PRESS RELEASE: WILEX AG: Further analysis of the ARISER study identifies a subgroup which shows significant improvement of disease-free survival with RENCAREX(R)
DGAP-News: WILEX AG / Key word(s): Study
WILEX AG: Further analysis of the ARISER study identifies a subgroup
which shows significant improvement of disease-free survival with
RENCAREX(R)
26.02.2013 / 18:54
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PRESS RELEASE
Further analysis of the ARISER study identifies a subgroup which shows
significant improvement of disease-free survival with RENCAREX(R)
- Patients expressing high CAIX tumour levels in clear cell renal cell
carcinoma (ccRCC) show a statistically and clinically significant
improvement in median disease-free survival with RENCAREX(R)
Munich, Germany, 26 February 2013 - WILEX AG (ISIN DE0006614720 / WL6 /
FSE) today announced that the subgroup and biomarker analysis of the Phase
III ARISER trial conducted over the last few months has been completed. The
subgroup analysis shows that with increasing density of CAIX expression in
tumour tissue, as quantified by a CAIX score, the more significant the
treatment effect becomes. Disease-free survival showed a clinically and
statistically significant improvement in the patient population with a high
CAIX level treated with RENCAREX(R) compared to both placebo and patients
with a low CAIX score.
The CAIX score can be determined by a FDA registered in vitro diagnostic
(IVD) marketed by WILEX Inc. and may be helpful in identifying and
stratifying patients who may benefit from RENCAREX(R). Therefore, an
immunotherapy for ccRCC in the adjuvant setting would appear to be still an
option. RENCAREX(R) has Fast Track designation for ccRCC in the USA and
Orphan Drug designation for RCC in the USA and EU.
The detailed results will be presented at a major conference in the second
quarter this year.
Dr Paul Bevan, Head of R&D at WILEX AG, said: 'This finding that
therapeutic success is dependent on the CAIX level is new and the result of
many detailed analyses. WILEX will now evaluate the business case and
discuss the implications for development with our partners and regulatory
authorities'.
About RENCAREX(R) and the ARISER study
The drug candidate RENCAREX(R) is based on the antibody Girentuximab, which
binds to the tumour-specific antigen CAIX - an antigen that is
overexpressed in clear cell renal cell carcinomas (ccRCC).
ARISER (Adjuvant RENCAREX(R) Immunotherapy trial to Study Efficacy in
non-metastasised Renal cell carcinoma) was an international, multicentre,
randomised Phase III trial that examined the efficacy of the antibody
RENCAREX(R) in comparison to placebo in the treatment of clear cell renal
cell cancer patients following complete or partial surgical removal of the
affected kidney in patients with no detectable metastases but at high risk
of recurrence. The study enrolled 864 patients that had had prior
nephrectomy of primary RCC no later than 12 weeks before study entry with
documented clear cell histology, an ECOG score of 0 or 1 and no evidence of
macroscopic or microscopic residual disease. Under the treatment schedule
patients received a once-weekly infusion of RENCAREX(R) or placebo (50:50)
for 24 weeks. Patients receiving RENCAREX(R) were dosed at 50 mg in the
first week followed by weekly doses of 20 mg during weeks 2-24.
The analysis - executed in October 2012 - showed no improvement in median
DFS (approximately 72 months) following RENCAREX(R) treatment compared with
placebo. The trial did not meet its primary endpoint. RENCAREX(R) was safe
and well tolerated. The Independent Data Monitoring Committee (IDMC)
recommended terminating the Phase III ARISER trial.
Invitation to the annual press conference:
On 27 February 2013, WILEX will hold a public conference call for media,
analysts and investors at 3:00 p.m. CET in English. Please dial in ten
minutes before the conference call using the following dial-in numbers:
1. Germany: +49 69 71044 5598
2. UK: +44 20 3003 2666
3. USA: +1 212 999 6659
4. USA Freephone: +1 866 966 5335
You will be welcomed by an operator taking your name and company. The
presentation slides for the conference will be available for download at
www.wilex.de on 27 February 2013 at 2:30 p.m. CET.
About WILEX
WILEX AG is a biopharmaceutical company based in Munich, Germany. Focused
on oncology, the Company develops diagnostic and therapeutic product
candidates for the specific detection and targeted treatment of various
types of cancer. In the field of therapeutics, WILEX develops small
molecules (MESUPRON(R) two Phase IIa trials completed, WX-554 in Phase
Ib/II and WX-037 in preclinical development). In the field of diagnostics,
REDECTANE(R) is an antibody-based imaging in vivo diagnostic agent that is
currently in a Phase III programme. The Company also has a portfolio of
research use only tests and in vitro diagnostic agents that are marketed
via its US subsidiary WILEX Inc. in Cambridge, MA, under the brand Oncogene
Science. WILEX's subsidiary Heidelberg Pharma GmbH offers preclinical
contract research services and a highly promising antibody drug conjugate
(ADC) technology platform. The business model of WILEX comprises research
and product development as well as the commercialisation of its activities.
WILEX's customers and partners include leading international pharmaceutical
companies. Website: http://www.WILEX.com, ISIN DE0006614720 / WKN 661472 /
Symbol WL6.
Contact
Katja Arnold (CIRO)
Corporate Communications
WILEX AG
Grillparzerstr. 10
81675 Munich, Germany
Tel.: +49 (0)89-41 31 38-126
Fax: +49 (0)89-41 31 38-99
Email: investors@wilex.com
This communication contains certain forward-looking statements relating to
the Company's business, which can be identified by the use of
forward-looking terminology such as 'estimates', 'believes', 'expects',
'may', 'will', 'should', 'future', 'potential' or similar expressions or by
a general discussion of the Company's strategy, plans or intentions. Such
forward-looking statements involve known and unknown risks, uncertainties
and other factors, which may cause our actual results of operations,
financial position, earnings, achievements, or industry results, to be
materially different from any future results, earnings or achievements
expressed or implied by such forward-looking statements. Given these
uncertainties, prospective investors and partners are cautioned not to
place undue reliance on such forward-looking statements. We disclaim any
obligation to update any such forward- looking statements to reflect future
events or developments.
End of Corporate News
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Language: English
Company: WILEX AG
Grillparzerstr. 10
81675 München
Germany
Phone: +49 (0)89 41 31 38 - 0
Fax: +49 (0)89 41 31 38 - 99
E-mail: info@wilex.com
Internet: www.wilex.com
ISIN: DE0006614720
WKN: 661472
Listed: Regulierter Markt in Frankfurt (Prime Standard);
Freiverkehr in Berlin, Düsseldorf, München, Stuttgart
End of News DGAP News-Service
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202412 26.02.2013
(END) Dow Jones Newswires
February 26, 2013 12:54 ET (17:54 GMT)
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