Galapagos starts Phase Ib clinical study in cancer patients
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, 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.
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.
Galapagos<http://www.glpg.com/> (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 ??.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.comwww.glpg.com>
Piet Wigerinck, SVP Development
Tel: +32 15 342 900
Elizabeth Goodwin, Director Investor Relations
Tel: +31 6 2291 6240
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.
 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.
Posted: March 2011