HATFIELD, England and
SAN DIEGO, July 31, 2015 /PRNewswire/ --
Clinical trial will explore
whether eribulin in combination with PEGPH20 can improve overall
response rate in women with advanced
breast cancer
Eisai Co., Ltd. and Halozyme Therapeutics, Inc. (NASDAQ: HALO)
today sign a clinical collaboration agreement that will evaluate
Halaven® (eribulin) in combination with Halozyme's
investigational PEGPH20 (PEGylated recombinant human hyaluronidase)
in first line HER2-negative metastatic breast cancer. Under the
agreement, the companies will jointly conduct and share the costs
of a Phase 1b/II clinical study seeking to determine whether the
combination therapy of eribulin and PEGPH20 can improve overall
response rate (the proportion of women that have a predefined
reduction in tumour burden), in advanced breast cancer patients
with high levels of hyaluronan.
PEGPH20 is an investigational drug administered intravenously
that targets the degradation of hyaluronan, a glycosaminoglycan -
or chain of natural sugars throughout the body - that can
accumulate around cancer cells to inhibit other therapies. By
degrading hyaluronan, PEGPH20 increases blood flow to the tumour
which may allow cancer therapies to be more efficiently delivered
to their target. The collaborative study will seek to determine
whether the combination therapy of eribulin and PEGPH20 can improve
overall response rate in patients with high levels of hyaluronan.
In hyaluronan-rich triple-negative breast preclinical animal
models, the addition of PEGPH20 to eribulin significantly increased
tumour growth inhibition and overall tumour regressions, when
compared to eribulin alone[1].
Eribulin is the first in the halichondrin class of microtubule
dynamics inhibitors with a novel mechanism of action. Structurally
eribulin is a modified and synthetically produced analog of
halichondrin B, a natural product isolated from the marine sponge
Halichondria okadai. Eribulin is believed to work by inhibition of
the growth phase of microtubule dynamics which prevents cell
division. Eribulin is currently approved in more than 60 countries
around the world, which include all of the European Union, Canada, United States, Russia, Switzerland, South
Korea, Japan and
Singapore.
"This is a very important collaboration in our continual drive
to beat advanced breast cancer and further confirms the distinct
mode of action of eribulin. We look forward to enrolling patients
in the clinical trial and obtaining the results," comments
Gary Hendler, President and CEO
Eisai EMEA and President, Eisai Oncology Global Business Unit.
"This agreement marks the first clinical collaboration agreement
for Halozyme and extends the study of PEGPH20 to a substantially
wider population of patients with a partner that is a clear leader
in the treatment of metastatic breast cancer," said Dr.
Helen Torley, President and CEO,
Halozyme Therapeutics.
Eribulin remains the only single agent chemotherapy to
significantly improve overall survival in women with advanced
breast cancer after anthracycline and taxane treatment. Advanced or
metastatic breast cancer is a very difficult condition to treat and
only 25.9% of women will survive beyond five
years[2].
Eribulin is indicated in the European Union for the treatment of
women with locally advanced or metastatic breast cancer who have
progressed after at least one chemotherapeutic regimen for advanced
disease[3]. Prior therapy should
have included an anthracycline and a taxane in either the adjuvant
or metastatic setting, unless patients were not suitable for these
treatments.
Eisai is dedicated to the discovery, development and production
of innovative oncology therapies that can make a difference and
impact the lives of patients and their families. This passion for
people is part of Eisai's human health care (hhc) mission,
which strives to better understand the needs of patients and their
families to increase the benefits health care provides.
Notes to Editors
PEGPH20
PEGPH20 (PEGylated recombinant human hyaluronidase) is an
investigational drug administered intravenously that targets the
degradation of hyaluronan (HA), a major component of the
extracellular matrix. By disrupting HA, PEGPH20 may inhibit tumour
growth and promote the dispersion of chemotherapeutic agents.
PEGPH20 is currently under development in combination with
chemotherapies for the treatment of metastatic pancreatic cancer
and non-small cell lung
cancer[4],[5]
with plans later for it to be studied in combination with an
immunotherapy agent later this year.
Halaven® (eribulin)
Eribulin is indicated for the treatment of women with locally
advanced or metastatic breast cancer who have progressed after at
least one chemotherapeutic regimen for advanced disease. Prior
therapy should have included an anthracycline and a taxane in
either the adjuvant or metastatic setting, unless patients were not
suitable for these
treatments[3].
Metastatic Breast Cancer and the HER2 Protein
Over 300,000 women are diagnosed with breast cancer in
Europe every year, of whom about
one third subsequently develop metastatic
disease[6],[7].
Metastatic disease is an advanced stage of the disease that occurs
when cancer spreads beyond the breast to other parts of the
body.
HER2 is a protein that is found on the surface of cells. In
HER2-positive breast cancer there is more (over expression) of this
protein found on the surface of tumour cells compared with normal
breast cells. This protein can be targeted with HER2 targeted
therapies such as Herceptin, in people who overexpress HER2, but
not in people with normal levels of HER2 protein (HER2-negative)
breast cancer. Breast cancers are routinely tested for the presence
of HER2 to decide the most appropriate treatment. Triple-negative
breast cancer (TNBC) refers to any breast cancer that does not
express the genes for oestrogen receptor, progesterone receptor
(<1%) and HER2 (<30%).
Eisai in Oncology
Our commitment to meaningful progress in oncology research,
built on scientific expertise, is supported by a global capability
to conduct discovery and preclinical research, and develop small
molecules, therapeutic vaccines, and biologic and supportive care
agents for cancer across multiple indications.
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 over
10,000 employees working across our global network of R&D
facilities, manufacturing sites and marketing subsidiaries, we
strive to realise our hhc philosophy by delivering
innovative products in multiple therapeutic areas with high unmet
medical needs, including 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
http://www.eisai.com.
About Halozyme
Halozyme Therapeutics is a biotechnology company focused on
developing and commercialising novel oncology therapies that target
the tumour microenvironment. Halozyme's lead proprietary program,
an investigational drug PEGPH20, applies a unique approach to
targeting solid tumours, allowing increased access of
co-administered cancer drug therapies to the tumour. PEGPH20
is currently in development for metastatic pancreatic cancer and
non-small cell lung cancer and has potential across additional
cancers in combination with different types of therapies. In
addition to its proprietary product portfolio, Halozyme has
established value-driving partnerships with leading pharmaceutical
companies including Roche, Pfizer, Janssen, Baxalta and AbbVie for
its drug delivery platform, ENHANZE™, which enables biologics and
small molecule compounds that are currently administered
intravenously to be delivered subcutaneously. Halozyme is
headquartered in San Diego. For
more information, visit http://www.halozyme.com.
References
- Zhao, C. et al. Hyaluronan-dependent Growth of Human Triple
Negative Breast Cancer MDA-MB-468 in Mouse Xenograft Models.
Abstract only #2392. Presented at American Association for Cancer
Research (AACR) Annual Meeting 2015. Available at:
http://www.halozyme.com/files/doc_downloads/Abstracts%20and%20Posters/AACR-2015-ABSTRACT-2392-FINAL-POSTER_v001_q3llpa.pdf
Accessed: July 2015
- http://seer.cancer.gov/statfacts/html/breast.html Accessed:
July 2015
- SPC Halaven (updated June 2014).
Available at
http://www.medicines.org.uk/emc/medicine/24382/SPC/Halaven+0.44+mg+ml+solution+for+injection/
Accessed: July 2015.
- Halozyme Therapeutics; PEGPH20 Plus Nab-Paclitaxel Plus
Gemcitabine Compared With Nab-Paclitaxel Plus Gemcitabine in
Subjects With Stage IV Untreated Pancreatic Cancer (HALO-109-202).
In: ClinicalTrials.gov [Internet]. Bethesda (MD): National Library of Medicine
(US). 2000- [cited 2015 July 21]. Available from:
https://clinicaltrials.gov/ct2/show/NCT01839487?term=pegph20&rank=1
NLM Identifier: NCT01839487
- Halozyme Therapeutics; A Phase 1b/2, Study of Pegylated
Recombinant Human Hyaluronidase Combined With Docetaxel Versus
Docetaxel Alone in Subjects With Recurrent Previously Treated
Locally Advanced or Metastatic NSCLC. (PRIMAL). In:
ClinicalTrials.gov [Internet]. Bethesda (MD): National Library of Medicine
(US). 2000- [cited 2015 July 21]. Available from:
https://clinicaltrials.gov/ct2/show/NCT02346370?term=pegph20&rank=7
NLM Identifier: NCT02346370
- World Health Organisation. Atlas of Health in Europe. 2003. World Health Organization,
Regional Office of Europe,
Copenhagen, Denmark.
- Cancer Research UK. Breast cancer incidence statistics.
Available at:
http://www.cancerresearchuk.org/cancer-info/cancerstats/types/breast/incidence/#world.
Accessed: July 2015
Job code: Corporate-UK2032
Date of preparation: July
2015