Sunesis says it will report data from phase 1 clinical trial SNS-595 for leukemia in September

By Jennifer Lanning Drey

Eugene, Ore., July 11 - Sunesis Pharmaceuticals, Inc. expects to present data in September from a phase 1 clinical trial of its lead small molecule drug SNS-595 for treatment of patients with refractory acute leukemias, according to Daniel Swisher, chief executive officer of the company.

Sunesis plans to report data from the study at the Annual Meeting of the American Society of Hematology, which will be held in December, Swisher said Tuesday at the C.E. Unterberg Emerging Growth Opportunities Conference.

"This could be the basis for a pivotal trial next year, and we look forward to talking to the agency as the study concludes on the design of the pivotal trial," Swisher said.

The study is an open-label, multi-center, dose-escalation assessment of the safety, tolerability and pharmacokinetics of SNS-595. Sunesis aims to establish an optimal dosing regimen for use in planned phase 2 clinical testing of patients with relapsed or refractory acute myelocytic leukemia and potentially other acute leukemias.

Sunesis is also currently studying SNS-595 for small cell and non-small cell lung cancer and hopes to have data from the non-small cell study in the first half of next year, Swisher said.

The small cell lung cancer data should be complete by the end of 2007, he added.

"Either of those could then lead to multiple registration paths, Swisher said.

The company also plans to study SNS-595 for acute myelocytic leukemia and in combination with standard lines of therapy in additional tumor types, he said.

Sunesis obtained worldwide rights to SNS-595 from Dainippon Pharmaceutical in 2003.

Advancing SNS-032, SNS-314

The company is also advancing its SNS-032 program, which is in a phase 1/2 clinical study to identify the maximum tolerated dose and examine its safety and preliminary evidence of anti-tumor activity in patients with advanced solid tumor malignancies, including lung cancer, breast cancer or melanoma.

The company presented data at the Annual Meeting of the American Association for Cancer Research in April from in vitro studies of SNS-032. The studies demonstrated that the compound is a potent, highly selective inhibitor of Cyclin Dependent Kinases (CDK) 2, 7 and 9, which play a role in cell-cycle progression and transcriptional regulation.

"We've got a clear therapeutic hypothesis and we're moving toward multiple clinical indications," said Swisher.

On the discovery side, Sunesis plans to file an Investigational New Drug application for its SNS-314 program and move into phase 1 clinical trials next year, Swisher said.

The company believes the SNS-314 aurora kinase inhibitor could potentially be a best-in-class drug, he added.

Sunesis is a clinical-stage biopharmaceutical company that is based in South San Francisco, Calif.

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