SAN DIEGO, March 16, 2016 /PRNewswire/ -- Halozyme
Therapeutics, Inc. (NASDAQ: HALO), a biotechnology company
developing novel oncology and drug-delivery therapies, today
announced the first patient has been dosed in its Halo-301 |
Pancreatic study, a Phase 3 clinical trial in previously untreated
metastatic pancreatic cancer patients.
The global, randomized, double-blind, placebo controlled trial
will study Halozyme's investigational drug, PEGPH20, in combination
with ABRAXANE® (nab-paclitaxel) and gemcitabine in
patients identified to have tumors that accumulate high levels of
hyaluronan (HA). HA is a glycosaminoglycan, or chain of natural
sugars that may impede access of drugs targeting the tumor.
Halozyme's PEGPH20 temporarily degrades HA and has been shown in
animal models to increase the concentration of co-administered
therapies in the targeted tumor.
Halozyme also announced that the investigational device
exemption (IDE) submitted to the FDA last month by
Halozyme's partner Ventana Medical Systems has been approved. This
IDE allows Halozyme to use the Ventana HA CDx Assay as the
companion diagnostic in Halo-301 to prospectively identify
HA-High patients for inclusion in the study.
"The initiation of our Phase 3 study of PEGPH20 in HA-High
pancreatic cancer patients marks a key milestone for the Halozyme
team and the PEGPH20 development program," said Dr. Helen Torley, President and CEO of Halozyme.
Dr. Margaret Tempero, Director of
the Pancreas Center at University of
California, San Francisco and one of the Principle
Investigators of the study, said, "High levels of HA have been
associated with a worse prognosis in certain cancers, notably
pancreas cancer. We have assembled a team of expert investigators
at nearly 200 global sites to further study this potential link
with the hope of bringing new treatment options to an area of high
unmet need."
Halo-301 has an enrollment target of 420 HA-high patients and
seeks to improve progression-free survival and overall survival in
the patients receiving PEGPH20 plus ABRAXANE and gemcitabine
compared to those receiving placebo plus ABRAXANE and
gemcitabine.
The FDA granted orphan drug designation to PEGPH20 for the
treatment of pancreatic cancer and fast track designation 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 as an orphan
medicinal product for the treatment of pancreatic cancer.
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
and clinical trials (including the potential identification of
HA-High patients for inclusion in such clinical trials using the
companion diagnostic) 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, clinical trials and
the companion diagnostic not producing the results we expect,
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 Annual
Report on Form 10-K recently filed with the Securities and Exchange
Commission.
UC Disclaimer
The information stated above was prepared by Halozyme Therapeutics,
Inc. and reflects solely the opinion of the corporation. Nothing in
this statement shall be construed to imply any support or
endorsement of Halozyme, or any of its products, by The Regents of
the University of California, its
officers, agents and employees.
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.