ONCODESIGN (FR0011766229 - ALONC), a biotechnology company serving the
pharmaceutical industry in the discovery of new therapeutic molecules to
fight cancer and other serious illnesses with no known effective
treatment, announced today the signing of an agreement with Eisai Inc.
Oncodesign will conduct in vivo pharmacology studies and Eisai will
provide gene expression profiling analysis using Oncodesign’s
patient-derived xenograft models (PDX) to investigate the potential of
eribulin mesylate (“eribulin”) in earlier line treatment of metastatic
breast cancer.
Eribulin (marketed by Eisai in the United States as HALAVEN® Injection)
is indicated for the treatment of patients with metastatic breast cancer
who have previously received at least two chemotherapeutic regimens for
the treatment of metastatic disease. Prior therapy should have included
an anthracycline and a taxane in either the adjuvant or metastatic
setting. Eribulin is a non-taxane, microtubule dynamics inhibitor
developed by Eisai and approved in more than 50 countries to treat
patients with metastatic breast cancer.
Biomarkers are designed to assist physicians in selecting effective
therapies for their patients, based on the individual characteristics of
each person. The use of clinically relevant breast PDX models generates
results to quickly and accurately investigate potential predictive
biomarkers and sensitive patient subgroups.
Oncodesign could receive revenues up to 1.25M Euros for their
contribution towards the total eribulin biomarker development program,
of which 0.9M Euros have already been received.
Philippe Genne, Chairman and CEO of Oncodesign, commented, “We are
very excited to be partnering with a leading and innovative
pharmaceutical company like Eisai. Preclinical research was recently
conducted by Oncodesign in collaboration with Eisai using
pharmaco-imaging to further investigate the mechanism of action for
eribulin. The results of the upcoming PDX pharmacology studies and gene
expression profiling could provide insights into patient responses to
Eisai’s eribulin.”
About ONCODESIGN: www.oncodesign.com
Founded 19 years ago by Dr. Philippe Genne, the Company’s CEO and
majority shareholder, ONCODESIGN is a biotechnology company that
maximizes the pharmaceutical industry’s chances of success in
discovering new therapeutic molecules to fight cancer and other serious
illnesses with no known efficient treatment. Backed by unique experience
acquired through more than 500 clients, including the world’s largest
pharmaceutical companies, and relying on a comprehensive technological
platform combining state-of-the-art medicinal chemistry, advanced animal
modeling and medical imaging, ONCODESIGN is able to predict and identify
for every molecule, very upstream, its therapeutic use and its potential
to become an efficient drug. Applied to kinase inhibitors, molecules
that represent a market estimated at over 40 billion dollars in 2016 and
accounting for almost 25% of the pharmaceutical industry’s R&D
investments, ONCODESIGN’s technology has already enabled the targeting
of 7 promising molecules with substantial therapeutic potential, in
oncology and elsewhere, and the signing of partnerships, potentially
worth €350 million in upfront payments should predefined milestones be
reached, with pharmaceutical groups Sanofi, Ipsen and UCB. Based in
Dijon, France, in the heart of the town’s university and hospital hub,
ONCODESIGN has 74 staff.
About HALAVEN® (eribulin mesylate) Injection:
Important Safety Information
-
Decreased White Blood Cells (Neutropenia)
-
Doctors should do blood tests to monitor patients' blood cells
before they receive each dose of HALAVEN, and should monitor them
more often if they develop lower white blood cells.
-
If patients develop severe neutropenia lasting longer than 7 days
or neutropenia with a fever, their next dose of HALAVEN should be
delayed and reduced. Severe neutropenia occurred in 57% of
patients who received HALAVEN and lasted more than 1 week in 12%
of patients.
-
Neutropenia with a fever occurred in 5% of patients; 2 patients
died from complications of neutropenia with a fever.
-
Neutropenia with a fever can result in serious infections that
could lead to hospitalization or death. Patients should call their
healthcare providers immediately if they have any of the following
symptoms: fever (temperature above 100.5 degrees F), chills,
coughing, burning or pain when they urinate.
-
Nerve Disorders (Peripheral Neuropathy)
-
HALAVEN can cause numbness, tingling, or burning in a patient's
hands and feet (peripheral neuropathy). Patients should be
monitored closely for signs of neuropathy. If they develop severe
neuropathy, treatment with HALAVEN should be delayed until the
neuropathy improves and the next dose of HALAVEN should be reduced.
-
Severe peripheral neuropathy occurred in 8% of patients who
received HALAVEN. Neuropathy lasting more than one year occurred
in 5% of patients. 22% of patients developed a new or worsening
neuropathy that had not recovered after an average of 269 days.
-
Peripheral neuropathy was the most common side effect that caused
patients to stop receiving HALAVEN.
-
Pregnancy and Nursing
-
HALAVEN may harm a patient's unborn baby. Patients must avoid
becoming pregnant while they are receiving HALAVEN. They should
tell their healthcare providers right away if they become pregnant
or think they are pregnant while they are receiving HALAVEN.
-
Patients and their healthcare providers should decide if they will
receive HALAVEN or breastfeed. They should not do both.
-
Heartbeat Changes
-
HALAVEN can cause changes in a patient's heartbeat (called QTc
prolongation). This can cause irregular heartbeats that may lead
to death.
-
Healthcare providers will decide if patients need heart monitoring
(electrocardiogram or ECG), or blood tests during their treatment
with HALAVEN to watch for this problem.
-
Liver and Kidney Problems
-
In patients with mild or moderate liver problems, and/or moderate
kidney problems, a lower starting dose of HALAVEN is recommended.
-
Most Common Side Effects
-
The most common side effects reported in >25% of patients
receiving HALAVEN were low white blood cells (82%), low red blood
cells (58%), weakness/tiredness (54%), hair loss (45%), numbness,
tingling or burning in your hands and feet (35%), nausea (35%),
and constipation (25%).
-
The most common serious side effects reported in patients
receiving HALAVEN were neutropenia with or without a fever (4% and
2%, respectively).
Please see the HALAVEN
full prescribing information.
Copyright Business Wire 2014