Over 420 patients enrolled in the Phase III trial
Milestone payment from Esteve received
Publication of the results of the "futility analysis" expected for H2 / 2007
Results expected in H2 / 2008
MUNICH, Germany | Apr 3, 2007 | The Munich-based biopharmaceutical company WILEX AG (ISIN DE0006614720 / Frankfurt Stock Exchange / Prime Standard) announced today that, in its pivotal Phase III study of RENCAREX(R) (the data of which are required for European and US filing for approval) over 420 of 856 patients planned have been enrolled. The international, multicentre, randomised trial, called ARISER (Adjuvant Rencarex Immunotherapy trial to Study Efficacy in non-metastasized Renal cell carcinoma), examines the efficacy of the antibody RENCAREX(R) in comparison to placebo for the treatment of clear cell renal cell cancer patients after complete or partial surgical removal of the affected kidney in patients with no detectable metastases. This cancer belongs to one of the particularly aggressive indications. RENCAREX(R) aims to inhibit these malignant kidney tumours from further growth and recurrence and to help to kill cancer cells and thereby prolong the disease-free survival of patients.
Dr. Paul Bevan, Head of Research and Development and member of the executive management board of WILEX, commented: "Patient recruitment is outstanding with the numbers increasing quarter on quarter. Furthermore, the drop-out rate, at roughly 3%, is very low and suggests that the treatment regimen of weekly injections is well tolerated. We are on track and can expect the results of the trial in the second half of 2008".
The next important milestone of the ARISER study is the so-called "futility analysis" as per the statistical analysis plan. An Independent Data Monitoring Committee will analyse the data after 100 patients have relapsed. This is expected in H2 2007. No-one outside the Committee will have access to the data. The Committee will inform WILEX of the outcome and its expectation as to whether the study is likely to deliver the result expected.
WILEX expects results of the study for European filing in the second half of 2008. The FDA requires a higher statistical significance which demands higher number of relapses and, therefore, filing for approval at the FDA is planned for 2009.
About WILEX
WILEX is a biopharmaceutical Company based in Munich, which was founded in 1997 by a team of physicians and oncologists from the Technical University of Munich. WILEX is focused on the development of new cancer therapies based on antibodies and small molecules. The therapeutic approach of WILEX targets the prevention of growth, spread and the metastasis of malignant tumours and the destruction of malignant tumours in the body. The portfolio includes both drug and medical product candidates ranging from research to late stage clinical development. Currently the following compounds are in clinical development: WX-G250 (development name: RENCAREX(R)), WX-671, WX-UK1 and CA9-SCAN.
WILEX has a license agreement with the Spanish pharmaceutical Company Laboratorios del Dr. Esteve S.A. Barcelona (Spain) for the marketing of RENCAREX(R) in particular countries in Southern Europe. Pursuant to the agreement, the Company has a claim for payments upon attainment of particular development milestones.
The company’s strategy is to develop WILEX into a commercially successful biopharmaceutical company with a broad portfolio of new drugs and medical products for the treatment of cancer. Since November 13, 2006 WILEX AG is listed at the Frankfurt Stock Exchange on the Official Market Segment (Amtlicher Markt) / Prime Standard.
ISIN DE0006614720 / WKN 661472 / Stock market symbol WL6
SOURCE: WILEX AG
Post Views: 98
Over 420 patients enrolled in the Phase III trial
Milestone payment from Esteve received
Publication of the results of the "futility analysis" expected for H2 / 2007
Results expected in H2 / 2008
MUNICH, Germany | Apr 3, 2007 | The Munich-based biopharmaceutical company WILEX AG (ISIN DE0006614720 / Frankfurt Stock Exchange / Prime Standard) announced today that, in its pivotal Phase III study of RENCAREX(R) (the data of which are required for European and US filing for approval) over 420 of 856 patients planned have been enrolled. The international, multicentre, randomised trial, called ARISER (Adjuvant Rencarex Immunotherapy trial to Study Efficacy in non-metastasized Renal cell carcinoma), examines the efficacy of the antibody RENCAREX(R) in comparison to placebo for the treatment of clear cell renal cell cancer patients after complete or partial surgical removal of the affected kidney in patients with no detectable metastases. This cancer belongs to one of the particularly aggressive indications. RENCAREX(R) aims to inhibit these malignant kidney tumours from further growth and recurrence and to help to kill cancer cells and thereby prolong the disease-free survival of patients.
Dr. Paul Bevan, Head of Research and Development and member of the executive management board of WILEX, commented: "Patient recruitment is outstanding with the numbers increasing quarter on quarter. Furthermore, the drop-out rate, at roughly 3%, is very low and suggests that the treatment regimen of weekly injections is well tolerated. We are on track and can expect the results of the trial in the second half of 2008".
The next important milestone of the ARISER study is the so-called "futility analysis" as per the statistical analysis plan. An Independent Data Monitoring Committee will analyse the data after 100 patients have relapsed. This is expected in H2 2007. No-one outside the Committee will have access to the data. The Committee will inform WILEX of the outcome and its expectation as to whether the study is likely to deliver the result expected.
WILEX expects results of the study for European filing in the second half of 2008. The FDA requires a higher statistical significance which demands higher number of relapses and, therefore, filing for approval at the FDA is planned for 2009.
About WILEX
WILEX is a biopharmaceutical Company based in Munich, which was founded in 1997 by a team of physicians and oncologists from the Technical University of Munich. WILEX is focused on the development of new cancer therapies based on antibodies and small molecules. The therapeutic approach of WILEX targets the prevention of growth, spread and the metastasis of malignant tumours and the destruction of malignant tumours in the body. The portfolio includes both drug and medical product candidates ranging from research to late stage clinical development. Currently the following compounds are in clinical development: WX-G250 (development name: RENCAREX(R)), WX-671, WX-UK1 and CA9-SCAN.
WILEX has a license agreement with the Spanish pharmaceutical Company Laboratorios del Dr. Esteve S.A. Barcelona (Spain) for the marketing of RENCAREX(R) in particular countries in Southern Europe. Pursuant to the agreement, the Company has a claim for payments upon attainment of particular development milestones.
The company’s strategy is to develop WILEX into a commercially successful biopharmaceutical company with a broad portfolio of new drugs and medical products for the treatment of cancer. Since November 13, 2006 WILEX AG is listed at the Frankfurt Stock Exchange on the Official Market Segment (Amtlicher Markt) / Prime Standard.
ISIN DE0006614720 / WKN 661472 / Stock market symbol WL6
SOURCE: WILEX AG
Post Views: 98
