Cellectar Biosciences (Nasdaq:CLRB), a clinical stage
biopharmaceutical company focused on the discovery, development and
commercialization of drugs for the treatment of cancer, today
announces positive interim results from the company’s Phase 2
clinical trial for its lead product candidate CLR 131, in patients
with diffuse large B-cell lymphoma (DLBCL). After a single 25.0
mCi/m2 IV administration of CLR 131, patients with
relapsed/refractory DLBCL were assessed for response. These interim
data show a 33% overall response rate (ORR) and a 50% clinical
benefit response (CBR). In addition, the observed responses to date
show overall tumor reduction ranged from 60% to greater than 90%.
As a result of these favorable outcomes, the company has expanded
this cohort to include up to 30 additional patients.
“We are very encouraged by the strong response rates and
meaningful reductions in tumor volumes seen in the trial to date in
this very sick and heavily pretreated relapsed/refractory DLBCL
patient population,” stated James Caruso, president and chief
executive officer of Cellectar Biosciences. “We believe these data
combined with the activity seen to date in other hematologic
malignancies further validate the continued development of CLR
131.”
The DLBCL cohort of this Phase 2 trial was initiated in January
2018 and represents the fourth B-cell hematologic cancer to be
studied in the trial. All DLBCL patients enrolled are required to
have relapsed or refractory disease to multidrug chemotherapy
regimens containing rituximab and an anthracycline. Part of the
funding for this study is provided by a multimillion-dollar NCI
Fast Track SBIR grant.
About the Phase 2 Study of CLR 131The Phase 2
study is being conducted in approximately 10 leading cancer centers
in the United States for patients with relapsed or refractory
B-cell hematologic cancers. The hematologic cancers being studied
in the trial 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).
The study's primary endpoint is clinical benefit response (CBR),
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.
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. Cellectar has been
awarded approximately $2 million in a non-dilutive grant from the
National Cancer Institute to help fund the trial. More information
about the trial, including eligibility requirements, can be found
at www.clinicaltrials.gov, reference NCT02952508.
About Diffuse Large B-Cell LymphomaAccording to
the Lymphoma Research Foundation, diffuse large B-cell lymphoma
(DLBCL) is an aggressive form of non-Hodgkin’s lymphoma (NHL),
accounting for about 30 percent of newly diagnosed cases of NHL in
the United States.
The American Cancer Society’s most recent estimates for NHL for
2018 project approximately 74,680 people (41,730 males and 32,950
females) will be diagnosed with NHL including both adults and
children. They estimate that approximately 19,910 people will
die from this cancer (11,510 males and 8,400 females).
DLBCL occurs in both men and women, although it is slightly more
common in men. Although DLBCL can occur in childhood, its incidence
generally increases with age, and roughly half of patients are over
the age of 60.
DLBCL is an aggressive (fast-growing) lymphoma that
can arise in lymph nodes or outside of the lymphatic system, in the
gastrointestinal tract, testes, thyroid, skin, breast, bone, or
brain. Often, the first sign of DLBCL is a painless, rapid swelling
in the neck, underarms, or groin that is caused by enlarged lymph
nodes. For some patients, the swelling may be painful. Other
symptoms may include night sweats, fever, and unexplained weight
loss. Patients may notice fatigue, loss of appetite, shortness of
breath, or pain.
About Phospholipid Drug Conjugates™
(PDCs)Cellectar's product candidates are built upon a
patented delivery and retention platform that utilizes optimized
PDCs to target cancer cells. The PDC platform selectively delivers
diverse oncologic payloads to cancerous cells and cancer stem
cells, including hematologic cancers and solid tumors. This
selective delivery allows the payloads’ therapeutic window to be
modified, which may maintain or enhance drug potency while reducing
the number and severity of adverse events. This platform takes
advantage of a metabolic pathway utilized by all tumor cell types
in all cell cycle stages. Compared with other targeted delivery
platforms, the PDC platform’s mechanism of entry does not rely upon
specific cell surface epitopes or antigens. In addition, PDCs can
be conjugated to molecules in numerous ways, thereby increasing the
types of molecules selectively delivered. Cellectar believes the
PDC platform holds potential for the discovery and development of
the next generation of cancer-targeting agents.
About CLR 131CLR 131 is Cellectar’s
investigational radioiodinated PDC therapy that exploits the
tumor-targeting properties of the company's proprietary
phospholipid ether (PLE) and PLE analogs to selectively deliver
radiation to malignant tumor cells, thus minimizing radiation
exposure to normal tissues. CLR 131, is in a Phase 2 clinical study
in relapsed or refractory (R/R) MM and a range of B-cell
malignancies and a Phase 1 clinical study in patients with (R/R) MM
exploring fractionated dosing. The company is currently initiating
a Phase 1 study with CLR 131 in pediatric solid tumors and
lymphoma, and is planning a second Phase 1 study in combination
with external beam radiation for head and neck cancer.
About Cellectar Biosciences, Inc.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 broaden our proprietary and partnered product
pipelines.
The company's lead PDC therapeutic, CLR 131, is in a Phase 1
clinical study in patients with relapsed or refractory (R/R) MM and
a Phase 2 clinical study in R/R MM and a range of B-cell
malignancies. The company is currently initiating a Phase 1 study
with CLR 131 in pediatric solid tumors and lymphoma, and is
planning a second Phase 1 study in combination with external beam
radiation for head and neck cancer. The company’s product pipeline
also includes two preclinical PDC chemotherapeutic programs (CLR
1700 and 1900) and partnered assets include PDCs from multiple
R&D collaborations.
For more information please visit www.cellectar.com.
Forward-Looking Statement DisclaimerThis 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, 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, 2017. These forward-looking
statements are made only as of the date hereof, and we disclaim any
obligation to update any such forward-looking statements.
CONTACT: LHA Investor RelationsMiriam
Weber Miller212-838-3777mmiller@lhai.com
Cellectar Biosciences (NASDAQ:CLRBW)
Graphique Historique de l'Action
De Nov 2024 à Déc 2024
Cellectar Biosciences (NASDAQ:CLRBW)
Graphique Historique de l'Action
De Déc 2023 à Déc 2024