Cornerstone receives FDA approval to initiate CPI-613 study
Cornerstone Pharmaceuticals announced that following successful End-of-Phase I Type B meetings with the U.S. FDA, the company has been given a clear clinical and regulatory path forward to conduct pivotal trials of its lead compound, CPI-613, in patients with acute myeloid leukemia and pancreatic cancer. CPI-613 is Cornerstone Pharmaceuticals' first-in-class anticancer compound from its proprietary Altered Energy Metabolism Directed platform. The drug is designed to disrupt the altered energy production pathways in cancer cells by targeting the mitochondrial tricarboxylic acid cycle, an indispensable process essential to cell multiplication and survival. The FDA has designated CPI-613 an orphan drug for the treatment of acute myeloid leukemia, pancreatic cancer and myelodysplastic syndromes. During the EOP1 Type B meetings with the FDA, Cornerstone Pharmaceuticals presented updated results from Phase I trials of CPI-613 in patients with AML and pancreatic cancer. The company's investors include IDT Corporation.