Pilot study on pancreatic cancer detection begins enrollment
The first patient has been enrolled in a pilot study to evaluate the ability of RG1068 to improve detection and characterization of pancreatic cancer in combination with contrast-enhanced MRI and CT.
In addition, the study will evaluate which imaging technique is optimal for pancreatic tumor detection, staging and evaluation for surgery, according to Waltham, Mass.-based biopharmaceutical maker Repligen.
The investigator-sponsored pilot study will enroll up to 40 patients with a known or suspected pancreatic mass and the presence of a tumor will be confirmed by either surgery or biopsy.
"Accurate and early tumor detection and staging are fundamental for treating patients with pancreatic cancer," stated the study's principal investigator Pablo R. Ros, MD, chair of radiology at University Hospital Case Medical Center in Cleveland. "We are excited about this prospective study we have started since if successful, RG1068 has the potential to improve our ability to detect and correctly stage pancreatic tumors by CT and MRI scans and may lead to improved patient outcomes."
RG1068, a synthetic version of the hormone secretin, is known to both stimulate the secretion of pancreatic fluid into the pancreatic ducts and to increase blood flow to the tissues of the pancreas. Pancreatic tumors have minimal blood flow and the addition of RG1068 to standard contrast-enhanced imaging techniques, which are currently ineffective in resolving early disease, may enable the tumor to become more visible. In general, tumors less than 3 cm are amenable to surgical removal, the only viable form of treatment. Optimal triage and planning for surgery requires the detection of the tumor, evaluation of its size and relationship to major blood vessels, lymph nodes and presence of metastases.
RG1068 has previously been shown in Phase III clinical trials to improve detection of pancreatic duct abnormalities in combination with MRI in patients with pancreatitis. Identification of pancreatic duct abnormalities is important in the identification of the cause of a patient's symptoms and improves the physician's ability to confidently plan the next step in treatment.
RG1068 has been granted fast-track designation and Repligen intends to request that the FDA grant its application priority review when it files a new drug application in the U.S. later this year. The company plans to build a lean commercial infrastructure to sell RG1068 in the U.S. directly and to establish one or more commercial partnerships outside of the U.S. There are approximately 300,000 MRI procedures conducted in patients with pancreatitis in the U.S. and Europe each year, according to Repligen.
In addition, the study will evaluate which imaging technique is optimal for pancreatic tumor detection, staging and evaluation for surgery, according to Waltham, Mass.-based biopharmaceutical maker Repligen.
The investigator-sponsored pilot study will enroll up to 40 patients with a known or suspected pancreatic mass and the presence of a tumor will be confirmed by either surgery or biopsy.
"Accurate and early tumor detection and staging are fundamental for treating patients with pancreatic cancer," stated the study's principal investigator Pablo R. Ros, MD, chair of radiology at University Hospital Case Medical Center in Cleveland. "We are excited about this prospective study we have started since if successful, RG1068 has the potential to improve our ability to detect and correctly stage pancreatic tumors by CT and MRI scans and may lead to improved patient outcomes."
RG1068, a synthetic version of the hormone secretin, is known to both stimulate the secretion of pancreatic fluid into the pancreatic ducts and to increase blood flow to the tissues of the pancreas. Pancreatic tumors have minimal blood flow and the addition of RG1068 to standard contrast-enhanced imaging techniques, which are currently ineffective in resolving early disease, may enable the tumor to become more visible. In general, tumors less than 3 cm are amenable to surgical removal, the only viable form of treatment. Optimal triage and planning for surgery requires the detection of the tumor, evaluation of its size and relationship to major blood vessels, lymph nodes and presence of metastases.
RG1068 has previously been shown in Phase III clinical trials to improve detection of pancreatic duct abnormalities in combination with MRI in patients with pancreatitis. Identification of pancreatic duct abnormalities is important in the identification of the cause of a patient's symptoms and improves the physician's ability to confidently plan the next step in treatment.
RG1068 has been granted fast-track designation and Repligen intends to request that the FDA grant its application priority review when it files a new drug application in the U.S. later this year. The company plans to build a lean commercial infrastructure to sell RG1068 in the U.S. directly and to establish one or more commercial partnerships outside of the U.S. There are approximately 300,000 MRI procedures conducted in patients with pancreatitis in the U.S. and Europe each year, according to Repligen.