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CYTOKINETICS REPORTS RESULTS OF NCI-SPONSORED TRIAL

October 3, 2006

Cytokinetics announced results from a planned interim analysis following Stage 1 of a two-stage Phase II clinical trial of ispinesib administered as monotherapy in the treatment of patients with recurrent and/or metastatic head and neck squamous cell carcinoma (RMHNSC). This clinical trial was conducted by the National Cancer Institute (NCI) in collaboration with GlaxoSmithKline.

This trial was designed to evaluate the safety and efficacy of ispinesib administered at 18 mg/m2 as an intravenous one hour infusion once every 21 days in patients with RMHNSC who had received no more than one prior chemotherapy regimen. This two-stage clinical trial was designed to require a minimum of one confirmed partial or complete response out of 19 evaluable patients in Stage 1 in order to proceed to Stage 2. The trial's primary endpoint was response rate as determined using RECIST criteria. A total of 21 patients were enrolled; one patient did not receive ispinesib due to disease progression prior to treatment, and another was evaluable for safety but not efficacy.

At the interim analysis after Stage 1 of this clinical trial, ispinesib in patients with RMHNSC at this dosing level did not satisfy the criteria for advancement to Stage 2. The best overall response to date in this clinical trial was disease stabilization, which was observed in five of the 19 patients evaluable for efficacy at cycle two. Overall, median time to disease progression was 5.9 weeks.

In addition to this study, the NCI is conducting four other Phase II clinical trials evaluating ispinesib in other tumor types, including hepatocellular, prostate, and renal cell cancers and in melanoma. The NCI is also conducting two other Phase I clinical trials evaluating a new schedule of ispinesib, one in leukemia and another in advanced solid tumors, and is expected to initiate a Phase I clinical trial evaluating ispinesib as monotherapy in pediatric patients with relapsed or refractory solid tumors in the second half of 2006.