Proteolix Initiates Multicenter Open-label Study of the Safety and Activity of Carfilzomib in Subjects With Relapsed So...( Phase 1b/2 Study to Explore the Effi...),Health

Phase 1b/2 Study to Explore the Efficacy of Novel Proteasome Inhibitor in

Patients with Relapsed Solid Tumors

SOUTH SAN FRANCISCO, Calif., and SAN ANTONIO, Oct. 10 /PRNewswire/ -- Proteolix, Inc. and South Texas Accelerated Research Therapeutics (START) today announced the enrollment of the first patient in a Phase 1 clinical trial to study Proteolix's investigational drug, carfilzomib (PR-171). START is participating in the study under the leadership of Kyriakos Papadopoulos, M.D., MSc, FCP(SA).

This trial is evaluating single agent carfilzomib, a novel proteasome inhibitor, in patients with recurrent or advanced solid tumors. The Phase 1b portion of the study is a dose-escalation study designed to determine the maximum tolerated dose of carfilzomib administered intravenously in patients with solid tumors. After determining the maximum tolerated dose, additional patients will be enrolled in Phase 2 and stratified according to disease type, including non-small cell lung cancer, small cell lung cancer, ovarian cancer and renal cancer.

"We are very excited about beginning this study in San Antonio. This next generation proteasome inhibitor has shown promising activity in myeloma and will offer a new option to our patients with advanced cancer," said Dr. Papadopoulos.

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. Carfilzomib has been shown in both preclinical and clinical studies to be well tolerated on intensive daily dosing schedules; in preclinical models, this intensive dosing results in greatly improved efficacy against solid tumors. 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 ca
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