- Results Presented at the 12th Congress of European Hematology Association
(EHA) -
VIENNA, Austria, June 11 /PRNewswire-FirstCall/ -- Immunomedics, Inc.
(Nasdaq: IMMU), a biopharmaceutical company focused on developing
monoclonal antibodies to treat cancer and other serious diseases, today
announced that data presented at the 12th Congress of EHA in Vienna,
Austria, showed positive responses in patients with non-Hodgkin's lymphoma
(NHL) treated with a new radioimmunotherapy (RAIT) using epratuzumab to
deliver toxic radiation directly to lymphoma cells in small fractions.
Franck Morschhauser, MD, Centre Hospitalier Regional Universitaire de
Lille, Lille, France, is the lead investigator of this open-label,
multicenter Phase I/II dose-escalation study and the presenter at the
meeting.
Current RAIT treatments for NHL such as tositumomab and ibritumomab
tiuxetan are radiolabeled murine antibodies targeting the CD20 antigen on
the surface of mature B-cells and B-cell tumors as expressed by NHL cells.
Immunomedics' epratuzumab is a humanized monoclonal antibody that targets
the CD22 antigen on B-cells, including malignant B-cells. The internalizing
property of epratuzumab is believed to be well suited for delivering
radiation from the potent radioisotope, yttrium-90, selectively and locally
to lymphoma cells that express the CD22 antigen. Moreover, because
epratuzumab is humanized, it is argued that the new RAIT can be
administered to patients repeatedly in smaller doses. Researchers found
that splitting the dose over two or three fractions made it tolerable to
patients while delivering higher radioactivity to tumor cells.
At the time of reporting, 54 patients were evaluated with an overall
objective response rate of 59% and a complete response rate of 43%.
Moreover, responses appear durable with 6 complete responders who remained
disease free for more than 1 year, including 4 continuing for more than 2
years. Both the objective and complete response rates appear to increase
with higher cumulative doses. Objective responses occurred for 41% of
patients at the lowest total doses of 5-10 mCi/m(2), compared to 55% in the
groups receiving 15-20 mCi/m(2), 63% in the 22.5-37.5 mCi/m(2) cohorts, and
90% receiving the highest cumulative doses of 37.5-45 mCi/m(2). Similarly,
complete responses occurred for 29% of patients in the 5-10 mCi/m(2) total
dose groups, compared to 45% at 15-20 mCi/m(2), 44% at 22.5-37.5 mCi/m(2),
and 60% at 37.5-45 mCi/m(2).
Importantly, 64% of patients who had received prior
rituximab-containing regimens responded to (90)Y-epratuzumab, as well as
41% of patients with prior bone marrow transplant. Moreover, responses were
seen in patients with different types of NHL. Sixty-eight percent of
patients with follicular lymphoma responded to the RAIT, compared to 57%
for mantle cell lymphoma, 22% for diffuse large B-cell lymphoma, and all 3
patients with marginal zone lymphoma.
"We are very encouraged by these results. Not only did we observe high
response rates but, more importantly, the responses were seen in patients
with different types of NHL, and in rituximab-treated or naïve patients
with or without a history of bone marrow transplants," remarked Dr. Franck
Morschhauser.
Adult patients with documented B-cell NHL who failed at least one prior
regimen of standard chemotherapy were eligible for this study. At the time
of reporting, 58 patients with a median of 3 prior therapies have completed
treatment. Patients were treated once weekly for two or three consecutive
weeks and the (90)Y dose was escalated in successive patient cohorts. For
patients with prior bone marrow transplants, dose escalation stopped at 10
mCi/m(2) total dose (5.0 mCi/m(2) x 2 weeks). For patients without prior
bone marrow transplants, however, the study is continuing at the highest
tested level of 45 mCi/m(2) total dose (15.0 mCi/m(2) x 3 weeks).
"We are particularly enthused by the strong safety profile, which we
believe allows us to increase the radiation dosage needed to achieve more
effective results. The 45 mCi/m(2) cumulative dose level is more than
two-fold higher than the maximum allowable dose of 32 mCi for ibritumomab
tiuxetan, or 18.5 mCi/m(2) based on a body area of 1.73 m(2) for a standard
person," commented Cynthia L. Sullivan, President and Chief Executive
Officer. "This study is now almost completed, and we will decide to either
out-license this agent, or complete the clinical development on our own,"
she added.
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 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. The Company is conducting clinical trials with hA20 in
patients with non-Hodgkin's lymphoma, epratuzumab as a potential
therapeutic for patients with lymphoma and leukemia, (90)Y-epratuzumab for
the therapy of patients with lymphoma, (90)Y- hPAM4 for pancreas cancer
therapy and hCD74 as a therapy for patients with multiple myeloma. 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 (DNL) 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. For additional
information on us, please visit our web site at
http://www.immunomedics.com. The information on our website does not,
however, form a part of this press release.
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), forecasts of future operating results,
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), our
dependence on our licensing partner for the further development of
epratuzumab for autoimmune indications, 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, of Immunomedics, Inc.,
+1-973-605-8200, extension 123, ccheng@immunomedics.com
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