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Proteolix Initiates Multicenter Open-label Study of the Safety and Activity of Carfilzomib in Subjects With Relapsed Solid Tumors
Date:10/10/2007

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 carfilzomib. In addition to this Phase 1b/2 trial in solid tumors, carfilzomib is currently being evaluated in two Phase 2 single-agent trials in myeloma, a Phase 1 study in lymphoma, and will enter clinical testing in combination with an FDA-approved agent in myeloma by the end of the year.

About South Texas Accelerated Research Therapeutics (START)

South Texas Accelerated Research Therapeutics is dedicated to the conduct of Phase 1 Clinical Trials of novel anticancer agents. The mission of START is to accelerate the development of new anti-cancer drugs with the purpose of improving quality of life and survival for patients with cancer. START consists of a team of highly trained physicians and staff, with extensive experience in Phase 1 clinical trials research. Research physicians at START have set unprecedented standards for the development of anticancer agents, having played a key role in the clinical development of numerous cancer drugs that are now approved by the Food and Drug Administration. Through the work of these physicians and their highly trained staff, advances have led to improved understanding and treatment of cancer. START is headquartered in San Antonio, Texas. For more information, please visit http://www.startthecure.com.

About Proteolix

Proteolix, Inc. is a biopharmaceutical company dedicated to discovering, developing and marketing pharmaceutical products that target certain cancers and immunological conditions by inhibiting the proteasome and thereby disrupting protein turnover in cells. In addition to its lead product candidate, carfilzomib (PR-171), which is delivered intravenously and is currently in multiple clinical trials to evaluate its safety and efficacy in different types of cancer, Proteolix is developing next generation proteasome inhibitors, including an oral proteasome inhibitor and a selective immunoproteasome inhibitor, to expand the therapeutic potential of this new target class. Proteolix is headquartered in South San Francisco. For more information, please visit the Company's website at http://www.proteolix.com.

START Contact: Tracy Dufresne, Physician Referral Coordinator,

210-593-5265

Proteolix Contact: Stephen R. Brady, Executive Director of Business &

Legal Affairs, 650-615-7521


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SOURCE Proteolix, Inc.
Copyright©2007 PR Newswire.
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