Proteolix Presents Phase 1b/2 Clinical Data for Carfilzomib in Advanced Solid Tumor Patients at the 2009 ASCO Annu...(e of 20 mg/m2 on days 1 and 2 followed b...),Health

Date:5/30/2009

e of 20 mg/m2 on days 1 and 2, followed by 36 mg/m2 on days 8, 9 and 15, 16 over a 28-day cycle. The ongoing Phase 2 clinical is intended to assess the safety and efficacy of single-agent carfilzomib in patients with recurrent or advanced solid tumors. Enrolled patients are stratified according to disease type, including non-small cell lung cancer, small cell lung cancer, ovarian cancer and renal cancer. The open-label, multi-center clinical trial is a two-stage design, with pre-determined criteria for continuation after an initial cohort of patients have been treated.

In the Phase 1b trial, carfilzomib demonstrated activity in advanced solid tumors, with partial responses observed in renal cancer and small cell lung cancer patients. A total of 55 patients are currently evaluable for response in the Phase 1b and Phase 2 clinical studies.

Carfilzomib was generally well tolerated. The most common adverse events include fatigue headache, nausea, diarrhea, constipation and anemia. Notably, there were no incidents of Grade 3/4 neuropathy, a common side effect associated with the approved proteasome inhibitor, bortezomib. To date, 65 patients in the Phase 1b and Phase 2 clinical trials have received 154.5 cycles of carfilzomib.

"We are genuinely excited by growing clinical evidence for carfilzomib as a promising new protease inhibitor in hematologic and solid tumor malignancies. Carfilzomib is well tolerated and active across a number of different tumor types in patients with advanced cancers," said Michael Kauffman, M.D., Ph.D., Chief Medical Officer of Proteolix. "We are committed to expeditiously demonstrating the treatment benefits of carfilzomib in multiple treatment settings. We expect to complete the first stage of our Phase 2 trial in advanced solid tumors and our late-stage clinical studies of carfilzomib in multiple myeloma, and we are actively planning a Phase 3 clinical trial in relapsed multiple
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SOURCE Proteolix, Inc. Copyright©2009 PR Newswire. All rights reserved

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