GRANTED ORPHAN DRUG DESIGNATION FOR TAUROLIDINE FOR TREATMENT OF NEUROBLASTOMA
A new biopharmaceutical company focused on developing and commercializing restorative products for the avoidance and treatment of infectious and other diseases, today announced that it received notification on Friday, February 23, 2018 that the U. S. Food and Drug Administration (FDA) provided orphan drug designation to taurolidine for the treatment of neuroblastoma. Taurolidine is currently in preclinical development for neuroblastoma and is a key component in the Company’s lead product, Neutrolin®, a novel anti-infective solution for the reduction and reduction of catheter-related infections and thrombosis in patients demanding core venous cathers in end stage renal disease.
“We are pleased to broaden on our potential signs for taurolidine and also to obtain orphan drug designation for treatment of neuroblastoma, ” said Khoso Baluch, Chief Exec Officer of CorMedix. “We believe taurolidine could have potential activity in this rare pediatric disease area, based on ongoing laboratory studies. Current treatments offer poor outcomes and based on its potential synergy with other drugs approved in this area, we believe taurolidine could become an important treatment for neuroblastoma. Our goal in this area is to partner with an appropriate cancer-focused company to progress taurolidine into clinical development and eventually obtain marketing approval. ”
Orphan medication designation is granted by the FDA to book drugs or biologics that treat rare diseases or conditions affecting less than 2 hundred, 000 patients in the U. S. The status provides CorMedix with a potential seven-year period of U. S. marketing uniqueness on approval of the drug for commercial distribution, and eligibility for offer funding, clinical trial design assistance, as well as tax credits for research costs, and the waiver of Prescription Drug User Fee Act (PDUFA) filing fees.
Neuroblastoma is a severe form of cancer that originates in certain types of nerve cells and most often begins in the adrenal intrigue, which are the small glands on top of the kidneys. It can develop in the chest, stomach, neck of the guitar, pelvis, or bones. Youngsters ages five or more youthful are most commonly afflicted and symptoms include tiredness, loss of appetite, and temperature. The tumor can cause a sizable bump in the neck region and bulging of the eyes and dark circles around the eyes. In infants it can cause difficulty inhaling. A genetic pattern of inheritance for neuroblastoma can be passed from parent to child and proof types of the illness are prevalent and can recur.
The Pediatric Oncology Experimental Therapeutics Investigators’ Consortium (POETIC) has been contracted by CorMedix to carry out tests on cell lines as well as in animal models. Dr. Antony Pffafle, Chief Scientific Police officer of CorMedix, spearheads the collaboration with POETIC on preclinical development of taurolidine-based therapies for cancer. Preliminary prospect therapies are being developed and formulated for delivery to tumors, including potential combo therapies concerning taurolidine plus another chemotherapy. The anti-cancer activity of these prospects was examined successfully in various malignancy cell lines, and pet studies are ongoing.
The Pediatric Oncology Experimental Therapeutics Investigators’ Holding (POETIC) was founded in February 2003 by Dr. Lia Gore at the University of Colorado Malignancy Center and Dr. Tanya Trippett at Memorial Sloan-Kettering Cancer Center. POETIC is composed of ten large academic medical centers in North America with an important emphasis on comprehensive tumor care and research that provide the collaborative and research strength needed to complete intensive phase i treatment and II studies.
POETIC’s engaging centers are:
Alberta Children’s Hospital (Aru Narenderan, MD, Ph. D)
Arkansas Children’s Hospital, Little Rock (Kathleen A. Neville, MD, MS)
Arnold Palmer Hospital for Children/MD Anderson Cancer Centre Orlando (Amy Smith, MD)
Dana-Farber/Children’s Hospital Cancer Center (Susan Chi, MD)
MARYLAND Anderson Cancer Center (Cynthia Herzog, MD)
Lucile Salter Packard Children’s Hospital, Stanford (Norman James Lacayo, MD)
Memorial Sloan-Kettering Cancer Center (Tanya Trippett, MD)
Penn State Hershey Children’s Clinic (Lisa M. McGregor, Mirielle. D., Ph. D. )
Phoenix Children’s Hospital (Jessica Boklan, MD)
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins (Dr. Patrick Brown)
University of Tx Health Science Center (Steve Weitman, M. D., Ph level. D. )
CorMedix Inc. is a biopharmaceutical company focused on developing and commercializing therapeutic products for the reduction and treatment of contagious and inflammatory diseases. Typically the Company is focused on establishing its lead product Neutrolin®, a novel, non-antibiotic anti-bacterial solution built to prevent costly and dangerous bloodstream attacks associated with the use of central venous catheters, currently in a Phase 3 clinical trial signing up patients undergoing chronic hemodialysis. Such infections cost the U. S. healthcare system approximately $6 billion yearly and contribute significantly to increased morbidity and mortality. Neutrolin has FDA Steps for success status and is designated as a Qualified Contagious Disease Product, which provides the potential for top priority report on a marketing application by FDA and allows for 5 additional years of QIDP market uniqueness in the event of U. S. approval. Neutrolin is already marketed as a CE Marked product in Europe and other territories. In parallel, CorMedix is leveraging its taurolidine technology to develop a pipeline of antimicrobial medical devices, with active programs in surgical sutures and meshes, and topical hydrogels. The business is also working with top-tier researchers to develop taurolidine-based therapies for rare pediatric cancers.
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