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News Archives
ChiRhoClin, Inc. is pleased to announce that Human Secretin product is now commercially available. The Food and Drug Administration gave final approval to ChiRhoClin’s new drug application for Human Secretin in April 2004. Human Secretin is a synthetically produced peptide, identical to the naturally occurring human gastrointestinal hormone. Secretin is secreted by intestinal cells in response to the ingestion of food. It circulates in the blood stream and binds to cells in the exocrine pancreas gland stimulating the production and release of digestive enzymes and bicarbonate rich pancreatic fluid. Human Secretin is FDA approved as a diagnostic drug for the following clinical indications and uses:
The pancreatic secretin stimulation test is considered the most accurate method to diagnose chronic pancreatitis, especially at an early stage when treatments with replacement enzymes can help preserve pancreatic function. The secretin gastrin stimulation test is considered the most sensitive and accurate method for diagnosing gastrin producing tumors, even when they are too small to be imaged, enabling potentially curative treatment to begin. Secretin is also the only FDA approved drug to assist the endoscopist in identifying and cannulating the pancreatic ducts during ERCP. Human Secretin is approved for the identical indications as ChiRhoClin’s currently marketed synthetic Porcine Secretin product. It offers several advantages including an improved stability profile, longer shelf-life and the same amino acid sequence as natural Human Secretin. ChiRhoClin’s CEO, Edward D. Purich, Ph.D., stated, “Human Secretin represents the next generation secretin drug product for diagnostic and endoscopic use. We are very pleased that FDA has approved our Human Secretin and authorized its commercial distribution. This is the culmination of many years of effort to provide the medical community with the ideal secretin product.” ChiRhoClin, Inc. of Burtonsville, Maryland is the developer and NDA holder of both synthetic Porcine Secretin and Human Secretin. For additional information or to place an order for Human Secretin, call 1-877-CRC-4888 or visit www.human-secretin.com. April 9th, 2004 ChiRhoClin, Inc. receives FDA approval of Human Secretin The
Food and Drug Administration, Center for Drug Evaluation and Research,
Office of Drug Evaluation has issued ChiRhoClin,
Inc. an approval for Human Secretin. The FDA approved three
indications. The indications of Human Secretin are the following:
2. Stimulation of gastrin secretion to aid in the diagnosis of gastrinoma, and
The FDA stated that they have completed the review of the NDA applications, as amended. The FDA has concluded that adequate information has been presented to demonstrate that the drug product is safe and effective for use as recommended in the agreed upon indications.
April 5, 2004 New Advances in Preventing ERCP induced Pancreatitis John Baillie, MD a Duke University medical professor has completed a study that identify agents that have been shown to reduce the frequency of ERCP-induced pancreatitis (gabexate, somatostatin and secretin). See the publication section for full study details. December 10, 2002 ChiRhoClin relocates to a new Facility ChiRhoClin, Inc. has moved into a new 3000 sq foot facility in Burtonsville MD. Included in the new office is a conference room, five offices, kitchenette, NDA filing room and a small state of the art laboratory. The new address is 4000 Blackburn Lane, Suite 270, Burtonsville MD 20866. The new phone is 301-476-8388 and fax number is 301-476-9529. November 4, 2002 ChiRhoClin Announces FDA Approval of New Indication for SecreFlo™ ChiRhoClin, Inc. announced today that the United States Food and Drug Administration (FDA) has approved a Supplemental New Drug Application to market SecreFlo™ to aid in the location and cannulation of the pancreatic ducts in patients undergoing ERCP. The FDA previously granted marketing approval to SecreFlo™ for stimulation of pancreatic secretions to aid in the diagnosis of pancreatic exocrine dysfunction or chronic pancreatitis and stimulation of gastrin secretion to aid in the diagnosis of gastrinoma, a gastrointestinal tumor. ERCP is an endoscopic procedure in which a cannula is inserted into the pancreas to diagnose or treat multiple diseases of the pancreas including pancreatitis, cysts, and cancers. Cannulation of the pancreas is difficult in some patients including those with pancreas divisum, a condition in which the main pancreatic duct is improperly formed. By stimulating the flow of pancreatic secretions, SecreFlo™ opens the pancreatic ducts and increases the likelihood of successful ERCP. There are approximately 50,000 ERCPs performed each year in the United States on patients in whom location and cannulation of the pancreas is difficult. A multicenter, double-blind, placebo-controlled clinical trial evaluated SecreFlo™ in patients with pancreas divisum and established that 89% of patients who received SecreFlo™ prior to ERCP were successfully cannulated versus a 6% success rate in patients who received a placebo (p<0.001). In addition to a dramatic increase in the success rate, the mean time to cannulation was significantly shorter with SecreFlo™ when compared to placebo (p<0.001). The average time to successful cannulation was 2 minutes after administration of SecreFlo™. The clinical development of SecreFlo™ is sponsored by ChiRhoClin, Inc. of Silver Spring, MD under its NDA. The FDA has granted SecreFlo™ Orphan Drug Designation, which means that it is the only form of secretin marketed for the approved indications in the United States until 2009. SecreFlo™ is marketed in the United States to hospital based gastroenterologists by Repligen’s gastroenterology sales specialists. Full prescribing information and information on how to order SecreFlo™ may be obtained at www.secreflo.com. For additional information contact ChiRhoClin, Inc. About ERCP and Pancreas DivisumERCP (Endoscopic Retrograde Cholangiopancreatography) is the primary procedure used by gastroenterologists to assess the health of pancreatic tissue and abnormalities in pancreatic structure and function. There are approximately 700,000 ERCP procedures carried out annually in the United States. In approximately 50,000 patients, the opening of the main pancreatic duct into the small intestine is deformed because of various medical conditions or the pancreatic ducts remain divided (pancreas divisum) and the minor pancreatic duct becomes the primary functional duct of the pancreas. The minor duct orifice is often challenging to identify which provides difficulty during ERCP. In both cases, administration of secretin causes pancreatic juices to flow from the pancreatic ducts, which visualizes their locations and aids in cannulation and successful completion of the procedure. Pancreas divisum is the most common congenital structural anomaly of the pancreas and is one of the most common causes of idiopathic pancreatitis.
October 2, 2002 ChiRhoClin and Repligen Corporation announced today the launch of SecreFlo™, the first synthetic version of the hormone secretin approved by the FDA. SecreFlo™ is approved by the FDA for stimulation of pancreatic secretions to aid in the diagnosis of pancreatic exocrine dysfunction, or chronic pancreatitis and stimulation of gastrin secretion to aid in the diagnosis of gastrinoma, Zollinger Ellison Syndrome. The FDA previously granted SecreFlo™ Orphan Drug Designation, which means that it is the only form of secretin that will be marketed for these indications in the United States until 2009 SecreFlo™ will be marketed in the United States to hospital based gastroenterologists by Repligen gastroenterology sales specialists. SecreFlo™ is manufactured for Repligen by ChiRhoClin, Inc. New indication for SecreFlo™ Earlier this year, a supplemental New Drug Application (sNDA) was filed by ChiRhoClin with the Food and Drug administration (FDA) for SecreFlo™, secretin for injection. ChiRhoClin believes that the clinical data submitted in the sNDA supports the use of SecreFlo™ to aid in the visual identification and cannulation of the pancreas in the patients undergoing ERCP. ERCP is currently the primary method to diagnose and treat many disease of the liver, bile duct and pancreas including gallstones, pancreatic and biliary cancers and pancreatitis. Secretin currently has no FDA-approved therapeutic use. Phasing Out Treatment IND for Secretin
With commercial availability of SecreFlo™ the treatment IND will be phased out. Investigators currently in the treatment IND will be sent a letter dealing with closing out the study.
May 28th 2002 A Supplemental NDA (sNDA) was filed with the Food and Drug Administration (FDA) secretin (synthetic porcine secretin) to Expand Label Claim. The clinical data submitted in the sNDA supports the use of secretin to aid in the location and cannulation of the minor pancreatic duct in patients with pancreas divisum undergoing an endoscopic gastrointestinal procedure called ERCP. The study was a multicenter, double blind, placebo controlled clinical trial sponsored by ChiRhoClin and conducted at Indiana University Medical Center, Medical University of South Carolina, Duke University Medical Center and University of Florida College of Medicine. This study supported the use of secretin during ERCP with clinical results indicating an overall rate of successful cannulation following secretin administration of 90% compared to a 6% success rate with placebo (p = 0.00005). The mean time to cannulate the pancreatic duct was significantly shorter with secretin when compared to placebo (p = 0.0001). The results of this study were presented at both Digestive Disease Week (DDW) and the American College of Gastroenterology conference and were recently accepted for publication in a peer review journal. Dr Edward Purich, one of the investigators for the study from ChiRhoClin, indicated “a similarly powered study with comparable results using synthetic human secretin was found approvable by the FDA on December 14, 2001. Since secretin and synthetic human secretin have nearly identical pharmacokinetics and pharmacodynamics activity, this should not be surprising”. While ChiRhoClin is responsible for the manufacturing, regulatory, and medical support for secretin, Repligen (Needham, MA) is responsible for marketing secretin using its trade name SecreFlo™. April 5th 2002 The Food and Drug Administration, Center for Drug Evaluation and Research, Office of Drug Evaluation has issued ChiRhoClin, Inc. an approval for synthetic porcine secretin. The FDA approved two indications. The indications of SecreFlo™ (secretin) for injection are: for the use in secretin stimulation testing for stimulation of pancreatic secretions, including bicarbonate, to aid in diagnostic of pancreatic exocrine dysfunction, and for the use in secretin stimulation testing for stimulation of gastrin secretion to aid in the diagnostic of gastrinoma. The FDA stated that they have completed the review of the NDA applications, as amended, and have concluded that adequate information has been presented to demonstrate that the drug product is safe and effective for use as recommended in the agreed upon indications. For additional information please contact Dr. Edward D. Purich at 301-476-8388. December 14, 2001- FDA issued ChiRhoClin, Inc. an Approvable Letter for its NDA for synthetic human secretin. Three diagnostic indications were found approvable: 1) stimulation of pancreatic secretions, including bicarbonate, to aid in the diagnosis of pancreatic exocrine dysfunction, 2) stimulation of pancreatic secretions to facilitate the identification of the ampulla of Vater and accessory papilla during endoscopic retrograde cholangiopancreatography (ERCP), and 3) stimulation of gastrin secretin to aid in the diagnosis of gastrinoma. An Approvable Letter provides information on what aspects of the New Drug Application are approved by the FDA and what remains to be completed for final NDA approval by the FDA. July/August 2001- ChiRhoClin, Inc. has completed making the additional batch of porcine secretin investigational drug substance and its parenteral product as requested by the FDA. The porcine secretin drug substance and parenteral after manufacture were thoroughly tested with satisfactory results. The final reports have been submitted to the FDA for review.
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