Lixte Biotechnology and City of Hope Enroll First Patient in Phase 1b Trial of Lead Compound LB-100 for Treatment of Small Ce...
02 Giugno 2021 - 3:35PM
Lixte Biotechnology Holdings, Inc. (Nasdaq: LIXT), a clinical-stage
drug discovery company developing pharmacologically active drugs
for use in cancer treatment, today announced the enrollment of the
first patient in a Phase 1b clinical trial with City of Hope, a
world-renowned independent cancer research and treatment center.
The trial will assess the combination of Lixte’s first-in-class
protein phosphatase 2A (PP2A) inhibitor LB-100 with a standard
regimen for previously untreated, extensive stage-disease small
cell lung cancer (ED-SCLC) (NCT04560972).
John S. Kovach, M.D., Lixte founder and chief
executive officer, said, “In collaboration with City of Hope, we
are eager to pursue our well-grounded rationale for
adding LB-100 to a standard ED-SCLC
regimen of carboplatin and etoposide chemotherapy
plus atezolizumab to enhance effectiveness. In preclinical studies,
the malignant cells of this uniformly fatal cancer are genetically
sensitive to PP2A inhibition by a process termed synthetic
lethality and the effectiveness of the standard regimen is enhanced
by LB-100.
“Small cell lung cancer comprises approximately
15% of all lung cancers worldwide with about 30,000 new cases
annually in the U.S.,” Dr. Kovach continued. “The median
survival of patients with this especially aggressive type of
lung cancer, even with current ‘best’ therapy, is approximately
nine months. Because of such rapid disease progression, the
therapeutic benefit of adding LB-100 to the standard treatment may
be seen early on in this Phase 1b clinical trial.”
Ravi Salgia, M.D., Ph.D., City of Hope’s Arthur
& Rosalie Kaplan Chair in Medical Oncology, said, “We are
hopeful that this trial testing a potentially more effective
therapeutic combination could provide another treatment option for
small cell lung cancer patients. It is a disease that is currently
difficult to treat, particularly after a patient has relapsed, so
more therapeutic options are needed.”
About the Study
In the Phase 1b trial of LB-100 for the
treatment of ED-SCLC, Lixte’s lead compound will be given in
combination with carboplatin, etoposide and atezolizumab, an FDA
approved but marginally effective regimen, in previously untreated
ED-SCLC. The dose of LB-100 will be escalated with fixed doses of
the 3-drug regimen to reach a recommended Phase 2 dose (RP2D).
Patient entry will then be expanded so that a total of 12 patients
will be evaluable at the RP2D to confirm its safety and to look for
objective evidence of potential therapeutic activity as assessed by
objective response rate, duration of overall response,
progression-free-survival and overall survival. The study is open
at City of Hope in Duarte, California.
About City of Hope
City of Hope is an independent biomedical
research and treatment center for cancer, diabetes and other
life-threatening diseases. Founded in 1913, City of Hope is a
leader in bone marrow
transplantation and immunotherapy such
as CAR T cell therapy. City of Hope’s translational research
and personalized treatment protocols advance care throughout the
world. Human synthetic insulin, monoclonal
antibodies and numerous breakthrough cancer
drugs are based on technology developed at the
institution. AccessHopeTM, a wholly owned subsidiary, was
launched in 2019 and is dedicated to serving employers and
their health care partners by providing access to City of Hope’s
exceptional cancer expertise. A National Cancer
Institute-designated comprehensive cancer center and a founding
member of the National Comprehensive Cancer Network, City of Hope
is ranked among the nation’s “Best Hospitals” in cancer by U.S.
News & World Report. Its main campus is located near Los
Angeles, with additional locations throughout Southern
California and in Arizona. For more information about City of
Hope, follow us
on Facebook, Twitter, YouTube or Instagram.
About Lixte Biotechnology Holdings, Inc.
Lixte Biotechnology Holdings, Inc. (Nasdaq:
LIXT), is a clinical-stage pharmaceutical company dedicated to
discovering drugs for more effective treatments for many forms of
cancer and other serious common diseases. A major driver of cancer
is defects in the switches that turn the biochemical pathways in
cells on and off. Most cancer research over the past 30 years has
focused on the “on” switches because the “off” switches, especially
the master “off” switch protein phosphatase (PP2A), were believed
to cause intolerable toxicity in patients. Lixte has achieved a
breakthrough with its novel, first-in-class lead compound, PP2A
inhibitor LB-100, by demonstrating that it is readily tolerated in
cancer patients at doses associated with anti-cancer activity. This
innovative approach encourages cancer cells, damaged by chemo or
other cancer therapies, to continue to replicate before repairing
the damage, leading to the more efficient death and elimination of
those cells from the body. Lixte has partnered with top medical
institutions and leading academic research centers to advance the
clinical development of its compounds. The LB-100 compound, of
which there are no competitors known to Lixte, is being tested in
three clinical cancer treatment studies with others in planning.
www.lixte.com
Forward-Looking Statements
This announcement contains certain
forward-looking statements within the meaning of Section 27A of the
Securities Act of 1933, and Section 21E of the Securities Exchange
Act of 1934. For example, statements regarding the Company's
financial position, business strategy and other plans and
objectives for future operations, and assumptions and predictions
about future product demand, supply, manufacturing, costs,
marketing and pricing factors are all forward-looking statements.
These statements are generally accompanied by words such as
"intend," anticipate," "believe," "estimate," "potential(ly),"
"continue," "forecast," "predict," "plan," "may," "will," "could,"
"would," "should," "expect" or the negative of such terms or other
comparable terminology. The Company believes that the assumptions
and expectations reflected in such forward-looking statements are
reasonable, based on information available to it on the date
hereof, but the Company cannot provide assurances that these
assumptions and expectations will prove to have been correct or
that the Company will take any action that the Company may
presently be planning. However, these forward-looking statements
are inherently subject to known and unknown risks and
uncertainties. Actual results or experience may differ materially
from those expected or anticipated in the forward-looking
statements. Factors that could cause or contribute to such
differences include, but are not limited to, regulatory policies,
available cash, research results, competition from other similar
businesses, and market and general economic factors. This
discussion should be read in conjunction with the Company's filings
with the United States Securities and Exchange Commission at
http://www.sec.gov/edgar.shtml.
Lixte Contact:info@lixte.comGeneral Phone:
(631) 830-7092Investor Phone: (888) 289-5533
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