TG Therapeutics Announces Orphan Drug Designation for TGR-1202 for Treatment of Chronic Lymphocytic Leukemia
August 24 2016 - 9:25AM
TG Therapeutics, Inc. (NASDAQ:TGTX) today announced that
the U.S. Food and Drug Administration (FDA) has granted
orphan drug designation for the Company’s oral, next generation
PI3K Delta inhibitor, TGR-1202, for the treatment of patients with
chronic lymphocytic leukemia (CLL). TGR-1202 is currently being
evaluated in the UNITY-CLL Phase 3 Trial for patients with both
frontline and previously treated CLL.
“We are pleased to receive orphan drug designation for
TGR-1202. In addition to our composition of matter patent for
TGR-1202 which issued earlier this year, the granting of this
orphan drug designation offers an additional level of proprietary
protection and also may provide us certain other regulatory and
financial benefits,” said Michael S. Weiss, Executive Chairman
and Interim CEO of TG Therapeutics. “We continue to be excited
about the differentiated safety profile of TGR-1202 over other PI3k
delta inhibitors and believe the UNITY-CLL Phase 3 Trial will
showcase those differences.”
Orphan drug designation is granted by the FDA to drugs and
biologics which are defined as those intended for the safe and
effective treatment, diagnosis or prevention of rare
diseases/disorders that affect fewer than 200,000 people in the
U.S. Orphan drug designation provides certain incentives
which may include tax credits towards the cost of clinical trials
and prescription drug user fee waivers. If a product that has
orphan drug designation subsequently receives the
first FDA approval for the disease for which it has such
designation, the product is entitled to orphan product
exclusivity.
Chronic lymphocytic leukemia (CLL) is a type of cancer in which
the bone marrow makes too many lymphocytes (a type of white blood
cell). CLL usually gets worse slowly and is one of the most
common types of leukemia in adults. It often occurs
during or after middle age. It is estimated that there are
approximately 20,000 new cases of CLL diagnosed each year in the
United States.
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 benefits from
Orphan Drug Designation for TGR-1202, future clinical trials, the
timing of commencing or completing such trials and business
prospects for TG-1101, TGR-1202, the IRAK4 inhibitor program, the
BET inhibitor program, and the anti-PD-L1 and anti-GITR antibodies
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 pre-clinical and clinical trials for
TG-1101, TGR-1202, the IRAK4 inhibitor program, the BET inhibitor
program, and the anti-PD-L1 and anti-GITR antibodies; the risk that
early pre-clinical and clinical results that supported our decision
to move forward with TG-1101, TGR-1202, the IRAK4 inhibitor
program, the BET inhibitor program, and the anti-PD-L1 and
anti-GITR antibodies will not be reproduced in additional patients
or in future studies; the risk that trends observed which underlie
certain assumptions of future performance of TGR-1202 will not
continue, the risk that TGR-1202 will not produce satisfactory
safety and efficacy results to warrant further development
following the completion of the current Phase 1 study; the risk
that the combination of TG-1101 and TGR-1202, referred to as
TG-1303, will not prove to be a safe and efficacious backbone for
triple and quad combination therapies; 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 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
CONTACT:
Jenna Bosco
Vice President, Investor Relations
TG Therapeutics, Inc.
Telephone: 212.554.4351
Email: ir@tgtxinc.com
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