Navigation Links
Proteolix Initiates Phase 2 Clinical Trial of Carfilzomib in Patients With Relapsed Solid Tumors
Date:5/1/2008

SOUTH SAN FRANCISCO, Calif., May 1 /PRNewswire/ -- Proteolix, Inc. today announced that patient dosing has commenced in 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.

About Carfilzomib

Carfilzomib is a structurally- and mechanistically-novel proteasome inhibitor that exhibits a high level of selectivity for a single active site in the proteasome, as well as minimal cross reactivity to other protease classes. In addition to the Phase 2 trial in solid tumors, carfilzomib is currently being evaluated in two Phase 2 single-agent trials in multiple myeloma and a Phase 1 study in lymphoma. Phase 1 clinical studies have shown that patients with hematologic malignancies who have relapsed or progressed following multiple therapies can achieve durable anti-tumor responses with carfilzomib.

About Proteolix

Proteolix, Inc. is a privately-held biopharmaceutical company, headquartered in South San Francisco, dedicated to discovering, developing and commercializing pharmaceutical therapies that target certain cancers and immunological conditions by inhibiting the proteasome and thereby disrupting protein turnover in cells. Proteolix' lead product, carfilzomib (PR-171), is currently in clinical studies to evaluate its safety and efficacy in multiple myeloma, lymphoma and solid tumor malignancies. Proteolix is also developing a pipeline of next-generation proteasome inhibitors, including an oral proteasome inhibitor and a selective immunoproteasome inhibitor. For additional information on Proteolix, please visit http://www.proteolix.com.

Contact information

Matthew Ferguson

investors@proteolix.com

650-266-2825


'/>"/>
SOURCE Proteolix, Inc.
Copyright©2008 PR Newswire.
All rights reserved

Related medicine technology :

1. The Multiple Myeloma Research Consortium (MMRC) and Proteolix Initiate Phase 2 Clinical Trial Investigating Carfilzomib for the Treatment of Multiple Myeloma
2. Proteolix Initiates Multicenter Open-label Study of the Safety and Activity of Carfilzomib in Subjects With Relapsed Solid Tumors
3. Carrington Subsidiary DelSite Initiates Critical Toxicology Studies of Its Nasal Powder Bird Flu Vaccine
4. Romark Initiates Clinical Trial of Alinia(R) for Chronic Hepatitis C in the United States
5. Millennium Initiates Clinical Trial to EVOLVE the Treatment of Patients with Newly Diagnosed Multiple Myeloma
6. Allos Therapeutics Initiates Study of PDX in Patients with Cutaneous T-Cell Lymphoma
7. MedImmune Initiates Phase 2a Multi-Dose Study in Patients with Asthma
8. Genta Initiates Phase 3 AGENDA Trial of Genasense(R) for Patients with Advanced Melanoma
9. Nuvelo Re-Initiates SONOMA-3 Trial of Alfimeprase in Patients With Catheter Occlusion
10. TorreyPines Therapeutics Initiates a Phase I Multiple Dose Clinical Trial of Tezampanel
11. Prolexys Pharmaceuticals Initiates Phase 1 Study
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:6/26/2016)... , June 27, 2016  VMS Rehab Systems, ... Board will take whatever measures required to build a ... stock which is currently listed on the OTC Markets-pink ... Company Chairman and CEO, "We are seeing an anomaly ... to understand, not only by the Company, but shareholders ...
(Date:6/24/2016)... N.J. , June 24, 2016  Collagen ... the design, development and manufacturing of collagen and ... regeneration announced today that Bill Messer ... and Marketing to further leverage the growing portfolio ... medical devices. Bill joins the Collagen ...
(Date:6/24/2016)... DUBLIN , June 24, 2016 ... and Markets has announced the addition of the ... their offering. ... products and provides an updated review, including its applications ... covering the total market, which includes three main industries: ...
Breaking Medicine Technology:
(Date:6/27/2016)... (PRWEB) , ... June 27, 2016 , ... "FCPX editors ... customizable inside of Final Cut Pro X," said Christina Austin - CEO of Pixel ... style. Final Cut Pro X users can now reveal the media of ...
(Date:6/26/2016)... (PRWEB) , ... June 27, 2016 , ... Quality metrics ... yet in many ways they remain in the eye of the beholder, according to ... a publication of The American Journal of Managed Care. For the full issue, ...
(Date:6/26/2016)... Birmingham, Lake Orion, Clarkston, Michigan (PRWEB) , ... ... ... their direction with respect to fertility once they have been diagnosed with endometriosis. ... for tolerable intercourse but they also require a comprehensive approach that can help ...
(Date:6/25/2016)... ... 25, 2016 , ... First Choice Emergency Room , the largest network ... the Medical Director of its new Mesquite-Samuell Farm facility. , “We are pleased ... location,” said Dr. James M. Muzzarelli, Executive Medical Director of First Choice Emergency Room. ...
(Date:6/24/2016)... ... June 24, 2016 , ... A recent article published June 14 ... The article goes on to state that individuals are now more comfortable seeking to ... operations such as calf and cheek reduction. The Los Angeles area medical group, Beverly ...
Breaking Medicine News(10 mins):