Clinical-stage biopharm company TG Therapeutics today announced that it has initiated a phase I/II trial to evaluate the safety, tolerability, and efficacy of TG-1101, the company's novel third-generation anti-CD20 monoclonal antibody, in combination with lenalidomide (Revlimid®) for patients with relapsed or refractory B-cell lymphoid malignancies who were previously treated with anti-CD20 antibody therapy.
This 30-patient multi-center trial is TG Therapeutics' second clinical trial of TG-1101 in North America; the company in September began enrollment of its on-going phase I/II trial with single agent TG-1101 in patients with Non-Hodgkin's Lymphoma (NHL).
TG-1101 has displayed high single agent activity in a phase I/II clinical trial in patients with relapsed Chronic Lymphocytic Leukemia (CLL), and has been granted orphan status in Europe and in the USA for B-cell CLL.
"We are very excited to announce the launch of our second clinical trial this year for TG-1101, now in combination with lenalidomide, targeting patients with advanced B-cell lymphoid malignancies, including CLL," Michael S. Weiss, executive chairman and interim CEO, stated in the press release.
Weiss noted that it's a common belief among lymphoma experts that the combination of anti-CD20 therapy with lenalidomide has the potential to significantly impact the treatment model for patients with B-cell malignancies.
"With a demonstrated ability to induce significantly greater ADCC activity over rituximab, TG-1101 is uniquely positioned to take advantage of the NK-cell activating properties exhibited by lenalidomide; providing a strong biological rationale for clinically meaningful synergy in the combination of these two agents," Weiss concluded.
For more information visit www.tgtherapeutics.com
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