Navigation Links
Proteolix Presents Phase 1b/2 Clinical Data for Carfilzomib in Advanced Solid Tumor Patients at the 2009 ASCO Annual Meeting

Promising Anti-cancer Activity Observed in Relapsed Patients

ORLANDO, Fla., and SOUTH SAN FRANCISCO, Calif. , May 30 /PRNewswire/ -- Proteolix, Inc. today reported on clinical advances for its carfilzomib solid tumor program in an oral presentation at the 2009 Annual Meeting of the American Society of Oncology (ASCO) in Orlando, Florida. Data from a Phase 1b study and an ongoing Phase 2 clinical trial of carfilzomib in relapsed patients with advanced solid tumors demonstrate promising single-agent anti-cancer activity. Carfilzomib is the first in a new class of selective, irreversible proteasome inhibitors being developed by Proteolix for the treatment of hematologic malignancies and solid tumors.

"In these clinical studies, carfilzomib demonstrated promising activity as a highly selective and potent inhibitor of the proteasome for treatment of solid tumor patients. The compound's unique characteristics enable the drug to be well tolerated with consecutive day dosing, which in turn appears to improve anti-cancer activity. Early results among patients with late-stage or metastatic solid tumors who have failed multiple prior treatments are encouraging, with a number of patients achieving stable disease or better lasting for several months," said Peter J. Rosen, M.D., Medical Director of the Tower Cancer Research Foundation and Emeritus Professor, UCLA.

Data from the Phase 1b/2 clinical trials of relapsed solid tumor patients were presented by Dr. Rosen at the 2009 Annual Meeting of the American Society of Clinical Oncology (ASCO) in an oral presentation titled "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).

The Phase 1b dose-escalating clinical trial enrolled patients with a variety of relapsed solid tumors established a dosing schedule of 20 mg/m2 on days 1 and 2, followed by 36 mg/m2 on days 8, 9 and 15, 16 over a 28-day cycle. The ongoing Phase 2 clinical is intended to assess the safety and efficacy of single-agent carfilzomib in patients with recurrent or advanced solid tumors. Enrolled patients are 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.

In the Phase 1b trial, carfilzomib demonstrated activity in advanced solid tumors, with partial responses observed in renal cancer and small cell lung cancer patients. A total of 55 patients are currently evaluable for response in the Phase 1b and Phase 2 clinical studies.

Carfilzomib was generally well tolerated. The most common adverse events include fatigue headache, nausea, diarrhea, constipation and anemia. Notably, there were no incidents of Grade 3/4 neuropathy, a common side effect associated with the approved proteasome inhibitor, bortezomib. To date, 65 patients in the Phase 1b and Phase 2 clinical trials have received 154.5 cycles of carfilzomib.

"We are genuinely excited by growing clinical evidence for carfilzomib as a promising new protease inhibitor in hematologic and solid tumor malignancies. Carfilzomib is well tolerated and active across a number of different tumor types in patients with advanced cancers," said Michael Kauffman, M.D., Ph.D., Chief Medical Officer of Proteolix. "We are committed to expeditiously demonstrating the treatment benefits of carfilzomib in multiple treatment settings. We expect to complete the first stage of our Phase 2 trial in advanced solid tumors and our late-stage clinical studies of carfilzomib in multiple myeloma, and we are actively planning a Phase 3 clinical trial in relapsed multiple myeloma patients."

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 clinical trial in relapsed patients stratified by prior treatment with bortezomib. Both Phase 2 clinical trials are being conducted by Proteolix in collaboration with the Multiple Myeloma Research Consortium (MMRC). 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

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

    Contact information
    Media Inquiries:                      All Other Inquiries:
    BCC Partners                          Craig C. Parker
    Karen L. Bergman or Michelle Corral   Senior Vice President, Finance and
    650-575-1509 or 415-794-8662          Corporate Development & Chief
                                          Financial Officer

SOURCE Proteolix, Inc.
Copyright©2009 PR Newswire.
All rights reserved

Related medicine technology :

1. Proteolix to Present Clinical and Preclinical Data at the 50th Annual Meeting of the American Society of Hematology
2. Proteolix Initiates Phase 1b Clinical Trial of Carfilzomib in a Combination Regimen for Patients With Relapsed Multiple Myeloma
3. Proteolix Initiates Phase 2 Clinical Trial of Carfilzomib in Patients With Relapsed Solid Tumors
4. Proteolix Initiates Multicenter Open-label Study of the Safety and Activity of Carfilzomib in Subjects With Relapsed Solid Tumors
5. The Multiple Myeloma Research Consortium (MMRC) and Proteolix Initiate Phase 2 Clinical Trial Investigating Carfilzomib for the Treatment of Multiple Myeloma
6. Optimer Pharmaceuticals Presents Results From Fidaxomicin Phase 3 Study for the Treatment of Clostridium difficile Infection
7. TYRX Presents Early Clinical Results from AIGISRX(TM) Antibacterial Envelope Retrospective Registry
8. Paloma Pharmaceuticals Presents at the Association for Research in Vision and Ophthalmology 2009 Meeting
9. MedImmune Presents New Data Demonstrating Increased Risk for Medically Attended RSV in Late-Preterm Infants
10. Dendreon Presents Preclinical Data Demonstrating Activity of TRPM8 Agonist, D-3263, in Benign Prostatic Hyperplasia
11. Micromet Presents Update on BiTE Antibody Pipeline and Reviews Key AACR Presentations at R&D Day
Post Your Comments:
(Date:11/26/2015)... , November 26, 2015 ... "Self Administration of High Viscosity Drugs" ... ) has announced the addition of the ... to their offering. --> Research and ... of the "Self Administration of High Viscosity ...
(Date:11/26/2015)... DUBLIN , November 26, 2015 /PRNewswire/ ... the addition of the "Radioimmunoassay Market ... User (Hospital, Pharmaceutical Industry, Academics, Clinical Diagnostic ... - Global Forecast to 2020" report ... ) has announced the addition of the ...
(Date:11/25/2015)... , Nov. 25, 2015 ... the addition of the "Global Brain ... their offering. --> ) ... "Global Brain Monitoring Devices Market 2015-2019" ... Research and Markets ( ) has ...
Breaking Medicine Technology:
(Date:11/27/2015)... ... 27, 2015 , ... A simply groundbreaking television series, "Voices in America", which ... into an array of issues that are presently affecting Americans. Dedicated to providing the ... show is changing the subjects consumers focus on, one episode at a time. ...
(Date:11/27/2015)... ... November 27, 2015 , ... The men and ... nonprofit healthcare organizations in the country. They have overseen financial turnarounds, shown commitment ... advance the healthcare industry as a whole through their advocacy and professional efforts. ...
(Date:11/26/2015)... ... November 26, 2015 , ... ... in central Michigan, have come together on Thanksgiving Day to share the things ... for viewing on the Serenity Point YouTube channel, patients displayed what they wrote ...
(Date:11/26/2015)... ... , ... The Catalent Applied Drug Delivery Institute today announced ... form selection in early phase drug development. The first of these is to ... the UK’s emerging life sciences companies, corporate partners, and investors, at Milton Park, ...
(Date:11/26/2015)... CA (PRWEB) , ... November 26, 2015 , ... ... a new set of retro-fused, self-animating trailer titles with ProTrailer: Vintage. This newly ... options. These classically-influenced trailer titles work with any font, giving users limitless opportunities ...
Breaking Medicine News(10 mins):