Guest guest Posted July 6, 2003 Report Share Posted July 6, 2003 Let us hope that Chiron is correct! A great advance, if this is actually the case, which it may well be! Thank you, Torsten and Love to all at cfparents, n Rojas Quote Link to comment Share on other sites More sharing options...
Guest guest Posted July 6, 2003 Report Share Posted July 6, 2003 PR Newswire June 4, 2003, Wednesday 2:00 AM Eastern Time HEADLINE: Chiron Presents Positive TOBI® Tobramycin Solution for Inhalation Data At 26th European Cystic Fibrosis Conference; Study Shows TOBI Treatment Reduces Hospitalizations for Young Cystic Fibrosis Patients with Asymptomatic or Mild Lung Disease by 50 percent; Update on Progress in Inhaled Therapeutics Franchise DATELINE: EMERYVILLE, Calif., June 4 Chiron Corporation (Nasdaq: CHIR) today announced that it has presented the results of a TOBI® tobramycin solution for inhalation study at the 26th European Cystic Fibrosis Conference in Belfast. The study, which involved 184 cystic fibrosis (CF) patients ages 6-15 years, showed that subjects undergoing TOBI treatment in conjunction with routine care were significantly less likely to be hospitalized for respiratory symptoms or to be treated with oral antibiotics than those undergoing routine care alone. TOBI, for CF patients with chronic pseudomonal lung infection, is the cornerstone of Chiron's inhaled therapeutics franchise. In addition to the study results presented at the European Cystic Fibrosis Conference, Chiron has seen recent positive data on TOBI's efficacy in decreasing Pseudomonas aeruginosa (Pa) in pediatric patients as well as in treating chronic bronchiectasis, indicating a potential role for the drug in treatment of these diseases. Chiron is also evaluating data on aerosolized cyclosporine, which it recently acquired from Novartis, for the treatment of acute lung transplant rejection. " TOBI has achieved strong penetration and compliance in the segment of CF patients with moderate and severe disease, and now we are seeing its value in earlier stages of the disease as well, " said Craig Wheeler, president of Chiron 's biopharmaceuticals business unit. " Chiron is dedicated to growing its strong pulmonology presence in order to benefit more patients. " TOBI Tobramycin Solution for Inhalation Study Results Chiron sponsored an open-label, randomized, multicenter, controlled trial of TOBI treatment (300 milligrams of tobramycin solution for inhalation administered twice daily for one month on-drug, one month off-drug) in 184 subjects over 14 months, which revealed a significantly higher incidence of respiratory hospitalizations in the control group under routine care relative to subjects treated with TOBI in addition to routine care. In the control arm, 26 percent of subjects were hospitalized; in the treatment arm, 11 percent were hospitalized (p < 0.01). Adverse events seen in the treatment arm were consistent with previous studies of TOBI (hoarseness, cough, sore throat and tinnitus), were not severe and were transient. The study concluded that the use of TOBI in young CF patients infected with Pa and with mild lung disease appears to decrease the rate of hospitalization and concomitant antibiotic use and may slow the rate of spirometric decline. Data published in the March 15, 2003, American Journal of Respiratory and Critical Care Medicine showed that TOBI had a significant microbiological effect in decreasing Pa in young children with CF. A double-blind, placebo-controlled, multicenter, randomized trial in 21 children under age 6 showed that TOBI treatment (300 milligrams of tobramycin solution for inhalation administered twice daily for 28 days) resulted in a profound decrease in Pa density from the lower airway of young children with CF. The trial was stopped early because the risk of additional bronchoscopies was deemed unacceptable in light of the evidence of a significant microbiological treatment effect -- Pa was eradicated in 8 of 8 TOBI-treated patients compared with 1 of 13 placebo patients (p < 0.001). No safety concerns were observed for TOBI in these young children based on adverse events, serum tobramycin concentrations, renal function, audiology testing, tobramycin MICs (minimal inhibitory concentrations) and lack of emergence of new pathogens. At the end of 2003, Chiron will initiate the ELITE (EarLy Intervention TOBI Eradication) trial in Europe to further study the benefits of TOBI in treatment of early onset Pa in CF patients. Data from a recent study of TOBI in patients with bronchiectasis, a chronic pulmonary disease often complicated by complex gram-negative respiratory infection, were presented at the American Thoracic Society Meeting in Seattle in May. In an open-label, multicenter clinical trial, 41 subjects were treated with TOBI (300 milligrams of tobramycin solution for inhalation administered twice daily for three cycles of 14 days on-drug followed by 14 days off-drug) to evaluate pulmonary symptom scores, respiratory quality of life and microbiologic efficacy. As seen in a previous study, a minority of subjects (N=10) did not tolerate chronic TOBI and withdrew from the study due to adverse events characterized by cough, wheezing or dyspnea. Subjects completing the trial showed significantly improved pulmonary symptom scores (p < 0.001) and benefited from TOBI with respect to respiratory symptoms and quality of life. About Cystic Fibrosis Cystic fibrosis (CF) is a genetic disease that primarily affects people of Caucasian origin. About 30,000 people in the United States and about 70,000 people worldwide have CF. Patients with CF have abnormal movement of salt in and out of the cells lining their lungs, which leads to secretion of thick, sticky mucus that supports bacteria growth. Pseudomonas aeruginosa (Pa) is the most common bacterium causing lung infections in people with CF. By the age of 17, nearly 70 percent of people with CF have Pa in their lungs. Pa infections cause lung inflammation and -- through cycles of inflammation, obstruction and infection -- lead to deterioration of lung function, at an estimated average rate of 1.4 percent to 4 percent per year. Treatment of CF lung disease is aimed at controlling infection, reducing lung obstruction and decreasing inflammation. About TOBI Tobramycin Solution for Inhalation TOBI® tobramycin solution for inhalation is an antibiotic approved in the United States and Europe for the treatment of cystic fibrosis (CF) patients with Pseudomonas aeruginosa, a bacterium frequently found in the lungs of these patients. Each ready-to-use ampule of TOBI contains 300 milligrams of tobramycin in a 5-milliliter solution. TOBI is inhaled twice daily, for about 15 minutes each time, in repeated cycles of 28 days on-drug, 28 days off-drug. The dose is the same for all patients regardless of weight, age or other factors. Safety and efficacy have not been demonstrated in patients under the age of 6 years, patients with forced expiratory volume in one second (FEV1) less than 25 percent or greater than 75 percent of predicted, or in patients colonized with Burkholderia cepacia. In controlled clinical trials, TOBI was well-tolerated, with voice alteration (13 percent versus 7 percent) and tinnitus (3 percent versus 0 percent) being the only adverse events reported by significantly more patients treated with TOBI than placebo. Patients with known or suspected renal, auditory, vestibulars or neuromuscular dysfunction should use caution when taking TOBI. About Chiron Chiron Corporation, headquartered in Emeryville, California, is a global pharmaceutical company that leverages a diverse business model to develop and commercialize high-value products that make a difference in people's lives. The company has a strategic focus on cancer and infectious disease. Chiron applies its advanced understanding of the biology of cancer and infectious disease to develop products from its platforms in proteins, small molecules and vaccines. The company commercializes its products through three business units: biopharmaceuticals, vaccines and blood testing. For more information about Chiron, visit the company's website at www.chiron.com. This news release contains forward-looking statements, including statements regarding sales growth, product development initiatives, new product marketing, acquisitions and in- and out-licensing activities that involve risks and uncertainties and are subject to change. A full discussion of the company's operations and financial condition, including factors that may affect its business and future prospects, is contained in documents the company has filed with the SEC, including the form 10-Q for the quarter ended March 31, 2003, and the form 10-K for year ended December 31, 2002, and will be contained in all subsequent periodic filings made with the SEC. These documents identify important factors that could cause the company's actual performance to differ from current expectations, including the outcome of clinical trials, regulatory review and approvals, manufacturing capabilities, intellectual property protections and defenses, stock-price and interest-rate volatility, and marketing effectiveness. In particular, there can be no assurance that Chiron will increase sales of existing products, successfully develop and receive approval to market new products, or achieve market acceptance for such new products. There can be no assurance that Chiron's out-licensing activity will generate significant revenue, nor that its in-licensing activities will fully protect it from claims of infringement by third parties. In addition, the company may engage in business opportunities, the successful completion of which is subject to certain risks, including shareholder and regulatory approvals and the integration of operations. Consistent with SEC Regulation FD, we do not undertake an obligation to update the forward-looking information we are giving today. NOTE: TOBI is a trademark of Chiron Corporation. SOURCE Chiron Corporation CONTACT: J. Forrest, Vice President, Corporate Communications & Investor Relations, +1-, or Gallagher, Media Relations Manager, Corporate Communications & Investor Relations, +1-, both of Chiron Corporation Peace Torsten, dad of Fiona 6wcf and Sebastian newborn wocf e-mail: torstenkrafft@... Quote Link to comment Share on other sites More sharing options...
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