SAN DIEGO, July 22, 2014 /PRNewswire/ -- Halozyme
Therapeutics, Inc. (NASDAQ: HALO) today announced that it has
resumed enrollment and dosing of patients in its ongoing Phase 2
trial (Study 202) evaluating PEGPH20 in patients with pancreatic
cancer under the revised clinical protocol agreed to with the FDA
in June. PEGPH20 is an investigational PEGylated form of Halozyme's
proprietary recombinant human hyaluronidase under development for
the systemic treatment of tumors that accumulate hyaluronan.
"Our diligent effort to rapidly re-initiate patient enrollment
and dosing of both previously enrolled and new patients in this
trial underscores our commitment to evaluating the potential role
of PEGPH20 in patients with stage 4 metastatic pancreatic cancer.
Approximately 50% of the anticipated clinical sites have received
IRB approvals, and we anticipate continued IRB approvals in the
coming weeks," commented Dr. Helen
Torley, President and Chief Executive Officer.
Study 202 Trial Design
Study 202 (Halo 109-202) is a
Phase 2 multicenter, randomized clinical trial evaluating 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 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.
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 such as
additional approvals of clinical sites by IRBs 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 the approval of clinical sites by IRBs, the
possibility that the revised protocol may not address the apparent
increased rate of thromboembolic events observed with the use of
PEGPH20 in the trial or satisfy future regulatory requirements, the
possibility of additional safety events, 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
Halozyme's Quarterly Report on Form 10-Q filed with the Securities
and Exchange Commission on May 12,
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.