Halozyme To Present New Data On PEGPH20 In Pancreatic Cancer At American
Society of Clinical Oncology Annual Meeting
SAN DIEGO, May 15, 2013
SAN DIEGO, May 15, 2013 /PRNewswire/ -- Halozyme Therapeutics, Inc. (NASDAQ:
HALO) today announced that clinical data from a Phase 1b trial of PEGPH20
(PEGylated Recombinant Human Hyaluronidase), an investigational new biologic,
in combination with gemcitabine for treatment of patients with stage IV
metastatic pancreatic cancer will be presented at the 2013 American Society of
Clinical Oncology (ASCO) Annual Meeting.
In this Phase 1b study, 28 stage IV pancreatic ductal adenocarcinoma patients
were treated with PEGPH20 in combination with gemcitabine. The overall
response rate (CR+PR) was 42 percent* (n=24) as assessed by independent review
at therapeutic dose levels of PEGPH20 (1.6 and 3.0 µg/kg). Treatment was
generally well tolerated and the adverse event profile was consistent with
those seen in previous studies of PEGPH20 as a single agent and as previously
reported for gemcitabine alone. There was no evidence of new observed
toxicity. Detailed clinical data, including CA 19-9 and pharmacodynamic
results will be presented at the meeting.
Emerging data show that most pancreatic cancers surround themselves with a
protective hyaluronan-rich matrix, which makes the disease difficult to treat
and is itself an indicator of poor prognosis. PEGPH20 depletes this matrix
component from the tumor and rapidly changes the tumor microenvironment and
metabolism, which may render it more vulnerable to therapy as well as inhibit
"Data from this single arm Phase 1b study clearly reinforce the hypothesis of
treating pancreatic cancer with PEGPH20 in conjunction with chemotherapeutic
agents," said Joy Zhu, M.D., Ph.D., Vice President, Oncology Clinical
Development, Halozyme. "We look forward to the study investigators presenting
the updated study results at the poster session and ensuing discussion."
Based on the magnitude of response and safety observed in the Phase 1b study,
Halozyme announced in April the initiation of a Phase 2 multicenter,
randomized clinical trial evaluating PEGPH20 as a first-line therapy for
patients with stage IV metastatic pancreatic cancer. Approximately 124
patients will participate in the study and receive gemcitabine and
nab-paclitaxel either with or without PEGPH20. Secondary endpoints of the
trial include clinical evaluation of patient response in both treatment arms
by tumor biopsy hyaluronan (HA) status.
Halozyme is also developing a HA diagnostic tool that will help evaluate
potential treatment benefit based on HA levels for use in the randomized Phase
2 trial. Clinically validating this HA-diagnostic approach in the pancreatic
cancer trial may also provide proof-of-concept for use of PEGPH20 in other
HA-rich tumor types.
Halozyme Abstracts at ASCO:
oPoster Presentation/Discussion: (E Hall D1): "A Phase 1b Study of
Gemcitabine Plus PEGPH20 (PEGylated Recombinant Human Hyaluronidase) in
Patients with Stage IV Previously Untreated Pancreatic Cancer" will be
presented by Sunil R. Hingorani M.D., Ph.D., Fred Hutchinson Cancer
Research Center on Monday, June 3 at 1:15PM-5:15PM CDT; discussion from
4:45 PM-5:45PM CDT. (Abstract #4010)
oEducational Book Abstract: "Pharmacokinetic (PK)/Pharmacodynamic (PD)
Results From a Phase 1b Study of PEGylated Hyaluronidase PH20 (PEGPH20) in
Combination with Gemcitabine (Gem) in Patients with Pancreatic Cancer"
(Abstract # e15005)
*33 percent response rate reported in the ASCO abstract based on partial data
available at the time of abstract submission.
About Pancreatic Cancer
In most patients diagnosed with metastatic pancreatic adenocarcinoma, survival
rates are the lowest of any cancer. In 2013, it is estimated that almost
45,000 new cases of pancreatic cancer will be diagnosed. About one-in-78
people in the U.S. will develop the disease, affecting equal numbers of men
and women, almost always after the age of 45. Its tendency to spread prior to
diagnosis makes it the fourth deadliest cancer with a less than six percent
five-year relative survivalrate, with more than 38,000 people succumbing to
the disease each year.^1-2
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 absorption and dispersion of biologics,
drugs and fluids. Halozyme's pipeline addresses therapeutic areas, including
diabetes, oncology and dermatology that have significant unmet medical need.
The Company markets Hylenex® recombinant (hyaluronidase human injection) and
has partnerships with Roche, Pfizer, Baxter, ViroPharma and Intrexon. 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 the possible benefits and attributes of PEGPH20, the anticipated
enrollment of patients and possible outcomes for the referenced Phase 2
clinical trial, the possible method of action of PEGPH20 and the anticipated
presentation of data from Halozyme's Phase 1b trial and the development of the
HA diagnostic tool and the potential uses of such tool. The forward-looking
statements are usually (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 risks and uncertainties including clinical trial
enrollment and results, regulatory approval requirements, unexpected
expenditures and costs, unexpected results or delays in development and
regulatory review, unexpected adverse events and competitive conditions. These
and other factors that may result in differences are discussed in greater
detail in the Company's Quarterly Report on Form 10-Q filed with the
Securities and Exchange Commission on May 8, 2013. Halozyme does not undertake
to update these forward-looking statements.
1. American Cancer Society, Cancer Facts & Figures 2013. Atlanta: American
Cancer Society; 2013
2. Pancreatic Cancer, American Cancer Society,
Accessed April 18, 2013
SOURCE Halozyme Therapeutics, Inc.
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