Proteolix to Present Carfilzomib Clinical Data During the 2009 ASCO Annual Meeting

Results from Phase 2 Clinical Trials of Carfilzomib in Relapsed/Refractory Multiple Myeloma and Advanced Solid Tumors Featured in Oral Presentations

SOUTH SAN FRANCISCO, May 15 /PRNewswire/ — Proteolix, Inc. today announced that data from clinical trials of carfilzomib in multiple myeloma and advanced solid tumors will be presented at the 2009 Annual Meeting of the American Society of Clinical Oncology (ASCO) being held May 29 – June 2, 2009 in Orlando, Florida. Carfilzomib is the first in a new class of selective, irreversible proteasome inhibitors and is currently enrolling patients in an accelerated approval study in relapsed/refractory multiple myeloma and Phase 2 clinical studies in relapsed multiple myeloma and other malignancies.

Of note, results from Proteolix’s Phase 2 study of carfilzomib for the treatment of patients with relapsed and refractory multiple myeloma will be presented on Monday, June 1 during an oral session by Sundar Jagannath, M.D., Chief of the Multiple Myeloma Program, Bone Marrow and Blood Stem Cell Transplantation at St. Vincent’s Comprehensive Cancer Center in New York. The Phase 2 trial is an open-label multi-center study of single-agent carfilzomib in patients who have previously failed at least two prior treatments, containing bortezomib and either lenalidomide or thalidomide, and are refractory to their last treatment. In addition, results from a Phase Ib/II study of carfilzomib in patients with selected advanced metastatic solid tumors will be presented on Saturday, May 30 during an oral session by Peter Rosen, M.D., Medical Director, Tower Cancer Research Foundation and Emeritus Professor, UCLA.

A complete list of the company’s oral and poster presentations at ASCO follows:

    Oral Presentations
      Saturday, May 30, 2009 at 5:00 p.m. ET
      Track: Developmental Therapeutics
      Session: Developmental Therapeutics: Molecular Therapeutics
      Location: Level 4, Valencia Room, W415A
        --  Phase II results of Study PX-171-007: A Phase Ib/II study of
            carfilzomib (CFZ), a selective proteasome inhibitor, in patients
            with selected advanced metastatic solid tumors. (Abstract #3515)

      Monday, June 1, 2009 at 3:45 p.m. ET
      Track: Developmental Therapeutics, Lymphoma and Plasma Cell Disorders
      Session: New Agents for Multiple Myeloma
      Location: Level 2, West Hall F1
        --  Final results of PX-171-003-A0, part 1 of an open-label, single-
            arm, Phase II study of carfilzomib (CFZ) in patients (pts) with
            relapsed and refractory multiple myeloma (MM). (Abstract #8504)

    Poster Presentations
      Monday, June 1, 2009 from 2:00 p.m. to 6:00 p.m. ET
      Track: Lymphoma and Plasma Cell Disorders
      Session: Lymphoma and Plasma Cell Disorders
      Location:  Level 2, W240A
        --  PX-171-004, a multicenter Phase II study of carfilzomib (CFZ) in
            patients with relapsed myeloma: An efficacy update. (Abstract
            #8537)

        --  PX-171-006: Phase Ib multicenter dose escalation study of
            carfilzomib (CFZ) plus lenalidomide (LEN) and low-dose
            dexamethasone (loDex) in relapsed and refractory multiple myeloma
             (MM): Preliminary results. (Abstract #8541)

About Carfilzomib

Carfilzomib is the first in a new class of selective, irreversible proteasome inhibitors. Carfilzomib produces specific and sustained inhibition of the proteasome, leading to apoptosis in cancer cells with minimal off-target effects. In Phase 1 and Phase 2 clinical trials, carfilzomib has demonstrated single-agent activity in hematologic malignancies and solid tumors, including multiple myeloma, Waldenstrom’s macroglobulinemia, mantle cell lymphoma, and renal cell carcinoma.

Proteolix is conducting a comprehensive clinical development program evaluating carfilzomib for the treatment of multiple myeloma, including an ongoing accelerated approval study in heavily pre-treated relapsed/refractory patients and a Phase 2 trial in relapsed patients. A Phase Ib clinical trial of carfilzomib in combination with lenalidomide and dexamethasone in patients with relapsed multiple myeloma is also ongoing. In addition, Proteolix is conducting a single-agent Phase 2 clinical trial of carfilzomib in patients with recurrent or advanced solid tumors. For the latest information regarding ongoing carfilzomib clinical trials, please visit www.clinicaltrials.gov.

About Proteolix

Founded in December 2003, Proteolix, Inc. is a privately-held biotechnology 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, is the first in a new class of selective, irreversible proteasome inhibitors. Proteolix is also developing a pipeline of novel proteasome inhibitors, including a selective, oral proteasome inhibitor and a selective immunoproteasome inhibitor. For additional information on Proteolix, please visit www.proteolix.com.

SOURCE Proteolix, Inc.