SAN DIEGO and WOODCLIFF LAKE, N.J., Dec. 9, 2015 /PRNewswire/ -- Halozyme
Therapeutics, Inc. (NASDAQ: HALO) and Eisai Inc. will present a
scientific poster entitled, "Pegylated Recombinant Human
Hyaluronidase PH20 (PEGPH20) Enhances Efficacy of Eribulin Mesylate
(HALAVEN®) in Triple Negative Breast Cancer Xenografts"
at the 38th Annual San Antonio Breast Cancer Symposium
(SABCS) on Dec. 9.
The research showed the potential impact for PEGPH20-mediated
hyaluronan (HA) removal on concentrations of eribulin and antitumor
effects of breast cancer therapy in preclinical models. Halozyme's
investigational new candidate drug, PEGPH20 targets the degradation
of HA, a glycosaminoglycan or chain of natural sugars that may
accumulate in certain tumors.
Halozyme, a biotechnology company developing novel oncology and
drug-delivery therapies, and Eisai Co., Ltd., the parent company of
Eisai Inc., announced a clinical collaboration in July 2015, with plans to initiate a phase 1b/2
clinical trial to evaluate PEGPH20 plus eribulin in first-line
HER2-negative metastatic breast cancer patients with high-HA
tumors.
"Our preclinical studies have revealed important data about the
potential for PEGPH20 when used in combination of eribulin, and we
are looking forward to expanding on these important preclinical
findings when we initiate our clinical study with Eisai," said Dr.
Helen Torley, president and CEO of
Halozyme. "We remain encouraged by the potential for PEGPH20 to
help patients across a range of cancer and therapy types. Our
presentation today reflects the growing body of research supporting
this potential of PEGPH20."
"Data presented today highlight a productive preclinical
collaboration with Halozyme and support Eisai's commitment to
address the unmet medical needs of patients with advanced breast
cancer," said Alton Kremer, Deputy President, Oncology PCU and
Chief Medical Officer, Global Oncology Business Unit, Eisai Inc.
"We are encouraged by these preclinical data and look forward to
enrolling patients in the clinical trial early next year."
SABCS Poster Presentation Details:
Poster Session:
P1-03-09, Wednesday, Dec. 9,
5:00 p.m. CT
About Eribulin Mesylate Injection (Available as
HALAVEN® in the United
States)
The above publication does not necessarily
contain information that is consistent with the U.S. prescribing
information for HALAVEN® (eribulin mesylate). It is an
investigational use and there is no guarantee that this use will
become available commercially.
HALAVEN® (eribulin mesylate) injection is indicated
for patients with metastatic breast cancer who have received at
least two chemotherapeutic regimens for the treatment of metastatic
breast cancer. Prior therapy should have included an anthracycline
and a taxane in either the adjuvant or metastatic setting. Eribulin
is a synthetic analog of halichondrin B, a natural product that was
isolated from the marine sponge Halichondria okadai. First
in the halichondrin class, eribulin is a microtubule dynamics
inhibitor with a distinct binding profile. Based on in vitro
studies, eribulin exerts its effect via a tubulin-based antimitotic
mechanism ultimately leading to apoptotic cell death after
prolonged and irreversible mitotic blockage.
Important Safety Information
Neutropenia
- Monitor complete blood counts prior to each dose, and increase
the frequency of monitoring in patients who develop Grade 3 or 4
cytopenias. Delay administration and reduce subsequent doses in
patients who experience febrile neutropenia or Grade 4 neutropenia
lasting longer than 7 days
- Severe neutropenia (ANC <500/mm3) lasting more than 1 week
occurred in 12% (62/503) of patients. Patients with elevated liver
enzymes >3 × ULN and bilirubin >1.5 × ULN experienced a
higher incidence of Grade 4 neutropenia and febrile neutropenia
than patients with normal levels
- Grade 3 and Grade 4 neutropenia occurred in 28% and 29%,
respectively, of patients who received eribulin. Febrile
neutropenia occurred in 5% of patients and two patients (0.4%) died
from complications
Peripheral Neuropathy
- Patients should be monitored closely for signs of peripheral
motor and sensory neuropathy
- Grade 3 peripheral neuropathy occurred in 8% of patients, and
Grade 4 in 0.4% of patients who received eribulin. Delay
administration of eribulin until resolution to Grade 2 or less
- Neuropathy lasting more than 1 year occurred in 5% of patients.
Twenty-two percent of patients developed a new or worsening
neuropathy that had not recovered within a median follow-up
duration of 269 days (range 25-662 days)
- Peripheral neuropathy (5%) was the most common adverse reaction
resulting in discontinuation
Pregnancy Category D
- Eribulin is expected to cause fetal harm when administered to a
pregnant woman and patients should be advised of these
risks
QT Prolongation
- In an uncontrolled ECG study in 26 patients, QT prolongation
was observed on Day 8, independent of eribulin concentration, with
no prolongation on Day 1. ECG monitoring is recommended for
patients with congestive heart failure; bradyarrhythmias;
concomitant use of drugs that prolong QT interval, including Class
Ia and III antiarrhythmics; and electrolyte abnormalities
- Correct hypokalemia or hypomagnesemia prior to initiating
eribulin and monitor electrolytes periodically during therapy.
Avoid in patients with congenital long QT syndrome
Hepatic and Renal Impairment
- For patients with mild (Child-Pugh A) or moderate (Child-Pugh
B) hepatic and/or moderate or severe (CrCl 15-49 mL/min) renal
impairment, a reduction in starting dose is recommended
Most Common Adverse Reactions
- Most common adverse reactions (>25%) reported in patients
receiving eribulin were neutropenia (82%), anemia (58%),
asthenia/fatigue (54%), alopecia (45%), peripheral neuropathy
(35%), nausea (35%), and constipation (25%)
- The most common serious adverse reactions reported in patients
receiving eribulin were febrile neutropenia (4%) and neutropenia
(2%)
For more information about HALAVEN®, click
here for the full Prescribing Information.
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. PEGPH20 is currently in development for metastatic
pancreatic 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 and AbbVie 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.
About Eisai Co., Ltd.
Eisai Co., Ltd. is a
leading global research and development-based pharmaceutical
company headquartered in Japan. We
define our corporate mission as "giving first thought to patients
and their families and to increasing the benefits health care
provides," which we call our human health care (hhc)
philosophy. With over 10,000 employees working across our global
network of R&D facilities, manufacturing sites and marketing
subsidiaries, we strive to realize our hhc philosophy by delivering
innovative products in various therapeutic areas with high unmet
medical needs, including oncology and neurology.
As a global pharmaceutical company, our mission extends to
patients around the world through our investment and participation
in partnership-based initiatives to improve access to medicines in
developing and emerging countries. For more information about Eisai
Co., Ltd., please visit www.eisai.com.
About Eisai Inc.
At Eisai Inc., human health
care is our goal. We give our first thoughts to patients and
their families, and helping to increase the benefits health care
provides. As the U.S. pharmaceutical subsidiary of Tokyo-based Eisai Co., Ltd., we have a
passionate commitment to patient care that is the driving force
behind our efforts to help address unmet medical needs. We are a
fully integrated pharmaceutical business with discovery, clinical,
manufacturing and marketing capabilities. Our key areas of
commercial focus include oncology and specialty care (Alzheimer's
disease, epilepsy and metabolic disorders). To learn more about
Eisai Inc., please visit us at www.eisai.com/US.
Eisai Inc. has affiliates that are part of a global product
creation organization that includes R&D facilities in
Massachusetts, New Jersey and Pennsylvania, as well as a global demand chain
organization that includes facilities in Maryland and North
Carolina. Eisai's global areas of R&D focus include
neuroscience; oncology; metabolic disorders; vascular, inflammatory
and immunological reaction; and antibody-based programs.
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 of product candidates
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 Halozyme Quarterly Report on Form 10-Q filed with the
Securities and Exchange Commission on November 9, 2015.
Media
Inquiries:
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Halozyme
Therapeutics, Inc.
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Eisai
Inc.
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Jim
Mazzola
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Patricia
Councill
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858-704-8122
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201-746-2139
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ir@halozyme.com
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Patricia_Councill@Eisai.com
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Investor
Inquiries:
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Eisai
Inc.
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Alex Scott
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201-746-2177
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SOURCE Halozyme Therapeutics, Inc.; Eisai Inc.