Submitted by Armen Hareyan on May 3rd, 2008
Proteolix initiates 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.
Source:
Proteolix, Inc. 