Randomized, Double-Blinded and Controlled Clinical Study Evaluates MORAb-009 for Extending Survival of Patients Treated with MORAb-009 Plus Gemcitabine
EXTON, Pa.--(Business Wire)--Morphotek(R), Inc., a subsidiary of Eisai Co., Ltd., today
announced that it has commenced a multi-centered Phase II study of its
MORAb-009 monoclonal antibody. The study will evaluate MORAb-009, plus
the chemotherapy drug gemcitabine, as a first line treatment for
patients with pancreatic cancer. The randomized, controlled,
double-blinded trial will compare MORAb-009 plus gemcitabine with a
placebo plus gemcitabine.
The primary objective of the study is to assess the efficacy of
MORAb-009 as determined by overall survival in patients with locally
advanced or metastatic pancreatic cancer. Secondary objectives include
safety and anti-tumor activity of MORAb-009 as determined by objective
response rate and progression free survival. The patient population
includes individuals with adenocarcinoma of the pancreas that cannot
be cured by surgery and who have had no other chemotherapy for
pancreatic cancer. Morphotek expects to enroll up to 152 patients in
this clinical study, which is being conducted at clinical centers in
North America, South America and Europe.
MORAb-009 is a monoclonal antibody that blocks the function of
mesothelin, a cell surface protein on pancreatic tumor cells that can
allow the tumor cells to attach, metastasize and grow. Mesothelin has
been demonstrated by several independent studies to be expressed on
virtually all pancreatic adenocarcinomas. Preclinical data support the
theory that MORAb-009 achieves its pharmacological effect by two
mechanisms: first by blockade of mesothelin's ability to interact with
its target, and second by recruiting the patient's immune system to
the tumor to specifically destroy those cells bound by the antibody.
The Phase II clinical trial is supported by safety data and clinical
observations from a recently completed Phase I trial of MORAb-009 in
patients with mesothelin-bearing tumors, including pancreatic,
mesothelioma and ovarian cancers as well as safety and efficacy data
derived from preclinical models. Preclinical studies have shown that
MORAb-009 works additively with gemcitabine to suppress tumor growth.
"We are excited to have initiated this Phase II study of MORAb-009
in pancreatic cancer," stated Martin Phillips, M.D., Senior Vice
President of Clinical Development at Morphotek. "We hope that
MORAb-009 will one day bring a benefit to pancreatic cancer patients."
Pancreatic cancer develops in the tissues of the pancreas, usually
growing asymptomatically before it is discovered. It is the eighth
most common cause of death from cancer in men and women worldwide,
accounting for more 227,000 deaths per year. More than 37,000 people
are diagnosed with pancreatic cancer each year in the United States
and approximately 50,000 people in the European Union.
About Morphotek
Morphotek(R), Inc., a subsidiary of Eisai Co., Ltd., is a
biopharmaceutical company specializing in the development of protein
and antibody products through the use of a novel and proprietary gene
evolution technology. The technology has been successfully applied to
a broad variety of cell lines and organisms to yield genetically
diverse offspring that are suitable for pharmaceutical product
development in the areas of antibody therapeutics, protein
therapeutics, product manufacturing, drug target discovery, and
improved output traits for commercial applications. The company is
currently focusing its platform on the development and manufacturing
of therapeutic antibodies for the treatment of cancer, inflammation
and infectious disease. For more information, please visit
www.morphotek.com.
About Eisai Co., Ltd.
Eisai Co., Ltd. is a research-based human health care (hhc)
company that discovers, develops and markets products throughout the
world. Eisai focuses its efforts in three areas of therapeutic focus:
Integrative neuroscience including neurology and psychiatric
medicines; gastrointestinal disorders; and integrative oncology
including oncotherapy and supportive-care treatments. Through a global
network of research facilities, manufacturing sites and marketing
subsidiaries, Eisai actively participates in all aspects of the
worldwide health care system. Eisai employs about 10,000 people
worldwide and reported worldwide sales of Yen 674.1 billion in FY2006
(year ended March 31, 2007). More than 50 percent of the group sales
are derived from overseas business. For more information, please visit
www.eisai.co.jp.
Morphotek, Inc.
Nicholas Nicolaides, 610-423-6100
info@morphotek.com
or
Eisai Inc.
Judee Shuler, 201-746-2241
judee_shuler@eisai.com
or
Reverb--DBC
Bryan Evans, 215-957-0300
bevans@dbcommunications.net
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