TAMPA, Florida, Sept. 12, 2019 /PRNewswire/ -- GT Biopharma, Inc.
(OTCQB: GTBP) (GTBP.PA) an immuno-oncology company focused on
innovative treatments based on the Company's proprietary NK cell
engager (TriKE™) platform and Multi-Target Directed Bispecific Drug
Conjugate platform, announced today that it notified FDA that it
was commencing enrollment in its first-in-human GTB-3550 Phase I/II
clinical trial. The clinical trial is being conducted at the
University of Minnesota's Masonic
Cancer Center in Minneapolis,
Minnesota under the direction of Dr. Erica Warlick.
The open-label, dose-escalation Phase I portion of the trial
will evaluate GTB-3550 in patients with CD33-expressing, high risk
myelodysplastic syndromes, refractory/relapsed acute myeloid
leukemia or advanced systemic mastocytosis, and will determine
safety and tolerability as well as the pharmacologically active
dose and maximum tolerated dose of GTB-3550. The Phase II
portion of the trial is planned to further evaluate the recommended
dose of GTB-3550 in this patient population.
Mr. Anthony Cataldo, the Chairman
and Chief Executive Officer of GT Biopharma commented "we are
pleased to begin patient enrollment in this population of advanced
cancer patients." Mr. Cataldo further stated, "We appreciate the
support Dr. Warlick and the University of
Minnesota have provided, and are looking forward to
furthering our relationship as we advance other TriKEs into the
clinic."
About GTB-3550 Trispecific NK cell Engager (TriKE™)
GTB-3550 (OXS-3550) is the Company's first Tri-specific NK cell
Engager (TriKE™) product candidate being initially developed for
the treatment AML. GTB-3550 is a single-chain, tri-specific
scFv recombinant fusion protein conjugate composed of the variable
regions of the heavy and light chains of anti-CD16 and anti-CD33
antibodies and a modified form of IL-15. The natural killer
(NK) cell stimulating cytokine human IL-15 portion of the molecule
provides a self-sustaining signal that activates NK cells and
enhances their ability to kill. We intend to study GTB-3550 in
CD33 positive leukemias such as acute myeloid leukemia (AML),
myelodysplastic syndrome (MDS), and other CD33+ hematopoietic
malignancies.
About GTB-1550 Multi-Target Directed Bispecific Drug
Conjugate
GTB-1550 targets cancer cells expressing the CD19 receptor or
CD22 receptor or both receptors thereby maximizing cancer cell
recognition by binding to CD19+, CD22+ and CD19+/CD22+ cancer
cells. When GTB-1550 binds to cancer cells, the cancer cells
internalize GTB-1550, and are killed due to the action of drug's
cytotoxic diphtheria toxin payload.
About GT Biopharma, Inc.
GT Biopharma, Inc. is a clinical stage biopharmaceutical company
focused on the development and commercialization of immuno-oncology
products based off our proprietary Tri-specific Killer Engager
(TriKE™) and Multi-Target Directed Bispecific Drug Conjugate
technology platforms. Our TriKE platform is designed to
harness and enhance the cancer killing abilities of a patient's
immune system natural killer cells (NK cells). GT Biopharma
has an exclusive worldwide license agreement with the University of Minnesota to further develop and
commercialize cancer therapies using proprietary TriKE technology
developed by researchers at the university to target NK cells to
cancer. Our Multi-Target Directed Bispecific Drug Conjugate
platform can generate product candidates that are bi-specific,
ligand-directed single-chain fusion proteins that, we believe,
represent the next generation of targeted therapy.
Forward-Looking Statements
This press release contains certain forward-looking statements
that involve risks, uncertainties and assumptions that are
difficult to predict, including statements regarding the potential
acquisition, the likelihood of closing the potential transaction,
our clinical focus, and our current and proposed trials.
Words and expressions reflecting optimism, satisfaction or
disappointment with current prospects, as well as words such as
"believes", "hopes", "intends", "estimates", "expects", "projects",
"plans", "anticipates" and variations thereof, or the use of future
tense, identify forward-looking statements, but their absence does
not mean that a statement is not forward-looking. Our
forward-looking statements are not guarantees of performance and
actual results could differ materially from those contained in or
expressed by such statements. In evaluating all such statements, we
urge you to specifically consider the various risk factors
identified in our Form 10-K for the fiscal year ended
December 31, 2018 in the section titled "Risk Factors" in Part
I, Item 1A and in our subsequent filings with the Securities and
Exchange Commission, any of which could cause actual results to
differ materially from those indicated by our forward-looking
statements.
Our forward-looking statements reflect our current views with
respect to future events and are based on currently available
financial, economic, scientific, and competitive data and
information on current business plans. You should not place
undue reliance on our forward-looking statements, which are subject
to risks and uncertainties relating to, among other
things: (i) the sufficiency of our cash position and our
ongoing ability to raise additional capital to fund our operations,
(ii) our ability to complete our contemplated clinical trials
for GTB-3550 or GTB-1550, or to meet the FDA's requirements with
respect to safety and efficacy, (iii) our ability to identify
patients to enroll in our clinical trials in a timely fashion,
(iv) our ability to achieve approval of a marketable product,
(v) design, implementation and conduct of clinical trials,
(vii) the results of our clinical trials, including the
possibility of unfavorable clinical trial results, (vii) the
market for, and marketability of, any product that is approved,
(viii) the existence or development of treatments that are
viewed by medical professionals or patients as superior to our
products, (ix) regulatory initiatives, compliance with
governmental regulations and the regulatory approval process, and
social conditions, and (x) various other matters, many of
which are beyond our control. Should one or more of these risks or
uncertainties develop, or should underlying assumptions prove to be
incorrect, actual results may vary materially and adversely from
those anticipated, believed, estimated, or otherwise indicated by
our forward-looking statements.
We intend that all forward-looking statements made in this press
release will be subject to the safe harbor protection of the
federal securities laws pursuant to Section 27A of the
Securities Act, to the extent applicable. Except as required
by law, we do not undertake any responsibility to update these
forward-looking statements to take into account events or
circumstances that occur after the date of this press
release. Additionally, we do not undertake any responsibility
to update you on the occurrence of any unanticipated events which
may cause actual results to differ from those expressed or implied
by these forward-looking statements.
For more information, please visit www.gtbiopharma.com.
800-304-9888
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SOURCE GT Biopharma, Inc.