Galapagos candidate metastasis drug shows good safety and biomarker response

(Thomson Reuters ONE) - * Successful conclusion of first clinical trial for GLPG0187 * Plans to initiate clinical trial in cancer patients this yearMechelen, Belgium; 19 January 2010 - Galapagos NV (Euronext: GLPG) announcedresults from the first-in-human trial with candidate drug GLPG0187.  GLPG0187offers a new approach to treat metastases, a severe complication of manycancers.  The candidate drug showed good safety and a promising biomarkerprofile in healthy volunteers.  Based on the results from the trial, Galapagosplans to initiate a second Phase I trial including cancer patients later thisyear."We are excited that our candidate drug demonstrated a clear biological responsein healthy volunteers.  With these promising biomarker data and the favorablesafety profile, we believe GLPG0187 has strong potential as a cancer drug," saidOnno van de Stolpe, CEO of Galapagos.  "Therefore, we have decided to broadenthe therapeutic focus to metastatic cancer, which is more prevalent than bonemetastasis."In the double-blind, placebo-controlled trial, 27 healthy volunteers were givenescalating doses of candidate drug GLPG0187 by either subcutaneous injection(17.5 to 315 mg) or oral administration (50 to 1200 mg).  For both routes ofadministration, systemic safety data were favorable with no severe adverseevents or changes in vital signs or laboratory parameters observed.  Localreactions occurring at or near the injection site were not attributable to thecandidate drug.  A biomarker relevant to bone metastasis (serum CTX, collagentelopeptide) showed a response lasting 24 hours.  Although bioavailability forthe oral formulation was low, a clear biomarker response was observed with twooral doses (300 and 1200 mg).  Given these results, Galapagos plans to initiatea second Phase I trial including cancer patients later this year.  Galapagos isalso working to improve the injectable formulation and the bioavailability ofthe oral formulation.About GLPG0187GLPG0187, an integrin receptor antagonist (IRA), blocks five integrin receptorsknown to be present in many metastatic cancers, affording a unique anti-integrinprofile.  In animal studies, oral administration of GLPG0187 as a single agenthas been shown to inhibit multiple processes involved in the spread and growthof metastatic tumors.About metastatic cancerMetastatic cancer is a cancer that has spread from its primary site (such as thebreast or prostate) to other parts of the body.  Once in the bloodstream,metastatic cancer can spread throughout the body, but the most common sites ofmetastases are the lungs, bones, liver and brain.  According to the AmericanCancer Society, an estimated half million cancer-related deaths occur annuallyin the U.S. and metastases are responsible for the majority of these cases.Once cancer has metastasized, it is rarely curable, but treatment options canincrease the length and quality of patient lives.About GalapagosGalapagos (Euronext: GLPG; OTC: GLPYY) is a drugdiscovery and development company with small molecule programs in bone and jointdiseases, metastatic cancer, cachexia, anti-infectives and metabolic diseases.It has established risk sharing alliances with GlaxoSmithKline, JanssenPharmaceutica, Eli Lilly, Merck & Co., Inc. and Roche.  Through an alliance withMorphoSys, Galapagos is also developing new antibody therapies in bone and jointdiseases.  Its division BioFocus offers a full suite of target-to-drug discoveryproducts and services to pharmaceutical and biotech companies and to patientfoundations, encompassing target discovery and validation, screening and drugdiscovery through to delivery of pre-clinical candidates.  Galapagos has morethan 500 employees and operates facilities in six countries, with globalheadquarters in Mechelen, Belgium.  More info at: www.glpg.comCONTACTGalapagos NVElizabeth Goodwin, Director Investor RelationsTel: +31 6 2291 6240ir(at)glpg.com This release may contain forward-looking statements, including, withoutlimitation, statements containing the words "believes," "anticipates,""expects," "intends," "plans," "seeks," "estimates," "may," "will," "could,""stands to," and "continues," as well as similar expressions.  Suchforward-looking statements may involve known and unknown risks, uncertaintiesand other factors which might cause the actual results, financial condition,performance or achievements of Galapagos, or industry results, to be materiallydifferent from any historic or future results, financial conditions, performanceor achievements expressed or implied by such forward-looking statements.  Giventhese uncertainties, the reader is advised not to place any undue reliance onsuch forward-looking statements.  These forward-looking statements speak only asof the date of publication of this document.  Galapagos expressly disclaims anyobligation to update any such forward-looking statements in this document toreflect any change in its expectations with regard thereto or any change inevents, conditions or circumstances on which any such statement is based, unlessrequired by law or regulation.[HUG#1374587]

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Datum: 19.01.2010 - 01:31 Uhr
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