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EX-99.2 - EXHIBIT 99.1 - TG THERAPEUTICS, INC. | v101617_ex992.htm |
EX-99.1 - EXHIBIT 99.1 - TG THERAPEUTICS, INC. | v101617_ex991.htm |
8-K - 8-K - TG THERAPEUTICS, INC. | v101617_8k.htm |
TG Therapeutics, Inc. Recaps Clinical Data Presentations at the
Upcoming 7th Joint ECTRIMS
– ACTRIMS Meeting
B-cell depletion data and MRI data at 24 weeks (6 months) to be
presented
Abstract data shows complete (100%) elimination of T1 Gd-enhancing
lesions at week 24
New
York, NY, (October 16, 2017)
TG Therapeutics, Inc. (NASDAQ: TGTX), today announced that clinical
abstracts featuring data 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) have been selected for presentation at the
upcoming 7th
Joint ECTRIMS – ACTRIMS meeting,
to be held next week, October 25 – 28, 2017, at the Le Palais
de Congrès de Paris, in Paris, France. Abstracts are now
available online and can be accessed on the ECTRIMS meeting website
at www.ectrims-congress.eu.
Details of the poster presentations are outlined
below.
Abstract Highlights:
●
TG-1101 completely eliminated all (100%) of T1 Gd-enhancing lesions
at week 24 (n=16)
●
At week 4, median 99% B-cell depletion was observed and maintained
at week 24 (6 months) (n=24)
●
TG-1101 was well tolerated with no study drug related SAE’s
reported and accelerated infusions times as short as 1 hour for the
450mg Phase 3 dose and regimen did not increase the rate of
Infusion Related Reactions (IRR) (n=24)
Michael S. Weiss, the Company’s Executive Chairman and Chief
Executive Officer stated, “We are excited to release the
first clinical MRI data of TG-1101 in patients with RMS as we
believe the abstract data presents an extremely compelling case for
the use of TG-1101 in the treatment of patients with MS. While
still early, the data thus far is setting the stage for a
best-in-class profile for TG-1101 in treating MS. We are looking
forward to presenting the full data on the first three cohorts
(n=24) through 24 weeks (6 months) of treatment at the
ECTRIMS-ACTRIMS meeting next week.” Mr. Weiss continued,
“We will continue to update these data at multiple
conferences over the next year as we treat and follow the full 48
patients (from the 6 cohorts) for up to 1 year. With our Phase 3
program now underway pursuant to a Special Protocol Assessment
(SPA), we believe MS represents the next level of growth for the
Company.”
Poster Presentation Details:
●
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 sclerosis
o
Presentation Date & Time: Thursday,
October 26th, 2017; 15:30-17:00
CEST
o
Session
Title: Poster Session 1
o
Presenter:
Edward Fox, MD, PhD, Central Texas Neurology Consultants, Round
Rock, Texas
●
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
o
Presentation Date & Time: Thursday, October
26th,
2017; 15:30-17:00 CEST
o
Session
Title: Poster Session 1
o
Presenter:
Matilde Inglese, MD, PhD, Icahn School of Medicine at Mount Sinai,
New York, NY
●
Placebo
controlled, phase 2a multicenter study of ublituximab (UTX), a
novel glycoengineered anti-CD20 monoclonal antibody (mAb), in
patients with relapsing forms of multiple sclerosis (RMS): 6 months
analysis of B cell subsets
o
Presentation Date & Time: Friday,
October 27th, 2017; 15:30-17:00
CEST
o
Session
Title: Poster Session 2
o
Presenter:
Amy E. Lovett-Racke, PhD, The Ohio State University, Columbus,
OH
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 abstracts can be found on the ECTRIMS meeting
website at www.ectrims-congress.eu.
Following each poster 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.
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. 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
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 early data seen in the
Phase 2 MS trial and anticipating the timing of our MS Phase 3
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: our ability to successfully
and cost-effectively complete the MS Phase 2 and Phase 3 trials;
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 TG-1101 for MS; the risk that TG-1101 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.
TGTX -
G
Jenna
Bosco
Vice President -
Investor Relations
TG Therapeutics,
Inc.
Telephone:
212.554.4351
Email: ir@tgtxinc.com