Cornerstone Pharmaceuticals obtains clearance for CPI-613 human clinical trial for hematologic malignancies

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.  

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.

"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.  

SOURCE Cornerstone Pharmaceuticals, Inc.