Ligand Partner GSK Announces the Start of a Phase 3 Study with Eltrombopag in Patients with Myelodysplastic Syndromes
SAN DIEGO--
Ligand Pharmaceuticals Incorporated (NASDAQ: LGND) announces that
its partner GlaxoSmithKline (GSK) plc has started a Phase 3 study to
evaluate the platelet supportive care effects of eltrombopag
(Promacta™/Revolade™) in combination with azacitidine (the current
standard of care) versus placebo in combination with azacitidine in
intermediate-1, intermediate-2 or high-risk patients with
myelodysplastic syndromes (MDS). The global SUPPORT (TRC112121) study
will assess the proportion of patients who are platelet transfusion free
during the first four cycles of treatment.
MDS is a type of cancer in which the bone marrow does not make enough
healthy blood cells and there are abnormal (blast) cells in the blood
and/or bone marrow1. The disease usually manifests itself
with one or more cytopenias, or reductions in the number of blood cells,
and patients typically present with complications related to anemia
(fatigue), neutropenia (infections) or thrombocytopenia (bleeding)2.
MDS may evolve into acute myeloid leukemia (AML) in up to 45% of
patients.3
“With the start of the SUPPORT trial GSK continues to advance
eltrombopag in multiple indications to boost platelets to treat
thrombocytopenia, including clinical programs and regulatory approvals
in oncology and infectious disease indications,” said John Higgins,
President and CEO of Ligand Pharmaceuticals. “GSK has maintained a
comprehensive global view of brand management and a deep commitment to
maximizing the reach of Promacta/Revolade to patients with significant
unmet needs. The SUPPORT trial is one of more than 25 active clinical
trials underway with eltrombopag.”
About the SUPPORT study
SUPPORT (StUdy of eltromboPag in myelodysPlastic
SyndrOmes Receiving azaciTidine) is a Phase 3,
randomized, double-blind, placebo-controlled, multicenter study of
eltrombopag or placebo in combination with azacitidine in subjects with
MDS. It is estimated that 350 patients across 30 countries and 156 study
sites with a baseline platelet count of < 75Gi/L, and intermediate-1,
intermediate-2 or high-risk MDS (by International Prognostic Scoring
System) will be enrolled in the study. Eligible patients will be
randomized to receive either eltrombopag (200 mg once daily [100 mg for
East Asians]) plus azacitidine (75 mg/m2 subcutaneously once
daily for 7 days) every 28 days, for at least 6 cycles, or placebo plus
azacitidine. Dose modifications of eltrombopag or placebo will be
permitted to ensure that patient platelet counts remain at a safe and
effective level.
The primary efficacy endpoint will determine the platelet supportive
care effects of eltrombopag in combination with azacitidine versus
placebo in combination with azacitidine by comparing the proportion of
subjects receiving eltrombopag plus azacitidine who are platelet
transfusion free during the first 4 cycles of azacitidine, versus those
treated with placebo plus azacitidine. Secondary objectives will compare
the following between treatment arms: overall survival, disease
response, hematologic improvement, platelet and red blood cell
transfusions, adverse events (≥ Grade 3), safety and tolerability,
health-related quality of life and medical resource utilization.
About Eltrombopag (Promacta™/Revolade™)
Eltrombopag – marketed as Promacta™ in the U.S. and as
Revolade™ in Europe and other countries around the world –
works by interacting with the TPO receptor leading to increased platelet
production. Eltrombopag is not approved or licensed anywhere in the
world for use in patients with myelodysplastic syndromes.
For full U.S. Prescribing Information for Promacta®
(eltrombopag), including Boxed Warning, please visit: https://www.gsksource.com/gskprm/htdocs/documents/PROMACTA-PI-MG-COMBINED.PDF.
For the European Union (EU) Summary of Product Characteristics (SPC) for
Revolade® (eltrombopag) in approved indications,
please visit http://health.gsk.com/.
Promacta™ and Revolade™ are trademarks of the GSK
group of companies.
About Ligand Pharmaceuticals
Ligand is a biopharmaceutical company with a business model that is
based upon the concept of developing or acquiring royalty revenue
generating assets and coupling them to a lean corporate cost structure.
Ligand’s goal is to produce a bottom line that supports a sustainably
profitable business. By diversifying our portfolio of assets across
numerous technology types, therapeutic areas, drug targets and industry
partners, we offer investors an opportunity to invest in the
increasingly complicated and unpredictable pharmaceutical industry. In
comparison to its peers, we believe Ligand has assembled one of the
largest and most diversified asset portfolios in the industry with the
potential to generate revenue in the future. These therapies address the
unmet medical needs of patients for a broad spectrum of diseases
including diabetes, hepatitis, muscle wasting, Alzheimer's disease,
dyslipidemia, anemia, asthma and osteoporosis. Ligand’s Captisol
platform technology is a patent protected, chemically modified
cyclodextrin with a structure designed to optimize the solubility and
stability of drugs. Ligand has established multiple alliances with the
world's leading pharmaceutical companies including GlaxoSmithKline, Onyx
Pharmaceuticals (a subsidiary of Amgen Inc.), Merck, Pfizer, Baxter
International, Eli Lilly & Co. and Spectrum Pharmaceuticals. Please
visit www.captisol.com
for more information on Captisol. For more information on Ligand, please
visit www.ligand.com.
Follow Ligand on Twitter @Ligand_LGND.
References
1 National Cancer Institute. Myelodysplastic Syndromes
Treatment (PDQ®). Available at: http://www.cancer.gov/cancertopics/pdq/treatment/myelodysplastic/Patient/page1.
Accessed June 12, 2014.
2 Faderl S, Kantarjian H.
Myelodysplastic Syndromes. In: Devita V, Hellman S, Rosenberg S, editor.
Cancer: Principles & Practice of Oncology 7th Edition. Philadelphia,
PA:Lippincott, Williams & Wilkins, 2005:2144-2154.
3
Greenberg P, Cox C, LeBeau MM, Fenaux P, Morel P, Sanz G, Sanz M,
Vallespi T, Hamblin T, Oscier D, Ohyashiki K, Toyama K, Aul C, Mufti G,
Bennett J. International scoring system for evaluating prognosis in
myelodysplastic syndromes. Blood. 1997; 89: 2079-2088.
Forward-Looking Statements
This news release contains forward-looking statements by Ligand that
involve risks and uncertainties and reflect Ligand’s judgment as of the
date of this release. These forward-looking statements include comments
regarding eltrombopag, data analysis and evaluation of eltrombopag,
utility or potential benefits to patients, the potential commercial
market for eltrombopag and plans for continued development and further
studies of eltrombopag. Actual events or results may differ from
Ligand’s expectations. For example, there can be no assurance that other
trials or evaluations of eltrombopag 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 eltrombopag
will provide utility or benefits to certain patients, that any
presentations will be favorably received, that eltrombopag will be
useful, that marketing applications will be filed or, if filed,
approved, or that clinical or commercial development of eltrombopag will
be initiated, completed or successful or that our rights to eltrombopag
will not be successfully challenged. The failure to meet expectations
with respect to any of the foregoing matters may reduce Ligand’s stock
price. Additional information concerning these and other risk factors
affecting Ligand can be found in prior press releases available at www.ligand.com
as well as in public periodic filings with the Securities and Exchange
Commission, available at www.sec.gov.
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.
Ligand Pharmaceuticals Incorporated
John Higgins, President and CEO
(858)
550-7500
investors@ligand.com
@Ligand_LGND
or
LHA
Bruce
Voss
(310) 691-7100
bvoss@lhai.com
@LHA_IR_PR
Source: Ligand Pharmaceuticals Incorporated
Released June 25, 2014