SAN DIEGO, Sept. 18, 2014 /PRNewswire/ -- Halozyme
Therapeutics, Inc. (NASDAQ: HALO) today announced that the U.S.
Food and Drug Administration (FDA) has removed the clinical hold on
patient enrollment and dosing of PEGPH20 in SWOG's ongoing Phase
1b/2 clinical trial (S1313). The trial is designed to evaluate
Halozyme's investigational drug PEGPH20 (PEGylated Recombinant
Human Hyaluronidase) in combination with modified FOLFIRINOX
chemotherapy (mFOLFIRINOX) in patients with metastatic pancreatic
adenocarcinoma. The study will resume under a revised
protocol, and patient enrollment is anticipated to recommence upon
review and approval of the amended protocol by the Independent
Review Boards at the participating clinical trial sites.
The trial, which will enroll approximately 170 patients, is
being sponsored by SWOG, a cancer research cooperative group of
approximately 5,000 researchers in more than 650 institutions
nationwide.
"Study S1313, along with our 202 Study, will provide important
data for evaluating the potential role of PEGPH20 in patients with
stage 4 metastatic pancreatic cancer," commented Dr. Helen Torley, President and CEO. "We are pleased
that SWOG is able to continue enrolling patients in this clinical
program as there remains a significant need for new treatment
options for pancreatic cancer patients."
Additional Information On Study S1313
The Phase 1b run
in portion of the S1313 study will be a limited dose de-escalation
clinical trial examining the dose-limiting toxicities (DLT) in 6 to
18 patients, to identify the optimal dose for PEGPH20 used in
combination with mFOLFIRINOX in patients with newly diagnosed
metastatic pancreatic adenocarcinoma in the Phase 2 portion of the
study. The Phase 2 portion will be a randomized, multicenter,
parallel arm study enrolling approximately 152 patients to yield
138 evaluable patients. The primary end point of the trial is
overall survival (OS) and secondary endpoints include
progression-free survival (PFS), overall response rate (ORR), and
toxicity. In addition, the study will also explore the
treatment impact on carbohydrate antigen 19-9 (CA 19-9), a
biomarker often associated with tumor cell burden1,
as well as the correlation of plasma hyaluronan (HA) and tumor HA
with OS, PFS and ORR. Additionally, low-molecular weight heparin
and aspirin may be used to manage thromboembolic events. The
mFOLFIRINOX treatment regimen consists of oxaliplatin, leucovorin,
irinotecan and 5-fluorouracil. Additional study details can be
found at http://www.clinicaltrials.gov using the study identifier
NCT01959139.
About PEGPH20
PEGPH20 is an investigational PEGylated
form of Halozyme's proprietary recombinant human hyaluronidase
under development for the systemic treatment of tumors that
accumulate hyaluronan.
About SWOG
SWOG Cancer Research is a consortium that
designs and conducts multidisciplinary clinical trials to improve
the practice of medicine in preventing, detecting, and treating
cancer, and to enhance the quality of life for cancer survivors.
The approximately 5,000 physician-researchers in the group's
network practice at more than 650 institutions nationwide,
including 28 of the National Cancer Institute (NCI)-designated
cancer centers, as well as cancer centers in almost a dozen other
countries. Formerly the Southwest Oncology Group, SWOG is part of
the NCI's National Clinical Trials Network and is supported
primarily through NCI research grant funding. The group is
headquartered at the Knight Cancer Institute at Oregon Health &
Science University in Portland,
Oregon, (503494-5586), has an operations office in
San Antonio, Texas, and has a
statistical center in Seattle,
Washington. Learn more at swog.org.
About Halozyme
Halozyme Therapeutics is a
biopharmaceutical company dedicated to developing and
commercializing innovative products that advance patient care. With
a diversified portfolio of enzymes that target the extracellular
matrix, the Company's research focuses primarily on a family of
human enzymes, known as hyaluronidases, which increase the
dispersion and absorption of biologics, drugs and fluids.
Halozyme's pipeline addresses therapeutic areas, including
oncology, diabetes and dermatology that have significant unmet
medical need today. The Company markets Hylenex®
recombinant (hyaluronidase human injection) and has partnerships
with Roche, Pfizer and Baxter. Halozyme is headquartered in San
Diego, CA. For more information on how we are innovating,
please visit our corporate website at 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
future actions relating to the development of PEGPH20 including
anticipated patient enrollment numbers in the trial and the
possibility that PEGPH20 may be used to address pancreatic cancer)
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 delays in completion of clinical trials and other
development activities, the possibility of safety events,
unexpected expenditures and costs, unexpected results or delays in
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
Halozyme's Quarterly Report on Form 10-Q filed with the Securities
and Exchange Commission on August 11,
2014.
References
1. Pancreatic Cancer
Treatment, National Cancer Institute,
http://www.cancer.gov/cancertopics/pdq/treatment/pancreatic/HealthProfessional/page1/AllPages,
Accessed September 16, 2014.
Investor Contact:
Schond Greenway
Halozyme Therapeutics
858-704-8352
ir@halozyme.com
Media Contact:
Susan Neath
Francis
212-301-7182
sfrancis@wcgworld.com
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SOURCE Halozyme Therapeutics, Inc.