Neogenix Oncology 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
GREAT NECK, NY, USA | September 17, 2009 | 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.”
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.
About Neogenix Oncology
Founded in 2004 and headquartered in Great Neck, NY, Neogenix Oncology, Inc., is a research-driven biopharmaceutical company that develops and commercializes innovative therapeutics and diagnostics for the management of solid tumors. Neogenix Oncology’s pipeline is derived in part from the Hollinshead library of clinically tested vaccines, with the potential to develop products for a wide range of cancers, including pancreas, colorectal, prostate, lung, ovarian, squamous, and others. The company conducts its research and development work in its laboratories in Rockville, MD. Please contact Neogenix Oncology at inquiries@neogenix.us for more information.
SOURCE: Neogenix Oncology
Post Views: 67
Neogenix Oncology 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
GREAT NECK, NY, USA | September 17, 2009 | 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.”
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.
About Neogenix Oncology
Founded in 2004 and headquartered in Great Neck, NY, Neogenix Oncology, Inc., is a research-driven biopharmaceutical company that develops and commercializes innovative therapeutics and diagnostics for the management of solid tumors. Neogenix Oncology’s pipeline is derived in part from the Hollinshead library of clinically tested vaccines, with the potential to develop products for a wide range of cancers, including pancreas, colorectal, prostate, lung, ovarian, squamous, and others. The company conducts its research and development work in its laboratories in Rockville, MD. Please contact Neogenix Oncology at inquiries@neogenix.us for more information.
SOURCE: Neogenix Oncology
Post Views: 67
