DGAP-News: ERYTECH PHARMA SA / Key word(s): Study results
ERYTECH reports positive top-line Phase III results from clinical
study with GRASPA(R) in Acute Lymphoblastic Leukemia
01.10.2014 / 09:30
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ERYTECH reports positive top-line Phase III results from clinical study
with GRASPA(R)in Acute Lymphoblastic Leukemia
- GRASPA(R) meets primary endpoints compared to native L-asparaginase:
- Statistically significant reduction of allergic reactions
- Statistically significant increase in duration of asparaginase
activity
- Secondary endpoints confirm the favorable clinical efficacy of
GRASPA(R)
- GRASPA(R) well tolerated by patients with previous allergies to
L-asparaginase
- Submission of European marketing authorization application targeted for
1H 2015
- Important validation of ERYTECH's technology forming strong basis for
further leveraging the product and platform in other oncology
indications
Lyon (France), September 30, 2014 - ERYTECH (Euronext Paris: FR0011471135 -
ERYP), the French biopharmaceutical company that develops innovative 'tumor
starvation' treatments for acute leukemia and other oncology indications
with unmet medical needs, reports positive Phase III results from its
pivotal study with GRASPA(R) in Acute Lymphoblastic Leukemia.
Analysis of the primary and first secondary efficacy endpoints of the
GRASPALL clinical trial with one year follow up shows that the GRASPIVOTALL
(GRASPALL2009-06) clinical trial convincingly meets both of its primary
endpoints, and that the secondary efficacy endpoints analyzed so far
confirm the favorable clinical efficacy profile of GRASPA(R). The study
also shows favorable results in patients with prior allergies to
L-asparaginase.
The GRASPIVOTALL study is a controlled, multicenter Phase II/III trial with
80 children and adults suffering from relapsing or refractory Acute
Lymphoblastic Leukemia (ALL) with three arms. The first two arms compare
GRASPA(R) to native E. Coli L-asparaginase, both in combination with
standard chemotherapy (COOPRALL), in a 1-to-1 randomization in patients
without prior allergies to L-asparaginase. The third arm is an open label
assessment of GRASPA(R) for patients who have experienced allergic
reactions related to asparaginase in their first line treatment.
The primary endpoint of the study consisted of two objectives, in
accordance with CHMP[1] advice: a) superior safety, expressed as a
significant reduction of the incidence of allergic reactions with GRASPA(R)
compared to the control group, and b) non-inferior duration of asparaginase
activity above the threshold of 100 IU/l during the induction phase in the
non-allergic patients. Both endpoints needed to be met for the study to be
considered positive. The main secondary efficacy endpoints included the
assessment of clinical parameters such as complete remission (CR), minimal
residual disease (MRD), event-free survival (EFS) and overall survival
(OS).
[1] Based on Scientific Advice obtained from the Scientific Advice Working
Party (SAWP) of the Commission for Human Medicinal Products (CHMP) at the
European Medicines Agency (EMA)
Primary endpoints met
- Statistically significant reduction of allergic reactions: none of the
26 patients in the GRASPA(R) arm experienced an allergic reaction
versus 12 of the 28 (42.9%) patients treated with reference
L-asparaginase in the control group (p< 001).
- Statistically significant increase in duration of circulating
asparaginase activity: in the GRASPA(R) group, asparaginase levels were
maintained above 100 IU/l for an average of 20.5 days with up to 2
injections during the first month of treatment (induction phase) versus
9.2 days in the control group with up to 8 injections of reference
L-asparaginase (p< 001).
Secondary endpoints confirm the favorable clinical efficacy of GRASPA(R)
- At the end of the induction phase, 15 patients (71.4%) in the GRASPA(R)
arm show complete remission versus 11 patients (42.3%) in the control
arm.
GRASPA(R) well tolerated by patients with previous allergies to
L-asparaginase
- A favorable clinical profile was seen in patients with prior allergies
to L-asparaginase with only 2 patients experiencing mild allergic
reactions.
"The results of this study are an important step forward for the treatment
of ALL patients that are at risk to receive L-asparaginase, which remains
an important unmet medical need. The virtual absence of allergic reactions,
also in patients with prior allergies to L-asparaginase, is very
encouraging." comments Professor Yves Betrand, hemato-oncologist at IHOP
(Institute for Pediatric Hematology and Oncology) in Lyon (France) and
principal investigator of the GRASPALL study.
These results confirm earlier observations with GRASPA(R) in a Phase I/II
randomized dose escalation study in 24 relapsing ALL patients, and a Phase
II study in first line ALL patients over 55 years of age.
Further analysis of additional secondary and exploratory endpoints is
ongoing. Results will be available later this year and are planned to be
presented at an upcoming scientific conference.
Based on the results of the GRASPALL study and the earlier studies
performed with GRASPA(R), ERYTECH intends to submit its application dossier
for European Marketing Authorization in the first half of 2015.
"We are very pleased and encouraged by the positive results of this Phase
III study. They validate the potential of our red cell bioreactor
technology platform to increase the therapeutic index and tolerability of
certain drugs. With GRASPA(R), the enzyme activity is protected by the red
cell membrane, preventing neutralisation by circulating antibodies. I wish
to take this opportunity to thank all people who contributed to this study,
patients, physicians and the Erytech team and collaborators, for their
efforts and dedication.", said Yann Godfrin, co-founder and Chief
Scientific Officer of ERYTECH Pharma.
"The positive Phase III results mark the start of an exciting new period
for ERYTECH", adds Gil Beyen, Chairman and Chief Executive Office. "Not
only will they form the basis for our filing for European Marketing
Authorization in ALL, they also strengthen the case for GRASPA(R)/ERY-ASP
in other hematological indications, such as AML and lymphomas, and in a
broad range of solid tumors, where the toxicity has been a limiting factor
for the use of asparaginase. Next to focusing on making the product
available to ALL patients throughout Europe together with our partner
Orphan Europe (Recordati Group), we will continue and even accellerate the
developments in other indications and with other active ingredients."
A Phase IIb study with GRASPA(R) in Acute Myeloid Leukemia (AML) is
progressing well with more than half of the patients enrolled and a Phase
II study in pancreatic cancer has been launched earlier this year. Building
on these positive results with GRASPA(R) in ALL, the company plans to
accelerate the development in ALL in the US and to launch Phase II clinical
trials in additional oncology indications with high unmet medical need.
About Acute Lymphoblastic Leukemia (ALL)
Acute Lymphoblastic Leukemia (ALL) is an aggressive form of leukemia (blood
or bone marrow cancer) that is characterized by a rapid and abnormal
proliferation of lymphoid precursor cells. ALL usually progresses quickly
and, if not treated, can be fatal within a few months. Every year about
10,000 people are diagnosed with ALL in Europe (EU27) and about 6,000 in
the US. About 60% of these are children, 20% adults and 20% seniors (above
55 years of age). Thanks to the development of new therapies and medicines,
notably asparaginase, the prognosis for children affected by ALL has
increased considerably with 5 year survival rates having increase from 30%
in the 1960s to around 90% today. For older patients (adults and seniors)
and patients in relapse, who often don't tolerate existing asparaginase
based therapies, overall long-term survival remains among the lowest in the
field of cancer (10% to 30%), leaving an important unmet medical need.
About ERYTECH and ERY-ASP/GRASPA(R): www.erytech.com
Created 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.
By encapsulating the asparaginase enzyme in red blood cells, ERYTECH has
developed ERY-ASP/GRASPA(R) , an original treatment that targets cancer
cells through "tumor starvation" while significantly reducing the side
effects for patients. ERY-ASP/GRASPA(R) 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
is also in Phase I/II clinical development in ALL in the USA.
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, current forms of asparaginase cannot be used due to
their toxicity. With a presumed improved safety profile, ERY-ASP/GRASPA(R)
is being developed to allow all leukemia patients to be treated, even the
most fragile ones, representing a market opportunity of more than EUR 1
billion.
The company is also developing other indications in solid tumors and
certain orphan indications outside oncology. A Phase II study in pancreas
cancer is ongoing and the company is exploring other solid tumor
indications for ERY-ASP.
ERYTECH has obtained orphan drug designations for ERY-ASP/GRASPA(R) in ALL,
AML and pancreas cancer, both in Europe and the USA, and has its own
GMP-approved and operational manufacturing site in Lyon (France), and a
site for clinical production in Philadelphia (USA).
The company has concluded licensing and distribution partnership agreements
for ALL and AML in Europe with Orphan Europe (Recordati Group), and for ALL
with TEVA in Israel.
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.
Forward-looking information
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. There can be no guarantees with
respect to pipeline products that the products will receive the necessary
regulatory approvals or that they will prove to be commercially successful.
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. Readers are cautioned not to
place undue reliance on any of these forward-looking statements. 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.
CONTACTS
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ERYTECH NewCap.
Gil Beyen Julien Perez / Emmanuel Huynh
Chairman and CEO Investor and press relations
Pierre-Olivier Goineau Tel: +33 1 44 71 98 52
Vice President and COO erytech@newcap.fr
Tel: +33 4 78 74 44 38
investors@erytech.com
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289744 01.10.2014
DGAP-News: ERYTECH reports positive top-line Phase III results from clinical study with GRASPA(R) in Acute Lymphoblastic Leukemia
| Source: EQS Group AG