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Phase 1 Lupus results
Phase 1 Lupus results.
About this update from Immupharma Plc
[{"type":"text","content":"\n Immupharma PLC\n10 May 2006\n\n\nFOR IMMEDIATE RELEASE 10 MAY 2006\n\n\n ImmuPharma\n announces successful results from its phase I clinical trial with\n IPP-201101 for Lupus\n\n - Phase II to start soon -\n\n\nImmuPharma PLC (LSE:IMM), the specialist drug discovery and development company,\nannounced today that it has successfully completed the placebo-controlled phase\nI study involving 24 healthy volunteers of its lead compound IPP-201101 for\nLupus, a chronic, life-threatening autoimmune disease.\n\n\nThis study, which took place in France, was the first administration in humans\nfor IPP-201101 and was designed to assess its safety and tolerability. The\npreliminary safety report confirmed that the drug was safe and well-tolerated.\n\n\nThese encouraging results have allowed ImmuPharma to proceed with a phase II\nproof-of-concept and efficacy study in Lupus patients in Europe. The phase II\nstudy protocol was recently approved by the ethics committees and has been filed\nwith the appropriate regulatory authorities. The dosing of Lupus patients in\nthis study is expected to start soon and the trial will measure recognised\nsurrogate markers of clinical efficacy, in preparation of the pivotal phase III\nstudies.\n\n\nTo that effect, ImmuPharma has also scheduled a meeting with the FDA to design\nthe appropriate development programme to get market authorisation of the drug in\nthe US.\n\n\nDr Robert Zimmer, President and Chief Scientific Officer of ImmuPharma, said:\n'IPP-201101, which has blockbuster potential, is a novel concept for the\ntreatment of Lupus. IPP-201101 modulates the signalling of CD4+ cells and may\nalso interact with the T-reg pathway. The key element is that IPP-201101 has\nbeen designed to interact only with the CD4+ cells linked to Lupus and leaves\nintact the remaining immune system, allowing Lupus patients to be protected by a\nfully operational immune system unlike the currently used therapies such as high\ndose corticoids and immunosuppressants. When administered appropriately it has\nthe potential to stop the progression of the disease and should therefore be\nprescribed as early as possible during the course of the Lupus disease. The\nalready available preclinical package demonstrating efficacy and selectivity for\nLupus together with the good results of the phase I safety and tolerability\nstudy ...