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Immunomedics Reports First Clinical Results with Epratuzumab in Systemic Lupus Erythematosus (SLE)
(05-13-2004) - - Humanized CD22 Antibody Shown to be Safe and Active in Clinical Study -
NEW YORK, May 11 /PRNewswire-FirstCall/ -- Immunomedics, Inc.
(Nasdaq: IMMU) reported today that a rheumatology group from the University of
Berlin, Germany, presented their initial Phase II results on eleven SLE
patients given epratuzumab at the 7th International Congress on Systemic Lupus
Erythematosus (SLE) and Related Conditions, being held in New York City.
Epratuzumab is under development by Immunomedics for the treatment of patients
with non-Hodgkin's lymphoma (NHL), where it has fully-enrolled patients in the
Phase II trials that have demonstrated safety and activity in both indolent
and aggressive forms of NHL.
"Since B-lymphocytes are involved in the production of autoantibodies, we
reasoned that epratuzumab may show activity in the treatment of autoimmune
diseases by affecting B-cell levels and function," commented Ivan D. Horak,
M.D., Executive Vice President and Chief Scientific Officer at the company.
"Our humanized CD22 antibody has been shown not to evoke any substantial
anti-epratuzumab antibodies in NHL patients, even after repeated dosing,
making it a good candidate for treating patients with a chronic, non-malignant
disease," he explained further.
The SLE study was designed to confirm the safety, tolerance, lack of
immunogenicity, and evidence of efficacy in SLE patients having moderately
active disease, who were receiving only maintenance doses of other therapeutic
agents. Eleven patients evaluated after receiving four, 30-minute, infusions
of epratuzumab every other week showed no infusion-related reactions or
serious adverse events due to the drug, including no evidence of antibodies
evoked against the drug.
"Using the BILAG scoring system, all patients showed initial evidence of
symptomatic improvement, with the majority having at least a 50 percent
decrease in their BILAG scores," Dr. Horak stated.
Cynthia L. Sullivan, President and Chief Executive Officer of
Immunomedics, remarked: "These promising results need to be confirmed in
future randomized trials of SLE patients. Furthermore, we are now expanding
studies into other autoimmune diseases with similar pathophysiology, which
could be of major significance to us because of the large numbers of patients
afflicted with such debilitating diseases."
"SLE in the U.S., for example, has been estimated at a prevalence of about
500,000 patients, but recently The Lupus Foundation of America has suggested
that as many as 1.5 million Americans have some form of lupus," Ms. Sullivan
said. She further added: "Whereas some patients die from lupus, most will
live a normal life span, but for some patients medical costs may exceed
several thousand dollars every month; two-thirds report a partial or complete
loss of income due to their disability, for which about 25 percent receive
disability payments. This is why new, safe and effective therapies for this
and other debilitating autoimmune diseases are needed, and we have accordingly
expanded our efforts in the development of such therapies with specific
antibodies. Since no new therapeutic has been approved for SLE in the past 30
years, we believe there is a significant need for new agents and approaches."
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 epratuzumab, for which certain Phase II clinical trials
for the treatment of non-Hodgkin's lymphoma have already been completed, and
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: Trish Merwin, Investor Relations, (973) 605-8200,
extension 263. Visit the Company's web site at
http://www.immunomedics.com.
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