SAN DIEGO, Nov. 26, 2018
/PRNewswire/ -- Halozyme Therapeutics, Inc. (NASDAQ: HALO), a
biotechnology company developing novel oncology and drug-delivery
therapies, today announced that prior to data analysis, the FDA has
agreed to Halozyme's request to change the primary endpoint of the
HALO-301 study to the single primary endpoint of overall survival
(OS). As a result, the previously planned interim analysis will not
be conducted. The company will host a webcast and conference call
today at 5 p.m. Eastern /
2 p.m. Pacific to discuss this change
in further detail.
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.
Webcast and Conference Call
Halozyme will webcast a conference call today at 5 p.m. ET / 2 p.m.
PT to discuss the HALO-301 statistical plan. Dr.
Helen Torley, president and chief
executive officer, will lead the call, which will be webcast live
through the "Investors" section of Halozyme's corporate website and
a replay will be available following the close of the call. To
access the webcast and additional documents related to the call,
please visit www.halozyme.com approximately fifteen minutes prior
to the call to register, download and install any necessary audio
software. The call may also be accessed by dialing (877) 410-5657
(domestic callers) or (334) 323-7224 (international callers) using
passcode 387156. 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 49634758.
About HALO 301
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 now be conducted at
approximately 200 sites with a single primary endpoint of 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 include progression-free survival and objective response
rate. More information may be found at clinicaltrials.gov (search
HALO 301 or trial identifier NCT02715804) or www.HALO301.com.
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 pegvorhyaluronidase alfa (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 the
treatment of several cancers and has the potential to be used 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, Lilly,
Bristol-Myers Squibb and Alexion for its ENHANZE® drug delivery
technology. 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, 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.
Contact:
Al Kildani
Vice President, Investor Relations and Corporate Communications
858-704-8122
akildani@halozyme.com
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SOURCE Halozyme Therapeutics, Inc.