Published on September 18, 2009 at 3:39 AM
Neogenix Oncology, Inc. (Neogenix) announced today that NPC-1C, the company’s first IND (Investigational New Drug Application) was granted permission by the Food and Drug Administration (FDA) for the company to begin a Phase I trial.
NPC-1C is derived from a colorectal cancer vaccine that had previously demonstrated safety and clinical activity in prior human studies. NPC-1C is a novel, monoclonal antibody intended for the treatment of advanced pancreatic and colorectal cancer.
This first human trial will evaluate the safety of NPC-1C in patients with late stage pancreatic or colorectal cancer. Anti-tumor activity has been demonstrated in both in-vitro ADCC assays and in multiple animal studies.
“The approval of our first IND for the initiation of our Phase I trial represents an important milestone toward the development of what could prove to be a breakthrough in cancer diagnostics and therapeutics,” said Neogenix President and Chief Medical Officer, Philip M. Arlen, MD. “This Phase I trial will evaluate NPC-1C in 12-24 patients with pancreatic or colorectal cancer and should provide important additional data regarding the safety and activity of our antibody. We expect the trial to complete enrollment in approximately 6-8 months.”
http://www.neogenixoncology.com/