SAN ANTONIO, Oct. 19 /PRNewswire--FirstCall/ -- Immunomedics, Inc.
(Nasdaq: IMMU) today reported all fourteen patients enrolled in the Company's
phase II study of epratuzumab in systemic lupus erythematosus (SLE) showed
symptomatic improvement twenty-four hours after the last treatment. The
results were presented at the 68th annual scientific meeting of American
College of Rheumatology (ACR)/Association of Rheumatology Health Professionals
(ARHP) by Professor Thomas Dorner of Charite University Hospital in Berlin,
Germany, a distinguished authority in the field of autoimmune diseases,
particularly SLE, and principal investigator of the study.
Professor Dorner also reported that a majority of patients (nine out of
fourteen or 64%) had lowered their global BILAG scores by 50% or more twenty-
four hours post-therapy. Furthermore, six of the seven patients who had
returned for their six-month check-up retained clinical benefit. A high BILAG
score indicates increased disease activity. In all patients, the treatment was
well tolerated with infusions completed in about one hour. Preliminary
results from this study had previously been reported (please refer to
http://www.immunomedics.com/news_pdf/2004_PDF/PR05112004.pdf ).
"We employed the scoring system devised by the British Isles Lupus
Assessment Group (BILAG) to monitor disease activity in this study because it
is a comprehensive index and is more appropriate for a complex autoimmune
disease like SLE," commented Ivan D. Horak, M.D., Executive Vice President,
Research and Development, and Chief Scientific Officer.
SLE is a serious autoimmune disease affecting predominantly young women in
the prime of their lives. The Lupus Foundation of America estimated that
about 1.5 million Americans are afflicted with the disease, with women
outnumbering men by a ratio of nine to one, and 80% of women patients develop
lupus between the ages of 15 and 45. At present, there is no cure for SLE.
Current treatments include corticosteroids, nonsteroidal anti-inflammatory
drugs, immunosuppressives, and antimalarials. More importantly, no new lupus
drug has been approved in the U.S. for 38 years.
"Lupus is a major women's health issue, especially for women of minority,"
commented Cynthia L. Sullivan, President and Chief Executive Officer, "Based
on recent discussions with FDA, we have an agreed clinical development plan to
go forward with registration trials in SLE in the near future. We look
forward to the opportunity to potentially help lupus patients lead a normal,
healthy and productive life."
"This is a major milestone in the clinical development of epratuzumab.
Although epratuzumab has shown activity in non-Hodgkin's lymphoma (NHL) in
recent phase II studies, our strategy is to proceed with the SLE registration
studies before those in NHL. Driven by the fact that SLE is a significant
market with an urgent need for a new therapeutic, we believe our decision will
add more value to epratuzumab and this has been suggested in our ongoing out-
licensing efforts," added Ms. Sullivan. "Another value-added strategy for
epratuzumab is to expand into other diseases," remarked Ms. Sullivan. New
clinical studies for epratuzumab include:
-- A Phase I/II clinical trial in Sjogren's syndrome, an autoimmune
disorder affecting as many as four million Americans where white blood
cells attack the moisture-producing glands, is ongoing in Europe.
-- A Phase I/II clinical trial in Waldenstrom's macroglobulinemia, a type
of low-grade lymphoma, is enrolling patients in the U.S. and in
Europe.
-- A Phase I/II trial for children with relapsed CD22-positive acute
lymphoblastic leukemia has been approved in the U.S. Funded by the
National Cancer Institute, this trial will be conducted by the
Children's Oncology Group, which is part of the Clinical Trials
Cooperative Group Program established by the federal government to,
among other things, promote and support clinical trials of new cancer
treatments.
"We are pleased with the continued clinical development of epratuzumab in
NHL and other autoimmune diseases, and we are grateful that the Children's
Oncology Group share our enthusiasm for epratuzumab with the addition of our
antibody to their studies to evaluate new methods of treating childhood
leukemia," commented Ms. Sullivan.
Immunomedics, Inc. 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 therapeutic product candidates in clinical development and has two
marketed diagnostic imaging products. Our most advanced therapeutic product
candidate is epratuzumab, for which certain Phase II clinical trials for the
treatment of non-Hodgkin's lymphoma have already been completed.
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, 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.
Company Contact: Chau Cheng, Associate Director, Investor Relations &
Business Analysis,(973) 605-8200, extension 123. Visit the Company's web site
at http://www.immunomedics.com .
SOURCE Immunomedics, Inc.
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Related links:
http://www.Immunomedics.com
http://www.immunomedics.com/news_pdf/2004_PDF/PR05112004.pdf
Company News On-Call:
http://www.prnewswire.com/comp/113121.html
CONTACT:
Chau Cheng, Associate Director, Investor
Relations & Business Analysis, of Immunomedics, Inc.,
+1-973-605-8200, ext. 123
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