WILEX announced that it has successfully completed patient recruitment in the Phase III trial with its diagnostic candidate REDECTANE
Munich, GERMANY | September 1, 2009 | The Munich-based biopharmaceutical company WILEX AG (ISIN DE0006614720 / Frankfurt Stock Exchange / Prime Standard) today announced that it has successfully completed patient recruitment in the Phase III trial with its diagnostic candidate REDECTANE®.
A total of 225 patients with suspected renal cancer have been enrolled in the study. They are examined prior to surgery by computer tomography (CT) and by positron emission tomography (PET/CT) scan using the imaging agent REDECTANE® to determine if they have a clear cell renal cell carcinoma. The trial examines whether using REDECTANE® as the imaging agent in conjunction with PET/CT can improve the diagnosis compared to CT alone, today’s current diagnostic standard. The REDECT trial is being conducted in 14 centres in the US.
Dr. Paul Bevan, Head of Research and Development and Member of the Executive Management Board at WILEX, said: “We are pleased to have successfully completed patient recruitment in the Phase III registration trial with REDECTANE®. We have reached an important milestone and are now eagerly awaiting the results”.
Subsequently, three radiologists and three specialists in nuclear medicine will perform independent analyses of all patients’ CTs and PET/CTs to determine whether or not clear cell renal cell cancer is present. The number of radiologists and nuclear medicine specialists was defined in the Special Protocol Assessment (SPA) in order to avoid potential deadlock. Histological examination of the surgically removed tumours will be performed at the same time in order to evaluate the accuracy of the analyses by the radiologists and nuclear medicine specialists. The data analysis will take approximately three to six months. Preliminary data are expected to be available by year end.
About the REDECT trial
REDECTANE®, the iodine 124-radioactively labelled form of the antibody WX-G250, binds like WILEX’s RENCAREX® therapeutic antibody with a high affinity to the tumour specific antigen CA IX expressed in clear cell renal cell cancer. The labelled antibody accumulates in the tumour tissue and can be visualised by means of Positron Emission Tomography (PET). Additional information provided by computer tomography (CT) can be used to localise accumulation of the antibody. REDECTANE® could determine whether the patient had clear cell renal cell carcinoma before surgery and the subsequent pathology. Therefore, REDECTANE® may significantly improve and simplify treatment planning for patients suspected of having renal cancer and possibly avoid a surgery of the kidney.
About WILEX AG
WILEX AG is a biopharmaceutical company based in Munich and is listed at the Frankfurt Stock Exchange at the Regulated Market / Prime Standard. WILEX’s mission is to develop drugs with a low side effect profile and targeted treatment of different types of cancer as well as diagnostic agents for specific detection of tumours. The Company’s product candidates are based on antibodies and small molecules. WILEX has an attractive product pipeline which includes both drug and diagnostic candidates: The substances RENCAREX® and REDECTANE® are currently undergoing a Phase III registration trial. MESUPRON® is in Phase II trials in two indications. WILEX acquired the MEK inhibitor WX-554 and the PI3K inhibitor WX-037 as well as three antibody programmes under the terms of the strategic partnership with UCB. An application for approval of a Phase I trial has been filed for WX-554. The other four oncology programmes are currently still in preclinical development. WILEX aims within a few years to be able to finance its research and development programmes from its operating cash flow.
SOURCE: Wilex AG
Post Views: 67
WILEX announced that it has successfully completed patient recruitment in the Phase III trial with its diagnostic candidate REDECTANE
Munich, GERMANY | September 1, 2009 | The Munich-based biopharmaceutical company WILEX AG (ISIN DE0006614720 / Frankfurt Stock Exchange / Prime Standard) today announced that it has successfully completed patient recruitment in the Phase III trial with its diagnostic candidate REDECTANE®.
A total of 225 patients with suspected renal cancer have been enrolled in the study. They are examined prior to surgery by computer tomography (CT) and by positron emission tomography (PET/CT) scan using the imaging agent REDECTANE® to determine if they have a clear cell renal cell carcinoma. The trial examines whether using REDECTANE® as the imaging agent in conjunction with PET/CT can improve the diagnosis compared to CT alone, today’s current diagnostic standard. The REDECT trial is being conducted in 14 centres in the US.
Dr. Paul Bevan, Head of Research and Development and Member of the Executive Management Board at WILEX, said: “We are pleased to have successfully completed patient recruitment in the Phase III registration trial with REDECTANE®. We have reached an important milestone and are now eagerly awaiting the results”.
Subsequently, three radiologists and three specialists in nuclear medicine will perform independent analyses of all patients’ CTs and PET/CTs to determine whether or not clear cell renal cell cancer is present. The number of radiologists and nuclear medicine specialists was defined in the Special Protocol Assessment (SPA) in order to avoid potential deadlock. Histological examination of the surgically removed tumours will be performed at the same time in order to evaluate the accuracy of the analyses by the radiologists and nuclear medicine specialists. The data analysis will take approximately three to six months. Preliminary data are expected to be available by year end.
About the REDECT trial
REDECTANE®, the iodine 124-radioactively labelled form of the antibody WX-G250, binds like WILEX’s RENCAREX® therapeutic antibody with a high affinity to the tumour specific antigen CA IX expressed in clear cell renal cell cancer. The labelled antibody accumulates in the tumour tissue and can be visualised by means of Positron Emission Tomography (PET). Additional information provided by computer tomography (CT) can be used to localise accumulation of the antibody. REDECTANE® could determine whether the patient had clear cell renal cell carcinoma before surgery and the subsequent pathology. Therefore, REDECTANE® may significantly improve and simplify treatment planning for patients suspected of having renal cancer and possibly avoid a surgery of the kidney.
About WILEX AG
WILEX AG is a biopharmaceutical company based in Munich and is listed at the Frankfurt Stock Exchange at the Regulated Market / Prime Standard. WILEX’s mission is to develop drugs with a low side effect profile and targeted treatment of different types of cancer as well as diagnostic agents for specific detection of tumours. The Company’s product candidates are based on antibodies and small molecules. WILEX has an attractive product pipeline which includes both drug and diagnostic candidates: The substances RENCAREX® and REDECTANE® are currently undergoing a Phase III registration trial. MESUPRON® is in Phase II trials in two indications. WILEX acquired the MEK inhibitor WX-554 and the PI3K inhibitor WX-037 as well as three antibody programmes under the terms of the strategic partnership with UCB. An application for approval of a Phase I trial has been filed for WX-554. The other four oncology programmes are currently still in preclinical development. WILEX aims within a few years to be able to finance its research and development programmes from its operating cash flow.
SOURCE: Wilex AG
Post Views: 67
