TG Therapeutics Inc common stock (NASDAQ:TGTX) stock closed Wednesday’s trading session at $4.14 a noteworthy uptick a week after it published Phase I triple therapy clinical trial data for Ublituximab, Umbralisib, and Ibrutinib.
The published data contains the safety and efficacy profile of the trio drug treatment in patients with refractory or relapsed. This includes data collected from 23 patients diagnosed with small lymphocytic lymphoma (SLL) or chronic lymphocytic leukemia (CLL). It also includes clinical trial data from 23 patients suffering from non-Hodgkin lymphoma (NHL).
The safety profile data provided covers all 46 patients treated with the three-drug combo of umbralisib, ublituximab, and ibrutinib. The results revealed that there were manageable adverse effects and that the drug combination was generally well tolerated. The drug combination did not have a maximum achieved tolerated dose. As far as efficacy is concerned, researchers observed that the three-drug combo was highly active in 44 patients.
“Tolerability and activity of ublituximab, umbralisib, and ibrutinib in patients with chronic lymphocytic leukemia and non-Hodgkin lymphoma: a phase 1 dose escalation and expansion trial,” stated the published manuscript.
TG Therapeutics awarded breakthrough therapy destination for Umbralisib
TG Therapeutics’ announcement about the published clinical trial data comes just a few days after the company announced that Umbralisib received a breakthrough therapy destination. The U.S Food and Drug Administration (FDA) issued the designation to umbralisib as a marginal zone lymphoma (MZL) treatment in adult patients.
The FDA issued the breakthrough therapy destination based on the interim data that TG Therapeutics submitted from clinical trials of the treatment. TG Therapeutics’ CEO Michael S. Weiss stated that the company would collaborate with the FDA to bring the treatment to market as fast as possible. The breakthrough therapy destination will speed up the development and review process, thus fast-tracking umbralisib’s official debut as an MZL treatment.
Umbralisib is quite promising to the MZL patients especially those that have previously been unsuccessfully gone through chemo-immunotherapy. Such patients have limited treatment options but umbralisib represents renewed hope. The life-threatening nature of the disease is also one of the reasons behind the FDA’s decisions to give umbralisib the breakthrough therapy destination.