Immunomedics Announces Clivatuzumab-Based Blood Test Can Differentiate Between
Pancreatic Cancer and Chronic Pancreatitis
WASHINGTON, April 8, 2013 (GLOBE NEWSWIRE) -- Immunomedics, Inc.
(Nasdaq:IMMU), a biopharmaceutical company primarily focused on the
development of monoclonal antibody-based products for the targeted treatment
of cancer, autoimmune and other serious diseases, today announced that the
Company's humanized antibody, clivatuzumab, is specifically reactive with
pancreatic ductal adenocarcinoma (PDAC) and does not react with chronic
pancreatitis (CP) tissues. Dr. David V. Gold, Director of Laboratory
Administration and Senior Member of the Garden State Cancer Center in Morris
Plains, NJ, presented the study at the 2013 Annual Meeting of the American
Association for Cancer Research in Washington, DC.
"These data have strong implications for the clivatuzumab-based blood test,
suggesting that individuals diagnosed with CP who are found to be positive for
this blood test, may in fact have cancer, and should be followed closely for
further indications of PDAC," commented Dr. Gold. The clivatuzumab-based blood
test has previously been shown to correctly identify nearly two thirds of
patients with early stage pancreatic cancer. (For more information, please
refer to the Company press release at
According to the American Cancer Society, pancreatic cancer is the 10^th most
common cancer diagnosis among men and the 9^th most common among women in the
U.S. In 2013, an estimated 45,220 new cases will be diagnosed nationwide. The
malignancy is one of the deadliest cancer types, accounting for about 7% of
all cancer deaths and is the fourth leading cause of cancer death among both
men and women. In 2013, approximately 38,460 people are expected to die from
pancreatic cancer nationwide.
The prognosis of pancreatic cancer is largely determined by the stage of the
disease at diagnosis, with median survival ranges from 4.5 months for the most
advanced stage to 24.1 months for the earliest stage. However, only about 7%
of pancreatic cancer cases are diagnosed at the early stages. It is,
therefore, generally recognized that better tests to diagnose pancreatic
cancer earlier, before it has metastasized, are needed.
In the current study, 64% of patients with confirmed early-stage disease and
85% with advanced disease were found to have the PAM4-antigen detected by
clivatuzumab. Overall specificity was 80% with respect to benign pancreatic
disease. Of 120 patients diagnosed with benign conditions of the pancreas, 24
(20%) were positive for the PAM4-antigen, with the majority of these cases
being diagnosed with CP (18 of 80 positive or 23%), all of whom had surgical
resection performed for severity and/or duration of disease activity.
This latter group would at first appear to constitute a rather large number of
false positives. However, immunohistochemistry data have shown the
PAM4-biomarker is absent from normal pancreas and benign, non-neoplastic
lesions of the pancreas. In over 50 surgical specimens of CP, the
PAM4-biomarker was identified only within pancreatic intraepithelial neoplasia
lesions (precursors to PDAC) that are associated with long-term CP, and not by
the inflamed tissue.
These results suggest that PAM4-positive CP patients, and likely other
PAM4-positive patients diagnosed with benign conditions of the pancreas, may
very likely have pancreatic neoplasia (invasive and/or precursor lesions), and
therefore should be followed closely.
Cynthia L. Sullivan, President and Chief Executive Officer of Immunomedics,
remarked: "We believe this blood test has the potential to become a companion
diagnostic for our clivatuzumab-directed radiation therapy we are developing
for pancreatic cancer. The Phase Ib study of yttrium-90-labeled clivatuzumab
has completed the enrollment of pancreatic cancer patients with 2 or more
prior therapies. Results from this study have been submitted for presentation
at an upcoming medical conference."
Immunomedics is a New Jersey-based biopharmaceutical company primarily focused
on the development of monoclonal antibody-based products for the targeted
treatment of cancer, autoimmune and other serious diseases.We have developed
a number of advanced proprietary technologies that allow us to create
humanized antibodies that can be used either alone in unlabeled or "naked"
form, or conjugated with radioactive isotopes, chemotherapeutics, cytokines or
toxins, in each case to create highly targeted agents.Using these
technologies, we have built a pipeline of therapeutic product candidates that
utilize several different mechanisms of action.We also have a majority
ownership in IBC Pharmaceuticals, Inc., which is developing a novel
DOCK-AND-LOCK™ (DNL™) method with us for making fusion proteins and
multifunctional antibodies, and a new method of delivering imaging and
therapeutic agents selectively to disease, especially different solid cancers
(colorectal, lung, pancreas, etc.), by proprietary, antibody-based,
pretargeting methods. We believe that our portfolio of intellectual property,
which includes approximately 220 active patents in the United States and more
than 400 foreign patents, protects our product candidates and technologies.
For additional information on us, please visit our website at
www.immunomedics.com. The information on our website does not, however, form a
part of this press release.
This release, in addition to historical information, may contain
forward-looking statements made pursuant to the Private Securities Litigation
Reform Act of 1995. Such statements, including statements regarding clinical
trials, out-licensing arrangements (including the timing and amount of
contingent payments), forecasts of future operating results, potential
collaborations, and capital raising activities, involve significant risks and
uncertainties and actual results could differ materially from those expressed
or implied herein. Factors that could cause such differences include, but are
not limited to, risks associated with any cash payment that the Company might
receive in connection with a sublicense involving a third party and UCB, which
is not within the Company's control, new product development (including
clinical trials outcome and regulatory requirements/actions), our dependence
on our licensing partners for the further development of epratuzumab and
veltuzumab for non-cancer indications, competitive risks to marketed products
and availability of required financing and other sources of funds on
acceptable terms, if at all, as well as the risks discussed in the Company's
filings with the Securities and Exchange Commission.The Company is not under
any obligation, and the Company expressly disclaims any obligation, to update
or alter any forward-looking statements, whether as a result of new
information, future events or otherwise.
CONTACT: Dr. Chau Cheng
Senior Director, Investor Relations & Grant Management
(973) 605-8200, extension 123
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