Artisan Pharma, Inc. Launches Phase 2b Trial of ART-123 for the Treatment of DIC in Sepsis.WALTHAM, Mass. -- Artisan Pharma, Inc. today announced that it has launched a Phase 2b clinical trial of its lead product ART-123 for the treatment of DIC DIC diffuse intravascular coagulation; disseminated intravascular coagulation. DIC abbr. disseminated intravascular coagulation Disseminated intravascular coagulation (DIC) in sepsis. The multi-center, double-blind, placebo controlled trial controlled trial Clinical research A clinical study in which one group of participants receives an experimental drug while the other receives either a placebo or an approved–'gold standard' therapy. See Blinding, Double-blinded. will enroll 800 sepsis patients who are at high risk of having concurrent disseminated intravascular coagulation disseminated intravascular coagulation n. Abbr. DIC A hemorrhagic disorder that occurs following the uncontrolled activation of clotting factors and fibrinolytic enzymes throughout small blood vessels, resulting in tissue necrosis and (DIC), which in sepsis patients may double their risk of death. Clinical sites expected to contribute to the study include those in North America North America, third largest continent (1990 est. pop. 365,000,000), c.9,400,000 sq mi (24,346,000 sq km), the northern of the two continents of the Western Hemisphere. , Europe, Australia, New Zealand New Zealand (zē`lənd), island country (2005 est. pop. 4,035,000), 104,454 sq mi (270,534 sq km), in the S Pacific Ocean, over 1,000 mi (1,600 km) SE of Australia. The capital is Wellington; the largest city and leading port is Auckland. , India and Argentina. ART-123 is being developed in Japan by Asahi Kasei Pharma Corporation ("AKP AKP Adalet Ve Kalkinma Partisi (Turkish: Party for Justice and Progress) AKP Arbeidernes Kommunist Parti (Norwegian Political Party) AKP Agjencia Kombetare e Privatizimit ")(Tokyo, Japan) for the treatment of DIC. Clinical results demonstrated that ART-123 has an advantage over heparin in resolving DIC and suggested that ART-123 has an encouraging benefit on mortality in DIC patients with infections. Commenting on the trial, Jeffrey D. Wager, M.D., President and CEO (1) (Chief Executive Officer) The highest individual in command of an organization. Typically the president of the company, the CEO reports to the Chairman of the Board. of Artisan, said, "There are almost 2 million cases of sepsis per year in North America and Europe alone. Up to a third of these cases have DIC secondary to their sepsis. ART-123's Phase 2b trial is an exciting step towards developing a therapy that could potentially save hundreds of thousands of lives every year. Such an advance would be truly revolutionary in terms of its impact, and inspires all of us here at Artisan." David Gelmont, M.D., Artisan's Chief Medical Officer, continued, "We believe that ART-123 has a very safe profile based on the safety assessments of this drug in previous clinical trials. In addition, data from preclinical and clinical trials suggest that ART-123 is effective in resolving DIC. Current standards of critical care practice implicate im·pli·cate tr.v. im·pli·cat·ed, im·pli·cat·ing, im·pli·cates 1. To involve or connect intimately or incriminatingly: evidence that implicates others in the plot. 2. the role of DIC as a major contributor to multi-organ dysfunction, organ failure and death in septic patients. We are therefore excited to investigate the possibility that ART-123 might represent a significant intervention in this disease." About ART-123 ART-123 is a novel, recombinant, soluble thrombomodulin for the treatment of DIC (disseminated intravascular coagulation) in sepsis. ART-123 uniquely targets both anti-coagulant and systemic anti-inflammatory pathways, and holds great promise as a self-regulating treatment of DIC in sepsis. Artisan holds all development and commercial rights for ART-123 outside of Japan, China, Taiwan and Korea. About DIC in Sepsis Almost 2 million patients in the United States and Europe suffer from sepsis annually, with approximately 30% of them developing DIC. For those that do, prognosis is poor. DIC is a severe condition in which widespread microthrombi formation ultimately contributes to organ dysfunction and death. This market is estimated at over $2 billion and is increasing due to the growing incidence of sepsis in the industrialized in·dus·tri·al·ize v. in·dus·tri·al·ized, in·dus·tri·al·iz·ing, in·dus·tri·al·iz·es v.tr. 1. To develop industry in (a country or society, for example). 2. world. About Artisan's ART-123 Phase 2b Trial in DIC in Sepsis The phase 2b study entitled "A Randomized ran·dom·ize tr.v. ran·dom·ized, ran·dom·iz·ing, ran·dom·iz·es To make random in arrangement, especially in order to control the variables in an experiment. , Double-Blind, Placebo-Controlled, Phase-2b Study to Assess the Safety and Efficacy Effects of ART-123 on Subjects with Sepsis and Disseminated Intravascular Coagulation" will enroll 800 subjects in 140 sites, worldwide. For further information please refer to http://clinicaltrials.gov/. About Artisan Pharma, Inc. Artisan Pharma is a biopharmaceutical company dedicated to bringing best-in-class acute care therapeutics to patients. Artisan's strategy is to acquire clinical stage or marketed drugs and develop them for markets with clear unmet medical needs. www.artisanpharma.net About Asahi Kasei Pharma Corporation Asahi Kasei Pharma, headquartered in Tokyo, Japan, is a research-based healthcare innovator that discovers, develops, manufactures, and markets products for the pharmaceutical, pharmaceutical intermediate, diagnostics, biopharmaceutical/biological filtration, medical device, medical nutrition, and contact lens contact lens, thin plastic lens worn between the eye and eyelid that may be used instead of eyeglasses. Actors, models, and others wear them for appearance, and athletes use them for safety and convenience. markets. Asahi Kasei Pharma is a wholly owned business unit of Asahi Kasei Corporation, a US$13 billion technology company that provides innovative, science-based solutions to a diverse range of markets including chemicals and plastics, apparel, housing and construction, healthcare, and electronics. For additional information, visit www.asahi-kasei.co.jp. |
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