Business
Pivotal phase II/III trial
Pivotal phase II/III trial.
About this update from Immupharma Plc
[{"type":"text","content":"\n Immupharma PLC\n10 July 2007\n\n\nFor Immediate Release 10 July 2007\n\n\n\n\n ImmuPharma PLC\n\n\n ImmuPharma submits file to the FDA for\n pivotal phase II/III trial in Lupus patients\n\n\n\nImmuPharma PLC (LSE:IMM), ('ImmuPharma' or the 'Company'), the specialist drug\ndiscovery and development company, announced today that it has just submitted an\nIND (Investigational New Drug) file to the US Food and Drug Administration (FDA)\nfor the initiation of a pivotal phase II/III trial for its drug IPP-201101 in\npatients suffering from Systemic Lupus Erythematosus.\n\n\nFollowing a previous meeting with the FDA and subsequent feedback announced in\nOctober 2006 and the positive outcome of the phase II study showing\nstatistically significant clinical efficacy in patients with Lupus, ImmuPharma\nhas now filed with the FDA an IND for the pivotal phase II/III trial. This\nproposed phase II/III double blind, randomized, placebo controlled, multicentre\nstudy will include 240 patients treated during 12 months all in line with the\nFDA guidelines. It will take place in the US, Europe and Latin America and is\nexpected to complete in early 2009.\n\n\nIf the phase II/III trial is positive, based on the feedback previously received\nfrom the FDA, the drug could be granted fast track approval (6 month review\ntime) and receive US marketing authorisation at the end of 2009 / early 2010.\nSimilar filings will also be made in key European and Latin American countries\nin the next few weeks.\n\n\n\n\n\nFor further information please contact:\n\nImmuPharma PLC:\nDimitri Dimitriou, Chief Executive +44 20 7152 4080\nOfficer\n\nDr Robert Zimmer, President & Chief + 33 389 32 76 50\nScientific Officer\nRichard Warr, Chairman +44 20 7152 4080\n\nBuchanan Communications + 44 20 7466 5000\nLisa Baderoon\nRebecca Skye Dietrich\n\nTeather & Greenwood Limited +44 20 7426 7710\nThilo Hoffmann\n\n\n\nNotes to Editors:\n\n\nAbout ImmuPharma\n\n\nImmuPharma PLC is a drug discovery and development company headquartered in\nLondon, UK and quoted on AIM of the London Stock Exchange (LSE:IMM). It has\nresearch operations in France (ImmuPharma (France) SA) and Switzerland\n(ImmuPharma AG). ImmuPharma is dedicated to the development of novel drugs,\nlargely based on peptide therapeutics, to treat serious medical conditions such\nas autoimmune diseases ch...