- Results from a Children's Oncology Group (COG) Study Presented at
American Society of Clinical Oncology Annual Meeting -
CHICAGO, June 4 /PRNewswire-FirstCall/ -- Immunomedics, Inc. (Nasdaq:
IMMU), a biopharmaceutical company focused on developing monoclonal
antibodies to treat cancer and other serious diseases, today announced that
treatment with epratuzumab plus standard chemotherapy is feasible and well
tolerated in children with B-precursor acute lymphoblastic leukemia (ALL),
producing favorable early responses in the majority of patients. Elizabeth
Raetz, MD, pediatric oncologist at New York University, New York, in an
oral presentation at the 43rd Annual Meeting of the American Society of
Clinical Oncology (ASCO) in Chicago, IL, reported results from this
multicenter feasibility/phase II study.
Fifteen patients with CD22-positive ALL in marrow relapse were enrolled
in the feasibility portion of the study. Nine patients were in first and 3
in second or later marrow relapse. Epratuzumab was given alone at 360 mg/m2
twice weekly for two weeks followed by 4 weekly doses of epratuzumab in
combination of standard cytotoxic chemotherapy. Within 24 hours of the
6-week treatment period, surface CD22 antigen was not detected on
peripheral blood leukemic blasts in all but one of the 12 assessable
patients, indicating effective targeting of leukemic cells by epratuzumab.
At the time of reporting, 9/12 patients (75%) achieved a complete
remission, of whom 7 showed no residual disease by flow cytometry; 1
patient had a partial response, 1 stable disease, and 1 with disease
progression.
"We are encouraged by these results. The phase-2 portion of the study
is now opened for enrollment of 112 patients, with a primary endpoint of
second complete remission rate," commented Dr. Raetz, the study chair.
"We are pleased that COG shares our enthusiasm for epratuzumab and has
chosen to evaluate our antibody in their ongoing search for new treatments
for childhood leukemia. We will continue to expand the application of
epratuzumab to other B-cell malignancies," remarked Ms. Cynthia L.
Sullivan, Immunomedics' President and Chief Executive Officer.
The most common toxicities were grade-1/2 infusion reactions, which
occurred during the initial infusions only. Two non-hematological
dose-limiting toxicities occurred. One patient had a grade-4 seizure of
unclear etiology and one patient had asymptomatic grade-3 transaminase
elevation that returned to baseline prior to the time for the next
treatment cycle. All patients were able to resume infusions at a slower
rate after additional premedication.
About Acute Lymphoblastic Leukemia (ALL)
According to the American Cancer Society, an estimate of 2,790 children
before age 20, which represents 23% of new cases, will be diagnosed with
ALL in the United States in 2007 making ALL the most common cancer in
children and adolescents. About 85% of ALL is B-cell ALL, and the most
common subtype of B-cell ALL is B-precursor ALL. CD22 is expressed in more
than 90% of childhood B-precursor ALL. Although the 5-year survival rate
for ALL in children is 87%, the prognosis for a child with relapsed ALL
remains poor.
About Children's Oncology Group
The Children's Oncology Group (COG) is a network of more than 5,000
doctors, nurses and scientists who conduct clinical trials and perform
cutting-edge research to cure childhood cancer at more than 200 COG member
institutions. COG represents every pediatric cancer program in North
America, providing state-of-the-art medical and nursing care to more than
90% of children with cancer.
The multicenter feasibility/phase II study reported by Elizabeth Raetz,
MD, pediatric oncologist at New York University, New York, was supported by
grant CA-98543 from the National Cancer Institute and the Jeffrey Pryde
Foundation for Leukemia Research.
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, 90Y-epratuzumab for
the therapy of patients with lymphoma, 90Y-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, Immunomedics, Inc.,
+1-973-605-8200, ext 123, or ccheng@immunomedics.com
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