- Follow-up Clinical Data Presented at the 48th Annual Meeting of American
Society of Hematology -
ORLANDO, Fla., Dec. 11 /PRNewswire-FirstCall/ -- Immunomedics, Inc.
(Nasdaq: IMMU), a biopharmaceutical company focused on developing
monoclonal antibodies to treat cancer and other serious diseases, presented
on Sunday, December 10th, follow-up clinical data that showed the Company's
humanized anti-CD20 (hA20) monoclonal antibody was active in patients with
non-Hodgkin's lymphoma (NHL) at a dose as low as 120 mg/m(2). Results of
this open-label, multi-center Phase I/II study were reported at the 48th
Annual Meeting of American Society of Hematology (ASH) in Orlando, FL, by
Franck Morschhauser, MD, Centre Hospitalier Regional Universitaire de
Lille, Lille, France, the study's lead investigator.
In the United States, NHL is the most common form of blood cancer,
affecting over 360,000 people. Each year, there are approximately 50,000
new cases and almost 25,000 deaths from this disease in the United States.
According to Dr. Morschhauser, "These results with hA20 compare
favorably to a published report of a similar patient population retreated
with rituximab after at least one prior course of this antibody, where
overall and complete response rates of 40% and 11%, respectively, were
observed for the usual dose of 375 mg/m(2) weekly for four weeks (TA Davis
et al., J Clin Oncol 2000; 18:3135-43). Throughout the doses studied with
hA20, an encouragingly high complete response rate, averaging 22%, and
durable responses at each dose level were observed in these low-grade or
follicular lymphoma patients."
Cynthia Sullivan, President and CEO of Immunomedics, commenting on the
low-dose responses seen with hA20, said, "The difference between the two
antibodies is that rituximab has been approved at a dose of 375 mg/m(2).
With hA20, we can go down to 120 mg/m(2) and achieve similar response rates
and B-cell depletion. The advantages of a lower dose include faster
infusion rates and fewer side effects." She further commented, "Because
hA20 is a humanized antibody, thus far we have not seen any immune reaction
to it." Ms. Sullivan also pointed out that during the study, no serious
infusion related events were reported.
A total of 57 adult patients with recurrent NHL were enrolled and were
infused once weekly for four consecutive weeks with 120, 200, 375, or 750
mg/m(2) of hA20. Fifty patients had received at least one prior rituximab-
containing regimen. Treatment responses from 48 assessable patients (32
with follicular lymphoma and 16 with non-follicular lymphoma) with at least
one post-treatment evaluation were reported at the meeting. The overall
objective response rate (partial and complete responses) was 44% (21/48),
with 17% (8/48) of patients having a complete response (CR/CRu).
In the 32 patients with follicular lymphoma, the overall response rate
was 47% (15/32), with a complete response rate of 22% (7/32). Responders
were across all dose groups, even at the lowest dose of 120 mg/m(2)
(approximately one-third the conventional dose of rituximab) where 36%
(5/14) were responders and 21% (3/14) had a complete response. In
non-follicular lymphomas, the overall responses rate was 38% (6/16),
including one complete response in marginal zone lymphoma. Higher overall
response rates with up to 50% complete responses were observed at higher
doses. In a median follow-up of 11 months post therapy, 9/21(43%) had
continuing responses, including 4 with long-lived responses (15-20 months).
"We expect to complete this study soon and to advance the development
of this humanized CD20 antibody in NHL as well as autoimmune diseases," Ms.
Sullivan said. "While we continue to discuss out-licensing this product
with potential partners, we are simultaneously developing a subcutaneous
formulation. hA20's efficacy at low doses given the relatively small amount
of protein involved, affords us the opportunity to develop a subcutaneous
formulation, potentially providing the benefits of ease of use and patient
acceptance."
This study was extended to focus on accruing patients at the 120 mg/m2
dose and continuing the de-escalation of doses below 120mg/m(2). The
results confirmed that hA20 was well tolerated with no serious infusion
related adverse events or immune reactions to date. The humanized anti-CD20
antibody was infused usually within 2 hours and depleted circulating
B-cells at all doses, even after the first week's infusion.
(http://www.immunomedics.com/news_pdf/2006_PDF/PR06052006a.pdf).
About hA20
hA20 was constructed using the same human donor frameworks and methods
employed to make the Company's anti-CD22 antibody, epratuzumab. Epratuzumab
has been studied in over 300 non-Hodgkin's lymphoma (NHL) patients and can
be infused within an hour. hA20 displays similar binding avidity,
specificity, and mechanisms of action as rituximab, but has structural
differences, and to date, shows an excellent safety and tolerability
profile, even when infused within 2 hours. At a single low dose of 120
mg/m(2), hA20 depleted circulatory B-cells, and produced high complete
responses in recurrent NHL patients with prior rituximab treatments when
given once weekly over 4 concurrent weeks. Doses between 120 and 750
mg/m(2) were evaluated in this multi-center clinical trial. To-date, no
patients have shown an elevated immune response to repeated injections of
hA20.
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. We have recently
licensed our lead product candidate, epratuzumab, to UCB, S.A. for the
treatment of all autoimmune disease indications worldwide. We have retained
the rights for epratuzumab in oncology indications for which UCB has been
granted a buy-in option. UCB has development, manufacture and
commercialization rights, and is responsible for all clinical trials
evaluating epratuzumab for the treatment of patients with moderate and
severe lupus. 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 108
patents issued in the United States, and more than 250 other issued patents
worldwide, protects our product candidates and technologies. We also have a
majority ownership in IBC Pharmaceuticals, Inc., which is developing a
novel dock and lock methodology, and a new method of delivering imaging and
therapeutic agents selectively to disease, especially different solid
cancers (colorectal, lung, pancreas, etc.) by proprietary, antibody-based,
pretargeting methods. 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 (including the timing
and amount of contingent payments), 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/
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
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