Astex Pharmaceuticals, Inc. (Nasdaq:ASTX), a pharmaceutical company dedicated to the discovery and development of novel small molecule therapeutics, today announced that Janssen Pharmaceutica NV has received clearance to commence a Phase I clinical trial of a Fibroblast Growth Factor Receptor (FGFR) kinase inhibitor from its collaborative, cancer drug discovery program with Astex. The regulatory approval required to take the compound into Phase I triggers a milestone payment to Astex of £3.5 million (US$5.4 million). Astex is also eligible to receive further milestones during clinical development and royalties on commercialization of products derived from the collaboration.
The FGFR inhibitor program between Janssen and Astex originated from an earlier collaboration between Astex, Cancer Research Technology, the Cancer Research UK Drug Discovery Group at the Newcastle Cancer Centre (NCC), and the Northern Institute for Cancer Research, Newcastle University, UK. As part of the collaboration, Astex applied its fragment-based drug discovery approach, Pyramid™, to identify lead compounds inhibiting FGFR kinase. The partnership with Janssen was entered into in June 2008. Janssen is responsible for the clinical and regulatory development of all products arising from the collaboration and for their global commercialization.
Harren Jhoti, PhD, president of Astex, commented: "We are delighted that Janssen has received approval to commence a Phase I study on this FGFR kinase inhibitor, a drug that has the potential to address a significant area of unmet medical need. This milestone underscores how effective collaborations between leading research institutions, biotech companies and pharmaceutical partners can be in delivering new drug candidates for patients."
About FGFR Kinase
The FGFR family of receptors and their somatic activation is increasingly recognized as a common abnormality in many cancers. This occurs through multiple mechanisms including, somatic mutation (e.g. bladder, endometrial and gastric cancers), gene amplification (e.g. lung and breast cancers) and chromosomal translocation and generation of gene fusions (e.g. multiple myeloma, and myeloproliferative disease).