Guest guest Posted October 20, 2003 Report Share Posted October 20, 2003 Hi, since we have so many newbies on the list I'd like to recommend once again to subscribe the newsletter from the Boomer Esiason Foundation. It's full of info about what's going on in CF research and is published at least once a week. To subscribe go to www.esiason.org Peace Torsten, dad of Fiona 6wcf and Sebastian 4months wocf e-mail: torstenkrafft@... Health & Medicine Week October 20, 2003 HEADLINE: CYSTIC FIBROSIS: Safety and efficacy study planned for potential cystic fibrosis treatment Sucampo Pharmaceuticals, Inc. has begun a multi-center, phase IIa safety and efficacy study for the treatment of cystic fibrosis (CF) with its proprietary agent SPI-8811. The Sucampo study will randomize 24-30 patients with documented CF into three, open-label, dose-escalating cohorts at four sites throughout the United States. At least eight subjects will complete dosing in each cohort. The company is working closely with the Cystic Fibrosis Therapeutic Development Network on the study. The network was established by the Cystic Fibrosis Foundation to conduct early-phase clinical studies (phase I and II) with novel therapies for CF. CF is caused by a defective chloride channel called the cystic fibrosis transmembrane regulator, which prevents the transport of chloride ions between cells. The defect causes the body to develop thick, sticky mucous in the lung, pancreas, and liver, and increases morbidity and mortality in CF patients. SPI-8811 is an ion transport modulator that facilitates transport of chloride ions across cell membranes by a process different from the defective one in CF patients. The agent's ability to activate chloride transport should reduce mucous viscosity and allow increased clearance of mucous in the lungs, pancreas, and liver. " Cystic fibrosis is a devastating disease with many dire effects, " said Sucampo chief executive officer Myra L. Patchen, PhD " This research holds a special place in our organization and we hope that SPI-8811 will prove beneficial in treating this terrible disease. " SPI-8811 received orphan drug status for use in treating CF from the U.S. Food and Drug Administration (FDA) in December 2002. The FDA designation encourages research and development of new therapies for the more than 5,000 orphan (rare) diseases that affect fewer than 200,000 U.S. residents, diseases that affect 20 million Americans in total. Espicom Business Intelligence October 16, 2003 HEADLINE: Corus' CF drug advancing to Phase II trials Corus Pharma has initiated a Phase II study of Corus 1020 (aztreonam formulated for inhalation) in cystic fibrosis (CF) patients to evaluate efficacy, safety and tolerability. Results from the recently completed Phase I studies, which will be presented at the 17th Annual North American Cystic Fibrosis Conference, being held from 16th to 19th October, in Anaheim, CA, indicate that Corus 1020 was well-tolerated in CF patients and had no serious adverse effects. The US multi-centre, randomised, blinded, placebo-controlled Phase II study will be conducted with the help of the Cystic Fibrosis Foundation Therapeutics Development Network. Aztreonam is an antibiotic that has a broad spectrum of activity against gram-negative bacteria. Corus has formulated the product to try to improve airway tolerability. The product will be delivered directly to the lung to increase the concentration of the drug at the site of infection using Pari's eFlow inhalation technology. Quote Link to comment Share on other sites More sharing options...
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