Cytokinetics begins phase I/II lymphoma trial

Cytokinetics is conducting this clinical trial in order to expand the development activities for SB-743921, based on a recently amended agreement with GlaxoSmithKline.

SB-743921 is the second drug candidate in clinical development arising from a strategic collaboration between Cytokinetics and GSK to discover, develop and commercialize novel small molecule therapeutics targeting human mitotic kinesins for applications in the treatment of cancer and other diseases.

GSK is conducting a broad phase II clinical trials program for the lead drug candidate from this program, the kinesin spindle protein (KSP) inhibitor ispinesib (SB-715992), and is evaluating SB-743921 in an ongoing phase I trial in patients with advanced solid tumors.

This phase I/II clinical trial is an open-label, non-randomized study to investigate the safety, tolerability, pharmacokinetic, and pharmacodynamic profile of SB-743921, administered as a one-hour infusion on days one and 15 of a 28-day schedule, in patients with non-Hodgkin’s lymphoma.

The objective of the phase I portion of the clinical trial is to identify the maximum tolerated dose (MTD) of SB-743921 on this schedule, in patients with either Hodgkin’s or non-Hodgkin’s lymphoma, first without prophylactic administration of granulocyte colony stimulating factor (GCSF). If the dose-limiting toxicity determining this first MTD is neutropenia, a second MTD will be determined with SB-743921 given with prophylactic administration of GCSF.

Following review of the phase I data from this clinical trial, the optimal dose and regimen of SB-743921 will be determined for phase II. In phase II, 70 NHL patients, with either aggressive or indolent disease, are planned to be treated with the objective of evaluating frequency and duration of disease response in these patients.