Cellectar Biosciences Announces Positive Data From Phase 1 Therapeutic Trial of CLR 131 in Multiple Myeloma
05 Januar 2016 - 2:30PM
Cellectar Biosciences, Inc. (NASDAQ:CLRB), an oncology-focused
biotechnology company, today announces data from the first cohort
of patients enrolled in its orphan drug-designated Phase 1 study of
CLR 131 in patients with relapsed or refractory multiple myeloma.
Based on safety and efficacy data from the first cohort, the
trial’s Data Monitoring Committee approved enrollment of the second
cohort of patients with a 50 percent escalation in dose level of
CLR 131.
The primary objective of the multi-center, open label, Phase 1
dose escalation study is to characterize the safety and
tolerability of CLR 131 in patients with relapsed or refractory
multiple myeloma. Secondary objectives include establishment of the
recommended Phase 2 dose, both with and without dexamethasone, as
well as an assessment of therapeutic activity.
Prior to their participation in this study, patients in the
first cohort had received a minimum of three systemic regimens and
up to 12 lines of therapy.
“Judging by the results of the first cohort, I believe there is
significant potential for CLR 131 as a safe and tolerable treatment
modality for relapsed or refractory multiple myeloma,” stated
Sikander Ailawadhi, MD, senior associate consultant, Division of
Hematology/Oncology, Department of Medicine, The Mayo Clinic,
Jacksonville, Florida, and the site's lead investigator. “I believe
initiating the second cohort of the trial will provide additional
useful information, both in terms of establishing an appropriate
treatment dose, as well as further understanding the compound’s
potential in this indication.”
Data from the first cohort of patients in the Phase 1 study
demonstrated safety and tolerability with a favorable adverse event
profile. Additionally, stable disease was achieved in four of five
treated patients with two of these patients maintaining stable
disease throughout the 85-day study monitoring period.
“Importantly, these data collectively demonstrate safety and
tolerability in heavily pre-treated multiple myeloma patients as
well as provide promising signals of activity,” said Jim Caruso,
president and CEO of Cellectar Biosciences. “These early
outcomes and feedback from the investigators are encouraging and we
look forward to further evaluating CLR 131 in the second cohort to
determine optimal dose and regimen. More globally, these
results provide us with further confirmation on the utility of our
PDC delivery platform, which we believe is instrumental to these
outcomes.”
The company is developing CLR 131, its lead radiotherapeutic
phospholipid drug conjugate (PDC), for the treatment of multiple
myeloma through the targeted delivery of iodine-131 to myelomatous
cells.
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 1 study in patients
with relapsed or refractory multiple myeloma. 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 additional
information please visit www.cellectarbiosciences.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/A for the year ended December 31, 2014. These
forward-looking statements are made only as of the date hereof, and
we disclaim any obligation to update any such forward-looking
statements.
INVESTOR AND MEDIA CONTACT:
Jules Abraham
JQA Partners
917-885-7378
jabraham@jqapartners.com
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