Ligand Initiates Phase II Trial with LGD-4665 in Idiopathic Thrombocytopenic Purpura
SAN DIEGO--
Ligand Pharmaceuticals Incorporated (NASDAQ: LGND) today announced
that it has initiated a Phase II study of its small-molecule
thrombopoietin (TPO) mimetic, LGD-4665. The 24 patient, double-blind
placebo-controlled trial is designed to evaluate the safety and
efficacy of LGD-4665 in adult patients with idiopathic
thrombocytopenic purpura (ITP) over six weeks of treatment.
LGD-4665 was found to be safe and well tolerated in a Phase I
study in healthy human volunteers that was completed in the fourth
quarter of 2007. Statistically significant platelet increases were
observed with both single and multiple daily dose regimens.
"Initiation of this Phase II trial represents an important
milestone in the continued development of LGD-4665. We are pleased to
advance another Ligand molecule into studies for the treatment of an
important medical disease. We plan to initiate additional clinical
studies with LGD-4665 this year," said John L. Higgins, President and
Chief Executive Officer of Ligand Pharmaceuticals. "Our TPO drug
program is focused on developing LGD-4665 for multiple indications as
well as advancing clinically distinctive next generation molecules. We
were also pleased to see that the March 2008 edition of R&D Directions
magazine listed LGD-4665 among its '100 Great Investigational Drugs.'"
About Idiopathic Thrombocytopenic Purpura
ITP is a bleeding disorder characterized by increased autoimmune
platelet destruction and/or inadequate platelet production. The cause
of the disease is currently unknown. Some patients with ITP are
asymptomatic or have mild bruising in skin or mucosa, while others
develop mucosal or central organ bleeding that can become severe.
There are approximately 50,000 to 100,000 chronic ITP patients in the
U.S. A similar patient population exists in the European Union.
About Ligand Pharmaceuticals
Ligand discovers and develops new drugs that address critical
unmet medical needs of patients in the areas of thrombocytopenia,
cancer, hepatitis C, hormone-related diseases, osteoporosis and
inflammatory diseases. Ligand's proprietary drug discovery and
development programs are based on its leadership position in gene
transcription technology.
Forward-Looking Statements
This press release contains forward-looking statements within the
meaning of section 21E of the Securities Exchange Act of 1934, as
amended, that involve risks and uncertainties and reflect Ligand's
judgment as of the date of this press release. These statements
include those regarding data analysis and evaluation of LGD-4665,
utility or potential benefits to patients, plans for continued
development and further studies of LGD-4665 for the treatment of
diseases associated with thrombocytopenia. Actual events or results
may differ from our expectations. For example, there can be no
assurance that other trials or evaluations of LGD-4665 or other
TPO-related product candidates will be favorable or that they will
confirm results of previous studies, that data evaluation will be
completed or demonstrate any hypothesis or endpoint, that LGD-4665 or
other TPO-related product candidates will provide utility or benefits
to certain patients, that any presentations will be favorably
received, that LGD-4665 or other TPO-related product candidates will
be useful as a single agent or in combination with other drugs, that
marketing applications will be filed or, if filed, approved, or that
clinical or commercial development of these product candidates will be
initiated, completed or successful or that our rights to LGD-4665 and
other TPO-related product candidates will not be successfully
challenged. Our stock price may suffer as a result of the failure of
any trials to be completed or meet their endpoints or if any actual
events differ from our expectations. Additional information concerning
these and other risk factors affecting Ligand can be found in prior
press releases as well as in public periodic filings with the
Securities and Exchange Commission, available via www.ligand.com.
Ligand disclaims any intent or obligation to update these
forward-looking statements beyond the date of this press release. This
caution is made under the safe harbor provisions of the Private
Securities Litigation Reform Act of 1995.
Source: Ligand Pharmaceuticals Incorporated
Released April 24, 2008