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

More Articles

More Articles

The term 'metastatic lymphoma' does not refer to a diagnosis. Unlike many of the subtypes of lymphoma we have...

It is nearly impossible to talk about a survival rate for...

Lymphosarcoma is a malignant tumor (or tumors) derived from lymphoid tissue (lymph nodes, tonsils, thymus, spleen, etc.). It is an illness that...

Diffuse Large B-Cell Lymphoma (DLBCL) is an aggressive Non-Hodgkin’s Lymphoma (NHL) that occurs in B-cells....

Burkitt's lymphoma is an aggressive B-cell lymphoma that is common in children...

Large Cell Lymphoma (LCL) is typically an aggressive (fast growing) cancer of either the B cell or T cell type. They are one of the most common...

A lymphoma diagnosis is not difficult to determine once a patient and doctor begin to look for signs of cancer...

The lymphatic system, or lymph system, defends the body from foreign invasion by disease causing agents such as viruses, bacteria, or fungi. The...

Lymphomas are classified based on the type of cells involved. Non-Hodgkin’s lymphomas are marked by mutations of...

Hodgkin's Lymphoma (Disease) has a colorful history: It was not the first cancer discovered but it was one of the first in which treatments were...

Often the one who makes the first diagnosis of Hodgkin's Lymphoma / Disease is the person affected. There are some...

Lymphoma is a general term for cancer in the lymph system. The lymph system is made up of many cells and organs, including the lymph nodes, thymus...

Advances in the treatment of Hodgkin's lymphoma have resulted in remarkable survival rates, even for...

While the average lifespan for hamsters is only about 2.5 years, and they are therefore less prone to long-term illnesses, it is possible for a...

Lymphoma is a cancer affecting the white blood cells (lymphocytes) of the body's immune system. The cells begin to grow abnormally and much faster...