FDA Clears TG Therapeutics' Ublituximab For Clinical Trials

TG Therapeutics, Inc. is announcing that the U.S. Food and Drug Administration has cleared the company's Investigational New Drug Application ("IND") for TGTX-1101, also referred to as ublituximab.

TG Therapeutics now intends to initiate a Phase I/II clinical trial in patients diagnosed with B-cell lymphomas, which it says it will do this summer. They intend to recruit up to 36 patients in the Phase I dose escalation component; following that, they hope to recruit up to 77 patients in the Phase II component with B-cell non-Hodgkin's lymphomas (including follicular lymphoma, diffuse large B-cell lymphoma, and other subtypes) who have relapsed, or who have refractory disease following CD20 directed antibody therapy.

"Having only executed the license in late January, we were delighted by the speed at which we were able to file and receive clearance of our first IND," said Michael S. Weiss, Executive Chairman and Interim CEO on learning the news. "We are excited to be able to test ublituximab in B-cell Lymphomas following the high rate of response seen in our original study in relapsed and refractory Chronic Lymphocytic Leukemia."

Ublituximab is a novel, third generation chimeric monoclonal antibody that targets a unique epitope on the CD20 antigen found on B-lymphocytes. It has been bioengineered to be especially effective in triggering an immune response as a single-agent to aid in wiping out a patient's B-cells. It has orphan drug designation in both Europe and in the United States for B-cell Chronic Lymphocytic Leukemia.

Source: MarketWatch