SAN DIEGO, Nov. 5, 2015 /PRNewswire/ -- Halozyme
Therapeutics, Inc. (NASDAQ: HALO) today announced the first patient
has received its investigational new drug, PEGPH20 in combination
with Merck's KEYTRUDA (pembrolizumab) in a clinical trial to
determine the maximum tolerated dose of PEGPH20 and antitumor
activity of the combined therapies.
The Halozyme sponsored Phase 1b study is being conducted at a
number of leading sites in the U.S., and is evaluating patients
with advanced non-small cell lung and gastric cancers.
Following an initial dose escalation portion to determine the
maximum tolerated dose of PEGPH20 in combination with KEYTRUDA, the
study will be expanded to determine antitumor activity including
overall response rate, duration of response and progression-free
survival in patients with high levels of hyaluronan (HA). HA is a
glycosaminoglycan, or chain of natural sugars in the body that can
accumulate around cancer cells creating high pressure in a tumor,
constricting blood flow and thereby reducing access of chemotherapy
and immunotherapeutic agents, like KEYTRUDA. PEGPH20 degrades HA,
reducing tumor pressure and increasing blood flow to treat the
tumor.
During the expansion portion, the study seeks to enroll
approximately 50 patients with high HA tumors who have relapsed or
refractory stage IIIB/IV non-small cell lung cancer treated with at
least one platinum-based regimen, or who have recurrent locally
advanced/metastatic gastric adenocarcinoma who are also PDL-1
positive and have failed at least one chemotherapy regimen.
"Our goal is to make a difference in the lives of patients, and
that starts by studying the safety, tolerability and efficacy of
PEGPH20 in a broad range of tumor types and in combination with a
broad range of therapeutic agents," said Dr. Helen Torley, president and CEO of Halozyme.
"With this study, we see an opportunity to expand the potential
benefits of immunotherapy through the novel combination of KEYTRUDA
and PEGPH20, targeting two of the most difficult to treat
cancers."
For information on Keytruda, please go to 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. PEGPH20 is
currently in development for metastatic pancreatic cancer,
non-small cell lung 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 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 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 of product candidates
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 August
10, 2015.
Contacts:
Jim
Mazzola
858-704-8122
ir@halozyme.com
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SOURCE Halozyme Therapeutics, Inc.