Galapagos initiates clinical studies with GLPG0187, a candidate drug
for bone metastasis
* 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
Mechelen, Belgium; 16 June 2009 - 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
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[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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