|[January 15, 2014]
ERYTECH announces clinical trial authorizations in Finland and Spain for its European Phase IIb study in AML
LYON, France --(Business Wire)--
ERYTECH Pharma (Paris:ERYP) (Euronext Paris: FR0011471135 - ERYP), a
French biopharmaceutical company that develops innovative treatments for
acute leukemia and other oncology indications with unmet medical needs,
announces it received authorizations for its Phase IIb GRASPA-ML
clinical trial in Acute Myeloid Leukemia (AML) in Finland and Spain.
The study was first launched in France in March 2013, where to-date more
than one third of the patients (out of a total of 123 patients to be
recruited to complete the study) have been enrolled. The opening of
centers in additional countries is adding international credibility and
visibility to the study and is expected to further accelerate the pace
of patient recruitment. Next to France, Spain and Finland, additional
countries are expected to be authorized in the coming months.
The GRASPA-ML study is a multicentre, randomized, controlled Phase IIb
trial evaluating efficacy and tolerability of GRASPA® in the treatment
of newly diagnosed AML patients over 65 years old that are unfit for
In November 2013, an independent Data and Safety Monitoring Board (DSMB)
completed its first assessment of the study and unanimously recommended
continuation of the trial as planned.
The study is performed in collaboration with Orphan Europe (Recordati
Group), ERYTECH's partner for the commercialization of GRASPA® in 38
pays European countries, under a licensing and distribution agreement
that was signed at the end of 2012.
"We are pleased with the good progress of our Phase IIb study in
Acute Myeloid Leukemia. Patient enrollment is in line with our
expectations and the opening of foreign centers will further strengthen
the study. If positive, the study will broaden the scope of use of our
GRASPA® product to AML, the most common type of acute leukemia in
adults," comments Yann Godfrin, Co-founder and CSO of ERYTECH.
About Acute Myeloid Leukemia (AML)
Acute Myeloid Leukemia (AML) is an aggressive form of leukemia (blood or
bone marrow cancer) that is characterized by a rapid and abnormal
proliferation of myeloid precursor cells. AML usually progresses quickly
and, if not treated, can be fatal within a few months. With about 34 000
new patients per year in Europe and the US, AML is the most common type
of acute leukemia. ffecting mainly the adult and senior patient
population that often cannot tolerate the existing forms of asparaginase
products, AML represents one of the highest mortality rates among all
type of cancers and an important unmet medical need. The median age of
patients affected by AML is 67 years.
About ERYTECH and GRASPA®: www.erytech.com
Founded in Lyon in 2004, ERYTECH is a French biopharmaceutical company
providing new prospects for cancer patients, particularly those with
acute leukemia and selected solid tumors.
Every year about 50,000 patients are diagnosed with Acute Lymphoblastic
Leukemia (ALL) or Acute Myeloid Leukemia (AML), the two forms of acute
leukemia. Today, for about 80% of these patients, mainly adults and
relapsing patients, there is no adequate solution due to the toxicity of
existing treatments. By encapsulating the asparaginase enzyme in red
blood cells, ERYTECH has developed GRASPA®, an original and effective
treatment that targets leukemia cells through "starvation" while
significantly reducing the side effects for patients, and allowing all
patients to be treated, even the most fragile ones, representing a
market opportunity of more than EUR 1 billion. GRASPA® is currently
completing Phase III clinical development in Acute Lymphoblastic
Leukemia (ALL) and is in Phase IIb clinical trial in Acute Myeloid
Leukemia (AML) in Europe. The product received FDA clearance to start
clinical development in ALL in the USA. ERYTECH has concluded
distribution partnership agreements for Europe with Orphan Europe
(Recordati Group), and with TEVA for Israel.
The company is also developing other indications in solid tumors and
certain orphan indications outside oncology. ERYTECH has its own
GMP-approved and operational manufacturing site.
ERYTECH is listed on Euronext regulated market in Paris. (ISIN code:
FR0011471135, ticker: ERYP) and is part of the CAC Healthcare, CAC
Pharm. & Bio and Next Biotech indexes.
This document may contain forward-looking statements and estimates with
respect to the financial situation, the results of operations, the
strategy, the project and to the anticipated future performance of
ERYTECH and of the market in which it operates. Certain of these
statements, forecasts and estimates can be recognized by the use of
words such as, without limitation, "believes", "anticipates", "expects",
"intends", "plans", "seeks", "estimates", "may", "will" and "continue"
and similar expressions. They include all matters that are not
historical facts. Such statements, forecasts and estimates are based on
various assumptions and assessments of known and unknown risks,
uncertainties and other factors, which were deemed reasonable when made
but may or may not prove to be correct. Actual events are difficult to
predict and may depend upon factors that are beyond the Company's
control. Therefore, actual results, the financial condition, performance
or achievements of ERYTECH, or industry results, may turn out to be
materially different from any future results, performance or
achievements expressed or implied by such statements, forecasts and
estimates. Documents filed by ERYTECH Pharma with the French Autorité
des Marchés Financiers (www.amf-france.org),
also available on our website (www.erytech.com)
describe such risks and uncertainties. Given these uncertainties, no
representations are made as to the accuracy or fairness of such
forward-looking statements, forecasts and estimates. Furthermore,
forward-looking statements, forecasts and estimates only speak as of the
date of the publication of this document. ERYTECH disclaims any
obligation to update any such forward-looking statement, forecast or
estimates to reflect any change in the Company's expectations with
regard thereto, or any change in events, conditions or circumstances on
which any such statement, forecast or estimate is based, except to the
extent required by French law.
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