- Initial Phase II Study Results Presented at Society of Nuclear Medicine
Annual Meeting -
WASHINGTON, June 4 /PRNewswire-FirstCall/ -- Immunomedics, Inc.
(Nasdaq: IMMU), a biopharmaceutical company focused on developing
monoclonal antibodies to treat cancer and other serious diseases, today
announced that its anti-carcinoembryonic antigen (CEA) antibody,
labetuzumab, labeled with the radioisotope, iodine-131, was found to be
safe and active when given in two doses to patients with colorectal cancer
that has metastasized to the liver. Dr. Johannes Meller of the University
of Gottingen, Germany, reported results from this study in an oral
presentation at the 54th Annual Meeting of the Society of Nuclear Medicine
(SNM) in Washington, DC.
Forty colorectal cancer patients with liver metastases have been
enrolled in this Phase-II study. After surgery to remove liver metastases,
patients were screened for cancer by PET and CT scans. At the time of
reporting, 32 patients were evaluated. Sixteen were found to be negative
for cancer (the adjuvant group) after surgery while the other 16 patients
were found to have evidence of recurrent disease (the non-adjuvant group).
Six weeks after liver surgery, both groups of patients received an
initial dose of 40 - 50 mCi/m2 of 131I-labetuzumab, followed by a second
infusion three months later. At the time of reporting, 62.5% of patients
(10/16) in the adjuvant group remained disease-free. For the non-adjuvant
group, 25% of patients (4/16) reported no cancer relapse.
"These initial results suggested that re-treatment with
131I-labetuzumab is safe, feasible and well accepted, with transient
myelosuppression the principal and only adverse effect," commented Dr.
Johannes Meller, Director of Nuclear Medicine, University of Gottingen,
Germany, and lead author of the study presented. "In 2008, we plan to
initiate a multicenter, randomized trial evaluating the radiolabeled
anti-CEA antibody at repeated doses of 40 - 50 mCi/m2," he commented
further.
In an early study, the German scientists reported a 5-year survival
rate of 51.3% in 19 colorectal cancer patients who received a single dose
of 131I- labetuzumab after surgery versus 7% of control patients who did
not receive the antibody therapy, but only conventional therapies. Median
overall survival from the first surgery was 68.0 months for the treatment
group compared to 31 months for the control group. Results of this study
were published in the September 20, 2005, issue of the Journal of Clinical
Oncology.
About Colorectal Cancer
According to the American Cancer Society, about 153,760 Americans will
be diagnosed with colorectal cancer in 2007. An estimated 52,180 people
will die from the malignancy this year. The liver is the most common site
of distant metastasis, affecting up to 60% of patients, and is the only
metastatic site in 30% of patients. The 5-year survival rate for colorectal
cancer patients with unresected liver metastases is close to 0%. With
complete resection of liver metastases, a 5-year survival rate of 25% to
37% can be achieved. However, despite postsurgical adjuvant systematic or
intrahepatic chemotherapy, cancer relapse occurs in approximately two
thirds of resected patients, with more than one half first experiencing
recurrence in the liver. Currently there is no established adjuvant therapy
for the treatment of colorectal cancer patients after resection of liver
metastases.
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. We have licensed our
lead product candidate, epratuzumab, to UCB, S.A. for the treatment of all
autoimmune disease indications worldwide. We have retained the rights for
epratuzumab in oncology indications for which UCB has been granted a buy-in
option. UCB has development, manufacture and commercialization rights, and
is responsible for all clinical trials evaluating epratuzumab for the
treatment of patients with moderate and severe lupus. 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. The Company is conducting clinical trials with hA20 in
patients with non-Hodgkin's lymphoma, epratuzumab as a potential
therapeutic for patients with lymphoma and leukemia, 90Y-epratuzumab for
the therapy of patients with lymphoma, 90Y-hPAM4 for pancreas cancer
therapy and hCD74 as a therapy for patients with multiple myeloma. We
believe that our portfolio of intellectual property, which includes
approximately 108 patents issued in the United States, and more than 250
other issued patents worldwide, protects our product candidates and
technologies. We also have a majority ownership in IBC Pharmaceuticals,
Inc., which is developing a novel Dock and Lock (DNL) methodology, 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. For additional
information on us, please visit our web site at
http://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,
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), our
dependence on our licensing partner for the further development of
epratuzumab for autoimmune 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.
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, +1-973-605-8200, ext 123, or
ccheng@immunomedics.com
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