MORRIS PLAINS, N.J., April 24 /PRNewswire-FirstCall/ -- Immunomedics,
Inc. (Nasdaq: IMMU), a biopharmaceutical company focused on developing
monoclonal antibodies, today announced that results from their phase II
study of epratuzumab in systemic lupus erythematosus (SLE) were published
on-line in Arthritis Research & Therapy. Entitled "Initial clinical trial
of epratuzumab (humanized anti-CD22 antibody) for immunotherapy of systemic
lupus erythematosus," and authored by T. Dorner, J. Kaufmann, W.A. Wegener,
N. Teoh, D.M. Goldenberg and G.R. Burmester, the article can be accessed at
http://arthritis-research.com/content/8/3/R74.
Fourteen patients with moderately active SLE were enrolled in this
open- label, single-center study. At the beginning of the study, total
baseline BILAG (British Isles Lupus Assessment Group) scores for the group
ranged from 6 to 12. In all 14 patients at some point during the study,
total BILAG scores decreased by 50% or more. Specifically, at 6 weeks of
follow-up, 77% of patients had their BILAG scores decreased by 50% or more,
with 92% having decreases of various amounts continuing to at least 18
weeks. Almost all patients (93%) experienced improvement in at least one
BILAG B- or C-level disease activity at 6, 10, and 18 weeks. Additionally,
3 patients with multiple BILAG B involvement at baseline had completely
resolved all B-level disease activities by 18 weeks.
Patients received 360 mg/m2 epratuzumab intravenously every 2 weeks for
4 doses with analgesic/antihistamine premedication (but no steroids) prior
to each dose. Evaluations, performed at 6, 10, 18 and 32 weeks (6 months
post- treatment), included safety, SLE activity (BILAG score), blood levels
of epratuzumab, B and T cells, immunoglobulins, and human anti-epratuzumab
antibody (HAHA) titers.
Epratuzumab was well tolerated, with a median infusion time of 32
minutes. Drug serum levels were measurable for at least 4 weeks
post-treatment and detectable in most samples at 18 weeks. B-cell levels
decreased by an average of 35% at 18 weeks and remained depressed at 6
months post-treatment. Changes in routine safety laboratory tests were
infrequent and without any consistent pattern, and there was no evidence of
immunogenicity, or significant changes in T cells, immunoglobulins, or
autoantibody levels.
Results from this study were presented at the 68th annual scientific
meeting of American College of Rheumatology (ACR)/Association of
Rheumatology Health Professionals (ARHP) (please refer to
http://www.immunomedics.com/news_pdf/2004_PDF/PR10192004.pdf).
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, 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.
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, 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:
Immunomedics Inc.
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.immunomedics.com/news_pdf/2004_PDF/PR10192004.pdf
http://arthritis-research.com/content/8/3/R74
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, or ccheng@immunomedics.com
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