Oral Presentation Title: Reduced Disease Progression with Ublituximab Vs Teriflunomide in the Phase 3 Ultimate I and II Studies in Relapsing Multiple Sclerosis
- Presentation Date/Time:
Thursday, June 2, 2022 / 3:10 –3:30 PM ET - Session: Disease Modifying Therapies Platform Session
- Presentation ID: DMT03
- Lead Author:
Enrique Alvarez , MD,University of Colorado ,Aurora, CO
Poster Presentation Title: Improved Cognitive Processing Speed with Ublituximab in Patients with Highly Active Relapsing Multiple Sclerosis
- Presentation Date/Time:
Thursday, June 2, 2022 / 5:00 –7:00 PM ET - Session: Poster Session in
Prince George’s Exhibit Hall - Poster Board Label: DMT19
- Lead Author:
Derrick Robertson , MD,University of South Florida ,Tampa, FL
Poster Presentation Title: Infusion-Related Reactions with Ublituximab in the Phase 3 Ultimate I and II Studies in Relapsing Multiple Sclerosis
- Presentation Date/Time:
Thursday, June 2, 2022 / 5:00 –7:00 PM ET - Session: Poster Session in
Prince George’s Exhibit Hall - Abstract Number/Poster Number: DMT23
- Lead Author:
Edward J. Fox , MD, PhD,Central Texas Neurology Consultants ,Round Rock, TX
Following the presentations, the data presented will be available on the Publications page, located within the Pipeline section, of the Company’s website at www.tgtherapeutics.com/publications.cfm.
ABOUT THE ULTIMATE I & II PHASE 3 TRIALS
ULTIMATE I and ULTIMATE II are two independent Phase 3, randomized, double-blinded, active-controlled, global, multi-center studies evaluating the efficacy and safety/tolerability of ublituximab (450mg dose administered by one-hour intravenous infusion every 6 months, following a Day 1 infusion of 150mg over four hours and a Day 15 infusion of 450mg over one hour) versus teriflunomide (14mg oral tablets taken once daily) in subjects with relapsing forms of Multiple Sclerosis (RMS). The ULTIMATE I & II trials enrolled a total of 1,094 patients with RMS across 10 countries. These trials were led by
ABOUT UBLITUXIMAB
Ublituximab is an investigational glycoengineered monoclonal antibody that targets a unique epitope on CD20-expressing B-cells. When ublituximab binds to the B-cell it triggers a series of immunological reactions, including antibody-dependent cellular cytotoxicity (ADCC) and complement dependent cytotoxicity (
ABOUT MULTIPLE SCLEROSIS
Relapsing multiple sclerosis (RMS) is a chronic demyelinating disease of the central nervous system (CNS) and includes people with relapsing-remitting multiple sclerosis (RRMS) and people with secondary progressive multiple sclerosis (SPMS) who continue to experience relapses. RRMS is the most common form of multiple sclerosis (MS) and is characterized by episodes of new or worsening signs or symptoms (relapses) followed by periods of recovery. It is estimated that nearly 1 million people are living with MS in
ABOUT
TG Therapeutics is a biopharmaceutical company focused on the acquisition, development and commercialization of novel treatments for B-cell diseases. In addition to a research pipeline including several investigational medicines, TG has completed a Phase 3 program for ublituximab, an investigational glycoengineered monoclonal antibody that targets a unique epitope on CD20-expressing B-cells, to treat patients with relapsing forms of multiple sclerosis (RMS). For more information, visit www.tgtherapeutics.com, and follow us on Twitter @TGTherapeutics and Linkedin.
Cautionary Statement
This press release contains forward-looking statements that involve a number of risks and uncertainties. For those statements, we claim the protection of the safe harbor for forward-looking statements contained in the Private Securities Litigation Reform Act of 1995. Such forward-looking statements include but are not limited to statements regarding the results of the ULTIMATE I & II Phase 3 studies and ublituximab as a potential treatment for relapsing forms of Multiple Sclerosis (RMS).
Any forward-looking statements in this press release are based on management's current expectations and beliefs and are subject to a number of risks, uncertainties and important factors that may cause actual events or results to differ materially from those expressed or implied by any forward-looking statements contained in this press release. In addition to the risk factors identified from time to time in our reports filed with the U.S. Securities and Exchange Commission (SEC), factors that could cause our actual results to differ materially include the following: the risk that the data from the ULTIMATE I & II trials that we announce or publish may change, or the perceived product profile may be impacted, as more data or additional endpoints are analyzed; the risk that data may emerge from future clinical studies or from adverse event reporting that may affect the perceived safety and tolerability profile and commercial potential of ublituximab; the risk that the clinical results from the ULTIMATE I & II trials will not support regulatory approval of ublituximab to treat RMS for efficacy, safety or other issues or, if approved, that we will not receive regulatory approval within the timeline projected; the risk that if approved, ublituximab will not be commercially successful; our ability to expand our commercial infrastructure, and successfully launch, market and sell ublituximab in RMS if approved; the Company’s reliance on third parties for manufacturing, distribution and supply, and a range of other support functions for our commercial and clinical products, including ublituximab; the uncertainties inherent in research and development; and the risk that the ongoing COVID-19 pandemic and associated government control measures have an adverse impact on our research and development plans or commercialization efforts. Further discussion about these and other risks and uncertainties can be found in our Annual Report on Form 10-K for the fiscal year ended December 31, 2021, our most recent Quarterly Report filed on Form 10-Q,and our other filings with the U.S. Securities and Exchange Commission. Any forward-looking statements set forth in this press release speak only as of the date of this press release. We do not undertake to update any of these forward-looking statements to reflect events or circumstances that occur after the date hereof. This press release and prior releases are available at www.tgtherapeutics.com. The information found on our website is not incorporated by reference into this press release and is included for reference purposes only.
CONTACT:
Investor Relations
Email: ir@tgtxinc.com
Telephone: 1.877.575.TGTX (8489), Option 4
Media Relations:
Email: media@tgtxinc.com
Telephone: 1.877.575.TGTX (8489), Option 6
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1. MS Prevalence.
Source:
2022 GlobeNewswire, Inc., source