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Although circulating anti GM CSF antibodies have been found in otherwise healthy volunteers,27 ,28 the presence of such antibodies appears to be associated with the development of PAP.29 Yet, previous single dose phase 1b studies with KB002 (the predecessor to KB003) in asthmatics and in patients with rheumatoid arthritis showed trends in improvements in forced expiratory volume in 1s (FEV1) or Disease Activity Score using the 28 joint count, respectively, without any safety concerns.In view of the positive trends in efficacy and an acceptable safety profile after a single dose, we speculated that multiple doses of KB003 would be beneficial in treating patients with severe asthma. As such, we conducted a randomised, double blind, placebo controlled trial in moderate to severe asthmatics to assess the potential benefits and safety profile resulting from neutralisation of GM CSF with KB003 over a 24 week period.MethodsStudy population and designThe present study was a phase 2 randomised, double blind, placebo controlled, parallel group, repeat dose study over 36weeks (including a 20 week treatment period and screening and follow up periods) to evaluate the safety, tolerability and efficacy of KB003 in adults with asthma inadequately controlled (defined by an asthma control questionnaire (ACQ) >1.5 at baseline) despite receiving treatment with long acting 2 agonists (LABA) and inhaled and/or oral corticosteroids. The study was approved by institutional review boards (Western Institutional Review Board on 2 July 2012 approval 20120727, and Quorum review IRB on 18 July 2012 Quorum file 27264).
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“We do not have sufficient evidence to warrant the filing of charges,” then Boulder County District Attorney Alex Hunter said in 1999. He did not sign the indictment, according to the Daily Camera.There will be nine pages on John Ramsey and nine pages on Patsy Ramsey released this week, according to the order from Judge J. Robert Lowenbach.The Daily Camera reported Wednesday the release was a response to a lawsuit by one of its reporters and the Reporters Committee for Freedom of the Press seeking the unprosecuted indictment.In 2008, then District Attorney Mary Lacy wrote a letter to Ramsey, saying that new DNA evidence had cleared him, his wife and son.John Ramsey’s attorney had written a letter last week to District Attorney Stan Garrett, requesting the documents be kept secret.”Public release of the allegations of an unprosecuted indictment only serves to further defame (John Ramsey) and his late wife Patricia Ramsey,” wrote Harold Haddon.But Lowenbach said state law requires official actions by the grand jury to be released.Ramseys’ attorney: Grand jury ‘likely confused’ about JonBenet”The court is sympathetic to the position of Mr.
