Neogenix Oncology® Receives FDA Orphan Drug Status for Ensituximab (NPC-1C) for Treatment of Pancreatic Cancer
November 01 2010 - 10:34AM
Business Wire
Neogenix Oncology, Inc. (Neogenix) announced today that the U.S.
Food and Drug Administration (FDA) has granted orphan drug
designation to the company’s product candidate ensituximab
(monoclonal antibody NPC-1C) for the treatment of pancreatic
cancer. The Company initiated in December 2009 a multi-center Phase
I clinical trial of ensituximab (NPC-1C) for the treatment of
advanced pancreatic and colorectal cancer.
“Receiving orphan drug designation from the FDA is a significant
step for Neogenix Oncology in development of ensituximab (NPC-1C),”
said Philip M. Arlen, M.D, President and CEO of Neogenix Oncology.
“With pancreatic cancer awareness month upon us, receiving orphan
status underscores the importance of our clinical research goals
along with our partners at The Johns Hopkins Hospital, Duke
University Medical Center and North Shore LIJ. We are committed to
improving treatment options for this deadly disease.”
Orphan status entitles Neogenix Oncology to seven years of
marketing exclusivity for ensituximab (NPC-1C) for the treatment of
pancreatic cancer upon regulatory approval, as well as the
opportunity to apply for grant funding from the U.S. government to
defray costs of clinical trial expenses, tax credits for clinical
research expenses and potential exemption from the FDA's
application user fee. The United States Orphan Drug Act of 1983 was
created to promote the development of new drug therapies for the
treatment of diseases that affect fewer than 200,000 individuals in
the United States.
According to the American Cancer Society (ACS), cancer of the
pancreas is the fourth leading cause of cancer-related death
overall in the United States. The ACS estimates that annual
incidence of pancreatic cancer in the United States to be greater
than 43,000 cases, and more than 36,000 people are expected to die
from the disease in 2010. The 1- and 5-year survival rates for
people in the United States diagnosed with any stage of pancreatic
cancer are 25 percent and 6 percent, respectively, according to the
ACS.
About Neogenix Oncology
Neogenix Oncology is a clinical stage biotechnology company
focused on developing and commercializing therapeutic and
diagnostic products for the early detection and treatment of
pancreatic, colorectal, lung, cervical, ovarian, prostate, and
other cancers. The company’s portfolio includes monoclonal
antibodies that are designed to be specific to cancer cells by
recognizing epitopes that are tumor specific, that is, found on
cancer cells, but not normal cells. Founded in late 2003 and
headquartered in Great Neck, NY, the company conducts its research
and development work in its laboratories in Rockville, MD. The
company is presently conducting a clinical study to establish
certain of its antibodies as a serum diagnostic for pancreatic and
colorectal cancers, and in December 2009 began a multicenter Phase
I therapeutic trial to evaluate the clinical safety of ensituximab
(NPC-1C antibody) in patients with metastatic pancreatic and
colorectal cancer.
Forward Looking Statements
Certain statements contained in this release are forward-looking
statements that relate to future events. These statements are based
on current expectations only and are subject to known and unknown
risks, uncertainties and other factors which may cause the actual
results to be materially different from any future results express
or implied by such forward-looking statements, including those risk
factors discussed in the company’s SEC reports, including the
company’s Form 10 and quarterly reports on Form 10-Q. We undertake
no obligation to publicly update or revise any forward-looking
statements, whether as a result of new information, future events
or otherwise.