Proteolix Initiates Phase 2 Clinical Trial of Carfilzomib in Patients With Relapsed Solid Tumors

Proteolix Initiates Phase 2 Clinical Trial of Carfilzomib in Patients With Relapsed Solid Tumors

SOUTH SAN FRANCISCO, Calif., May 1 -- Proteolix, Inc. today announced that patient dosing has commenced in a Phase 2 clinical trial of carfilzomib (PR-171), a selective blocker of proteasome activity, in relapsed solid tumors. A Phase 1b dose-escalation trial of carfilzomib in patients with advanced solid tumors has recently been completed.

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.

"We are pleased to advance carfilzomib into Phase 2 in patients with solid tumors, building on the positive safety data and encouraging signals of activity observed in our Phase 1b trial," said Lori Kunkel, M.D., Proteolix' Chief Medical Officer. "In addition to its demonstrated anti-tumor activity against hematologic malignancies, carfilzomib's unique profile points to its potential as a new treatment for solid tumor cancers. Carfilzomib exhibits a highly selective mechanism of action for the proteasome, an important therapeutic target for cancer, and we believe this selectivity may reduce or eliminate toxicities seen with other proteasome inhibitors."

"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. For additional information on Proteolix, please visit http://www.proteolix.com.

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