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Published on 11/15/2005 in the Prospect News Biotech Daily.

Sunesis starts phase 1 trial of SNS-595 for acute leukemia

New York, Nov. 15 - Sunesis Pharmaceuticals, Inc. said it has begun treatment of patients with refractory acute leukemias in a phase 1 clinical trial of its lead small molecule drug, SNS-595.

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.

"The commencement of this phase I trial for SNS-595 allows us to explore the potential benefits of SNS-595 in patients with acute leukemias. Based on the strong myelosuppressive effects of SNS-595 seen at higher doses in our phase I clinical trials in patients with advanced solid malignancies, we believe SNS-595 has the potential to offer a significant advance in the treatment of acute leukemias," said Daniel Adelman, senior vice president of research and development at Sunesis, quoted in a news release.

The South San Francisco, Calif., biopharmaceutical company will enroll patients at three centers in the United States, the H. Lee Moffitt Cancer Center & Research Institute, MD Anderson Cancer Center and the Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins University.

Patients will receive SNS-595 either as three weekly doses per treatment cycle or twice weekly for four doses per treatment cycle.

SNS-595 acts during the S phase of the cell cycle to induce rapid apoptosis of cells that are actively synthesizing DNA. In clinical trials conducted to date, SNS-595 has been well tolerated and has shown promising signs of clinical activity, Sunesis said. The drug has exhibited broad activity in xenograft studies and drug-resistant tumor models.

SNS-595 is being evaluated in phase 1 clinical studies and will be soon entering phase 2 clinical trials in lung cancer.


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