DGAP-News

WILEX AG: Phase III ARISER data for the adjuvant treatment of clear cell renal cancer with RENCAREX(R) including retrospective subgroup analysis presented at ASCO

DGAP-News: WILEX AG / Key word(s): Research Update
WILEX AG: Phase III ARISER data for the adjuvant treatment of clear
cell renal cancer with RENCAREX(R) including retrospective subgroup
analysis presented at ASCO

03.06.2013 / 17:35

---------------------------------------------------------------------

PRESS RELEASE

Phase III ARISER data for the adjuvant treatment of clear cell renal cancer
with RENCAREX(R) including retrospective subgroup analysis presented at
ASCO

- RENCAREX(R) improves disease free survival significantly by over 22
months (44%) in the subgroup of patients (ITT) with a high CAIX score
>=2.6 (HR=0.54; p=0.02)

- In patients under the age of 65 years RENCAREX(R) clinically and
statistically improves disease free survival with a CAIX score >= 2.0
(HR=0.60; p=0.01)

Munich, Germany, 03 June 2013 - WILEX AG (ISIN DE0006614720 / WL6 / FSE)
published the results from the Phase III ARISER trial with RENCAREX(R) for
the adjuvant treatment of patients with clear cell renal cell carcinoma at
the Annual Meeting of the American Society of Clinical Oncology (ASCO). The
data were presented by Professor Arie S. Belldegrun, Principal Investigator
of the ARISER trial, Director of the UCLA Institute of Urologic Oncology
and Chief of Urologic Oncology at the David Geffen School of Medicine at
UCLA, Los Angeles.

In the ARISER trial 864 subjects were enrolled from 142 sites across
Europe, North and South America. Baseline demographics were well balanced
across treatment groups. Up to six months of treatment demonstrated an
excellent safety profile and was well tolerated. As reported previously,
the primary endpoint in the ARISER trial was not reached. After 54 months
median duration of follow up, the median disease free survival (DFS) was
71.4 months in the RENCAREX(R) arm and was not reached in the placebo arm
(HR=0.97; p=0.74).

Analysis of the data confirmed that CAIX expression is a characteristic of
ccRCC. However, the antigen density, as determined by the CAIX score,
varies from patient to patient. Subgroup analysis for all CAIX scores from
0.0 to 3.0 revealed that as the CAIX score increases, the more pronounced
the RENCAREX(R) treatment effect becomes. A CAIX score of >= 2.6 resulted
in
a clinically and statistically significant treatment effect with median DFS
increasing from 51.2 months in the placebo arm to 73.6 months in
RENCAREX(R) patients (N=151; HR=0.54; p=0.02).

Patients who had received at least eight consecutive administrations of
study medication (week 1 to 8) and had no major protocol deviation were