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FDA GRANTS IMMUPHARMA AMENDED SPA
FDA GRANTS IMMUPHARMA AMENDED SPA.
About this update from Immupharma Plc
[{"type":"text","content":"\n \nRNS Number : 5274K Immupharma PLC 31 July 2013 \n\n \n\n \nFOR IMMEDIATE RELEASE 31 JULY 2013\n \n \nImmuPharma PLC\n \nFDA GRANTS IMMUPHARMA AMENDED SPA FOR LUPUZOR PHASE III;\nCOMPANY PROGRESSES DEVELOPMENT ACTIVITIES\n \n \nImmuPharma plc (LSE:IMM) (\"ImmuPharma\" or the \"Company\" or the \"Group\"), the specialist drug discovery and development company, is delighted to announce that following its discussions with the FDA (the US Food & Drug Administraton), it has been granted an updated SPA (Special Protocol Assessment) for Lupuzor.\n \nUnder the new SPA, the necessary number of patients for the phase III programme has been reduced to 2 studies with 200 patients each. This number is lower compared to other drugs in clinical trials for lupus and underpins the significant efficacy shown by Lupuzor. Furthermore, the design of the phase III study is similar to that of the ImmuPharma phase IIb study.\n \nImmuPharma is now completing the manufacturing of the phase III drug supplies as well as the CMC (chemistry manufacturing and controls) section proving appropriate stability of the drug product. \n \nCommenting on the announcement, Dr Robert Zimmer, President & Chief Scientific Officer of ImmuPharma, said: \"The amended SPA is a tremendous success and validation of our development efforts and the reduced number of patients, due to the unrivalled efficacy that Lupuzor has shown in phase IIb means that the cost of the phase III trial will also be substantially lower. The phase III programme has a similar design to our phase IIb study which demonstrated substantial efficacy compared to other drugs in Lupus clinical trials.\"\n \n \nFor further information please see the Group's web site, www.immupharma.org, or contact:\n \n \n\n\n\n\nImmuPharma PLC\n\n\n\n\n\n\n\nDimitri Dimitriou, Chief Executive Officer \n\...