SAN DIEGO, July 26, 2016 /PRNewswire/ -- Halozyme
Therapeutics, Inc. (NASDAQ: HALO) announced today that Eisai Inc.
has dosed the first patient in a collaborative phase 1b/2 clinical
trial to assess whether Eisai's eribulin mesylate
(HALAVEN®) in combination with Halozyme's
investigational drug PEGPH20 (PEGylated recombinant human
hyaluronidase) can improve overall response rate (ORR) – the
proportion of women that have a predefined reduction in tumor
burden – as compared with eribulin alone as a therapy in women with
advanced or metastatic, High-Hyaluronan (HA) HER2-negative breast
cancer.
"Initiation of this study is not only a major milestone in our
collaboration with Eisai, it underscores our combined focus on
advancing the treatment of metastatic breast cancer—one of the most
common cancers in women worldwide," said Dr. Helen Torley, president and chief executive
officer.
PEGPH20 is an investigational drug administered intravenously
that targets the degradation of HA, a glycosaminoglycan – or chain
of natural sugars throughout the body – that can accumulate around
cancer cells to inhibit other therapies. Eribulin, a synthetic
analog of halichondrin B, a natural product that was isolated from
the marine sponge Halichondria okadai, is a microtubule
dynamics inhibitor with a distinct binding profile that has been
shown in in vitro studies to lead to apoptotic cell death
after prolonged and irreversible mitotic blockage. In HA-high
triple-negative breast preclinical animal models, the addition of
PEGPH20 to eribulin showed a significant increase in tumor growth
inhibition and overall tumor regression when compared to eribulin
alone.
The collaborative study will seek to determine whether or not
the combination therapy of eribulin and PEGPH20 can improve the
overall response rate in patients with metastatic breast cancer
with high levels of HA. The study protocol includes metastatic
HER2-negative patients with HA-high breast cancer that were
previously untreated and those that received one prior line of
therapy.
About Advanced Breast Cancer
Advanced or metastatic breast cancer is a very difficult
condition to treat and only 26.3 percent of women will survive
beyond five years. (SEER 2016)
About PEGPH20
PEGPH20 is an investigational PEGylated form of Halozyme's
proprietary recombinant human hyaluronidase under clinical
development for the potential systemic treatment of tumors that
accumulate hyaluronan.
FDA granted orphan drug designation to PEGPH20 for treatment of
pancreatic cancer and fast track for PEGPH20 in combination with
gemcitabine and nab-paclitaxel for the treatment of metastatic
pancreatic cancer. Additionally, the European Commission, acting on
the recommendation from the Committee for Orphan Medicinal Products
of the European Medicines Agency, designated investigational drug
PEGPH20 an orphan medicinal product for the treatment of pancreatic
cancer.
About Eribulin Mesylate Injection (Available as
HALAVEN®)
Halaven® (eribulin mesylate) is a microtubule
dynamics inhibitor indicated for the treatment of patients
with:
- Metastatic breast cancer who have previously received at least
two chemotherapeutic regimens for the treatment of metastatic
disease. Prior therapy should have included an anthracycline and a
taxane in either the adjuvant or metastatic setting.
- Unresectable or metastatic liposarcoma who have received a
prior anthracycline-containing regimen.
Discovered and developed by Eisai, eribulin is a synthetic
analog of halichondrin B, a natural product that was isolated from
the marine sponge Halichondria okadai. First and only in the
halichondrin class, eribulin is a microtubule dynamics inhibitor
with a distinct binding profile. Eribulin is believed to work
primarily via a tubulin-based mechanism that causes prolonged and
irreversible mitotic blockage, ultimately leading to apoptotic cell
death. Additionally, in preclinical studies of human breast cancer,
eribulin demonstrated complex effects on the tumor biology of
surviving cancer cells, including increases in vascular perfusion
resulting in reduced tumor hypoxia, and changes in the expression
of genes in tumor specimens associated with a change in phenotype,
promoting the epithelial phenotype, opposing the mesenchymal
phenotype. Eribulin has also been shown to decrease the migration
and invasiveness of human breast cancer cells.
For more information about eribulin, click here for the full
Prescribing Information.
About Eisai Inc.
At Eisai Inc., human health care (hhc) is our
goal. We give our first thoughts to patients and their families,
and helping to increase the benefits health care provides. As the
U.S. pharmaceutical subsidiary of Tokyo-based Eisai Co., Ltd., we have a
passionate commitment to patient care that is the driving force
behind our efforts to discover and develop innovative therapies to
help address unmet medical needs.
Eisai is a fully integrated pharmaceutical business that
operates in two global business groups: oncology and neurology
(dementia-related diseases and neurodegenerative diseases). Each
group functions as an end-to-end global business with discovery,
development, manufacturing and marketing capabilities. Our U.S.
headquarters, commercial and clinical development organizations are
located in New Jersey; our
discovery labs are in Massachusetts and Pennsylvania; and our global demand chain
organization resides in Maryland
and North Carolina. To learn more
about Eisai Inc., please visit us at http://us.eisai.com.
About Eisai Co., Ltd.
Eisai Co., Ltd. is a leading global research and
development-based pharmaceutical company headquartered in
Japan. We define our corporate
mission as "giving first thought to patients and their families and
to increasing the benefits health care provides," which we call our
human health care (hhc) philosophy. With approximately 10,000
employees working across our global network of R&D facilities,
manufacturing sites and marketing subsidiaries, we strive to
realize our hhc philosophy by delivering innovative products to
address unmet medical needs, with a particular focus in our
strategic areas of Oncology and Neurology.
As a global pharmaceutical company, our mission extends to
patients around the world through our investment and participation
in partnership-based initiatives to improve access to medicines in
developing and emerging countries. For more information about Eisai
Co., Ltd., please visit www.eisai.com.
About Halozyme
Halozyme Therapeutics is a biotechnology company focused on
developing and commercializing novel oncology therapies that target
the tumor microenvironment. Halozyme's lead proprietary program,
investigational drug PEGPH20, applies a unique approach to
targeting solid tumors, allowing increased access of
co-administered cancer drug therapies to the tumor in animal
models. PEGPH20 is currently in development for metastatic
pancreatic cancer, non-small cell lung cancer, gastric cancer,
metastatic breast cancer and has potential across additional
cancers in combination with different types of cancer therapies. In
addition to its proprietary product portfolio, Halozyme has
established value-driving partnerships with leading pharmaceutical
companies including Roche, Baxalta, Pfizer, Janssen, AbbVie and
Lilly for its ENHANZE™ drug delivery platform. Halozyme is
headquartered in San Diego. For
more information visit www.halozyme.com.
Safe Harbor Statement
In addition to historical information, the statements set forth
above include forward-looking statements (including, without
limitation, statements concerning the possible activity, benefits
and attributes of PEGPH20, the possible method of action of
PEGPH20, its potential application to improve cancer therapies and
statements concerning future actions relating to the development of
PEGPH20) that involve risk and uncertainties that could cause
actual results to differ materially from those in the
forward-looking statements. The forward-looking statements are
typically, but not always, identified through use of the words
"believe," "enable," "may," "will," "could," "intends," "estimate,"
"anticipate," "plan," "predict," "probable," "potential,"
"possible," "should," "continue," and other words of similar
meaning. Actual results could differ materially from the
expectations contained in forward-looking statements as a result of
several factors, including unexpected expenditures and costs,
unexpected results or delays in development and regulatory review,
regulatory approval requirements, unexpected adverse events and
competitive conditions. These and other factors that may result in
differences are discussed in greater detail in the Company's
Quarterly Report on Form 10-Q filed with the Securities and
Exchange Commission on May 9,
2016.
The information discussed in this release presents an
investigational use for an FDA-approved product (eribulin). It is
not intended to convey conclusions about efficacy or safety. There
is no guarantee that the investigational use of the combination of
eribulin and PEGPH20 will successfully gain FDA approval.
Contacts:
Jim
Mazzola
858-704-8122
ir@halozyme.com
Chris Burton
858-704-8352
ir@halozyme.com
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SOURCE Halozyme Therapeutics, Inc.