SOURCE: Galapagos NV

June 16, 2009 01:38 ET

Galapagos Initiates Clinical Studies With GLPG0187, a Candidate Drug for Bone Metastasis

MECHELEN, BELGIUM--(Marketwire - June 16, 2009) -


* Initiation of Phase 1 human clinical studies with novel compound
* Initial indication aimed at bone metastasis in breast and prostate
  cancer patients
* Second clinical trial initiated by Galapagos this year

Galapagos NV (Euronext: GLPG) announced that today it has initiated Phase I clinical development of its integrin receptor antagonist (IRA), GLPG0187. This is the second small molecule therapeutic from Galapagos' internal drug discovery program to enter the clinic in 2009. Candidate drug GLPG0187 could offer a promising new therapeutic approach for treating cancer patients. Initial development will focus on bone metastases from prostate and breast cancer.

Strong anti-cancer therapeutic profile in pre-clinical models

GLPG0187 offers a potentially highly competitive therapeutic profile compared to currently available agents to treat bone metastasis, a severe aspect of many cancers. GLPG0187 blocks five 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 tumors and the destruction of bone. In these models, GLPG0187 also provided additive benefits to the bone protective action reported for currently used treatments(1). Based on the pre-clinical safety and efficacy data, Galapagos has been granted permission to initiate a first-in-human Phase I study to evaluate this compound's safety, tolerability and pharmacokinetic properties, which will aid in evaluating its further development for the treatment of bone metastases.

"We are pleased to announce the transition of GLPG0187 into clinical development," said Onno van de Stolpe, CEO of Galapagos. "This candidate drug has been shown to affect several steps in cancer disease progression in pre-clinical studies - suggesting that it may slow down the growth of existing bone metastasis as well as protect organs from invading cancer cells."

Details of the Phase I clinical trial

The primary endpoints of this first-in-human trial will be to determine the safety, tolerability and pharmacokinetics of the candidate drug GLPG0187 as well as the evaluation of biomarkers to aid in the design of later trials. The double-blind, single ascending dose study will be conducted in 18 healthy human volunteers in Belgium over the coming months.

About Galapagos

Galapagos (Euronext: GLPG; OTC: GLPYY) is a drug discovery and development company with small molecule programs in bone and joint diseases, bone metastasis, cachexia, anti-infectives and metabolic diseases. It has established risk sharing alliances with GSK, Janssen Pharmaceutica, Eli Lilly and Merck. Through an alliance with MorphoSys, Galapagos is also developing new antibody therapies in bone and joint diseases. Its division BioFocus DPI offers a full suite of target-to-drug discovery products and services to pharmaceutical and biotech companies and to patient foundations, encompassing target discovery and validation, screening and drug discovery through to delivery of pre-clinical candidates. Galapagos currently employs 490 people and operates facilities in six countries, with global headquarters in Mechelen, Belgium. More info at: www.glpg.com.

CONTACT:

Galapagos NV
Onno van de Stolpe, CEO
Tel: +31 6 2909 8028
ir@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.

(1) such as zolendronate, the standard prescribed treatment to treat bone loss related to malignancy, and denosumab, an antibody therapeutic currently in late stage clinical trials for treatment of malignancy-related bone loss


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