The Munich-based biopharmaceutical company WILEX AG has received an Investigational New Drug approval from the U.S. Food and Drug Administration for a pivotal Phase III trial with the medical product candidate CA9-SCAN
MUNICH, Germany | October 12, 2007 | The Munich-based biopharmaceutical company WILEX AG (ISIN DE0006614720 / Frankfurt Stock Exchange / Prime Standard) has received an Investigational New Drug (IND) approval from the U.S. Food and Drug Administration (FDA) for a pivotal Phase III trial with the medical product candidate CA9-SCAN. CA9-SCAN is now the second product can-didate of the WILEX portfolio to enter a Phase III registration trial.
190 patients suspected of having kidney cancer will be enrolled in approximately 17 study centres in the USA. Patients with a renal mass are scheduled for surgery to remove the affected kidney. These patients will be imaged with CA9-SCAN prior to the surgery to determine whether they have clear cell renal cell cancer. As previously announced, WILEX intends to follow FDA` recommendation to conclude a special protocol assessment (SPA) before initiating the trial. The clinical research organisation and trial centres have already been chosen. Results are expected to be available at the end of 2008.
Dr. Paul Bevan, Head of Research & Development and Member of the Executive Management Board of WILEX AG comments: “The IND approval from FDA signals an important milestone in the development of CA9-SCAN. Furthermore, our portfolio continues to mature as planned with the addition of a second Phase lll product in pivotal clinical trials.”
About “SPA”
By applying for a SPA 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. 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
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. CA9-SCAN is the 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.
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.
SOURCE: WILEX
Post Views: 124
The Munich-based biopharmaceutical company WILEX AG has received an Investigational New Drug approval from the U.S. Food and Drug Administration for a pivotal Phase III trial with the medical product candidate CA9-SCAN
MUNICH, Germany | October 12, 2007 | The Munich-based biopharmaceutical company WILEX AG (ISIN DE0006614720 / Frankfurt Stock Exchange / Prime Standard) has received an Investigational New Drug (IND) approval from the U.S. Food and Drug Administration (FDA) for a pivotal Phase III trial with the medical product candidate CA9-SCAN. CA9-SCAN is now the second product can-didate of the WILEX portfolio to enter a Phase III registration trial.
190 patients suspected of having kidney cancer will be enrolled in approximately 17 study centres in the USA. Patients with a renal mass are scheduled for surgery to remove the affected kidney. These patients will be imaged with CA9-SCAN prior to the surgery to determine whether they have clear cell renal cell cancer. As previously announced, WILEX intends to follow FDA` recommendation to conclude a special protocol assessment (SPA) before initiating the trial. The clinical research organisation and trial centres have already been chosen. Results are expected to be available at the end of 2008.
Dr. Paul Bevan, Head of Research & Development and Member of the Executive Management Board of WILEX AG comments: “The IND approval from FDA signals an important milestone in the development of CA9-SCAN. Furthermore, our portfolio continues to mature as planned with the addition of a second Phase lll product in pivotal clinical trials.”
About “SPA”
By applying for a SPA 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. 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
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. CA9-SCAN is the 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.
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.
SOURCE: WILEX
Post Views: 124
