- Abstract Published at American Society of Hematology (ASH) 47th Annual
Meeting -
ATLANTA, Dec. 9 /PRNewswire-FirstCall/ -- Immunomedics, Inc.
(Nasdaq: IMMU), a leading biopharmaceutical company focused on developing
monoclonal antibodies, announced today results of a trial conducted at eight
centers in Europe testing the safety and response rates of its lead product,
epratuzumab, in combination with rituximab in the treatment of patients with
non-Hodgkin's lymphoma (NHL).
The multi-center trial enrolled a total of thirty two patients with
follicular or indolent NHL who received four consecutive weekly infusions of
360 mg/m2 of epratuzumab followed by the same weekly schedule of 375 mg/m2
rituximab. Prior to joining this study, sixteen patients had received two or
more chemotherapy regimens and eleven patients had rituximab therapy. Twenty
patients, or 62%, achieved an objective response, including 25% with complete
responses (CR/CRu) and 37% with partial responses. The median response
duration was 16.5 months and the median time-to-progression was 11 months.
Further analysis using the Follicular Lymphoma International Prognostic
Index (FLIPI), a new prognostic index specifically designed for follicular
lymphoma patients, revealed that those patients having the lowest prognostic
index scores, or best prognosis, had the best outcome. Specifically, at FLIPI
scores of 0-1, there was an 82% (9/11) objective response rate and a complete
response rate of 36% (4/11), with a median duration of response of 15.7 months
and a median time-to-progression of 19.2 months.
"These results are encouraging regarding the potential of combination
therapy involving CD22 and CD20 monoclonal antibodies in the treatment of
patients with NHL, and confirm earlier results from a single-center trial at
the NY Hospital-Cornell Medical Center where patients with good prognostic
indices were studied," commented Cynthia L. Sullivan, President and Chief
Executive Officer. "It appears that both antibodies have different mechanisms
of action. We anticipate that the complete trial results, including patients
with aggressive NHL, toxicity data, and longer follow-up, will be published in
2006," she commented further.
In addition to the two pivotal Phase III ALLEVIATE trials in patients with
lupus, epratuzumab is currently being studied in patients with Waldenstrom's
Macroglobulinemia, a rare, chronic type of lymphoma, and by the Children's
Oncology Group (COG) of the National Cancer Institute (NCI) in children with
acute lymphoblastic leukemia. The North Central Cancer Treatment Group, a
national clinical research group sponsored by the NCI, also plans to evaluate
epratuzumab in combination with rituximab and CHOP chemotherapy in aggressive
NHL patients.
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.
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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, ext. 123,
ccheng@immunomedics.com
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