Clinical-stage
biopharmaceutical company TG Therapeutics announced it has commenced a
multicenter Phase 2 clinical trial to evaluate the safety and efficacy of the
combination of TG-1101 (ublituximab) and ibrutinib (IMBRUVICA) for patients
with chronic lymphocytic leukemia (CLL) and mantle cell lymphoma (MCL). The
trial represents the first clinical study evaluating this combination. TG-1101
is TG Therapeutics’ novel glycoengineered anti-CD20 monoclonal antibody; ibrutinib
is the oral bruton tyrosine kinase (BTK) inhibitor that was recently granted
U.S. FDA approval.
Entitled
“A Multi-center Phase 2 Study with Safety Run-in Evaluating the Efficacy and
Safety of Ublituximab in Combination with Ibrutinib in Patients with Select
B-Cell Malignancies,” the trial will enroll CLL and MCL patients who are
eligible to receive ibrutinib. The company has partnered with the U.S. Oncology
Network, Columbia University and other select centers throughout the U.S. The
study chair for the CLL patient group will be Jeff Sharman, MD, who is the
medical director for hematology research at U.S. Oncology Network; Owen A.
O’Connor, MD, PhD, a professor and the director of the Center for Lymphoid
Malignancies at Columbia University Medical Center, will serve as the study
chair for the MCL patient group.
“I
am impressed with the speed at which our team was able to launch this important
combination study, with ibrutinib being approved just over three weeks ago,”
said TG Therapeutics Executive Chairman and CEO Michael S. Weiss.
TG
Therapeutics believes the addition of TG-1101 to ibrutinib will substantially
enhance the efficacy that has been shown with ibrutinib alone in CLL and MCL
patients. Having also recently announced the combination trial of TG-1101 with
TGR-1202, the company’s novel PI3K-delta inhibitor, TG Therapeutics marks
another noteworthy milestone with the launch of this new combination study.
For
more information, visit www.tgtherapeutics.com
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