To: ezXit who wrote (5268 ) 6/22/1998 9:34:00 AM From: Don Powrie Respond to of 8798
>>>>NEWS! Nasdaq: SCLN SOURCE: SciClone Pharmaceuticals, Inc. SciClone Completes Successful Phase 1 Trial of CPX in Cystic Fibrosis Patients CPX Phase 2 Trial to Begin in the Third Quarter of 1998 SAN MATEO, Calif., June 22 /PRNewswire/ -- SciClone Pharmaceuticals (Nasdaq: SCLN - news) today announced that a Phase 1 trial of CPX, its lead cystic fibrosis (CF) drug, demonstrates that the compound is safe, orally absorbed and achieves anticipated blood levels. SciClone plans to start a CPX Phase 2 trial in the third quarter of 1998. The Phase 1 trial was a multicenter, single ascending oral dose study involving 37 CF patients. The results of the study will be presented at the Twelfth Annual North American Cystic Fibrosis Conference in October. ''The data confirm that CPX is a novel, orally available, non-toxic compound,'' said David A. Karlin, M.D., SciClone's Vice President and Medical Director. ''We accomplished our objectives for the Phase 1 program and are excited about advancing CPX into a Phase 2 clinical trial as soon as possible.'' CF is the most common fatal genetic disorder in the U.S. It affects approximately 70,000 children and young adults worldwide, including 30,000 in the U.S. and 30,000 in Europe. Currently, there is no cure for CF. Approved therapies for CF treat only the symptoms of the disease, such as lung infections. The average annual cost of care for a CF patient is $50,000. The median age of survival for a person with CF is 31 years. CF is caused by a defect in the CFTR protein, which is responsible for transporting chloride from epithelial cells that line organs such as the lungs and pancreas. The blockage of chloride causes the body to produce abnormally thick, sticky mucus, which clogs the airways and leads to fatal lung infections. In CF, there are more than 600 mutations in the gene coding for the CFTR protein. Approximately 70% of the CF population has the delta F508 mutation. All CF patients in SciClone's Phase 1 trial have the delta F508 mutation. All patients in the Company's Phase 2 trial will have the delta F508 mutation. In preclinical studies run by the National Institutes of Health, CPX corrected the two cellular defects that cause the production of mucus in CF patients with the delta F508 mutation: (1) impaired chloride ion transport and (2) abnormal trafficking of the CFTR protein. The Food and Drug Administration has granted CPX orphan drug status and awarded SciClone a $100,000 Orphan Drug Grant for Phase 1 development of the compound as a treatment for CF. SciClone Pharmaceuticals is an international biopharmaceutical company that acquires, develops and commercializes specialist-oriented drugs for treating chronic and life-threatening diseases such as hepatitis B, hepatitis C, cystic fibrosis, cancer and immune system disorders. Press releases and corporate information from SciClone Pharmaceuticals, Inc. are available on the Internet at www.sciclone.com and by fax at 800-996-7256. SOURCE: SciClone Pharmaceuticals, Inc.