FDAnews
www.fdanews.com/articles/108190-candidate-demonstrates-acceptable-safety-tolerability-in-phase-ib-trial

Candidate Demonstrates Acceptable Safety, Tolerability in Phase Ib Trial

July 1, 2008

Data from Cytokinetics’ Phase Ib trial evaluating ispinesib in combination with capecitabine, an oral chemotherapy agent commonly used in the treatment of breast cancer, support the ongoing development of ispinesib, the company said.

Sponsored by GlaxoSmithKline, the open-label, dose-escalation study assessed the safety and tolerability of the drug for treatment of advanced solid tumors. Researchers concluded that the combination had acceptable safety and tolerability among 24 patients, Cytokinetics said.

Ispinesib is a novel, small molecule inhibitor of kinesin spindle protein (KSP), which is essential for proper cell division.