MORRIS PLAINS, N.J., Dec. 4 /PRNewswire-FirstCall/ -- Immunomedics,
Inc. (Nasdaq: IMMU), a biopharmaceutical company focused on developing
monoclonal antibodies, today reported that adding epratuzumab to rituximab
and combined cyclophosphamide, doxorubicin, vincristine, and prednisone
chemotherapy (ER-CHOP) to treat patients with newly diagnosed diffuse large
B-cell lymphoma (DLBCL) produced promising results. This study was
published in an on-line article in Cancer.
Fifteen patients with previously untreated DLBCL were enrolled in this
Phase II study led by Dr. Ivana Micallef at the Division of Hematology,
Department of Internal Medicine, Mayo Clinic College of Medicine,
Rochester, MN. Thirteen of 15 patients responded (87%), including 10
complete responses (67%) and 3 partial responses (20%). At a median
follow-up of 30 months, 13 of 15 patients remained alive. The 1-year
progression-free survival (PFS) and overall survival (OS) rates were 93%
and 100%, respectively, and the 2-year PFS and OS rates were 86% and 86%,
respectively.
"To our knowledge, this is the first study to combine epratuzumab with
chemotherapy. The results from this pilot study showed that ER-CHOP is a
safe and effective regimen for the treatment of patients with newly
diagnosed DLBCL," remarked Dr. Ivana Micallef, senior author. "These
encouraging initial results have led us to conduct a Phase II multicenter
study using ER-CHOP for newly diagnosed DLBCL under the auspices of the
North Central Cancer Treatment Group, funded by the National Cancer
Institute. The new trial is progressing very well in accrual," she added.
Patients received epratuzumab at 360 mg/m2, followed by rituximab at
375 mg/m2, and a standard dose of CHOP every 3 weeks for 6 to 8 cycles.
Although, grade 3 or 4 neutropenia was observed in 14 patients (93%), or in
28 of 92 cycles (30%), only 3 patients developed grade 3 or more infection
or fever. Eleven patients (73%) required dose reductions mainly secondary
to grade 4 neutropenia. No grade 3 antibody infusion-related toxicity was
reported.
Authored by I.N.M. Micallef, B.S. Kahl, M.J. Maurer, A. Dogan, S.M.
Ansell, S.M. Ansell, J.P. Colgan, S. Geyer, D.J. Inwards, W.L. White and
T.M. Habermann, the article entitled "A pilot study of epratuzumab and
rituximab in combination with cyclophosphamide, doxorubicin, vincristine,
and prednisone chemotherapy in patients with previously untreated, diffuse
large B-cell lymphoma" can be accessed at
http://www3.interscience.wiley.com/cgi- bin/abstract/113456987/ABSTRACT.
Epratuzumab is being studied in two NCI-sponsored clinical trials
involving the Children's Oncology Group and the North Cancer Center
Treatment Group, and is anticipated to expand to other study group trials
in the future as the safety and efficacy results in such lymphoma and
leukemia trials are reported. Two prior trials published in the Journal of
Clinical Oncology in 2005 and 2006 showed that epratuzumab can be combined
with rituximab safely, with a suggestion of improved complete and durable
response rates in patients with indolent and aggressive NHL types.
About Diffuse Large B-Cell Lymphoma
According to the American Cancer Society, an estimated 365,000
Americans have non-Hodgkin's lymphoma (NHL). More than 58,000 new cases
will be diagnosed in 2006 and about 18,840 people will die from the
malignancy this year. Diffuse large B-cell lymphoma (DLBCL) is an
aggressive subtype of NHL, which makes up about 33% of the disease in the
United States, making it the most common type of NHL in this country.
Originated in the lymph nodes, this lymphoma can spread rapidly in the
body. DLBCL can affect any age group but occurs mostly in older people.
About 40% to 50% of DLBCL patients are cured with therapy.
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 recently
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. 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 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. Visit our web site at http://www.immunomedics.com.
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
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CONTACT:
Dr. Chau Cheng, Associate Director, Investor
Relations & Business Analysis of Immunomedics, +1-973-605-8200,
extension 123, ccheng@immunomedics.com
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