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Cytokinetics Reports Additional Clinical Trials Data for Ispinesib

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?These three Phase II clinical trials sponsored by NCI are components of a clinical trials program designed to identify signals of clinical activity of ispinesib across multiple tumor types,? stated Dr. Andrew A. Wolff, Cytokinetics Senior Vice President of Clinical Research and Development and Chief Medical Officer. ?Although these three trials did not meet the protocol-specified criteria for progression, we are encouraged by the anti-cancer activity of ispinesib observed to date in three other Phase II trials in breast, ovarian and non-small cell lung cancers. Based on these data, we plan to move forward in further clinical development of ispinesib with a focused approach to the potential treatment of breast cancer with ispinesib.?

Clinical Trials of Ispinesib

Ispinesib has been the subject of a broad Phase II clinical trials program under the sponsorship of GlaxoSmithKline (GSK) and is also being developed in collaboration with the NCI. GSK has sponsored three Phase II clinical trials, one evaluating ispinesib as second- or third-line treatment for patients with locally advanced or metastatic breast cancer, one evaluating ispinesib as second-line treatment for patients with non-small cell lung cancer, and one evaluating ispinesib as second-line treatment for patients with advanced ovarian cancer. Enrollment in all of these trials has been closed. To date, clinical activity with ispinesib has been observed in breast cancer, in non-small cell lung cancer, and ovarian cancer with the more robust clinical activity observed in a Phase II clinical trial evaluating ispinesib in the treatment of metastatic breast cancer patients that have failed treatment with taxanes and anthracyclines. In this clinical trial, The best overall responses observed with ispinesib were partial responses in 4 of 45 evaluable patients as measured by the RECIST criteria. Responses were confirmed by independent radiology review and were seen in
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