Proteolix Initiates Phase 1b Clinical Trial of Carfilzomib in a Combination Regimen for Patients With Relapsed Multip...(se 2 clinical trial of single-agent carf...),Health

Date:7/10/2008

se 2 clinical trial of single-agent carfilzomib in patients with relapsed and refractory multiple myeloma recently began enrolling its second cohort of approximately 40 patients to explore safety, tolerability and activity using a higher dose schedule. This trial is being conducted in collaboration with the Multiple Myeloma Research Consortium (MMRC) and is designed to evaluate patients' overall response rate after four cycles of carfilzomib. All patients enrolled in the trial have received prior treatment(s) with bortezomib and either lenalidomide or thalidomide and are refractory to their last treatment.

A second open-label, multi-center Phase 2 trial of single-agent carfilzomib in relapsed multiple myeloma patients is also currently enrolling patients. The goal of this study is to evaluate carfilzomib's activity based on a patient's prior treatment with bortezomib. The company plans to present interim data from both of these Phase 2 trials by year end. A complete list of Proteolix's ongoing clinical trials of carfilzomib may be found at http://www.clinicaltrials.gov.

About Carfilzomib

Carfilzomib is a structurally- and mechanistically-novel proteasome inhibitor that exhibits a high level of selectivity for a single active site in the proteasome with minimal cross reactivity to other protease classes. In addition to the ongoing clinical trials in multiple myeloma, Proteolix is evaluating carfilzomib as a single agent in a Phase 2 trial of patients with advanced solid tumors and in a Phase 1 study of lymphoma. Phase 1 clinical studies have shown that patients with hematologic malignancies who have relapsed or progressed following multiple therapies can achieve durable anti-tumor responses with carfilzomib.

About Multiple Myeloma

According to the American Cancer Society, in 2008, approximately 19,900 new cases of multiple myeloma will be diagnosed in the United States. Newly
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SOURCE Proteolix, Inc. Copyright©2008 PR Newswire. All rights reserved

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