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

Friday, May 2, 2008 General News J E 4
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SOUTH SAN FRANCISCO, Calif., May 1 Proteolix, Inc. todayannounced that patient dosing has commenced in a Phase 2 clinical trial ofcarfilzomib (PR-171), a selective blocker of proteasome activity, in relapsedsolid tumors. A Phase 1b dose-escalation trial of carfilzomib in patientswith advanced solid tumors has recently been completed.

The Phase 2 trial will evaluate the safety and efficacy of single-agentcarfilzomib in patients with recurrent or advanced solid tumors. Subjectswill be enrolled and stratified according to disease type, including non-smallcell lung cancer, small cell lung cancer, ovarian cancer and renal cancer.The open-label, multi-center clinical trial is a two-stage design, withpre-determined criteria for continuation after an initial cohort of patientshave been treated. Patients enrolled in the study will receive carfilzomibtwice a week for three weeks with a one week rest period.

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

"Targeted agents with novel mechanisms of action can complement currenttreatment regimens and improve outcomes. Carfilzomib has demonstratedtolerability and anti-tumor activity in early studies and these Phase 2 trialsin patients with solid tumors are an exciting step forward in the clinicaldevelopment of the drug," said Kyri Papadopoulos, M.D., a principalinvestigator on the study from South Texas Accelerated Research Therapeutics(START).

In preclinical models of solid tumors, carfilzomib demonstrates activityand induces apoptosis of cancer cells when administered on a consecutive daydose schedule (day 1, day 2). Proteolix completed a 14-patient Phase 1bclinical trial designed to assess the safety of escalating doses ofcarfilzomib administered intravenously on this schedule to patients with avariety of solid tumors. This trial established a maximum-tolerated dose of36 mg/m2 for carfilzomib in relapsed patients with solid tumor malignancies.Proteolix expects to present data from the Phase 1b trial in a peer-reviewforum in the second half of this year.

About Carfilzomib

Carfilzomib is a structurally- and mechanistically-novel proteasomeinhibitor that exhibits a high level of selectivity for a single active sitein the proteasome, as well as minimal cross reactivity to other proteaseclasses. In addition to the Phase 2 trial in solid tumors, carfilzomib iscurrently being evaluated in two Phase 2 single-agent trials in multiplemyeloma and a Phase 1 study in lymphoma. Phase 1 clinical studies have shownthat patients with hematologic malignancies who have relapsed or progressedfollowing multiple therapies can achieve durable anti-tumor responses withcarfilzomib.

About Proteolix

Proteolix, Inc. is a privately-held biopharmaceutical company,headquartered in South San Francisco, dedicated to discovering, developing andcommercializing pharmaceutical therapies that target certain cancers andimmunological conditions by inhibiting the proteasome and thereby disruptingprotein turnover in cells. Proteolix' lead product, carfilzomib (PR-171), iscurrently in clinical studies to evaluate its safety and efficacy in multiplemyeloma, lymphoma and solid tumor malignancies. Proteolix is also developinga pipeline of next-generation proteasome inhibitors, including an oralprotea
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