Full Press Release Details
Lixte Biotechnology Announces a Clinical
Trial Agreement with Moffitt Cancer Center to Initiate a Phase 1b/2 Trial Evaluating the Safety and Efficacy of LB-100 in Treatment
of Patients with Low or Intermediate-1 Risk Myelodysplastic Syndrome
- (August 21, 2018) - Lixte Biotechnology Holdings, Inc. (OTCQB: LIXT) announced that it has entered into a Clinical
Trial Agreement and Exclusive License Agreement with Moffitt Cancer Center to conduct a Phase 1b/2 study of the safety
and therapeutic benefit of Lixte's lead clinical compound, LB-100, in patients with myelodysplastic syndrome (MDS). The
trial will enter low and intermediate-1 risk MDS patients, including those with del(5q) MDS who have failed or are intolerant
of standard treatment.
Dr. John S. Kovach, founder and CEO of
Lixte, said, "Certain cancers possessing unique genetic changes are vulnerable to inhibition of an enzyme, protein phosphatase
2A (PP2A), by LB-100. Among these is myelodysplastic syndrome (MDS), an increasingly common family of neoplastic diseases, especially
in persons aged 65 and older. MDS is characterized by failure of the bone marrow often causing significant anemia and requiring
frequent blood transfusions. In preclinical models of MDS, treatment with LB-100 inhibits the growth and/or induces the death of
the abnormal blood cells. Cells of one variant of MDS, termed del(5q) MDS, are missing 50% of their PP2A activity rendering them
sensitive to PP2A inhibition."
Currently there is only one drug, lenalidomide,
approved for the treatment of del(5q) MDS, and virtually all patients become resistant to this therapy.
"We are excited to embark on the clinical
investigation of LB-100 in lower-risk MDS patients. If LB-100 proves to be effective in the clinic, it could be an important addition
to the limited treatment options for patients failing standard treatment," said David Sallman, M.D., assistant member
of Moffitt's Malignant Hematology Department.
Lixte Biotechnology Holdings, Inc.
is a biotech company that identifies enzyme targets associated with serious common diseases and then designs novel compounds
to attack those targets. Lixte's product pipeline is primarily focused on inhibitors of protein phosphatases, used alone
and in combination with cytotoxic agents and immune checkpoint blockers.
About Moffitt Cancer Center
Moffitt is dedicated to one lifesaving
mission: to contribute to the prevention and cure of cancer. The Tampa-based facility is one of only 49 National Cancer Institute-designated
Comprehensive Cancer Centers, a distinction that recognizes Moffitt's scientific excellence, multidisciplinary research,
and robust training and education. Moffitt is a Top 10 cancer hospital and has been nationally ranked by U.S. News & World
Report since 1999. Moffitt devotes more than 2 million square feet to research and patient care. Moffitt's expert nursing
staff is recognized by the American Nurses Credentialing Center with Magnet status, its highest distinction. With
more than 6,000 team members, Moffitt has an economic impact in the state of $2.1 billion. For more information, call 1-888-MOFFITT
(1-888-663-3488), visit MOFFITT.org, and follow the momentum on Facebook, Twitter and YouTube.
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
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"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.
information on the Company is available at www.lixte.com.