Cytokinetics (CYTK) Announces Results of Multicenter Phase II Clinical Trial Sponsored by GlaxoSmithKline (GSK) for Ispinesib
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Cytokinetics, Incorporated (Nasdaq: CYTK) announced today the final results from a multicenter Phase II clinical trial sponsored by GlaxoSmithKline (NYSE: GSK), which evaluated ispinesib in patients with locally advanced or metastatic breast cancer. Ispinesib is a novel small molecule inhibitor of kinesin spindle protein (KSP), a mitotic kinesin essential for proper cell division. Ispinesib has arisen from a broad strategic collaboration between Cytokinetics and GlaxoSmithKline (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 recently communicated the final results of this clinical trial to Cytokinetics. 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 liver, lung and lymph node metastases. The duration of response, independently reviewed, ranged from 7.1 weeks to 30.0 weeks. The median time to progression in the treated population was 5.9 weeks. The adverse events were manageable, predictable and consistent with those seen in the Phase I trials of ispinesib. The most common grade 3/4 adverse events observed in the 50 patients evaluable for safety were neutropenia (21 patients), febrile neutropenia (4 patients) and neutropenic sepsis (1 patient).
Based on these data, and consistent with a focused approach to the further development of ispinesib, Cytokinetics anticipates initiating a Phase I/II clinical trial in the first-line treatment of patients with locally advanced or metastatic breast cancer during the second half of 2007. The results from this trial are expected to provide data that may inform a decision on further development of ispinesib in advanced breast cancer.
GSK recently communicated the final results of this clinical trial to Cytokinetics. 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 liver, lung and lymph node metastases. The duration of response, independently reviewed, ranged from 7.1 weeks to 30.0 weeks. The median time to progression in the treated population was 5.9 weeks. The adverse events were manageable, predictable and consistent with those seen in the Phase I trials of ispinesib. The most common grade 3/4 adverse events observed in the 50 patients evaluable for safety were neutropenia (21 patients), febrile neutropenia (4 patients) and neutropenic sepsis (1 patient).
Based on these data, and consistent with a focused approach to the further development of ispinesib, Cytokinetics anticipates initiating a Phase I/II clinical trial in the first-line treatment of patients with locally advanced or metastatic breast cancer during the second half of 2007. The results from this trial are expected to provide data that may inform a decision on further development of ispinesib in advanced breast cancer.
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