Key findings from Phase I clinical trial of CPI-613 in AML to be presented at ASCO 2011

Cornerstone Pharmaceuticals and Wake Forest Baptist Medical Center today announced key findings from a Phase I clinical trial of Cornerstone's first-in-class cancer metabolism inhibitor drug, CPI-613 in Acute Myeloid Leukemia (AML). Data will be presented at the 47th Annual meeting of American Society of Clinical Oncology (ASCO): http://www.chicago2011.asco.org/. Cornerstone is a leader in the discovery and development of cancer therapies based on the science of cancer metabolism.

CPI-613 is being studied at Wake Forest Baptist's Comprehensive Cancer Center to evaluate safety, tolerability, maximum tolerated dose, efficacy, and pharmacokinetics for patients with relapsed and refractory hematologic malignancies. The novel agent, CPI-613, has activity against several acute leukemia cell lines and may have activity in patients with relapsed disease. The mode of cytotoxicity and degree of synergy with more traditional agents remains a focus of ongoing study.

"This study is important because relatively few treatment options exist for patients with AML," said CEO Cornerstone Pharmaceuticals, Robert Shorr, Ph.D. "Preliminary results from the ongoing Phase I study demonstrate the safety of first-in-class agent, CPI-613, with very few adverse events, and support further exploration of CPI-613 as a potential treatment for AML and other hematologic malignancies."

According to the National Cancer Institute, 1 in 77 men and women will be diagnosed with leukemia during their lifetime. It is estimated that of the 43,050 Americans diagnosed annually, 21,840 of those will die of leukemia in 2011. Chemotherapy is the standard of treatment for untreated adult acute myeloid leukemia (AML). Cornerstone's CPI-613 may represent a potential new alternative treatment for this disease

"I am very excited at the opportunity to present our data from the lab as well as our ongoing phase I trial at ASCO," said Timothy S. Pardee, M.D., Ph.D., lead investigator for the study. "CPI-613 is a very intriguing compound and I hope our studies will lead to improved care for patients who suffer hematologic malignancies."

Pardee will present the data at ASCO June 3-7 in Chicago. The poster session for the study will be on Monday, June 6 from 1 p.m. to 5 p.m. at McCormick Place Hall A.