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Immunomedics Reports Initial Clinical Results With Hpam4 For Pancreatic Cancer Therapy
Immunomedics, Inc.
(Nasdaq: IMMU), a biopharmaceutical company focused on developing
monoclonal antibodies to treat cancer and other serious diseases, today
announced that initial results from a Phase I study with the Company's
humanized anti-MUC1 monoclonal antibody (hPAM4), labeled with the
radioisotope, Yttrium-90 (Y-90), in patients with unresectable and
metastatic pancreatic cancer reported at the 54th Annual Meeting of the
Society of Nuclear Medicine in Washington, DC, by Seza Gulec, MD, Center
for Cancer Care, Goshen, IN, were encouraging.
Stage III pancreatic cancer patients who have failed one line of
chemotherapy and Stage IV patients with or without a history of systemic
therapy were eligible for the open-label, multicenter dose-escalation
study. Prior to therapy, all patients received a diagnostic dose of hPAM4
labeled with the radioisotope, Indium-111, to ensure an acceptable
distribution within the body and radiation dose to the pancreas for
intended therapy. Patients then received a single infusion of 90Y-hPAM4
with the Y-90 dose escalating in increments of 5mCi/m(2) in groups of 3-6
patients. CT based measurements were used to evaluate tumor response 4, 8,
and 12-weeks after therapy.
Results from the Goshen study site were reported at the meeting. Eleven
patients, of whom 9 had previously received systemic therapy predominantly
with gemcitabine regimens, and 2 patients who were chemotherapy naïve were
enrolled at this cancer center. In all patients, pre-therapy imaging with
111In-hPAM4 showed acceptable distribution within the body and radiation
dosage to the pancreas. 90Y-hPAM4 was administrated at 15 mCi/m(2), 20
mCi/m(2) or 25 mCi/m(2). One patient, enrolled into the clinical trial at
this site, showed shrinkage of a liver lesion.
Two patients, from other study sites, have also had reported tumor
shrinkage. All patients, however, showed disease progression at or after
week 8. The maximum tolerated dose was 20 mCi/m(2) with bone marrow being
the dose-limiting organ.
"Because of the refractory nature of pancreatic cancer, single agent
treatment is not expected to offer clinical benefit. Based on this Phase I
experience, combined/sequential treatment with chemotherapy and
fractionated radioimmunotherapy is being considered for future trials,"
commented Dr. Gulec.
"We have presented these preliminary results to the FDA and are in
discussion with the regulatory authority for a new Phase I dose-escalation
study for 90Y-hPAM4 in combination with gemcitabine using smaller Y-90
doses repeatedly," added Cynthia L. Sullivan, President and CEO of
Immunomedics.
In addition, the Company presented two posters at today's meeting on
the pretargeting of pancreatic cancer and B-cell lymphoma using new
bispecific antibodies constructed from the Company's proprietary platform
technology for protein engineering termed the dock-and-lock (DNL).
One poster was on TF10, which is a DNL construct with two binding sites
for the same MUC1 antigen targeted by PAM4, and a single binding site for
the histamine-succinyl-glycine (HSG) peptide. Initial therapy studies
showed that pretargeting with TF10 and Y-90 labeled HSG peptide can
effectively cause the complete regression of human pancreatic cancer in
mice at doses well below the maximum tolerated level.
The other poster was on TF4 for the pretargeting of B-cell lymphoma.
Constructed with two sites that target the CD20 antigen and one for the HSG
peptide, TF4, when used in combination with radiolabeled HSG-peptide, is
highly effective for imaging lymphoma implanted in mouse models either
subcutaneously or intravenously. Early results indicate therapy of tumors
can be achieved with 500 microCi of Y-90 or less.
About hPAM4
hPAM4 is a humanized monoclonal antibody targeting an epitope in the
MUC1 antigen expressed in most pancreatic cancer, but not pancreatitis,
normal pancreas or most other normal tissues. Preclinical studies with PAM4
labeled with the radioisotope, Yttrium-90, demonstrated favorable tumor
responses, which could be further improved when given in combination with
gemcitabine.
About Pancreatic Cancer
According to the National Cancer Institute, pancreatic cancer is the
fourth leading cause of cancer death in the United States. In 2007, an
estimated 37,000 Americans will be diagnosed with the disease, and about
33,000 patients will die from it. For patients with advanced cancers, the
overall 5-year survival rate of all stages is less than 1%. For those
patients with small and localized disease that can be completely resected
surgically, 5-year survival rates improve to 18% to 24%. Currently, the
standard therapy for pancreatic cancer is gemcitabine, alone or in
combination with other chemotherapeutics.
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.
Immunomedics, Inc.
http://www.immunomedics.com
Immunomedics rapoarte cu rezultatele clinice, iniþial Hpam4 terapie pentru cancer pancreatic - Immunomedics Reports Initial Clinical Results With Hpam4 For Pancreatic Cancer Therapy - articole medicale engleza - startsanatate