Cellectar Initiates Cohort 6 of Phase 1b Trial Evaluating CLR 131 in Relapsed/Refractory Multiple Myeloma
04 Décembre 2018 - 2:30PM
Cellectar Biosciences (Nasdaq: CLRB), a clinical-stage
biopharmaceutical company focused on the discovery, development and
commercialization of drugs for the treatment of cancer, announces
the initiation of Cohort 6 of its ongoing Phase 1b trial evaluating
CLR 131 for the treatment of relapsed/refractory (R/R) multiple
myeloma (MM). Cohort 6 will evaluate up to four patients with each
receiving two doses of 18.75 mCi/m2 of CLR 131 administered one
week apart. This fractionated dosing regimen will result in each
patient being treated with a total of approximately 75.0 mCi of CLR
131, representing an increase in average total exposure of greater
than 15% over Cohort 5.
Cohort 5 also used a fractionated dosing regimen and results
showed an ability to administer higher average drug exposure
compared with previous cohorts that used bolus dosing. The results
seen in Cohort 5 suggest the potential of fractionated dosing to
reduce adverse events while improving efficacy. The independent
Data Monitoring Committee (DMC) determined the Cohort 5 dose to be
safe and well tolerated, and the DMC recommended advancement to the
higher dose being used in Cohort 6.
“Cohort 6 builds upon the fractionated dosing we successfully
employed with Cohort 5, and we look forward to the results from
utilizing a higher drug concentration in this two-dose fractionated
approach,” said James Caruso, president and chief executive officer
of Cellectar Biosciences. “Importantly,” Caruso continued,
“while cohort 5 showed fewer adverse events than cohort 4, total
radiation exposure was greater.”
Cohort 5 ResultsResults from Cohort 5 indicated
enhanced tolerability and safety compared with Cohort 4 despite an
18% increase in total average dose, from 55.29 mCi in Cohort 4 to
65.15 mCi in Cohort 5. Patients in Cohort 5 required less
supportive care such as transfusions of platelets or packed red
blood cells than seen in previous cohorts.
In addition to the improved safety profile demonstrated in
Cohort 5, the company also monitored signals of efficacy. Despite
Cohort 5 patients averaging five lines of prior systemic therapies,
all patients experienced clinical benefit with two patients
achieving minimal responses and two achieving stable disease.
Furthermore, looking at surrogate markers, patients in Cohort 5
monitored by M-protein showed a nearly 50% further reduction in
M-protein than seen in Cohort 4.
Based on these results and the DMC recommendation, Cellectar
plans to modify the single-dose regimen of its ongoing Phase 2
trial of R/R hematologic malignancies to fractionated dosing.
About CLR 131CLR 131 is Cellectar’s
investigational radioiodinated phospholipid ether-drug conjugate
(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/refractory multiple myeloma (R/R
MM) and a range of B-cell malignancies, and a Phase 1b clinical
study in patients with R/R MM exploring fractionated dosing. The
objective of the multicenter, open-label, Phase 1b dose-escalation
study is the characterization of safety and tolerability of CLR 131
in patients with R/R MM. Patients in Cohorts 1-4 received single
doses of CLR 131 ranging from 12.5 mCi/m2 to 31.25 mCi/m2 as well
as a fractionated dose of 15.625 mCi/m2 given twice over seven days
in Cohort 5. All study doses and regimens have been deemed safe and
well tolerated by an independent Data Monitoring Committee. The
company plans to initiate a Phase 1 study with CLR 131 in pediatric
solid tumors and lymphoma as well as a second Phase 1 study in
combination with external beam radiation for head and neck
cancer.
About Phospholipid Drug Conjugates™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 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 R/R MM and a Phase 2 clinical study
in R/R MM and a range of B-cell malignancies. The company plans to
initiate a Phase 1 study with CLR 131 in pediatric solid tumors and
lymphoma as well as a second Phase 1 study in combination with
external beam radiation for head and neck cancer.
The company’s product pipeline also includes one preclinical PDC
chemotherapeutic program (CLR 1900) and partnered assets including
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 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, 2017 and our Form 10-Q for the
quarterly period ended September 30, 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.
CONTACT: LHA Investor RelationsMiriam
Weber Miller212-838-3777mmiller@lhai.com
Cellectar Biosciences (NASDAQ:CLRBW)
Graphique Historique de l'Action
De Août 2024 à Sept 2024
Cellectar Biosciences (NASDAQ:CLRBW)
Graphique Historique de l'Action
De Sept 2023 à Sept 2024