Full Press Release Details
TG Therapeutics, Inc. Announces Final Phase 2 Multiple Sclerosis
Data Presentation at the 34th Congress of
Annualized Relapse Rate (ARR) of 0.07 observed for all patients on
ECTRIMS data review conference call to be held today, October 11,
2018, 19:30 CEST/1:30pm ET
York, NY, (October 11, 2018)
TG Therapeutics, Inc. (NASDAQ: TGTX), today announced the final
results from the Phase 2 multicenter trial of ublituximab
(TG-1101), the Company's novel glycoengineered anti-CD20
monoclonal antibody, in relapsing forms of Multiple Sclerosis
(RMS). The data is being presented today during an oral session at
Congress of the European Committee for
Treatment and Research in Multiple Sclerosis (ECTRIMS), in Berlin,
Germany. Highlights from the presentation are outlined
Michael S. Weiss, the Company's Executive Chairman and Chief
Executive Officer stated, We are extremely pleased by the
final Phase 2 MS data presented today during the annual congress of
ECTRIMS. We believe this complete dataset, which now includes all
patients through 48 weeks, confirms the efficacy and safety profile
of ublituximab and provides a compelling rationale for its use to
treat patients with MS. This final data compare very favorably with
previously presented data for ocrelizumab, the only approved
anti-CD20 for the treatment of MS. With more than 1 million
patients currently living in the United States with MS, we believe
ublituximab will become an important treatment option, representing
a major market opportunity for us. Mr. Weiss continued,
These data support our fully enrolled global Phase 3
ULTIMATE program, being conducted under SPA agreement with the FDA,
which if successful would support the full approval of ublituximab
in relapsing forms of MS.
final Phase 2 ublituximab data presented today is highly
encouraging and further confirms the safety and efficacy seen in
Multiple Sclerosis patients treated with ublituximab. It was
especially interesting to see that the one hour infusion was well
tolerated by patients. The approval of ocrelizumab confirmed anti-
CD20's as an important part of the MS treatment paradigm and
ublituximab's shorter infusion time and tolerable safety
profile offer a real advantage to our patients. We look forward to
the results of the ublituximab Phase 3 ULTIMATE program and
advancing this important treatment option forward, stated
Edward Fox, MD, PhD, Director of the Multiple Sclerosis Clinic of
Central Texas and Clinical Associate Professor at the University of
Texas Dell Medical School in Austin, TX and the Principal
Investigator for this Phase 2 study.
oral presentation includes final data on all patients enrolled in
the study through 48 weeks of treatment.
Oral Presentation Highlights:
Annualized Relapse Rate (ARR) of 0.07 was observed with 93% of
subjects relapse free at Week 48
B cell depletion was >99% at the primary analysis point of Week
4 (n=48), and maintained at Week 24 and Week 48
completely eliminated all (100%) of T1 Gd-enhancing lesions at Week
24 and maintained complete elimination at Week 48
reduction in T2 lesion volume from baseline to Week 48
of patients met the criteria for 24 Week Confirmed Disability
Improvement (CDI) at Week 48
well tolerated across all patients including those receiving rapid
infusions, as low as a one hour for the 450mg dose currently being
studied in the Phase 3 ULTIMATE Program and no study drug related discontinuations
Conference Call Details:
Title: TG Therapeutics ECTRIMS Data Review
October 11th, 2018; 19:30 CEST/
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
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 (TG-1101) for the treatment of relapsing
forms 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.
The data presented are available on the Publications page, located
within the Pipeline section, of the Company's website
ABOUT TG THERAPEUTICS, INC.
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