Full Press Release Details
TG Therapeutics Presents Data for Ublituximab at the 35th Annual Congress of
the European Committee for Treatment and Research in Multiple
York, NY, (September 12,
2019) TG Therapeutics, Inc. (NASDAQ: TGTX), today presented
the first look at the ULTIMATE I & II Phase 3 trial design and
demographic data and updated Phase 2 extension trial data for
ublituximab, the Company's novel, glycoengineered anti-CD20
monoclonal antibody, in relapsing forms of multiple sclerosis (RMS)
at the 35th Annual Congress of
the European Committee for Treatment
and Research in Multiple Sclerosis (ECTRIMS), being held in
S. Weiss, the Company's Executive Chairman and Chief
Executive Officer stated, We are pleased to present the
first look at the study design and patient demographics data from
our Phase 3 ULTIMATE program. Importantly, the population enrolled
appears consistent with a typical RMS population and similar to the
patient populations enrolled in other CD20 Phase 3 trials.
Mr. Weiss continued, We are also highly encouraged by the
Phase 2 long-term safety data demonstrating ublituximab continues
to be very well tolerated with a median duration of follow-up of
124.7 weeks and no discontinuations due to AEs reported. We look
forward to continuing to follow our Phase 2 patients and to topline
results from our Phase 3 trial in the middle to second half of
2020. If successful, we believe ublituximab will represent an
important anti-CD20 treatment option for patients with RMS that can
be delivered in a convenient one-hour infusion every six
following summarizes the highlights from each presentation during
Title: Study Design and
Patient Demographics of the ULTIMATE Phase III Trials Evaluating
Ublituximab (UTX), a Novel Glycoengineered Anti-CD20 Monoclonal
Antibody (mAb), in Patients with Relapsing Multiple Sclerosis
This presentation includes the study design and demographic data
from ULTIMATE I & II, two identical, randomized, international,
multi-center, double-blinded, double dummy, active controlled Phase
3 trials, evaluating a twice per year one-hour 450mg infusion of
ublituximab in RMS. These trials 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.
Presentation Highlights:
for ULTIMATE I & II was successfully completed in the second
characteristics of patients enrolled in ULTIMATE I & II are
consistent with a typical RMS population.
& II trials are expected to elucidate the therapeutic potential
of a one hour, 450mg infusion of ublituximab in patients with RMS.
Topline results are expected in the second half of
Title: Long-term Follow-up
Results from the Phase 2 Multicenter Study of Ublituximab (UTX), a
Novel Glycoengineered Anti-CD20 Monoclonal Antibody (mAb), in
Patients with Relapsing Multiple Sclerosis
This presentation includes long-term follow-up data for 45 patients
from the Phase 2 trial that enrolled into the Open Label Extension
(OLE) trial and recaps the final efficacy data on patients enrolled
in the Phase 2 study through 48 weeks of treatment.
Presentation Highlights:
continues to be well tolerated, with a median duration of follow-up
discontinued due to an Adverse Event (AE) related to ublituximab on
the Phase 2 or during the OLE.
possibly related to ublituximab were infrequent during the OLE with
all patients dosed at 450mg of ublituximab administered in a
one-hour infusion (Phase 3 dose).
Reactions (IRRs) were rare during the OLE, occurring in only 5
patients (11%), all Grade 1 or 2.
Relapse Rate (ARR) of 0.07 was observed with 93% of subjects
relapse free at Week 48.
above referenced data presented are available on the Publications
page, located within the Pipeline section, of the Company's
website at www.tgtherapeutics.com/publications.cfm.
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 multiple 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 oral, once-daily inhibitor of PI3K-delta.
Umbralisib uniquely inhibits CK1-epsilon, which may allow it to
overcome certain tolerability issues associated with first
generation PI3K-delta inhibitors. 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 into
Phase 1 clinical development, TG-1501, its anti-PD-L1 monoclonal
antibody, TG-1701, its covalently-bound Bruton's Tyrosine
Kinase (BTK) inhibitor and TG-1801, its anti-CD47/CD19 bispecific
antibody. TG Therapeutics is headquartered in New
Cautionary Statement
included in this press release, particularly those with respect to
anticipating the benefit of the data seen in the Phase 2 and OLE MS
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