WILEX AG announced today that it has recruited the first patients in its Phase III registration trial with the diagnostic product candidate CA9-SCAN
Munich, Germany | May 19, 2008 | The Munich-based biopharmaceutical company WILEX AG (ISIN DE0006614720 / Frankfurt Stock Exchange / Prime Standard) announced today that it has recruited the first patients in its Phase III registration trial with the diagnostic product candidate CA9-SCAN. This marks the next important milestone in this project after the Investigational New Drug (IND) approval in October 2007 and a special protocol assessment (SPA) in February 2008.
WILEX will conduct the study in accordance with the approved protocol. The FDA confirms with the SPA that the design and planned analysis of the clinical trial adequately address the requirements for a regulatory submission for CA9-SCAN. The FDA considers itself bound by this protocol assessment as part of the approval process.
166 patients suspected of having kidney cancer will be enrolled in more than 15 centres in the USA. Patients included are scheduled for complete or partial surgical removal of the affected kidney. They will be imaged with computer tomography (CT) and CA9-SCAN (positron emission tomography (PET)-CT) prior to surgery to examine whether they have clear cell renal cell carcinoma. The trial will evaluate whether imaging with CA9-SCAN can improve the diagnosis in comparison to the current standard (CT alone). CA9-SCAN could improve the planning of treatment and the post-operative monitoring of renal tumour patients.
Patient recruitment and follow-up is expected to be completed by the end of 2008 with the data and report available three to six months later.
Dr. Paul Bevan, Head of R&D and Member of the Executive Management Board at WILEX AG remarked: “We are pleased to have commenced patient recruitment and expect the trial to progress as scheduled. CA9-SCAN represents the second product from WILEX developed in a Phase III registration trial.”
About CA9-SCAN
CA9-SCAN is one of two product candidates from WILEX’s late stage multi-product portfolio which is in a Phase III registration trial. CA9-SCAN is a radioactively labelled form of the antibody WX-G250. The labelled antibody WX-G250 targets clear cell renal cell carcinoma and accumulates in the tumour tissue. This accumulation can be visualised by means of Positron Emission Tomography (PET). An earlier feasibility study found that a positive result with CA9-SCAN was confirmed as clear cell renal cell carcinoma in 100% of cases (positive predictive value). CA9-SCAN could determine whether the patient had clear cell renal cell carcinoma before surgery and the subsequent pathology. Therefore, CA9-SCAN could improve treatment planning for patients suspected of having renal cancer.
About WILEX
WILEX is a biopharmaceutical Company based in Munich which is listed at the Frankfurt Stock Exchange at the Regulated Market / Prime Standard. WILEX’s mission is to develop drugs and diagnostic agents with a low side effect profile and targeted treatment of different types of cancer as well as for early detection of tumours. WILEX’s product candidates are based on antibodies and small molecules. WILEX possesses an attractive pipeline which includes both drug and diagnostic product candidates: The substances RENCAREX® and CA9-SCAN are currently undergoing a Phase III registration trial. The substance WX-671 is currently in a Phase II programme. Based on this pipeline, WILEX’s aim is to achieve profitability within a few years through the commercialisation of its products and in the long term to finance its research and development programmes from its operating business.
SOURCE: WILEX AG
Post Views: 129
WILEX AG announced today that it has recruited the first patients in its Phase III registration trial with the diagnostic product candidate CA9-SCAN
Munich, Germany | May 19, 2008 | The Munich-based biopharmaceutical company WILEX AG (ISIN DE0006614720 / Frankfurt Stock Exchange / Prime Standard) announced today that it has recruited the first patients in its Phase III registration trial with the diagnostic product candidate CA9-SCAN. This marks the next important milestone in this project after the Investigational New Drug (IND) approval in October 2007 and a special protocol assessment (SPA) in February 2008.
WILEX will conduct the study in accordance with the approved protocol. The FDA confirms with the SPA that the design and planned analysis of the clinical trial adequately address the requirements for a regulatory submission for CA9-SCAN. The FDA considers itself bound by this protocol assessment as part of the approval process.
166 patients suspected of having kidney cancer will be enrolled in more than 15 centres in the USA. Patients included are scheduled for complete or partial surgical removal of the affected kidney. They will be imaged with computer tomography (CT) and CA9-SCAN (positron emission tomography (PET)-CT) prior to surgery to examine whether they have clear cell renal cell carcinoma. The trial will evaluate whether imaging with CA9-SCAN can improve the diagnosis in comparison to the current standard (CT alone). CA9-SCAN could improve the planning of treatment and the post-operative monitoring of renal tumour patients.
Patient recruitment and follow-up is expected to be completed by the end of 2008 with the data and report available three to six months later.
Dr. Paul Bevan, Head of R&D and Member of the Executive Management Board at WILEX AG remarked: “We are pleased to have commenced patient recruitment and expect the trial to progress as scheduled. CA9-SCAN represents the second product from WILEX developed in a Phase III registration trial.”
About CA9-SCAN
CA9-SCAN is one of two product candidates from WILEX’s late stage multi-product portfolio which is in a Phase III registration trial. CA9-SCAN is a radioactively labelled form of the antibody WX-G250. The labelled antibody WX-G250 targets clear cell renal cell carcinoma and accumulates in the tumour tissue. This accumulation can be visualised by means of Positron Emission Tomography (PET). An earlier feasibility study found that a positive result with CA9-SCAN was confirmed as clear cell renal cell carcinoma in 100% of cases (positive predictive value). CA9-SCAN could determine whether the patient had clear cell renal cell carcinoma before surgery and the subsequent pathology. Therefore, CA9-SCAN could improve treatment planning for patients suspected of having renal cancer.
About WILEX
WILEX is a biopharmaceutical Company based in Munich which is listed at the Frankfurt Stock Exchange at the Regulated Market / Prime Standard. WILEX’s mission is to develop drugs and diagnostic agents with a low side effect profile and targeted treatment of different types of cancer as well as for early detection of tumours. WILEX’s product candidates are based on antibodies and small molecules. WILEX possesses an attractive pipeline which includes both drug and diagnostic product candidates: The substances RENCAREX® and CA9-SCAN are currently undergoing a Phase III registration trial. The substance WX-671 is currently in a Phase II programme. Based on this pipeline, WILEX’s aim is to achieve profitability within a few years through the commercialisation of its products and in the long term to finance its research and development programmes from its operating business.
SOURCE: WILEX AG
Post Views: 129
