DGAP-News

ERYTECH PHARMA SA: Business Update and Financial Results for the First Half of 2014 - Seite 2

Business Update

Phase III clinical study in ALL on track for results early Q4

In August 2013, ERYTECH completed patient enrollment in its pivotal Phase
III study in Acute Lymphoblastic Leukemia (ALL). The last one-year follow
up visit took place in August. Data base cleaning is ongoing and ERYTECH
expects to communicate top-line results early Q4. The study is comparing
GRASPA(R) with native asparaginase in a randomized, controlled, multicenter
clinical trial with 80 children and adults suffering from relapsing or
refractory ALL. The study was launched in 2009 as a Phase II/III study with
an adaptive design protocol.

International sites opened in Phase IIb AML study and positive DSMB
assessment after first 60 patients

In March 2013, ERYTECH initiated a multicenter, open, randomized,
controlled Phase IIb trial evaluating the efficacy and tolerability of
GRASPA(R) in the treatment of newly diagnosed Acute Myeloid Leukemia (AML)
patients, over 65 years of age, unfit for intensive chemotherapy.

Today, more than half of a total of 123 patients have been enrolled in the
study in 15 active centers in France. The company has recently received
regulatory authorizations for this trial in Spain, Finland, Germany and
Italy, and the first 4 sites outside France have been initiated. The
opening of these European centers will internationalize the study and
further accelerate patient enrollment.

Last week the company announced that an independent Data and Safety
Monitoring Board (DSMB) completed its second safety assessment of the study
and unanimously recommended continuation of the trial without modification.
This second DSMB assessment was based on a pre-planned safety analysis on
the first 60 patients included in the study and with a minimum of 1 month
follow-up. A first DSMB assessment took place at the end of 2013 when 30
patients had been treated in the study. The next step will be another DSMB
analysis, this time for safety and futility, when 60 patients will have
experienced an event in the study. This analysis is foreseen by the end of
this year.

Phase II trial launched in pancreatic cancer; first patient enrolled

After the completion of a Phase I study in late stage pancreas cancer, in
which the tolerability of ERY-ASP was found acceptable in this fragile
patient population, ERYTECH launched a Phase II study in 2014 in second
line treatment of patients with progressive metastatic pancreas cancer.
Clinical trial authorization was received in April by the ANSM, the French
authority for drug safety. The first patient was enrolled in July 2014.