TG Therapeutics unveils long-term data from ublituximab Phase 2 study
Category: #health  By Pankaj Singh  Date: 2019-05-09
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TG Therapeutics unveils long-term data from ublituximab Phase 2 study

TG Therapeutics, a biopharmaceutical company focused on developing medicines for patients having B-cell mediated diseases, has recently announced the long-term follow-up data of its Phase 2, Open Label Extension trial of ublituximab (TG-1101), the firm’s new glycoengineered, anti-CD20 monoclonal antibody targeting relapsing Multiple Sclerosis (RMS) forms.

Sources familiar with the matter informed that the data was being presented at the 71st Annual Meeting of the American Academy of Neurology (AAN), which took place in Philadelphia, PA.

This presentation comprises long-term follow-up data from the Phase 2 study for 45 patients that were enrolled into the OLE and summarizes the final efficacy data on patients which were enrolled in the Phase 2 study through 48 weeks of treatment. During the OLE, Infusion Related Reactions (IRRs) were rare which occurred in only 4 patients (9%), all Grade 1 or 2.

TG Therapeutics’ Chief Executive Officer and Executive Chairman, Michael S. Weiss, stated that the long-term safety data that was recently presented at AAN showed that ublituximab, a monoclonal antibody, continues to be well endured with no patients discontinuing treatment because of a drug related adverse events at an average follow-up of 97.5 weeks. These data support company’s continuing Phase 3 ULTIMATE program which is enrolled fully with data anticipated by next year.

Apparently, these Phase 2 efficacy data and long-term safety data support the fully enrolled, continuing, international Phase 3 program assessing ublituximab, which is administered in a quick one-hour infusion, for the treatment of RMS.

The Phase 3 trial enabled ULTIMATE I and ULTIMATE II are being managed under the agreement of Special Protocol Assessment (SPA) with the USFDA (United States Food and Drug Administration) and are being directed by Lawrence Steinman (MD) of Stanford University, sources mentioned.

The data that was recently presented are available on the Publications page, placed within the Pipeline section, of the Company’s website.

 

Source Credit: https://www.streetinsider.com/Corporate+News/TG+Therapeutics+%28TGTX%29+Announces+Long-term+Follow-up+Data+from+the+Phase+2+Trial+of+Ublituximab+in+Patients+with+Multiple+Sclerosis+at+AAN/15462622.html

http://ir.tgtherapeutics.com/news-releases/news-release-details/tg-therapeutics-announces-long-term-follow-data-phase-2-trial



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Pankaj Singh

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Pankaj Singh

Pankaj Singh Develops content for Market Size Forecasters, Algosonline, and a couple of other platforms. A Post Graduate in Management by qualification, he worked as an underwriter in the UK insurance domain before deciding to switch his field of profession. With exp...

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