Full Press Release Details
TG Therapeutics, Inc. Announces Updated Results from the Ongoing
Phase 2 Study of TG-1101 (ublituximab) in Patients with Multiple
Sclerosis at the 7th Joint ECTRIMS
100% reduction of T1 Gd-enhancing lesions at week 24
99% median B-cell depletion was observed at week 4 and maintained
TG-1101 was well tolerated across all patients including those
receiving 1 hour infusions of the Phase 3 450mg dose
York, NY, (October 26, 2017)
TG Therapeutics, Inc. (NASDAQ: TGTX), today announced results from
the Phase 2 multicenter trial of TG-1101 (ublituximab), the
Company's novel glycoengineered anti-CD20 monoclonal
antibody, in relapsing forms of Multiple Sclerosis (RMS). The data
is being presented today in two posters during Poster Session 1,
from 15:30 17:00 CEST, at the 7th Joint ECTRIMS ACTRIMS meeting in Paris,
Michael S. Weiss, the Company's Executive Chairman and Chief
Executive Officer stated, We are extremely pleased with the
data presented today demonstrating not only sustained B-cell
depletion by week 24 but even more importantly, complete
elimination of T1 Gd-enhancing lesions, as well as a well-tolerated
safety profile at our Phase 3 dose. We believe these data, although
early, compare very favorably to the results seen with other
anti-CD20s in the class, with TG-1101 exhibiting what could be a
best-in-class profile. These data support our currently enrolling
Phase 3 program in MS, which is being launched globally. Mr.
Weiss continued, We look forward to presenting additional
B-cell data tomorrow during the second poster session as well as
presenting updated data, including additional patients, from this
trial at conferences over the next year.
clinical and MRI data presented today is highly encouraging and
further confirms the compelling efficacy seen in Multiple Sclerosis
patients treated with ublituximab. While still early, it appears
ublituximab can be a highly competitive anti-CD20 with a shorter
infusion time, which is a great benefit to our patients. We look
forward to additional data from this Phase 2 trial and to
participating in the Phase 3 ULTIMATE trials and advancing this
important treatment option, 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
This Phase 2 trial is a 52-week randomized, placebo controlled,
multi-center study evaluating the safety and efficacy of TG-1101
(ublituximab) at accelerated infusion times. Today's posters
include data from 24 patients with RMS that were treated with
TG-1101 across three dosing cohorts.
Poster Presentation Title: Patient
characteristics, safety, and preliminary results of a placebo
controlled, phase 2a multicenter study of ublituximab (UTX), a
novel glycoengineered anti-CD20 monoclonal antibody (mAb), in
patients with relapsing forms of multiple
depletion was observed at week 4 and maintained at week 24 (6
(23/24) were relapse free at week 24
relapse was reported in a patient initially randomized to the
placebo arm. The relapse occurred 12 days after the patients first
infusion of 150mg of TG-1101. The patient remains on study and has
received the second and third infusions of TG-1101 and to date has
remained relapse free.
improvement from baseline of 0.35 with 79% of subjects showing
improved or stable EDSS
tolerated across all patients including those receiving rapid
infusions, as low as a one hour for the 450mg Phase 3 dose, and
produced similar levels of B-cell depletion with no identified
change in IRR or overall safety profile.
Title: Preliminary results of
phase 2 multicenter study of ublituximab (UTX), a novel
glycoengineered anti-CD20 monoclonal antibody (mAb), in patients
with relapsing forms of multiple sclerosis (RMS) demonstrates rapid
Gd-enhancing lesions decrease
completely eliminated all (100%) of T1 Gd-enhancing lesions at week
Reduction in the T2 lesion volume at Week 24 from baseline
(p=0.02), suggestive of a decrease in burden of
Reduction in T1 hypointense lesion volume at Week 24 from baseline
These data presentations support the recently announced
international Phase 3 program evaluating TG-1101 (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 will be led by
Lawrence Steinman, MD, of Stanford University.
A copy of the above posters can be found 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. TG-1101 (ublituximab) 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
TGR-1202 (umbralisib), 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 TG-1101 and
TGR-1202, or the combination of which is referred to as "U2", are
in Phase 3 clinical development for patients with hematologic
malignancies, with TG-1101 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