Full Press Release Details
BIOTECHNOLOGY HOLDINGS ANNOUNCES EXPANSION OF CLINICAL SITES FOR ITS PHASE I TRIAL OF ITS LEAD ANTI-CANCER COMPOUND, LB-100
Setauket, New York (January 23, 2015). Lixte Biotechnology Holdings, Inc. (OTCQB: LIXT), announced that the number of clinical
sites where its Phase I trial of Lixte's lead compound, LB 100, is being conducted, has been expanded from 1 to 5 institutions.
S. Kovach, M.D., the founder and President of Lixte, said that "the initial trial was planned to be completed at a single
site. Accrual of patients, however, was slower than projected. The recent addition of 4 more active clinical oncologic research
sites has already enhanced the rate of accrual with patient entry at the 5th planned dose escalation to be completed this month.
The original time-line for completion of both parts of this 2-part trial was June 30, 2015. The estimated time to completion of
Part 1 of the trial, the determination of dose and safety of LB-100 alone (maximum tolerated dose (MTD), is now projected to be
the 2nd quarter of 2015 and completion of Part 2, determination of the MTD of LB-100 combined with docetaxel, the 2nd quarter
of 2016. The estimated cost for completion of both Part 1 and 2 is $2,615,000 versus the original projection of $2,038,000. The
ultimate cost may vary depending on such factors as the number and rate of accrual of patients. The increase in cost is for management
of the study, predominantly the monitoring of the additional new sites over a longer period of time."
Lixte Biotechnology Holdings, Inc.
is a drug discovery company that uses biomarker technology to identify enzyme targets associated with serious common diseases
and then design novel compounds to attack those targets. Lixte's product pipeline encompasses two major categories of compounds
at various stages of pre-clinical and clinical development which the company believes have broad therapeutic potential not only
for cancer but for other debilitating and life-threatening diseases. Lixte's unique phosphatase inhibitor, LB-100, is in
a Phase I cancer trial (see ClinicalTrials.gov: Identifier NCTO1837667).
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
condensed consolidated financial statements and notes thereto in the Annual Report on Form 10-Q for September 30, 2014.
information, please see: www.lixte.com.
Ramson, PCG Advisory Group