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ERYTECH announces granting of new patent in the United States - Seite 2
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).
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
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
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