Pancreatic And Colorectal Cancer Novel Antibody Developed From A Vaccine To Begin Phase I Trial

Main Category: Pancreatic Cancer
Also Included In: Clinical Trials / Drug Trials;  Colorectal Cancer;  Immune System / Vaccines
Article Date: 20 Sep 2009 - 0:00 PDT

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Neogenix Oncology, Inc. (Neogenix) announced 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."

Neogenix Oncology is a cancer therapeutics and diagnostic company focused on developing innovative new products for a broad range of cancers.

The company's portfolio includes monoclonal antibodies that have been shown to recognize tumor-specific immunogenic proteins derived from specific tumor subtypes. Neogenix Oncology monoclonal antibodies are unique in that they define the immunogenic tumor protein as both a diagnostic marker and as a therapeutic target for tumor destruction. This revolutionary approach could offer patients a new range of therapeutic alternatives in the future.

Source
Neogenix Oncology