WILEX AG is to apply to the Food & Drug Administration (FDA) for a special protocol assessment (SPA) for the registration trial for its medicinal product candidate CA9-SCAN
MUNICH, Germany | June 29, 2007 | The Munich-based biopharmaceutical company WILEX AG (ISIN DE0006614720 / Frankfurt Stock Exchange / Prime Standard) is to apply to the Food & Drug Administration (FDA) for a special protocol assessment (SPA) for the registration trial for its medicinal product candidate CA9-SCAN. This will be the second product candidate out of WILEX’ portfolio to be tested in a Phase III registration trial. CA9-SCAN is an investigational imaging diagnostic based on an antibody and is being developed for the pre-surgical diagnosis of clear cell Renal Cell Cancer which is expected to improve treatment planning for patients with renal cancer.
WILEX is following the recommendation of the FDA resulting from the pre-IND meeting in which the draft clinical protocol was reviewed. Following this discussion, which took place in the first quarter of 2007, the Company revised the trial protocol and drafted the Imaging Charter which describes the evaluation procedure to be carried out by independent experts. Both the protocol and Imaging Charter were recently submitted to the US authorities.
The clinical research organisation and trial centres have already been chosen for this registration trial which will begin as soon as the Company receives the SPA. WILEX AG has confirmed the schedule for the development of CA9-SCAN; the submission of the IND later this year would allow filing for approval in 2008 at the earliest, assuming positive results.
Dr. Paul Bevan, Head of R&D and Member of the Executive Management at WILEX AG, pointed out: “The strategic decision to request an SPA from the FDA will enhance the quality and speed up the review process once the study is completed. To the best of our knowledge, CA9-SCAN would represent the first diagnostic radiopharmaceutical to be granted an SPA”
About "SPA"
Special protocol assessment (SPA) is an instrument of the FDA introduced in 2002 whereby, if granted, the FDA evaluates a clinical protocol, submitted by a sponsor. The SPA documents the fact that the FDA assumes, following the assessment of the design and planned analysis of the clinical trial, that these adequately and appropriately address the requirements of the application submission. The FDA is then bound to this protocol assessment as part of the application process. In general, the SPA can significantly reduce development time since the design of the pivotal protocol has been approved in advance.
About CA9-SCAN
WILEX’s late stage multi-product portfolio includes CA9-SCAN as 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 significantly improve and simplify treatment planning for patients suspected of having renal cancer. The company is not aware of any other available imaging technique with comparable specificity and sensitivity. Patients with suspected renal cancer will be enrolled in about ten centres in the USA under the registration trial. They will be examined prior to surgery using the CA9-SCAN imaging procedure.
About WILEX
WILEX is a biopharmaceutical Company based in Munich 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 late stage multi-product portfolio includes both drug and medicinal product candidates ranging from research to late stage clinical development. Currently the following compounds are in clinical development: WX-G250 (development name: RENCAREX®), WX-671, WX-UK1 and CA9-SCAN. 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. WILEX AG is listed at the Frankfurt Stock Exchange on the Official Market Segment (Amtlicher Markt) / Prime Standard since November 13, 2006.
SOURCE: WILEX AG
Post Views: 129
WILEX AG is to apply to the Food & Drug Administration (FDA) for a special protocol assessment (SPA) for the registration trial for its medicinal product candidate CA9-SCAN
MUNICH, Germany | June 29, 2007 | The Munich-based biopharmaceutical company WILEX AG (ISIN DE0006614720 / Frankfurt Stock Exchange / Prime Standard) is to apply to the Food & Drug Administration (FDA) for a special protocol assessment (SPA) for the registration trial for its medicinal product candidate CA9-SCAN. This will be the second product candidate out of WILEX’ portfolio to be tested in a Phase III registration trial. CA9-SCAN is an investigational imaging diagnostic based on an antibody and is being developed for the pre-surgical diagnosis of clear cell Renal Cell Cancer which is expected to improve treatment planning for patients with renal cancer.
WILEX is following the recommendation of the FDA resulting from the pre-IND meeting in which the draft clinical protocol was reviewed. Following this discussion, which took place in the first quarter of 2007, the Company revised the trial protocol and drafted the Imaging Charter which describes the evaluation procedure to be carried out by independent experts. Both the protocol and Imaging Charter were recently submitted to the US authorities.
The clinical research organisation and trial centres have already been chosen for this registration trial which will begin as soon as the Company receives the SPA. WILEX AG has confirmed the schedule for the development of CA9-SCAN; the submission of the IND later this year would allow filing for approval in 2008 at the earliest, assuming positive results.
Dr. Paul Bevan, Head of R&D and Member of the Executive Management at WILEX AG, pointed out: “The strategic decision to request an SPA from the FDA will enhance the quality and speed up the review process once the study is completed. To the best of our knowledge, CA9-SCAN would represent the first diagnostic radiopharmaceutical to be granted an SPA”
About "SPA"
Special protocol assessment (SPA) is an instrument of the FDA introduced in 2002 whereby, if granted, the FDA evaluates a clinical protocol, submitted by a sponsor. The SPA documents the fact that the FDA assumes, following the assessment of the design and planned analysis of the clinical trial, that these adequately and appropriately address the requirements of the application submission. The FDA is then bound to this protocol assessment as part of the application process. In general, the SPA can significantly reduce development time since the design of the pivotal protocol has been approved in advance.
About CA9-SCAN
WILEX’s late stage multi-product portfolio includes CA9-SCAN as 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 significantly improve and simplify treatment planning for patients suspected of having renal cancer. The company is not aware of any other available imaging technique with comparable specificity and sensitivity. Patients with suspected renal cancer will be enrolled in about ten centres in the USA under the registration trial. They will be examined prior to surgery using the CA9-SCAN imaging procedure.
About WILEX
WILEX is a biopharmaceutical Company based in Munich 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 late stage multi-product portfolio includes both drug and medicinal product candidates ranging from research to late stage clinical development. Currently the following compounds are in clinical development: WX-G250 (development name: RENCAREX®), WX-671, WX-UK1 and CA9-SCAN. 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. WILEX AG is listed at the Frankfurt Stock Exchange on the Official Market Segment (Amtlicher Markt) / Prime Standard since November 13, 2006.
SOURCE: WILEX AG
Post Views: 129
