TG Therapeutics unveils long-term data from ublituximab Phase 2 study
Category: #health  By Paroma Bhattacharya  Date: 2019-05-09
  • share
  • Twitter
  • Facebook
  • LinkedIn

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



About Author

Paroma Bhattacharya

Email: [email protected]   

Paroma Bhattacharya

Paroma currently works as a content developer for Algosonline, MSF and a series of alike platforms. Fortified with a post-graduation degree in Journalism and Mass Communication, she delved head long into a writing career, creating resourceful and information enriched ...

Read More

More News By Paroma Bhattacharya

MacroGenics, I-Mab team up to develop & market enoblituzumab in China
MacroGenics, I-Mab team up to develop & market enoblituzumab in China
By Paroma Bhattacharya

MacroGenics, Inc. and I-Mab Biopharma, a U.S. and China based clinical-stage biopharmaceutical company that is committed to discover and develop biologics in autoimmune and immune-oncology diseases, have recently announc...

ViiV Healthcare announces positive result in TANGO Phase 3 study
ViiV Healthcare announces positive result in TANGO Phase 3 study
By Paroma Bhattacharya

ViiV Healthcare Limited, a pharmaceutical company specializing in HIV treatment, recently announced positive results from Phase 3 TANGO study.

The study was conducted to assess vira...

Skyhawk Therapeutics expands licensing partnership with Biogen
Skyhawk Therapeutics expands licensing partnership with Biogen
By Paroma Bhattacharya

Skyhawk Therapeutics, Inc. has recently announced the expansion of its partnership with Biogen, which was initially announced on January 4, 2019.

The expansion, which leverages on the breadth of SkySTAR™ technology platform from Skyh...