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EX-99.1 - EXHIBIT 99.1 - TG THERAPEUTICS, INC. | v061518_ex991.htm |
8-K - 8-K - TG THERAPEUTICS, INC. | v061518_8k.htm |
Exhibit 99.2
TG Therapeutics, Inc. Announces Oral Presentation of Umbralisib
plus Ruxolitinib in Patients with Myelofibrosis at the
23rd
Congress of the European Hematology Association
Data demonstrates that the addition of umbralisib to ruxolitinib
can induce responses in patients with sub-optimal response to
ruxolitinib single agent
NEW
YORK, NY (June 15, 2018) - TG Therapeutics, Inc. (NASDAQ: TGTX),
today announced updated clinical data from its ongoing Phase I
study evaluating umbralisib (TGR-1202), the Company’s PI3K
delta inhibitor in combination with ruxolitinib, the JAK 1/2
inhibitor, in ruxolitinib experienced patients with myelofibrosis
(MF). Data from this trial are being presented this morning during
the 23rd
Congress of the European Hematology Association (EHA).
Michael
S. Weiss, the Company's Executive Chairman and Chief Executive
Officer, stated, “The data presented in patients with
myelofibrosis represents yet another unique opportunity for
umbralisib, in this case providing a treatment option to patients
who are not achieving an optimal response to ruxolitinib
monotherapy. This type of study highlights the unique breadth of
activity of PI3K delta inhibition across hematological malignancies
and underscores the importance of umbralisib’s safety
profile, that permits a wide range of combinations.” Mr.
Weiss continued, “We look forward to evaluating this
combination further, potentially in a randomized pivotal
setting.”
Highlights
from this morning’s presentation include the
following:
Oral Presentation:
Resurrecting response to ruxolitinib: a phase I study testing the
combination of ruxolitinib and the PI3Kdelta inhibitor umbralisib
in ruxolitinib-experienced myelofibrosis (Abstract Number
S133)
This
oral presentation includes data from patients with myelofibrosis
treated with the combination of ruxolitinib, the JAK1/2 inhibitor
and umbralisib (TGR-1202). Importantly, per protocol, all enrolled
patients were on a stable dose of ruxolitinib monotherapy and had
achieved their best response to ruxolitinib prior to enrolling to
receive umbralisib. Presentation highlights included:
●
The combination of
umbralisib + ruxolitinib was well-tolerated with limited Grade 3/4
adverse events;
o
Dose-limiting
toxicities of asymptomatic amylase/lipase elevations were observed
of unclear clinical consequence;
●
Increases in
hemoglobin, improvements in spleen size, and reduction in symptoms
meeting IWG-MRT criteria for clinical improvement were seen in 13
(57%) ruxolitinib-experienced myelofibrosis patients;
●
Importantly, 2
patients (9%) achieved a durable complete remission after
progressing on ruxolitinib;
●
The addition of
umbralisib to ruxolitinib demonstrates the ability to augment or
resurrect a response in myelofibrosis patients who had suboptimal
or lost response to ruxolitinib alone.
PRESENTATION DETAILS
The
above referenced presentation is now 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.
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
Some of the statements included in this press release or in the
abstracts mentioned in this press release 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 preclinical and clinical trials; the risk that
early clinical trial results (both safety and efficacy), that may
have supported the acceptance of our data for presentation or
influenced our decision to proceed with additional clinical trials,
will not be reproduced in future studies or in the final
presentations; the risk that the differentiated tolerability
profile for umbralisib observed will not be reproduced in full
presentations or later larger studies the risk that we will not
evaluate the combination of ruxolitinib and umbralisib in
myelofibrosis or any other indication; 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
SVP,
Corporate Communications
TG
Therapeutics, Inc.
Telephone:
212.554.4351
Email:
ir@tgtxinc.com