CRANBURY, N.J., April 19 Cornerstone Pharmaceuticals, Inc. (http://www.cornerstonepharma.com), a private pharmaceutical company, with a singular focus on cancer metabolism, has announced today that U.S. regulatory clearance has been obtained for the initiation of a physician-sponsored, Phase I human clinical trial of Cornerstone's first-in-class anticancer agent, CPI-613.
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The study, which is currently enrolling patients suffering from advanced hematologic malignancies, is to be led by Timothy S. Pardee, MD, Ph.D., and is being conducted at Wake Forest University Baptist Medical Center. The clinical trial will enroll eligible leukemia and lymphoma patients including patients with acute myeloid leukemia, a very aggressive and resistant form of leukemia. In 2009, there were over 900,000 people in the United States living with, or in remission from, hematologic malignancies.
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"We are very grateful to be expanding our previously established relationship with Wake Forest University and Dr. Pardee's research laboratory, which involves the evaluation of CPI-613 in a mouse model of acute myeloid leukemia (AML), considered to be predictive of responsiveness to drug treatment in humans, to the clinical evaluation of CPI-613 in patients with advanced leukemias and lymphomas," remarked Dr. Robert Shorr, Chief Executive Officer for Cornerstone Pharmaceuticals.
Dr. Pardee stated, "We are very pleased to be involved in both the clinical and preclinical evaluation of this novel compound, and to be working with Cornerstone Pharmaceuticals to bring CPI-613 to those who are suffering, and we share Cornerstone's goal to make cancer more manageable and treatable in the future."
Chemotherapy resistance is a major cause of death in patients with advanced hematologic malignancies. The proposed novel mechanism of action, non-cross resistance with chemotherapeutic agents currently used in the clinic, and lack of CPI-613-related myelosuppression in humans to date, make CPI-613 a suitable candidate for clinical evaluation in these types of cancers.
CPI-613 is the lead candidate to emerge from Cornerstone's Altered Energy Metabolism Directed (AEMD) technology platform. CPI-613 is the first drug in a new chemical class that, through a novel mechanism, targets metabolic changes that may be common to many cancer types.
About Dr. Timothy S. Pardee
Dr. Timothy S. Pardee is an Assistant Professor in the Section on Hematology and Oncology in the Department of Internal Medicine at Wake Forest University Baptist Medical Center, an academic health system comprised of North Carolina Baptist Hospital, Brenner Children's Hospital, Wake Forest University Physicians, and Wake Forest University Health Sciences, which operates the university's School of Medicine. The system includes 1,069 acute care and rehabilitation beds and has been ranked as one of "America's Best Hospitals" by U.S. News & World Report since 1993. Dr. Pardee was a Postdoctoral Fellow at the Dr. Scott Lowe Laboratory at Cold Spring Harbor Laboratories, NY. Prior to that, he was a Hematology/Oncology Fellow at Stony Brook University in New York following his Internal Medicine Residency at Massachusetts General Hospital. Dr. Pardee received his MD and PhD from the University of Buffalo. Dr. Pardee is a recipient of both the Stony Brook Clinical Scholar Award and the Ambassador Felix Schnyder Memorial Fund Grant from the Lauri Strauss Leukemia Foundation.
About Cornerstone Pharmaceuticals
Cornerstone Pharmaceuticals, Inc. is a privately held pharmaceutical company singularly focused on the discovery and development of innovative cancer therapies that exploit the metabolic pathways that are common to different cancer types but different from normal cells and tissues. This unique approach, i.e. understanding and addressing what is similar to multiple cancer types rather than the differences between each, offers a significant opportunity to make a profound impact on the clinical treatment of a variety of cancers.
Cornerstone's AEMD technology platform was established on cancer metabolism research performed in the laboratories of Paul M. Bingham, Ph.D. and Zuzana Zachar, Ph.D., at the State University of New York at Stony Brook, Stony Brook, NY.
Cornerstone has offices and laboratory facilities in Cranbury, NJ. and Stony Brook, NY. For further information, visit http://www.cornerstonepharma.com. To arrange an interview with Cornerstone Pharmaceuticals CEO Dr. Robert Shorr, please call (212) 843-8073 or email [email protected].
SOURCE Cornerstone Pharmaceuticals, Inc.
