SAN FRANCISCO, Jan. 26 /PRNewswire-FirstCall/ -- Immunomedics, Inc.
(Nasdaq: IMMU) reported results presented at the GI Cancer Symposium of the
American Society of Clinical Oncology being held in San Francisco. Dr. T.
Liersch, a senior surgeon at the University Hospital in Gottingen, Germany,
gave a summary of a Phase II study involving 23 patients who had their liver
metastases from colorectal cancer surgically removed. The purpose of the study
was to determine the safety and efficacy of the Company's humanized monoclonal
antibody against carcinoembryonic antigen (CEA), called labetuzumab, labeled
with therapeutic amounts of iodine-131 (131I) and given after attempted
curative surgery of liver metastases.
"These patients operated on for their liver metastases usually have a very
poor outcome, with about 70% dying of their disease within five years,"
commented Dr. Ivan D. Horak, Executive Vice President of Research and
Development, and Chief Scientific Officer, as well as a coauthor of the paper
presented.
Dr. Horak remarked: "Dr. Liersch's presentation demonstrated that this
post-surgical therapy showed good safety, with hematological toxicity related
to the radioisotope dose being the major side effect. Further, and most
important, with a follow-up period of over 5 years in some patients, 11 remain
alive and 3 patients have no evidence of cancer recurring."
Dr. Liersch and coworkers reported that of the 19 patients eligible for
analysis, the overall median survival was 54.2 months (i.e., half of the
patients were still alive at this time point), with a median disease-free
survival of 18.4 months (range: 7.8 to 22.3 months).
"These results of a Phase II trial with 131I-labetuzumab suggest that both
disease-free survival and overall survival after one injection of our product
(two patients were retreated) are very encouraging, supporting the
justification for conducting a prospective, randomized trial in the setting of
colorectal cancer patients with resectable metastases to the liver," stated
Cynthia L. Sullivan, President and Chief Executive Officer of Immunomedics.
"We plan to seek a commercial partner for this product while we prepare for a
Phase III, multicenter trial," Ms. Sullivan added.
In a recent press release, the Company reported that it was awarded U.S.
Patent 6,676,924 covering humanized CEA antibodies conjugated with diagnostic
or therapeutic agents. Ms. Sullivan commented: "This patent is one of several
covering this product."
Immunomedics is a biopharmaceutical company focused on the development,
manufacture and commercialization of diagnostic imaging and therapeutic
products for the detection and treatment of cancer and other serious diseases.
Integral to these products are highly specific monoclonal antibodies and
antibody fragments designed to deliver radioisotopes and chemotherapeutic
agents to tumors and other sites of disease. Immunomedics has nine
therapeutic product candidates in clinical or near clinical development and
has two marketed diagnostic imaging products. The most advanced therapeutic
product candidates are LymphoCide(R) (epratuzumab), for which certain Phase II
clinical trials for the treatment of non-Hodgkin's lymphoma have already been
completed, and CEA-Cide(R) (labetuzumab), which is in Phase I/II clinical
trials for the treatment of certain solid tumors.
This release, in addition to historical information, contains forward-
looking statements made pursuant to the Private Securities Litigation Reform
Act of 1995. Such statements, including statements regarding clinical trials,
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 financing and other sources of capital, as well as the risks discussed in
the Company's Annual Report on Form 10-K for the year June 30, 2003.
Company Contact: Rebecca A. Kinner, Investor Relations, (973) 605-8200.
Visit the Company's web site at http://www.Immunomedics.com
SOURCE Immunomedics, Inc.
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Related links:
http://www.Immunomedics.com
Company News On-Call:
http://www.prnewswire.com/comp/113121.html
CONTACT:
Rebecca A. Kinner, Investor Relations of
Immunomedics, Inc., +1-973-605-8200
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