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Proteolix Announces Positive Data From Two Ongoing Phase 2 Clinical Trials of Carfilzomib in Multiple Myeloma at the 50th Annual Meeting of the American Society of Hematology
Date:12/9/2008

ctivity," said Dr. Jagannath.

The most common adverse events reported have been fatigue, anemia and thrombocytopenia. Patients with impaired renal function tolerated the drug and responses were independent of renal status. Treatment with carfilzomib was associated with a low incidence of peripheral neuropathy, a common side effect associated with the approved proteasome inhibitor, bortezomib. Exacerbation of pre-existing peripheral neuropathy was rare and did not result in dose reductions or discontinuation of therapy. Overall, carfilzomib was generally well tolerated and toxicities were manageable.

These data were presented by Dr. Jagannath in an oral presentation titled Initial Results of PX-171-003, an Open-Label, Single-Arm, Phase 2 Study of Carfilzomib in Patients with Relapsed and Refractory Multiple Myeloma (MM) (Abstract #864).

Carfilzomib Activity in Relapsed Patients by Prior Exposure to Bortezomib

A second presentation by Dr. Vij described interim results from a Phase 2 clinical trial of single-agent carfilzomib in multiple myeloma patients designed to evaluate response rates based on patients' bortezomib treatment history. Patients enrolled in this trial received one to three prior therapies, such as bortezomib, thalidomide, lenalidomide or stem cell transplantation and had subsequently relapsed. A total of 31 patients have been enrolled in this study and are currently evaluable for response.

Of fourteen evaluable bortezomib-naive patients, eight (57%) achieved responses, including one patient with a complete response, two with very good partial responses and five with partial responses. Four additional patients achieved stable disease. Among seventeen patients who have received prior treatment with bortezomib, three (18%) achieved partial responses, one patient achieved a minor response, and ten patients achieved stable disease. The median time to disease
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SOURCE Proteolix, Inc.
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