Proteolix, Inc. and South Texas Accelerated Research Therapeutics (START) announced the enrollment of the first patient in a Phase 1 clinical
trial to study Proteolix's investigational drug, carfilzomib (PR-171).
START is participating in the study under the leadership of Kyriakos
Papadopoulos, M.D., MSc, FCP(SA).
This trial is evaluating single agent carfilzomib, a novel proteasome
inhibitor, in patients with recurrent or advanced solid tumors. The Phase
1b portion of the study is a dose-escalation study designed to determine
the maximum tolerated dose of carfilzomib administered intravenously in
patients with solid tumors. After determining the maximum tolerated dose,
additional patients will be enrolled in Phase 2 and stratified according to
disease type, including non-small cell lung cancer, small cell lung cancer,
ovarian cancer and renal cancer.
"We are very excited about beginning this study in San Antonio. This
next generation proteasome inhibitor has shown promising activity in
myeloma and will offer a new option to our patients with advanced cancer,"
said Dr. Papadopoulos.
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. Carfilzomib has been shown in both preclinical and clinical
studies to be well tolerated on intensive daily dosing schedules; in
preclinical models, this intensive dosing results in greatly improved
efficacy against solid tumors. 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. In addition to this Phase 1b/2 trial in solid tumors,
carfilzomib is currently being evaluated in two Phase 2 single-agent trials
in myeloma, a Phase 1 study in lymphoma, and will enter clinical testing in
combination with an FDA-approved agent in myeloma by the end of the year.
About South Texas Accelerated Research Therapeutics (START)
South Texas Accelerated Research Therapeutics is dedicated to the
conduct of Phase 1 Clinical Trials of novel anticancer agents. The mission
of START is to accelerate the development of new anti-cancer drugs with the
purpose of improving quality of life and survival for patients with cancer.
START consists of a team of highly trained physicians and staff, with
extensive experience in Phase 1 clinical trials research. Research
physicians at START have set unprecedented standards for the development of
anticancer agents, having played a key role in the clinical development of
numerous cancer drugs that are now approved by the Food and Drug
Administration. Through the work of these physicians and their highly
trained staff, advances have led to improved understanding and treatment of
cancer. START is headquartered in San Antonio, Texas. For more information,
please visit startthecure.
About Proteolix
Proteolix, Inc. is a biopharmaceutical company dedicated to
discovering, developing and marketing pharmaceutical products that target
certain cancers and immunological conditions by inhibiting the proteasome
and thereby disrupting protein turnover in cells. In addition to its lead
product candidate, carfilzomib (PR-171), which is delivered intravenously
and is currently in multiple clinical trials to evaluate its safety and
efficacy in different types of cancer, Proteolix is developing next
generation proteasome inhibitors, including an oral proteasome inhibitor
and a selective immunoproteasome inhibitor, to expand the therapeutic
potential of this new target class. Proteolix is headquartered in South San
Francisco. For more information, please visit the Company's website at
proteolix.
Proteolix, Inc.
proteolix