VIENNA, Austria, June 10 /PRNewswire-FirstCall/ -- Immunomedics, Inc.
(Nasdaq: IMMU), a leading biopharmaceutical company focused on developing
monoclonal antibodies, today reported encouraging results from its Phase I/II
trial with its compound, epratuzumab, for the treatment of Sjogren's syndrome,
an autoimmune disease that currently affects between 2 to 4 million Americans.
Results were presented at the 2005 Annual European Congress of Rheumatology in
Vienna, Austria, organized by The European League Against Rheumatism (EULAR).
Professor Serge D. Steinfeld of Erasme University Hospital, Brussels, Belgium,
was the principal investigator.
"Current therapies for Sjogren's syndrome do not adequately treat the
signs and symptoms, which is why these results are so encouraging," commented
Ivan D. Horak, M.D., Executive Vice President, Research and Development, and
Chief Scientific Officer of Immunomedics. "Our first set of epratuzumab data
demonstrates clinical improvement in this difficult-to-treat population of
patients with Sjogren's syndrome. We intend to meet with the FDA shortly to
discuss further development of epratuzumab in this indication."
Evidence suggests that B-cells may play a key role in the inflammatory
cascade of Sjogren's syndrome or lupus. Consistent with the Company's past
clinical experience with epratuzumab, the investigators also found a reduction
of 50% to 60% in circulating B-cells in the patients enrolled in the trial.
This data suggests that B-cell modulation may be the primary mechanism of
action of epratuzumab, and that complete depletion of B-cells is not necessary
to provide a clinical benefit.
Fifteen patients with primary Sjogren's syndrome were enrolled in this
open-label, non-randomized, two-center study to assess feasibility, safety,
and early evidence of efficacy. Over an eight-week period, patients received
360 mg/m2 of epratuzumab every two weeks for a total of four doses. Fourteen
patients received all four infusions without reactions with a median infusion
time of fifty minutes. One patient discontinued the third infusion due to an
acute infusion reaction, but completed the fourth infusion with no further
reaction.
Patients reported improvements in their clinical signs and symptoms that
include: dry eyes, dry mouth, fatigue, tender joints, tender points, tear and
salivary flow. Specifically, twenty-four hours after the last treatment,
symptomatic improvements ranging from 100% of patients experiencing tender
joints to 33% of patients with salivary flow were observed. Moreover, when
these patients were evaluated twelve weeks post therapy, 86% of patients who
showed tender joints improvement retained clinical benefit, as did 20% of
patients with increased salivary flow. A final evaluation is planned for six
months after the last epratuzumab dose.
About Epratuzumab
Epratuzumab is a humanized monoclonal antibody that targets CD22 antigen,
found on the surface of B-lymphocytes, a type of white blood cell.
Epratuzumab is being evaluated in patients with Sjogren's syndrome and is also
Immunomedics' lead product candidate in two pivotal Phase III trials for the
treatment of patients with moderate and severe systemic lupus erythematosus
(SLE). The FDA granted a Fast Track designation to the clinical development
program for epratuzumab for the treatment of patients with SLE. Epratuzumab
has also demonstrated good safety, tolerability, and clinical efficacy in more
than 340 patients with non-Hodgkin's lymphoma, resulting in reports published
in The Journal of Clinical Oncology and Clinical Cancer Research.
About Sjogren's Syndrome
Sjogren's syndrome is a chronic autoimmune syndrome characterized by
lymphocyte infiltration of salivary glands resulting in symptomatic eye and
mouth dryness. Sjogren's syndrome can be associated with extraglandular
presentations such as musculoskeletal features including fatigue and
fibromyalgia in nearly 50% of patients and fewer patients complain of
arthralgias. According to the Sjogren's Syndrome Foundation, the condition
affects approximately two million to four million Americans, mostly middle-age
women.
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. At present, there is no cure for lupus and no new
lupus treatment 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 issued patents in the United States, and more than 250 other
issued patents worldwide, protects its product candidates and technologies.
Visit the Company's web site at http://www.immunomedics.com.
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,
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 financing and other sources of capital, as well as the risks discussed in
the Company's Annual Report on Form 10-K for the fiscal year ended June 30,
2004. 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
+1-973-605-8200, extension 123
ccheng@immunomedics.com
Julie Huang
Financial Dynamics
+1-212-850-5628
jhuang@fd-us.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:
Dr. Chau Cheng, Associate Director, Investor
Relations & Business Analysis, +1-973-605-8200, extension 123,
ccheng@immunomedics.com; or Julie Huang, +1-212-850-5628,
jhuang@fd-us.com of Financial Dynamics
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