SAN DIEGO, March 30, 2017 /PRNewswire/ -- Halozyme
Therapeutics, Inc. (NASDAQ: HALO) today announced it has been
informed by SWOG, an independent network of researchers that design
and conduct cancer clinical trials, that the SWOG Phase 1b/2 trial
evaluating PEGPH20 plus modified FOLFIRINOX chemotherapy versus
modified FOLFIRINOX alone in patients with previously untreated
metastatic pancreas cancer has been temporarily closed to
enrollment.
During a planned early futility analysis, the independent Data
Monitoring Committee found, based on preliminary data in an all
comer population, that the addition of PEGPH20 given every two
weeks to modified FOLFIRINOX would be unlikely to demonstrate a
statistically significant improvement in the primary endpoint of
overall survival compared to modified FOLFIRINOX alone. Halozyme is
working with SWOG to verify and analyze the initial data set,
including a planned analysis by hyaluronan (HA) level, following
completion of retrospective determination of tumor HA levels.
"We see every clinical trial involving PEGPH20 as a possibility
to advance the study and understanding of how to treat patients
with some of the most difficult cancers," said Dr. Helen Torley, president and CEO. "We will work
with SWOG to better understand these data and the patients who may
best benefit from the addition of PEGPH20."
Halozyme and its collaboration partners have ongoing studies to
evaluate PEGPH20 in combination with chemotherapies and
immunotherapies in pancreatic, gastric, lung and breast cancers,
with plans to initiate additional combination studies in
pancreatic, gastric, gall bladder and bile duct cancers later this
year.
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 most
recent Annual and Quarterly Reports filed with the Securities and
Exchange Commission.
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.