Proteolix Presents Solid Tumor Clinical Trial Results For Carfilzomib At EORTC-NCI-AACR International Conference

Main Category: Cancer / Oncology
Also Included In: Clinical Trials / Drug Trials;  Conferences;  Pharma Industry / Biotech Industry
Article Date: 24 Oct 2008 - 0:00 PDT

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Proteolix, Inc., a leader in the discovery and development of novel therapeutics that target protein degradation pathways in cancer and autoimmune diseases, presented positive data from a Phase 1 clinical trial of carfilzomib (PR-171) in patients with advanced solid tumors at the 20th EORTC-NCI-AACR symposium on "Molecular Targets and Cancer Therapeutics" in Geneva, Switzerland.

The Phase 1 clinical trial was designed to assess the safety, pharmacokinetics and pharmacodynamics of carfilzomib among patients with advanced solid tumors who had previously failed at least two rounds of prior treatment with approved chemotherapies. Patients received carfilzomib administered for two consecutive days for each of the first three weeks on a four week cycle. Dosing commenced at 20 mg/m2 and escalated thereafter to a dose of 36 mg/m2.

A total of fourteen patients were enrolled in the study. Of those, one renal cell (clear cell) patient who had previously failed three prior rounds of treatment achieved a partial response and remains on the study after eight months of treatment. One small cell lung cancer patient achieved stable disease and is continuing on study after six months, and a mesothelioma patient achieved stable disease for five months.

"Carfilzomib is a highly specific inhibitor of the proteasome and the results observed in this Phase 1 clinical trial are very encouraging," said Kyri Papadopoulos, M.D., principal investigator on the study from South Texas Accelerated Research Therapeutics (START). "Novel agents that positively impact patient outcomes without adding significant toxicities are desperately needed to complement and improve existing cancer treatment regimens. I look forward to the results from further clinical evaluation of the activity of carfilzomib in a variety of tumor types."

Carfilzomib was generally well tolerated with a low incidence of Grade 3 or higher adverse events. The most common adverse events were reversible and/or transient fatigue, headache, diarrhea, nausea and constipation. Notably, incidence of peripheral neuropathy was rare and did not require dose discontinuation or reduction.

"We are pleased by the promising response results and the solid safety profile observed in our Phase 1 clinical trial of carfilzomib in patients with advanced solid tumors. These results demonstrate that carfilzomib appears to be highly targeted and generally well tolerated at active doses without resulting in the dose-limiting peripheral neuropathy that typically occurs with other proteasome inhibitors," said Lori Kunkel, M.D., Proteolix's Chief Medical Officer. "We believe carfilzomib exhibits strong potential in diverse cancer indications. Based on these encouraging results, we recently initiated a Phase 2 clinical trial evaluating carfilzomib's activity in four types of solid tumor cancers. In addition, we look forward to reporting data from our ongoing trials of carfilzomib in hematologic malignancies later this year."

Carfilzomib is the first in a new class of highly specific proteasome inhibitors. Carfilzomib produces specific and sustained inhibition of the proteasome, leading to apoptosis in cancer cells with minimal off-target effects. Based on the safety and efficacy observed in this Phase 1 study, Proteolix initiated a Phase 2 clinical trial of single-agent carfilzomib in selected solid tumors (non-small cell lung, ovarian, small cell lung, and renal cell cancers) in May 2008. Carfilzomib is also being studied in relapsed/refractory multiple myeloma patients as a single agent in two Phase 2 clinical trials and as part of a combination regimen with lenalidomide and dexamethasone in a Phase 1b trial. For more information on the ongoing clinical trials with carfilzomib, please visit http://www.clinicaltrials.gov.

Clinical data from Proteolix's Phase 1 clinical trial of carfilzomib were presented today in a poster titled "A Phase 1 safety, pharmacokinetic and pharmacodynamic study of carfilzomib, a selective proteasome inhibitor, in subjects with advanced solid tumors" during the Phase 1 session during the 20th EORTC-NCI-AACR symposium on "Molecular Targets and Cancer Therapeutics" in Geneva, Switzerland.

About Proteolix

Proteolix, Inc. is a privately-held biopharmaceutical company, headquartered in South San Francisco, dedicated to discovering, developing and commercializing novel therapeutics that target protein degradation pathways for cancer and autoimmune diseases. Proteolix's lead product, carfilzomib (PR-171), the first in a new class of highly specific proteasome inhibitors, is currently in multiple Phase 2 clinical studies to evaluate its safety and efficacy in hematologic and solid tumor malignancies. Proteolix is also developing a pipeline of novel proteasome inhibitors, including an oral proteasome inhibitor and a selective immunoproteasome inhibitor. For additional information on Proteolix, please visit http://www.proteolix.com.

Proteolix, Inc.
http://www.proteolix.com