October 26, 2008

Proteolix Reports Encouraging Results From Phase I Cancer Trial

Proteolix has reported positive data from a Phase I clinical trial of carfilzomib in patients with advanced solid tumors.

The Phase I 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 20mg/m2 and escalated thereafter to a dose of 36mg/m2.

A total of 14 patients were enrolled in the study. Of those, one renal 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 was generally well tolerated with a low incidence of grade three or higher adverse events.

Lori Kunkel, chief medical officer of Proteolix, said: "We believe carfilzomib exhibits strong potential in diverse cancer indications. Based on these encouraging results, we recently initiated a Phase II 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."