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Proteolix Initiates Multicenter Open-label Study of the Safety and Activity of Carfilzomib in Subjects With Relapsed Solid Tumors

Thursday, October 11, 2007 General News
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SOUTH SAN FRANCISCO, Calif., and SAN ANTONIO, Oct. 10 Proteolix, Inc. and South Texas Accelerated Research Therapeutics (START)today announced the enrollment of the first patient in a Phase 1 clinicaltrial to study Proteolix's investigational drug, carfilzomib (PR-171). STARTis participating in the study under the leadership of Kyriakos Papadopoulos,M.D., MSc, FCP(SA).
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This trial is evaluating single agent carfilzomib, a novel proteasomeinhibitor, in patients with recurrent or advanced solid tumors. The Phase 1bportion of the study is a dose-escalation study designed to determine themaximum tolerated dose of carfilzomib administered intravenously in patientswith solid tumors. After determining the maximum tolerated dose, additionalpatients will be enrolled in Phase 2 and stratified according to disease type,including non-small cell lung cancer, small cell lung cancer, ovarian cancerand renal cancer.
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"We are very excited about beginning this study in San Antonio. This nextgeneration proteasome inhibitor has shown promising activity in myeloma andwill offer a new option to our patients with advanced cancer," said Dr.Papadopoulos.

About Carfilzomib

Carfilzomib is a structurally- and mechanistically-novel proteasomeinhibitor that exhibits a high level of selectivity for a single active sitein the proteasome with minimal cross reactivity to other protease classes.Carfilzomib has been shown in both preclinical and clinical studies to be welltolerated on intensive daily dosing schedules; in preclinical models, thisintensive dosing results in greatly improved efficacy against solid tumors.Phase 1 clinical studies have shown that patients with hematologicmalignancies who have relapsed or progressed following multiple therapies canachieve durable anti-tumor responses with carfilzomib. In addition to thisPhase 1b/2 trial in solid tumors, carfilzomib is currently being evaluated intwo Phase 2 single-agent trials in myeloma, a Phase 1 study in lymphoma, andwill enter clinical testing in combination with an FDA-approved agent inmyeloma by the end of the year.

About South Texas Accelerated Research Therapeutics (START)

South Texas Accelerated Research Therapeutics is dedicated to the conductof Phase 1 Clinical Trials of novel anticancer agents. The mission of START isto accelerate the development of new anti-cancer drugs with the purpose ofimproving quality of life and survival for patients with cancer. STARTconsists of a team of highly trained physicians and staff, with extensiveexperience in Phase 1 clinical trials research. Research physicians at STARThave set unprecedented standards for the development of anticancer agents,having played a key role in the clinical development of numerous cancer drugsthat are now approved by the Food and Drug Administration. Through the work ofthese physicians and their highly trained staff, advances have led to improvedunderstanding 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 cancersand immunological conditions by inhibiting the proteasome and therebydisrupting protein turnover in cells. In addition to its lead productcandidate, carfilzomib (PR-171), which is delivered intravenously and iscurrently in multiple clinical trials to evaluate its safety and efficacy indifferent types of cancer, Proteolix is developing next generation proteasomeinhibitors, including an oral proteasome inhibitor and a selectiveimmunoproteasome inhibitor, to expand the therapeutic potential of this newtarget class. Proteolix is headquartered in South San Francisco. For moreinformation, please visit the Company's website at http://www.proteolix.com.START Contact:
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