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 (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
Piet Wigerinck, SVP Development
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 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.