BOSTON, May 21 /PRNewswire/ -- Bayer HealthCare Pharmaceuticals, Inc. today announced presentation of data in a poster titled "Results from a multicenter, open-label Phase 3 study to determine the safety and efficacy of gadobutrol, a macrocyclic 1.0 molar GBCA in patients referred for contrast-enhanced MRI of the central nervous system (CNS)" at the 48th Annual Meeting of the American Society of Neuroradiology (ASNR) in Boston, MA. The results of this study of this investigational drug met all of its pre-specified primary efficacy objectives. Gadobutrol is investigational in the United States and is not approved by the U.S. Food and Drug Administration.
This phase 3 study had four primary efficacy objectives. In results comparing unenhanced CNS MRI versus the combined unenhanced and gadobutrol-enhanced CNS MRI, statistically significant superiority (P<0.0001) of gadobutrol images compared to unenhanced images was shown for all three individual blinded readers as well as the average blinded reader for three of the primary efficacy variables (internal morphology, degree of contrast enhancement and border delineation). Non-inferiority was the objective for the number of lesions detected in this study and was demonstrated for two of three blinded readers, as well as the average of the blinded readers.(1)
In the study, 14 subjects (4.1%) reported at least one adverse event which the investigators considered related to gadobutrol. No deaths were reported during the study period, and none of the subjects discontinued from the study due to an AE. One subject experienced a serious adverse event (SAE), which was not considered by the investigator to be related to the study drug.
"This was a large multicenter study that included patients referred to contrast-enhanced MRI of the central nervous system based on clinical symptoms and results from previous procedures," said Juan Gutierrez, MD, Assistant Professor of Radiology, Neuroradiology Section, Director, Clinical Trials Division, the University of Texas Health Science Center at San Antonio. "We are pleased to be presenting the data from this study at the ASNR meeting."
"The results from this Phase 3 study are an important milestone in our overall development program and in our approach to gain regulatory approval for gadobutrol in the United States," said Thomas Balzer, MD, Vice President, Global Clinical Development, Diagnostic Imaging, Bayer HealthCare.
About the Study Design(1)
Results from the open-label Phase 3 study of gadobutrol 1.0 molar contrast agent were based on MRI images from 321 patients who underwent two sets of MRI scans. Three independent blinded readers evaluated the images in two sets, unenhanced and the combination of unenhanced and gadobutrol-enhanced MRI, giving assessment on each of the efficacy variables and a radiological diagnosis. The primary efficacy objectives were superiority for degree of lesion contrast enhancement, lesion border delineation, lesion internal morphology, and non-inferiority in the number of lesions detected. All available patient-related clinical information was collected up to three months after the MRI scans and an independent truth panel gave the assessment of the final clinical diagnosis. The safety profile of gadobutrol after IV administration was also assessed.
About Gadolinium Based Contrast Agents
Gadolinium based contrast agents (GBCAs) are used for the detection and visualization of certain lesions that are detected through unenhanced MRI scans. In May 2007, the FDA requested that all gadolinium-based contrast agents approved for marketing in the U.S. contain a boxed warning regarding the potential risk of Nephrogenic Systemic Fibrosis (NSF) for patients with acute or chronic severe renal insufficiency (glomerular filtration rate <30 mL/min/1.73m2), or acute renal insufficiency of any severity due to the hepatorenal syndrome or in the perioperative liver transplantation period In these patients, avoid the use of a GBCA unless the diagnostic information is essential and not available with non-contrast enhanced magnetic resonance imaging. Gadobutrol is investigational in the United States and is not approved by the U.S. Food and Drug Administration.
About Bayer HealthCare Pharmaceuticals Inc.
Bayer HealthCare Pharmaceuticals Inc. is the U.S.-based pharmaceuticals business of Bayer HealthCare LLC, a subsidiary of Bayer AG. Bayer HealthCare is one of the world's leading, innovative companies in the healthcare and medical products industry, and combines the activities of the Animal Health, Consumer Care, Diabetes Care, and Pharmaceuticals divisions. Bayer HealthCare Pharmaceuticals comprises the following business units: Women's Healthcare, Diagnostic Imaging, General Medicine, which includes Cardiology and Primary Care and Specialty Medicine, which includes Hematology, Oncology and Neurology. The company's aim is to discover and manufacture products that will improve human health worldwide by diagnosing, preventing and treating diseases.
This news release contains forward-looking statements based on current assumptions and forecasts made by Bayer Group management. Various known and unknown risks, uncertainties and other factors could lead to material differences between the actual future results, financial situation, development or performance of the company and the estimates given here. These factors include those discussed in our public reports filed with the Frankfurt Stock Exchange and with the U.S. Securities and Exchange Commission (including Form 20-F). The company assumes no liability whatsoever to update these forward-looking statements or to conform them to future events or developments.
(1) Juan E Gutierrez, M.D., Sara Koenig, B.S., Santiago E. Rossi, M.D., Bum-Soo Kim, M.D., Ricardo Garcia-Monaco, M.D., Yi Huan, M.D., Josy Breuer, M.D., Martin Rosenberg, M.D., Guenther Brueggenwerth, M.D., et al. Results from a multicenter, open-label, phase 3 study to determine the safety and efficacy of gadobutrol, a macrocylic 1.0 molar GBCA in patients referred for contrast-enhanced MRI of the central nervous system (CNS). Poster presented at the 48th Annual Meeting of the American Society of Neuroradiology (ASNR), May 17-20, 2010.
SOURCE Bayer HealthCare Pharmaceuticals, Inc.
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This phase 3 study had four primary efficacy objectives. In results comparing unenhanced CNS MRI versus the combined unenhanced and gadobutrol-enhanced CNS MRI, statistically significant superiority (P<0.0001) of gadobutrol images compared to unenhanced images was shown for all three individual blinded readers as well as the average blinded reader for three of the primary efficacy variables (internal morphology, degree of contrast enhancement and border delineation). Non-inferiority was the objective for the number of lesions detected in this study and was demonstrated for two of three blinded readers, as well as the average of the blinded readers.(1)
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In the study, 14 subjects (4.1%) reported at least one adverse event which the investigators considered related to gadobutrol. No deaths were reported during the study period, and none of the subjects discontinued from the study due to an AE. One subject experienced a serious adverse event (SAE), which was not considered by the investigator to be related to the study drug.
"This was a large multicenter study that included patients referred to contrast-enhanced MRI of the central nervous system based on clinical symptoms and results from previous procedures," said Juan Gutierrez, MD, Assistant Professor of Radiology, Neuroradiology Section, Director, Clinical Trials Division, the University of Texas Health Science Center at San Antonio. "We are pleased to be presenting the data from this study at the ASNR meeting."
"The results from this Phase 3 study are an important milestone in our overall development program and in our approach to gain regulatory approval for gadobutrol in the United States," said Thomas Balzer, MD, Vice President, Global Clinical Development, Diagnostic Imaging, Bayer HealthCare.
About the Study Design(1)
Results from the open-label Phase 3 study of gadobutrol 1.0 molar contrast agent were based on MRI images from 321 patients who underwent two sets of MRI scans. Three independent blinded readers evaluated the images in two sets, unenhanced and the combination of unenhanced and gadobutrol-enhanced MRI, giving assessment on each of the efficacy variables and a radiological diagnosis. The primary efficacy objectives were superiority for degree of lesion contrast enhancement, lesion border delineation, lesion internal morphology, and non-inferiority in the number of lesions detected. All available patient-related clinical information was collected up to three months after the MRI scans and an independent truth panel gave the assessment of the final clinical diagnosis. The safety profile of gadobutrol after IV administration was also assessed.
About Gadolinium Based Contrast Agents
Gadolinium based contrast agents (GBCAs) are used for the detection and visualization of certain lesions that are detected through unenhanced MRI scans. In May 2007, the FDA requested that all gadolinium-based contrast agents approved for marketing in the U.S. contain a boxed warning regarding the potential risk of Nephrogenic Systemic Fibrosis (NSF) for patients with acute or chronic severe renal insufficiency (glomerular filtration rate <30 mL/min/1.73m2), or acute renal insufficiency of any severity due to the hepatorenal syndrome or in the perioperative liver transplantation period In these patients, avoid the use of a GBCA unless the diagnostic information is essential and not available with non-contrast enhanced magnetic resonance imaging. Gadobutrol is investigational in the United States and is not approved by the U.S. Food and Drug Administration.
About Bayer HealthCare Pharmaceuticals Inc.
Bayer HealthCare Pharmaceuticals Inc. is the U.S.-based pharmaceuticals business of Bayer HealthCare LLC, a subsidiary of Bayer AG. Bayer HealthCare is one of the world's leading, innovative companies in the healthcare and medical products industry, and combines the activities of the Animal Health, Consumer Care, Diabetes Care, and Pharmaceuticals divisions. Bayer HealthCare Pharmaceuticals comprises the following business units: Women's Healthcare, Diagnostic Imaging, General Medicine, which includes Cardiology and Primary Care and Specialty Medicine, which includes Hematology, Oncology and Neurology. The company's aim is to discover and manufacture products that will improve human health worldwide by diagnosing, preventing and treating diseases.
This news release contains forward-looking statements based on current assumptions and forecasts made by Bayer Group management. Various known and unknown risks, uncertainties and other factors could lead to material differences between the actual future results, financial situation, development or performance of the company and the estimates given here. These factors include those discussed in our public reports filed with the Frankfurt Stock Exchange and with the U.S. Securities and Exchange Commission (including Form 20-F). The company assumes no liability whatsoever to update these forward-looking statements or to conform them to future events or developments.
(1) Juan E Gutierrez, M.D., Sara Koenig, B.S., Santiago E. Rossi, M.D., Bum-Soo Kim, M.D., Ricardo Garcia-Monaco, M.D., Yi Huan, M.D., Josy Breuer, M.D., Martin Rosenberg, M.D., Guenther Brueggenwerth, M.D., et al. Results from a multicenter, open-label, phase 3 study to determine the safety and efficacy of gadobutrol, a macrocylic 1.0 molar GBCA in patients referred for contrast-enhanced MRI of the central nervous system (CNS). Poster presented at the 48th Annual Meeting of the American Society of Neuroradiology (ASNR), May 17-20, 2010.
SOURCE Bayer HealthCare Pharmaceuticals, Inc.
