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EX-99.1 - EXHIBIT 99.1 - TG THERAPEUTICS, INC. | v120616_ex99-1.htm |
8-K - FORM 8-K - TG THERAPEUTICS, INC. | v120616_8k.htm |
Exhibit 99.2
TG
Therapeutics, Inc. Announces that the GENUINE Phase 3 Study has
Reached Target Enrollment
Top-line data expected first half 2017
NEW
YORK, NY (December 6, 2016) - TG Therapeutics, Inc. (NASDAQ:TGTX),
today announced that the target enrollment of 120 patients in the
GENUINE Phase 3 study has been met and enrollment will be closed
shortly. The GENUINE Phase 3 study is a randomized study of
TG-1101, the Company’s novel, glycoengineered
anti-CD20 monoclonal antibody in combination with ibrutinib,
the oral Bruton’s tyrosine kinase (BTK), versus ibrutinib
alone in approximately 120 patients with high-risk relapsed or
refractory Chronic Lymphocytic Leukemia (CLL). In October, the
study was modified to convert the primary endpoint solely to
Overall Response Rate (ORR). If the study results are positive, and
subject to a positive outcome of pre-BLA meeting with the FDA, the
Company plans to utilize the results to file for accelerated
approval. The Company expects to release top-line data from the
GENUINE Phase 3 study in the first half of 2017.
Michael
S. Weiss, the Company’s Executive Chairman and Interim CEO
commenting on the announcement stated, “Today’s news
puts us on a clear path toward our first pivotal data for TG-1101.
As demonstrated in our Phase 2 study evaluating TG-1101 plus
ibrutinib, we believe the addition of an anti-CD20 monoclonal
antibody can enhance the clinical response of single agent
ibrutinib by more rapidly reducing tumor burden, increasing the
rate of response, deepening responses and, ideally, leading to
better long-term outcomes. Overall response rate has been utilized
as an acceptable surrogate endpoint for improved progression free
survival and overall survival for a number of recent approvals in
high-risk CLL and we believe the results, if positive, may support
an accelerated approvable for the combination. We want to thank our
clinical collaborators and their patients for their participation
in this study.”
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, 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 are in clinical
development for patients with hematologic malignancies, with
TG-1101 recently entering clinical development for autoimmune
disorders. The Company also has pre-clinical programs to develop
IRAK4 inhibitors, BET inhibitors, and anti-PD-L1 and anti-GITR
antibodies. TG Therapeutics is headquartered in New York
City.
Cautionary
Statement
Some of
the statements included in this press release, particularly those
with respect to anticipating the timing of the completion of the
GENUINE study, timing of the completion of the UNITY-CLL study,
timing of filing of a BLA for TGR-1101, and projected cost savings
from amending the GENUINE study 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 GENUINE
or the UNITY-CLL trials; the risk that the clinical results from
the GENUINE or UNITY-CLL studies will be not positive and/or will
not support regulatory approval of TG-1101 or TGR-1202; the risk
that the FDA will not grant us a pre-BLA meeting to discuss the
results of the GENUINE study; the risk that we will not file a BLA
for TG-1101 or an NDA for TGR-1202 based on either the GENUINE or
the UNITY-CLL; the risk that despite early positive trends in
enrollment in the UNITY-CLL study that enrollment will be delayed
beyond our projections; the risk that the planned interim analysis
will not allow early closure of the single agent arms in the
UNITY-CLL study, necessitating enrollment beyond the projected 450
patients, which would extend enrollment beyond our projections; the
risk that safety issues or trends will be observed in the GENUINE
study or the UNITY-CLL study that prevent approval of either
TG-1101 and/or TGR-1202 or require us to terminate either the
GENUINE study or the UNITY-CLL study prior to completion; the risk
that the data (both safety and efficacy) from future clinical
trials will not coincide with the data produced from prior
pre-clinical and clinical trials; the risk that the GENUINE study,
as amended or the UNITY-CLL study, or any of our other
registration-directed clinical trials as designedor amended may not
be sufficient or acceptable to support regulatory approval; the
risk that trials will take longer to enroll than expected; the risk
that the projected cost savings to be realized by amending the
GENUINE trial will not be realized; 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
CONTACT:
Jenna
Bosco
Vice President,
Investor Relations
TG Therapeutics,
Inc.
Telephone:
212.554.4351
Email:
ir@tgtxinc.com