SAN DIEGO, July 25, 2016 /PRNewswire/ -- Halozyme
Therapeutics, Inc. (NASDAQ: HALO) today announced that it has
resumed the enrollment and dosing of patients in its ongoing Phase
1b trial evaluating its investigational new drug, PEGPH20, in
combination with KEYTRUDA (pembrolizumab) in patients with advanced
non-small cell lung and gastric cancers under a revised clinical
protocol.
The revised protocol has been submitted to all institutional
review boards (IRB) and is pending feedback from
the FDA. The majority of IRBs have completed their review and
approved the revised protocol allowing the study to
resume.
The Phase 1b study will enroll up to approximately 80 patients
at a number of leading sites in the
United States. For more information, go to
www.clinicaltrials.gov and reference NCT02563548.
For information on KEYTRUDA, please go to
www.keytruda.com.
About PEGPH20
PEGPH20 (PEGylated recombinant human hyaluronidase) targets the
degradation of hyaluronan (HA), a chain of natural sugars that can
accumulate around cancer cells, inhibiting other therapies. By
degrading HA, PEGPH20 may increase the access of co-administered
chemotherapeutic and immunotherapeutic agents.
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 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 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-Q filed with the Securities
and Exchange Commission on May 9,
2016.
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.