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"Based on the promising clinical data achieved to date, we have made astrategic decision to focus the organization on generating critical clinicaldata by advancing our lead compound, voreloxin, into late-stage trials in theacute myeloid leukemia and ovarian cancer indications," said Daniel Swisher,Sunesis' Chief Executive Officer. "Late-stage development requires increasedfocus of our resources. We are also expanding and strengthening ourdevelopment team with the additions of Drs. Steve Ketchum and Mary Bolton.Their extensive product development and regulatory expertise and track recordsof successful FDA submissions in a breadth of therapeutic areas will supportour plan to advance voreloxin through late-stage trials."
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Steven B. Ketchum, Ph.D., has been appointed as Senior Vice President,Research and Development and Mary G. Bolton, M.D., Ph.D., as Vice President,Clinical Development. In addition, Judith A. Fox, Ph.D., has been promoted toVice President, Product and Preclinical Development and Glenn C. Michelson,M.D., has been promoted to Vice President, Clinical Strategy.
To date, voreloxin has demonstrated objective responses in both solid andhematologic tumors and has been consistently well tolerated in multipleclinical trials. Sunesis is currently conducting Phase 2 clinical trials ofvoreloxin as a single agent for the treatment of platinum-resistant ovariancancer and previously untreated acute myeloid leukemia (AML), as well as aPhase 1b clinical trial of voreloxin in combination with cytarabine inrelapsed/refractory AML. Data recently reported at the 44th ASCO AnnualMeeting in the Phase 2 ovarian cancer trial demonstrated that 48 percent ofplatinum-resistant ovarian cancer patients treated at a dose of 48 mg/m2 onceevery 21 days achieved disease control, defined as stable disease for 90 daysor more or a complete or partial response. Preliminary median progression-free survival in this group of patients was 13 weeks at this dose; twenty-three patients at this dose remained on study as of May 12, 2008. Later thismonth, at the European Hematology Association Congress, Sunesis will reportupdated data on voreloxin's activity alone, and interim data on voreloxin'sactivity in combination with cytarabine for the treatment of AML.
Sunesis continues ongoing trials in its earlier-stage clinical programs,including the Phase 1 dose-escalation study of its cyclin-dependent kinaseinhibitor, SNS-032, and its pan-Aurora kinase inhibitor, SNS-314, and expectsto report data from these clinical trials this year. The company plans toseek a development partner to support advanced clinical trials of SNS-314.Future development of SNS-032 will depend on achieving positive results fromthe ongoing trial.
With the closing of its internal discovery research activities, Sunesiswill also explore opportunities to monetize the company's extensive fragment-based drug discovery capabilities, its preclinical programs and/or itsintellectual property portfolio through a potential spin out or strategicalliance.
Sunesis will continue to benefit from any down-stream milestones orroyalties based on future progress made in compounds emerging from itsexisting drug discovery collaborations with Biogen Idec Inc., Johnson &J
