SAN DIEGO, Jan. 5, 2017 /PRNewswire/ -- Halozyme
Therapeutics, Inc. (NASDAQ: HALO) today reported topline results
from the combined analysis of Stages 1 and 2 and Stage 2 alone of
its HALO 202 study, a Phase 2 randomized, multi-center clinical
trial of lead investigational drug PEGPH20 in combination with
ABRAXANE® (nab-paclitaxel) and gemcitabine in stage IV
pancreas cancer patients.
Among the findings, the overall study population showed a
statistically significant increase in progression-free survival
(PFS) in patients with high levels of hyaluronan (HA-High) treated
with PEGPH20 plus ABRAXANE and gemcitabine when compared to HA-High
patients receiving ABRAXANE and gemcitabine alone. Stage 2 of the
study, which completed enrollment in February 2016, showed a 91 percent improvement in
median PFS for HA-High patients in the PEGPH20 arm, 8.6 months
compared to 4.5 months in the control arm, and achieved its primary
endpoint to evaluate and demonstrate a reduction in the rate of
thromboembolic events in the PEGPH20 arm.
"These findings confirm our confidence in the development of
PEGPH20 in this difficult to treat cancer," said Dr. Helen Torley, president and CEO. "We are pleased
by the overall consistency of both the efficacy and safety data
which are supportive of our ongoing Phase 3 clinical trial, HALO
301, currently underway at more than 160 sites worldwide."
Dr. Sunil R. Hingorani, the
principal investigator leading this trial, and a pancreas cancer
expert at Fred Hutchinson Cancer Research Center and professor at
University of Washington School of
Medicine, said: "The Study 202 data confirm for the first time in a
randomized Phase 2 trial using the current standard of care that
a biopsy-based biomarker for hyaluronan content can
potentially identify patients who will have a meaningfully greater
response when PEGPH20 is added to their treatment. The
analysis suggests statistically significant and clinically
important progress in this very difficult to treat cancer. The
median PFS is a notable increase over the current standard of care
and supports ongoing exploration in the current Phase 3 study."
Pancreas cancer is the third-leading cause of cancer related
death in the United States, and
more than 65,000 people in the U.S. and top five European countries
are diagnosed annually with advanced cases of the disease.
Webcast and Conference Call
Halozyme will host a
webcast and conference call to discuss the results, today,
Jan. 5 at 8:00
a.m. ET/5:00 a.m. PT.
Presenting on the call will be Dr. Torley and Dr. Athena Countouriotis, chief medical officer. Two
leading pancreas cancer experts will also participate: Dr.
Hingorani, and Dr. Eileen M.
O'Reilly, associate director of the David M. Rubenstein
Center for Pancreatic Cancer Research, attending physician, member
at Memorial Sloan Kettering Cancer Center and Professor of Medicine
at Weill Cornell Medical College.
The call will be webcast live through the "Investors" section of
Halozyme's corporate website and a recording will be made available
following the close of the call. To access the webcast and
additional documents related to the call, please visit
http://www.halozyme.com approximately fifteen minutes prior to the
call to register, download and install any necessary audio
software. The live call may also be accessed by calling
877-410-5657 (domestic callers) 334-323-7224 (international
callers) using passcode 769890. A telephone replay will be
available after the call by dialing (877) 919-4059 (domestic
callers) or (334) 323-0140 (international callers) using replay ID
number 24712688.
About HALO 301 and HALO 202
HALO 301 is a phase 3
global, randomized, double-blind placebo controlled clinical trial
evaluating investigational new drug PEGPH20 as a first-line therapy
for potential treatment of patients with metastatic pancreas
cancer. The trial will be conducted at approximately 200 sites with
two primary endpoints, progression free survival and overall
survival in patients receiving investigational new drug PEGPH20 in
combination with gemcitabine and ABRAXANE®
(nab-paclitaxel) compared to gemcitabine and nab-paclitaxel alone.
Secondary endpoints also include objective response rate and
overall survival. More information may be found at
clinicaltrials.gov (search HALO 301 or trial identifier
NCT02715804) or www.HALO301.com.
HALO 202 (Halo 109-202) is a phase 2 multi-center, randomized
clinical trial evaluating investigational new drug PEGPH20 as a
first-line therapy for potential treatment of patients with
metastatic pancreas cancer. The primary outcome of the trial is to
measure improvement in progression-free survival in patients
receiving investigational new drug PEGPH20 in combination with
gemcitabine and nab-paclitaxel compared to gemcitabine and
nab-paclitaxel alone. A second primary endpoint assesses the
thromboembolic event rate in the PEGPH20 treatment arm. Secondary
endpoints also include objective response rate and overall
survival.
About PEGPH20
PEGPH20 is an investigational PEGylated
form of Halozyme's proprietary recombinant human hyaluronidase
under clinical development for the potential systemic treatment of
tumors that accumulate hyaluronan. PEGPH20 is an enzyme that
temporarily degrades HA, a dense component of the tumor
microenvironment that can accumulate in higher concentrations
around certain cancer cells, potentially constricting blood vessels
and impeding the access of other therapies.
FDA granted orphan drug designation to PEGPH20 for
treatment of pancreas cancer and fast track for PEGPH20 in
combination with gemcitabine and nab-paclitaxel for the treatment
of metastatic pancreas 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 pancreas 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 pancreas 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 http://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.