical trial in patients with relapsed or refractory multiple myeloma. The company plans to initiate a Phase II
clinical study to assess efficacy in a range of B-cell malignancies in the first quarter of 2017. Based upon pre-clinical 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 response rate (ORR), an improvement in progression-free survival (PFS) 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)
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 over 70 different xenograft models of cancer.
About Relapsed or Refractory Multiple Myeloma
myeloma is the second most common blood or hematologic cancer with approximately 30,000 new cases in the United States every year.
It affects a specific type of blood cells known as plasma cells. Plasma cells are white blood cells that produce antibodies to
help fight infections. While treatable for a time, multiple myeloma is incurable and almost all patients will relapse or the cancer
will become resistant/refractory to current therapies.
About Cellectar Biosciences, Inc.
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. In addition, the company plans
to initiate a Phase II clinical study to assess efficacy in a range of B-cell malignancies in the first quarter of 2017. The company
is also developing PDCs for targeted delivery of chemotherapeutics such as paclitaxel (CLR 1602-PTX), a preclinical stage product
candidate, and plans to expand its PDC chemotherapeutic pipeline through both in-house and collaborative R&D efforts. For
additional information please visit www.cellectar.com.
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/A for the year ended December 31, 2015. These forward-looking
statements are made only as of the date hereof, and we disclaim any obligation to update any such forward-looking statements.