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News > Press ReleaseProteolix Initiates Phase 2 Clinical Trial of Carfilzomib in Patients with
The Phase 2 trial will evaluate the safety and efficacy of single-agent carfilzomib in patients with recurrent or advanced solid tumors. Subjects will be enrolled and stratified according to disease type, including non-small cell lung cancer, small cell lung cancer, ovarian cancer and renal cancer. The open-label, multi-center clinical trial is a two-stage design, with pre-determined criteria for continuation after an initial cohort of patients have been treated. Patients enrolled in the study will receive carfilzomib twice a week for three weeks with a one week rest period. “Targeted agents with novel mechanisms of action can complement current treatment regimens and improve outcomes. Carfilzomib has demonstrated tolerability and anti-tumor activity in early studies and these Phase 2 trials in patients with solid tumors are an exciting step forward in the clinical development of the drug ,” said Kyri Papadopoulos, M.D., a principal investigator on the study from South Texas Accelerated Research Therapeutics (START). In preclinical models of solid tumors, carfilzomib demonstrates activity and induces apoptosis of cancer cells when administered on a consecutive day dose schedule (day 1, day 2). Proteolix completed a 14-patient Phase 1b clinical trial designed to assess the safety of escalating doses of carfilzomib administered intravenously on this schedule to patients with a variety of solid tumors. This trial established a maximum-tolerated dose of 36 mg/m2 for carfilzomib in relapsed patients with solid tumor malignancies. Proteolix expects to present data from the Phase 1b trial in a peer-review forum in the second half of this year. 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, as well as minimal cross reactivity to other protease classes. In addition to the Phase 2 trial in solid tumors, carfilzomib is currently being evaluated in two Phase 2 single-agent trials in multiple myeloma and a Phase 1 study in 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 Proteolix Proteolix, Inc. is a privately-held biopharmaceutical company, headquartered in South San Francisco, dedicated to discovering, developing and commercializing pharmaceutical therapies that target certain cancers and immunological conditions by inhibiting the proteasome and thereby disrupting protein turnover in cells. Proteolix’ lead product, carfilzomib (PR-171), is currently in clinical studies to evaluate its safety and efficacy in multiple myeloma, lymphoma and solid tumor malignancies. Proteolix is also developing a pipeline of next-generation proteasome inhibitors, including an oral proteasome inhibitor and a selective immunoproteasome inhibitor. CONTACT: Matthew Ferguson
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