SAN DIEGO, Nov. 15 /PRNewswire-FirstCall/ -- Immunomedics, Inc.
(Nasdaq: IMMU), a leading biopharmaceutical company focused on developing
monoclonal antibodies, today reported that patients with primary Sjogren's
syndrome, an autoimmune disease that currently affects between 2 to 4 million
Americans, retained clinical benefits six months after being treated with
epratuzumab. The results were presented at the 2005 annual scientific meeting
of American College of Rheumatology (ACR)/Association of Rheumatology Health
Professionals (ARHP) by Dr. Serge D. Steinfeld, Professor of Medicine,
Department of Rheumatology, Erasme University Hospital, Brussels, Belgium.
The clinical trial was an open-label, non-randomized, two-center Phase
I/II study to assess feasibility, safety, and early evidence of efficacy in
fifteen patients with primary Sjogren's syndrome. Epratuzumab, a recombinant
humanized antibody against CD22 expressed on B-lymphocytes, was administered
intravenously in about one hour, every other week, for four doses of 360mg/m2
each. Patients were then evaluated twenty-four hours, four weeks, twelve
weeks and six months post therapy. Epratuzumab therapy was associated with a
mean decrease in circulating B-cells of 33% during the six- month evaluation.
No immunogenicity was observed, and 1 patient experienced a serious drug-
related infusion reaction, which resolved completely with no further
recurrence of symptoms.
Efficacy was evaluated in four categories: tear production, unstimulated
salivary flow, fatigue and laboratory analysis of erythrocyte sedimentation
rate or IgG levels. Responders were defined as patients who have demonstrated
improvement of 20% or more in two out of the four domains. At 20% level of
improvement, the responder rates were between fifty to sixty percent
throughout the entire six-month evaluation period. At 30% level of
improvement, the rates decreased slightly to forty to fifty percent. At 50%
level of improvement, the responder rates ranged from ten to forty percent,
depending on the evaluation time point. These results were based on all
patients who entered the study, but if the analysis is calculated based on the
number of patients who were evaluable at the various time-points, then the
responses were 9/10, 7/10, and 6/10 patients at 6 months for the 20%, 30% and
50% levels of improvement, respectively.
"These initial efficacy results suggest that epratuzumab is a promising
therapy in patients with active primary Sjogren's syndrome. Further
controlled, blinded, studies to confirm these early efficacy results are
warranted," commented Serge D. Steinfeld, M.D., Ph.D., principal investigator
of the study. Preliminary results from this study had previously been
reported (http://www.immunomedics.com/news_pdf/2005_PDF/PR06102005.pdf).
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 effect 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 (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:
Dr. Chau Cheng
Associate Director, Investor Relations & Business Analysis
(973) 605-8200, extension 123
ccheng@immunomedics.com
SOURCE Immunomedics, Inc.
 back to top
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, 973-605-8200, extension 123, or
ccheng@immunomedics.com
|
