Galapagos starts Phase Ib clinical study in cancer patients
(Thomson Reuters ONE) -
Mechelen, Belgium; 14 March 2011 - Galapagos NV (Euronext: GLPG) announced today
that it has started a Phase Ib clinical study for GLPG0187, a novel drug being
developed for metastatic cancer. In this clinical study, Galapagos plans to
assess the safety and explore the preliminary efficacy of GLPG0187 in cancer
patients.
"GLPG0187 marks the third Galapagos compound to be tested in patients," said
Onno van de Stolpe, CEO of Galapagos. "This compound has already shown
potential in the treatment in metastatic cancers in preclinical testing and
shown promising biomarker data in healthy volunteers. With this trial we aim to
gain the first insight into GLPG0187's antitumor effects in cancer patients."
Details of the Phase Ib clinical trial
The clinical Phase Ib study for GLPG0187 will involve cancer patients with solid
tumors. Patients with confirmed diagnosis of advanced, recurrent, or metastatic
cancer who are refractory to standard therapy or for whom no standard therapy
exists, are eligible to enroll in the trial. They will receive intravenous
administration of GLPG0187 for an initial period of four weeks. The primary
endpoint will be to assess the safety and tolerability of GLPG0187 in cancer
patients during this four week period. The secondary endpoints include
pharmacokinetics and pharmacodynamics (CTX biomarker) of the candidate drug and
preliminary antitumor effects of GLPG0187 according to RECIST[1] 1.1, the
standard endpoint for cancer clinical trials. The number of patients enrolled
in this study will depend on the number of dose levels needed to determine the
maximum tolerated dose (MTD), which is essential for any cancer therapeutic.
Galapagos has received regulatory approvals to start the study at a first site
in Utrecht, The Netherlands. A second center will be added during the course of
the trial.
About GLPG0187
GLPG0187, an integrin receptor antagonist (IRA), binds to six integrin receptors
known to be present in many metastatic cancers, affording a unique anti-integrin
profile. In animal studies, oral administration of GLPG0187 as a single agent
has been shown to inhibit multiple processes involved in the spread and growth
of metastatic tumors. A Phase I clinical study for GLPG0187 in healthy
volunteers showed good safety and a promising biomarker profile.
About metastatic cancer
Metastatic cancer is a cancer that has spread from its primary site (such as the
breast or prostate) to other parts of the body. Once in the bloodstream,
metastatic cancer cells can spread throughout the body, but the most common
sites of metastases are the lungs, bones, liver and brain. According to the
American Cancer Society, an estimated half million cancer-related deaths occur
annually in the U.S. and metastases are responsible for the majority of these
cases. Once cancer has metastasized, it is rarely curable, but treatment
options can increase the length and quality of patient lives.
About Galapagos
Galapagos (Euronext: GLPG; OTC: GLPYY) is a mid-size biotechnology company
specialized in the discovery and development of small molecule and antibody
therapies with novel modes-of-action. The Company is progressing one of the
largest pipelines in biotech, with seven clinical and over 50
discovery/preclinical programs. Through risk/reward-sharing alliances with
GlaxoSmithKline, Eli Lilly, Janssen Pharmaceutica, Roche and Servier, Galapagos
is eligible to receive up to ?2.5 billion in downstream milestones, plus
royalties. The Galapagos Group has over 800 employees and operates facilities
in seven countries, with global headquarters in Mechelen, Belgium. More info
at: www.glpg.com
CONTACT
Galapagos NV
Piet Wigerinck, SVP Development
Tel: +32 15 342 900
Elizabeth Goodwin, Director Investor Relations
Tel: +31 6 2291 6240
ir(at)glpg.com
This release may contain forward-looking statements, including, without
limitation, statements containing the words "believes," "anticipates,"
"expects," "intends," "plans," "seeks," "estimates," "may," "will," "could,"
"stands to," and "continues," as well as similar expressions. Such forward-
looking statements may involve known and unknown risks, uncertainties and other
factors which might cause the actual results, financial condition, performance
or achievements of Galapagos, or industry results, to be materially different
from any historic or future results, financial conditions, performance or
achievements expressed or implied by such forward-looking statements. Given
these uncertainties, the reader is advised not to place any undue reliance on
such forward-looking statements. These forward-looking statements speak only as
of the date of publication of this document. Galapagos expressly disclaims any
obligation to update any such forward-looking statements in this document to
reflect any change in its expectations with regard thereto or any change in
events, conditions or circumstances on which any such statement is based, unless
required by law or regulation.
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[1] RECIST (Response Evaluation Criteria In Solid Tumors) is a set of published
rules that define when cancer patients improve ("respond"), stay the same
("stable") or worsen ("progression") during treatments. The majority of
clinical trials evaluating cancer treatments for objective response in solid
tumors use RECIST.
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Source: Galapagos NV via Thomson Reuters ONE
[HUG#1496529]
Unternehmensinformation / Kurzprofil:
Datum: 14.03.2011 - 07:30 Uhr
Sprache: Deutsch
News-ID 52394
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contact information:
Town:
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