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Oct 08, 2018

TG Therapeutics, Inc. Highlights Schedule of Events at the Upcoming 34th Congress of ECTRIMS

Final ublituximab phase 2 Multiple Sclerosis data to be featured in an oral presentation, Thursday, October 11, 2018, 16:51-17:03 CEST

ECTRIMS data review conference call to be held Thursday, October 11, 2018, 19:30 CEST/1:30pm ET

NEW YORK, Oct. 08, 2018 (GLOBE NEWSWIRE) -- TG Therapeutics, Inc. (NASDAQ: TGTX), today recapped the schedule of events featuring ublituximab (TG-1101), the Company’s novel glycoengineered anti-CD20 monoclonal antibody, in relapsing forms of Multiple Sclerosis (RMS) at the upcoming 34thCongress of the European Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS), to be held October 10 – 12, 2018, at City Cube in Berlin, Germany.

Final results from the Phase 2 trial of ublituximab in RMS patients will be presented via an oral presentation during the annual congress of ECTRIMS.  Following the oral presentation, the Company will host a data review conference call during which Dr. Edward Fox, PhD, Director of the MS Clinic of Central Texas, Central Texas Neurology Consultants, PA, Clinical Associate Professor at the University of Texas Dell Medical School and the Principal Investigator for the Phase 2 trial, will review the data presented and will be available for questions. Additional details are provided below.

Oral Presentation Details:

  • Title: Final Results of a Placebo Controlled, Phase 2 Multicenter Study of Ublituximab (UTX), a Novel Glycoengineered Anti-CD20 Monoclonal Antibody (mAb), in Patients with Relapsing Forms of Multiple Sclerosis (RMS)
    • Presentation Date & Time:Thursday, October 11th, 2018; 16:51-17:03 CEST
    • Session Title:  Free Communications 4 - Treatment
    • Location: City Cube, Berlin, Germany
    • Presenter: Edward Fox, MD, PhD, Director, MS Clinic of Central Texas, Central Texas Neurology Consultants, PA and Clinical Associate Professor at the University of Texas Dell Medical School

Following the presentation, 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.

Conference Call Details:

  • Title: TG Therapeutics ECTRIMS Data Review Call
    • Date & Time:Thursday, October 11th, 2018; 19:30 CEST/1:30pm ET
    • Dial in: 1-877-407-8029 (U.S.), 1-201-689-8029 (outside the U.S.)
    • Webcast:http://ir.tgtherapeutics.com/events
    • Presenter:Edward Fox, MD, PhD, Director, MS Clinic of Central Texas, Central Texas Neurology Consultants, PA and Clinical Associate Professor at the University of Texas Dell Medical School

An audio recording of the conference call will also be available for replay at www.tgtherapeutics.com, for a period of 30 days after the call.

These data support the ongoing international Phase 3 program evaluating ublituximab for the treatment of relapsing form of Multiple Sclerosis (RMS). The Phase 3 trials, entitled ULTIMATE I and ULTIMATE II, are being conducted under Special Protocol Assessment (SPA) agreement with the U.S. Food and Drug Administration (FDA) and are being led by Lawrence Steinman, MD, of Stanford University.

ABOUT TG THERAPEUTICS, INC.

TG Therapeutics is a biopharmaceutical company focused on the acquisition, development and commercialization of novel treatments for B-cell malignancies and autoimmune diseases. Currently, the company is developing two therapies targeting hematological malignancies and autoimmune diseases. Ublituximab (TG-1101) is a novel, glycoengineered monoclonal antibody that targets a specific and unique epitope on the CD20 antigen found on mature B-lymphocytes. TG Therapeutics is also developing umbralisib (TGR-1202), an orally available PI3K delta inhibitor.  The delta isoform of PI3K is strongly expressed in cells of hematopoietic origin and is believed to be important in the proliferation and survival of B‐lymphocytes. Both ublituximab and umbralisib, or the combination of which is referred to as "U2", are in Phase 3 clinical development for patients with hematologic malignancies, with ublituximab also in Phase 3 clinical development for Multiple Sclerosis.  Additionally, the Company has recently brought its anti-PD-L1 monoclonal antibody into Phase 1 development and aims to bring additional pipeline assets into the clinic in the future.  TG Therapeutics is headquartered in New York City.

Cautionary Statement

Statements included in this press release, particularly those with respect to anticipating the benefit of the data seen in the Phase 2 MS trial program and performance of ublituximab in the Phase 3 ULTIMATE clinical program may be 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.  Among the factors that could cause our actual results to differ materially are the following: the risk that early clinical results that supported our decision to move forward will not be reproduced in additional patients in expansion cohorts or in the MS Phase 3 program; the risk that data included in the abstract submission will not be reproduced in the full data presentation; the risk that the clinical results from the MS Phase 3 program, will not be positive and/or will not support regulatory approval of ublituximab to treat MS; the risk that we will not be able to successfully and cost-effectively complete the MS Phase 3 trials; the risk that ublituximab will not have a differentiated profile from the other drugs in the class and that early signs of best-in-class attributes will not be supported by future results; the risk that trials will take longer to enroll than expected; our ability to achieve the milestones we project over the next year; our ability to manage our cash in line with our projections, and other risk factors identified from time to time in our reports filed with the 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:

Jenna Bosco
Senior Vice President,
Corporate Communications
TG Therapeutics, Inc.
Telephone: 212.554.4351
Email: ir@tgtxinc.com

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Source: TG Therapeutics, Inc.