- Updated Clinical Results Presented at the 42nd Annual Meeting of American
Society of Clinical Oncology (ASCO) -
ATLANTA, June 5 /PRNewswire-FirstCall/ -- Immunomedics, Inc. (Nasdaq:
IMMU), a biopharmaceutical company focused on developing monoclonal
antibodies, today reported updated clinical results with the Company's
humanized anti-CD20 (hA20) monoclonal antibody in patients with
non-Hodgkin's lymphoma (NHL) at the 42nd Annual Meeting of the American
Society of Clinical Oncology (ASCO) in Atlanta, Georgia. Franck
Morschhauser, MD, Centre Hospitalier Regional Universitaire de Lille,
Lille, France, was the lead investigator of this open-label, multi-center,
Phase I/II, dose-escalation study.
A total of forty-seven adult patients with recurrent NHL were enrolled
and were infused once weekly for four consecutive weeks with 120, 200, 375,
or 750 mg/m2 of hA20. Forty-three patients had received at least one prior
rituximab-containing regimen. Treatment responses from forty-two assessable
patients (27 with follicular lymphoma and 15 with non-follicular lymphoma)
with at least one post-treatment evaluation were reported at the meeting.
The overall objective response rate (partial and completed responses) was
43% (18/42), with 17% (7/42) of patients having a complete response
(CR/CRu).
In follicular lymphoma, the overall response rate was 44% (12/27), with
a complete response rate of 22% (6/27). All dose groups were found to be
responders, even at the lowest dose of 120 mg/m2, where 42% (5/12) were
responders and 25% (3/12) had a complete response. In the most favorable
patient group of FLIPI 0-1 prognostic indices, an objective response rate
of 75% (6/8), with 38% (3/8) complete responses, were reported. In
non-follicular lymphomas, the overall responses rate was 40% (6/15),
including one complete response in marginal zone lymphoma. Importantly,
B-cell depletion effects were similar between the different dose groups,
while those at the lowest doses tolerated infusion times of less than 2
hours for the first infusion.
"We are pleased that our humanized anti-CD20 antibody shows not only
good tolerability in these patients, but appears to be very active at doses
as low as 120 mg/m2, showing similar B-cell depletion and antitumor
activity as much higher doses," commented Cynthia L. Sullivan, President
and Chief Executive Officer of Immunomedics. "Now that hA20 is known to be
active in NHL, we can begin evaluating it in combination with our CD22
antibody, epratuzumab, which has been reported to show evidence of
improving the effects of rituximab when these two antibodies were combined
in the treatment of patients with indolent and aggressive NHL," she added.
In the current study of hA20, 45 patients received all four infusions
with one rituximab-sensitive patient discontinuing treatment after
developing allergic reactions at first infusion. Other than mild to
moderate transient infusion reactions, predominantly with the first
infusion, no significant toxicity was reported. No immunogenicity was seen
in twenty-nine patients tested at least once. As expected, peripheral blood
B-cell depletion occurred after the first infusion and persisted after the
fourth infusion, with analysis continuing at 3 to 6 months. Earlier results
from this study had previously been reported
(http://www.immunomedics.com/news_pdf/2005_PDF/PR12122005.pdf).
About hA20
hA20 is a humanized monoclonal antibody that binds to the CD20 antigen
on B lymphocytes. The antibody contains over 90% of human amino acid
sequences, and the human framework regions are identical to epratuzumab,
the Company's CD22 humanized antibody that has been studied in over 300 NHL
patients. hA20 displays similar binding avidity, specificity, and
mechanisms of action, including antibody-dependent cellular cytotoxicity,
complement-dependent cytotoxicity, and apoptosis, as rituximab. It has
comparable in vitro and in vivo CD20 binding and efficacy against lymphoma
as rituximab.
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, +1-973-605-8200, ext. 123, or
ccheng@immunomedics.com
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