Immunomedics, Inc.
(Nasdaq: IMMU), a biopharmaceutical company focused on developing
monoclonal antibodies to treat cancer and other serious diseases, reported
today in an oral presentation at the 2007 Annual Meeting of the American
Association for Cancer Research (AACR) that the antigen targeted by the
humanized PAM4 antibody is expressed in early stage pancreatic cancer
specimens, a stage before the tumor becomes invasive.
Using immunohistochemical labeling of patient tumor specimens, Dr.
David. V. Gold of the Garden State Cancer Center, Belleville, NJ, in
collaboration with Dr. Ralph. H. Hruban of Johns Hopkins Medical
Institutions, Baltimore, MD, found that over 89% of 56 specimens of early
pancreatic cancer tested positive with the PAM4 antibody. Likewise, 87% of
48 specimens of invasive adenocarcinoma of the pancreas showed positive
labeling with PAM4.
According to Dr. Gold, "We found the expression of this biomarker
identified by the PAM4 antibody in the earliest phase of pancreatic cancer,
specifically, in 89% of 24 specimens. Importantly, the antibody did not
react with normal pancreatic tissue. We believe this indicates to us that
the PAM4 antibody recognizes an early biomarker for this disease, which is
commonly diagnosed too late for effective therapy."
Dr. Gold is collaborating with Immunomedics to develop an early blood
test to detect pancreatic cancer. Immunomedics is completing a dose-finding
study evaluating the safety and tolerability, as well as initial anticancer
activity, of its humanized PAM4 antibody labeled with the therapeutic
isotope, yttrium-90. At the AACR conference, Dr. Gold reported on a case
where the PAM4 antibody was able to localize a recurrence of pancreatic
cancer in a patient who had earlier tumor resected.
Cynthia L. Sullivan, President and Chief Executive Officer of
Immunomedics, remarked: "PAM4's improved sensitivity for early pancreas
cancer, matched with its known high specificity for this disease based on
prior work by this group, is supportive of our decision to bring it rapidly
into clinical trials. Initial results from our phase I/II studies of hPAM4
in patients with pancreatic cancer will be released at the annual meeting
of the Society of Nuclear Medicine in June."
About PAM4
PAM4 is an antibody that recognizes a specific biomarker (MUC1) made
almost exclusively by pancreatic cancer. Developed by Dr. David V. Gold,
the antibody was reported to detect an elevation of this biomarker in the
blood of over 80% of patients diagnosed with pancreatic cancer. Animal
studies with transplanted human pancreatic cancer demonstrated that PAM4,
radiolabeled with yttrium-90, had a very strong effect in reducing tumor
growth, even curing some animals. Although the radiolabeled PAM4 antibody
was superior to gemcitabine alone, the combination of radiolabeled PAM4
antibody and gemcitabine was more active in controlling pancreatic cancer
growth than either agent by itself, thus suggesting synergistic effects.
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, about
37,000 Americans are expected to 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%. Although early
detection and diagnosis is key for survival, it is rare to detect this
lethal cancer early due to the retroperitoneal location of the pancreas, a
relatively inaccessible location in the abdomen. The tumor is allowed to
grow in a silent fashion with only vague symptoms that makes it difficult
to distinguish from an inflammation of the pancreas, or pancreatitis.
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 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. 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. Visit our web site at immunomedics.
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), 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.
immunomedics