ATLANTA, June 2 /PRNewswire-FirstCall/ -- Immunomedics, Inc. (Nasdaq:
IMMU), a biopharmaceutical company focused on developing monoclonal
antibodies, today reported that repeated use of its radiolabeled antibody
against the carcinoembryonic antigen (CEA), 131I-labetuzumab, has been
found to be safe and well-tolerated by patients with colorectal cancer that
has metastasized to the liver. Results from this study were accepted for
publication at the 42nd Annual Meeting of the American Society of Clinical
Oncology (ASCO) in Atlanta, Georgia.
Twelve patients have been enrolled in this Phase II study led by Dr.
Torsten Liersch at the Department of General Surgery of the University of
Gottingen, Germany. Within 2 months of surgery to remove liver metastases
of colorectal cancer, patients received a first dose of 50 mCi/m2 of
131I-labetuzumab. Three months after the first radioimmunotherapy (RAIT), a
second infusion of the radiolabeled, humanized, CEA-antibody was given in
the same amount. Transient grade-4 myelosuppression occurred in 4 out of 12
patients after the first dose, but no cumulative toxicity was seen thus far
in 7 patients who have received the second infusion. Complete bone marrow
recovery was reported in all cases. At a median follow-up of 4 months, no
cancer recurrence has been detected in the 12 patients enrolled to date. In
all, a total of 15 patients will be enrolled in this study.
"We are pleased that a new study has been initiated to evaluate the
effect of repeated dosing of 131I-labetuzumab in colorectal cancer patients
and we look forward to learning more about the clinical effects," commented
Cynthia L. Sullivan, President and Chief Executive Officer of Immunomedics.
"Since about two-thirds of patients with colorectal cancer metastases to
the liver relapse after resection of these liver tumors, an adjuvant
therapeutic, such as perhaps our 131I-labetuzumab, may prove useful in this
setting of disseminated disease," she remarked.
This is a second trial conducted by the German researchers using
131I-labetuzumab for colorectal cancer patients with liver metastases. In
the previous study, only one 131I-labetuzumab dose was given to colorectal
cancer patients after surgery to remove liver metastases. Five-year
survival was achieved by 51.3% of the 19 patients who received RAIT. Median
overall survival from the first surgery was 68.0 months and median
disease-free survival was 18.0 months. Results of this study had been
published in the September 20, 2005, issue of the Journal of Clinical
Oncology.
About Colorectal Cancer
According to the American Cancer Society, about 106,680 Americans will
be diagnosed with colorectal cancer in 2006. An estimated 55,170 people
will die from the malignancy this year. When the disease is detected early
at a localized stage, the 5-year survival is 90%. However, only 39% of the
cancer is diagnosed at this stage. After the cancer has spread to adjacent
lymph nodes or organs, the 5-year rate drops to 68%. For all stages
combined, the 5-year survival for patients with colorectal cancer is 64%.
When the cancer has metastasized to distant tissues and organs, 5-year
survival is only 10%.
About Immunomedics
Immunomedics is a New Jersey-based biopharmaceutical company 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 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. Our lead product
candidate, epratuzumab, which development, manufacture and
commercialization rights we have licensed to UCB, S.A. for the treatment of
all autoimmune indications worldwide, is currently in two pivotal Phase III
trials for the treatment of patients with moderate and severe lupus
(ALLEVIATE A and B). At present, there is no cure for lupus and no new
lupus drug has been approved in the U.S. in the last 40 years. We believe
that our portfolio of intellectual property, which includes approximately
90 patents issued in the United States, and more than 250 other issued
patents worldwide, protects our product candidates and technologies. Visit
our web site at http://www.immunomedics.com . We also have a majority
ownership in IBC Pharmaceuticals, Inc., which is developing a novel dock
and lock platform technology, 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.
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), 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 new
product development (including clinical trials outcome and regulatory
requirements/actions), 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.
For More Information:
Dr. Chau Cheng
Associate Director, Investor Relations & Business Analysis
(973) 605-8200, extension 123
ccheng@immunomedics.com
SOURCE Immunomedics, Inc.
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Related links:
http://www.Immunomedics.com
http://www.prnewswire.com/comp/113121.html /
CONTACT:
Dr. Chau Cheng, Associate Director, Investor
Relations & Business Analysis of Immunomedics, Inc.,
+1-973-605-8200, extension 123, ccheng@immunomedics.com
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