Immunomedics Announces 90 Y-Clivatuzumab Tetraxetan in Combination With
Low-Dose Gemcitabine is Active in Patients With Late-Stage Pancreatic Cancer
LYON, France, Oct. 23, 2013 (GLOBE NEWSWIRE) -- Immunomedics, Inc.
(Nasdaq:IMMU), a biopharmaceutical company primarily focused on the
development of monoclonal antibody-based products for the targeted treatment
of cancer, autoimmune and other serious diseases, today reported that multiple
cycles of therapy with the Company's pancreatic cancer therapeutic,
clivatuzumab tetraxetan labeled with yttrium-90 (^90Y), in combination with
low-dose gemcitabine, produced a median overall survival (OS) of more than 5
months in patients with metastatic pancreatic cancer who had received at least
2 prior treatments.
Results from the Phase Ib clinical trial were updated by Dr. William A.
Wegener, Senior Vice President, Clinical Research, in an oral presentation at
the 26^th Annual Congress of the European Association of Nuclear Medicine in
Despite a difficult-to-treat patient population with relapsing disease, a
partial response in 53 CT-assessable patients was reported at the Congress. In
addition, median OS for patients with partial response or stable disease as
best response was longer than those with disease progression (131 days vs. 66
"Based on these encouraging results, which have to be confirmed with a Phase
III clinical trial, we are proceeding with our plan to initiate such trial
with clivatuzumab in this late-stage disease setting," commented Cynthia L.
Sullivan, President and Chief Executive Officer. "We are preparing to open
this pivotal study before the end of 2013 or the beginning of 2014," Ms.
With the acronym PANCRIT, which stands for PANcreatic Cancer
RadioImmunotherapy Trial, the Phase III study will be a double-blind,
randomized trial of ^90Y-clivatuzumab tetraxetan with low-dose gemcitabine,
versus placebo and low-dose gemcitabine in metastatic pancreatic cancer
patients who have progressed on at least 2 prior therapies, 1 of which must be
a gemcitabine-containing regimen.
Target enrollment for this multicenter, international trial is 440 patients. A
majority of these patients will be recruited at clinical sites across the
U.S., with additional sites in Canada, Europe and Israel participating.
Patients will be randomized 2 to 1 to the treatment arm.
Primary endpoint of PANCRIT will be overall survival, with objective response,
progression-free survival and clinical benefit such as quality of life serving
as secondary outcome measures.
About Pancreatic Cancer
According to the American Cancer Society, an estimated 45,220 Americans will
be diagnosed with pancreatic cancer in 2013, making it the 10^th most common
cancer diagnosis among men and the 9^th most common among women in the U.S. It
is, however, the fourth leading cause of cancer death among both men and women
nationwide, with approximately 38,460 deaths expected, or about 7% of all
The outlook for pancreatic cancer patients is bleak, with median survival
ranges from 4.5 months for the most advanced stage to 24.1 months for the
earliest stage. For patients with the advanced disease, treatment options are
limited to gemcitabine alone or in combination with other agents. Although
FOLFIRINOX, the drug combination of leucovorin, fluorouracil, irinotecan, and
oxaliplatin, has recently been shown to prolong survival in patients with
newly-diagnosed advanced disease, many patients could not tolerate this
Immunomedics is a New Jersey-based biopharmaceutical company primarily 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, cytokines 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.Our lead product candidate,
epratuzumab, is currently in two Phase III clinical trials in lupus. In
oncology, we are planning to launch a Phase III pivotal trial for clivatuzumab
labeled with a radioisotope in advanced pancreatic cancer patients. Other
solid tumor therapeutics in Phase II clinical development include 2
antibody-drug conjugates, labetuzumab-SN-38 (IMMU-130) and hRS7-SN-38
(IMMU-132).We also have a majority ownership in IBC Pharmaceuticals, Inc.,
which is developing a novel DOCK-AND-LOCK™ (DNL™) method with us for making
fusion proteins and multifunctional antibodies. DNL™ is being used
particularly to make bispecific antibodies targeting cancers and infectious
diseases as a T-cell redirecting immunotherapy, as well as bispecific
antibodies for next-generation cancer and autoimmune disease therapies. We
believe that our portfolio of intellectual property, which includes
approximately 231 active patents in the United States and more than 400
foreign patents, protects our product candidates and technologies.Our
strength in intellectual property has resulted in the top-10 ranking in the
2012 IEEE Spectrum Patent Power Scorecards in the Biotechnology and
Pharmaceuticals category.For additional information on us, please visit our
website at 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, potential
collaborations, 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 any cash payment that the Company might
receive in connection with a sublicense involving a third party and UCB, which
is not within the Company's control, new product development (including
clinical trials outcome and regulatory requirements/actions), our dependence
on UCB for the further development of epratuzumab for non-cancer 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.
CONTACT: Dr. Chau Cheng
Senior Director, Investor Relations & Grant Management
(973) 605-8200, extension 123
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