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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

progression has not yet been established for this study.

According to Dr. Vij, "Single-agent carfilzomib has shown impressive and durable activity, notably among patients who have failed transplantation and have not yet received treatment with a proteasome inhibitor. The emerging safety profile makes this an attractive option in patients who have pre-existing neuropathy. Continued evaluation of carfilzomib in less heavily pre-treated patients is warranted given these promising findings."

Carfilzomib was generally well tolerated among relapsed patients and toxicities were manageable. The most common adverse events were fatigue, anemia and neutropenia. Two cases of tumor lysis syndrome were observed among bortezomib-naive patients, and with additional monitoring and management guidelines no further events have been reported. No treatment-emergent Grade 3 or 4 peripheral neuropathy was reported in this study.

Dr. Vij presented these interim data from a study of relapsed patients in a presentation titled Initial Results of PX-171-004, an Open-Label, Single-Arm, Phase 2 Study of Carfilzomib in Patients with Relapsed Multiple Myeloma (MM) (Abstract #865).

"We are encouraged by the data that show that carfilzomib is active and has been successful in providing durable responses in patients who have relapsed or who do not respond to currently available treatment options," said Lori A. Kunkel, M.D., Proteolix's Chief Medical Officer. "We believe carfilzomib may have broad application in the treatment of hematologic malignancies and solid tumors."

Supporting Preclinical Data

In addition to the two oral presentations of Phase 2 clinical data, Proteolix scientists presented results of preclinical studies that further characterize the mechanism and safety profile of carfilzomib. These data were presented on Sunday, December 7 in two poster presentations: Non-Proteasom
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SOURCE Proteolix, Inc.
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