SAN DIEGO, April 8, 2015 /PRNewswire/ -- Halozyme
Therapeutics, Inc. (NASDAQ: HALO), a biotechnology company
developing novel oncology and drug-delivery therapies, today
announced it plans to proceed with a Phase 3 clinical study (Study
301) of its investigational new drug PEGPH20 in patients with
metastatic pancreatic cancer, using a design allowing for potential
marketing application based on either progression free survival
(PFS) or overall survival.
The use of PFS as the basis for marketing approval will be
subject to the overall benefit and risk associated with PEGPH20
combined with nab-paclitaxel (ABRAXANE®) and gemcitabine
therapy, including the:
- Magnitude of the PFS treatment effect observed;
- Toxicity profile; and
- Interim overall survival data.
The study will enroll patients whose tumors accumulate high
levels of hyaluronan (HA) –
a sugar that is sometimes more prevalent in the
areas surrounding cancer cells. Halozyme recently discussed the
study as part of a planned Type B meeting with the U.S. Food and
Drug Administration (FDA).
Data discussed at the meeting focused on interim results from
the company's randomized Phase 2 study in pancreatic cancer, Study
202, which showed a doubling in median PFS in metastatic pancreatic
cancer patients with high levels of HA who were treated with
Halozyme's investigational new drug PEGPH20 combined with
nab-paclitaxel (ABRAXANE®) and gemcitabine (9.2 months
vs. 4.3 months in patients treated with nab-paclitaxel
ABRAXANE® and gemcitabine alone). The potential risk
profile, including rate of thromboembolic events, was also
discussed.
Additional takeaways from the meeting include:
- Halozyme affirmed plans to enroll and evaluate
high-HA patients using a companion diagnostic test; and
- FDA provided feedback on the current companion diagnostic
approach and confirmed that an approved companion diagnostic
strategy is required prior to Phase 3 study initiation.
"We are encouraged by the FDA's feedback and their willingness
to consider a novel primary endpoint such as PFS given the high
unmet medical need in high-HA metastatic pancreatic cancer," said
Dr. Helen Torley, President and
Chief Executive Officer. "We are committed to rapidly finalizing
the Phase 3 protocol and developing the companion diagnostic
regulatory filings required to initiate Study 301."
Based on this FDA feedback, the company is targeting the end of
first quarter 2016 to initiate the Phase 3 study.
About Study 202
Study 202 (Halo 109-202) is a Phase 2 multi-center, randomized
clinical trial evaluating investigational new drug PEGPH20 as a
first-line therapy for treatment of patients with stage 4
metastatic pancreatic 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 will assess the
thromboembolic event rate in the PEGPH20 treatment arm. Secondary
endpoints also include objective response rate and overall
survival. More information may be found at:
http://oncologytrials.halozyme.com/pancreatic/
About PEGPH20
PEGPH20 is an investigational PEGylated form of Halozyme's
proprietary recombinant human hyaluronidase under clinical
development for the systemic treatment of tumors that accumulate
hyaluronan.
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,
our 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 and
non-small cell lung 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, Pfizer, Janssen and Baxter 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 planned additional studies, regulatory
filings and other 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 trial results,
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-K filed
with the Securities and Exchange Commission on March 2, 2015.
Contacts:
Schond Greenway
Halozyme Therapeutics
858-704-8352
ir@halozyme.com
Jim Mazzola
Halozyme Therapeutics
858-704-8122
ir@halozyme.com
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SOURCE Halozyme Therapeutics, Inc.