Provides Update on Carfilzomib Development Program in Multiple Myeloma SOUTH SAN FRANCISCO, Calif., July 10
SOUTH SAN FRANCISCO, Calif., July 10 /PRNewswire/ -- Proteolix, Inc. today
announced that patient dosing has commenced in a Phase 1b clinical trial to
evaluate the safety and efficacy of Proteolix's lead anti-cancer agent,
carfilzomib (PR-171), in combination with lenalidomide and dexamethasone in
patients with relapsed multiple myeloma. Carfilzomib selectively blocks
proteasome activity, causing apoptosis in cancer cells. In single agent Phase
1 studies carfilzomib has demonstrated encouraging anti-tumor activity and has
been generally well tolerated.
The Phase 1b clinical trial is designed to evaluate safety and to
establish a maximum-tolerated dose of carfilzomib in combination with
lenalidomide and dexamethasone on a twenty-eight day treatment cycle.
Lenalidomide in combination with dexamethasone is indicated for use in
patients with multiple myeloma who have had at least one prior therapy.
Patients will be divided into four cohorts and will receive escalating doses
of carfilzomib and lenalidomide, combined with a set dose of dexamethasone. A
secondary endpoint for the trial is overall response rate at four months.
"Carfilzomib has been generally well-tolerated in patients and we believe
that the product's selectivity and potency provide a solid rationale for use
in combination with existing treatment protocols," said Lori Kunkel, M.D.,
Proteolix's Chief Medical Officer. "Initiating our first combination trial of
carfilzomib complements our multi-pronged strategy to thoroughly explore
carfilzomib's potential in the treatment of patients with multiple myeloma for
whom treatment options may be limited."
Carfilzomib Clinical Program in Multiple Myeloma
In addition to the Phase 1b clinical trial announced today, Proteolix is
currently evaluating carfilzomib as a single agent for the treatment of
multiple myeloma in two Phase 2 clinical trials.
A Phase 2 clinical trial of single-agent carfilzomib in patients with
relapsed and refractory multiple myeloma recently began enrolling its second
cohort of approximately 40 patients to explore safety, tolerability and
activity using a higher dose schedule. This trial is being conducted in
collaboration with the Multiple Myeloma Research Consortium (MMRC) and is
designed to evaluate patients' overall response rate after four cycles of
carfilzomib. All patients enrolled in the trial have received prior
treatment(s) with bortezomib and either lenalidomide or thalidomide and are
refractory to their last treatment.
A second open-label, multi-center Phase 2 trial of single-agent
carfilzomib in relapsed multiple myeloma patients is also currently enrolling
patients. The goal of this study is to evaluate carfilzomib's activity based
on a patient's prior treatment with bortezomib. The company plans to present
interim data from both of these Phase 2 trials by year end. A complete list
of Proteolix's ongoing clinical trials of carfilzomib may be found at
http://www.clinicaltrials.gov.
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 with minimal cross reactivity to other protease classes. In
addition to the ongoing clinical trials in multiple myeloma, Proteolix is
evaluating carfilzomib as a single agent in a Phase 2 trial of patients with
advanced solid tumors and in a Phase 1 study of 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 Multiple Myeloma
According to the American Cancer Society, in 2008, approximately 19,900
new cases of multiple myeloma will be diagnosed in the United States. Newly
diagnosed patients have treatment options that include combination
chemotherapeutic agents and stem cell transplantation. While many patients
respond to treatment, most eventually relapse and require subsequent treatment
and few patients are ultimately cured of their disease.
About Proteolix
Proteolix, Inc. is a privately-held biopharmaceutical 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
(PR-171), is currently in multiple Phase 2 clinical studies to evaluate its
safety and efficacy in hematologic and solid tumor malignancies. Proteolix is
also developing a pipeline of novel 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.
