Caprion's caStx 1-2 Antibodies Receive European and US Orphan Drug Designation for Treatment of Shiga-Toxin Producing E. Coli.MONTREAL -- Caprion Pharmaceuticals Inc. today announced that caStx1 and caStx2, investigational therapeutic monoclonal antibodies, have been granted orphan drug status for the treatment of Shiga-toxin producing E. Coli (STEC STEC shiga toxin-producing Escherichia coli. ) infections by the European Medicines Agency The European Medicines Agency (EMEA) is a European agency for the evaluation of medicinal products. Until 2004, the European Medicines Agency was known as The European Agency for the Evaluation of Medicinal Products. Roughly parallel to the U.S. (EMEA (Europe, Middle East, Africa) Refers to that region of the world. For example, one might see products packaged differently for the UK, EMEA and Asia Pacific markets. ) and the United States (US) Food and Drug Administration (FDA FDA abbr. Food and Drug Administration FDA, n.pr See Food and Drug Administration. FDA, n.pr the abbreviation for the Food and Drug Administration. ). This designation provides Caprion with, among other benefits, ten years of potential market exclusivity if the product is approved for marketing in the European Union (EU) and seven years exclusivity if approved in the US. "We are pleased with the European and American regulators' decision to grant our product orphan drug status," stated Marc Riviere ri·vière n. A necklace of precious stones, generally set in one strand. [French rivière (de diamants), river (of diamonds), from Old French rivere, from Vulgar Latin , MD, Executive Vice-President of Clinical Development at Caprion. "These key designations in two critical jurisdictions reinforce our belief that our drug has the potential to become the first viable treatment for this devastating dev·as·tate tr.v. dev·as·tat·ed, dev·as·tat·ing, dev·as·tates 1. To lay waste; destroy. 2. To overwhelm; confound; stun: was devastated by the rude remark. disease." EMEA and FDA regulations on orphan medicinal products are designed to encourage companies to develop and market treatments for rare medical conditions. In addition to the potential ten years of market exclusivity in the EU and seven year market exclusivity in the US following marketing approval, orphan drug status provides regulatory assistance, reduced regulatory fees associated with applying for marketing approval, and protocol assistance for clinical development. About STEC Shiga-toxin producing bacterial infection comprises infections caused by bacteria called Shigella dysenteriae type 1 and Shiga-toxin producing Escherichia coli. (STEC). The disease is transmitted by contaminated food or water. These bacteria produce a poison (Shiga-toxin) that blocks production of cell proteins. Serious gastrointestinal disease, bloody diarrhea, destruction of red blood cells Red blood cells Cells that carry hemoglobin (the molecule that transports oxygen) and help remove wastes from tissues throughout the body. Mentioned in: Bone Marrow Transplantation red blood cells and platelets, and haemolytic Adj. 1. haemolytic - relating to or involving or causing hemolysis; "hemolytic anemia" hemolytic uraemic U`rae´mic a. 1. (Med.) Of or pertaining to uræmia; as, uræmic convulsions s>. Adj. 1. uraemic syndrome (HUS) are among the multiple complications of this disease. STEC is a life-threatening condition that affects approximately 97,000 persons annually in the EU and more than 100,000 people per year in the US according to the Centers for Disease Control. There is no known treatment for STEC infections. Caprion is developing its product to neutralize the circulating toxins in the body in order to treat the disease and prevent its major complications. About Caprion Pharmaceuticals Inc. Caprion is a drug discovery and development company applying its proprietary proteomics technologies to develop innovative pharmaceutical products, initially in oncology and infectious disease. The Company's most advanced program is in late Phase I clinical trials in the US for Shiga-toxin producing E. coli infection (STEC). Caprion's proteomics discovery platform - CellCarta(R) - has become a leading means for profiling proteins in blood and solid tumors. Caprion's strategy is to leverage platform discovery and development collaborations in two key areas - oncology and plasma profiling - to fund and further build its own pipeline of clinical programs. In addition to its leading program in STEC, Caprion has signed major research alliances in Colon, Prostate and Lung Cancer with Biogen Idec, AstraZeneca, ICOS Corporation and Abbott Laboratories, as well as numerous alliances for plasma profiling and novel biomarker discovery with leading pharmaceutical companies. For more on Caprion, please visit www.caprion.com |
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