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Phase II Data
Phase II Data.
About this update from Immupharma Plc
[{"type":"text","content":"\n Immupharma PLC\n17 October 2006\n\n\nFor Immediate Release 17 October 2006\n\n\n ImmuPharma announces highly positive preliminary Phase II results for its\n potential blockbuster treatment for Lupus\n\n\nImmuPharma PLC (LSE:IMM), the specialist drug discovery and development company,\nannounced today that its potential blockbuster IPP-201101 for Lupus treatment\nhas met its Phase II primary endpoints.\n\nIPP-201101 is a drug that specifically modulates the immune system of Lupus\npatients by modifying the behaviour of some of the key cells (CD4+ T cells)\ninvolved in the pathogenesis of the disease. Lupus patients are often associated\nwith high levels of antibodies against their own DNA (anti-dsDNA antibodies).\nThe use of these antibodies as 'surrogate markers', e.g. indicators of the\noverall modulation of the immune system of Lupus patients are particularly\nuseful with our drug due to its mechanism of action.\n\nPhase II clinical trial highlights\n\n • Study was a proof of concept, dose ranging and safety study\n\n • The drug met its primary endpoints (p< 0.0001)\n\n • The anti dsDNA antibodies decreased dose dependently and reductions of\n 47% were achieved\n\n • In one of the two dose groups, 80% of the patients were responders\n\n • The profile of other biomarkers supported the validation of the Proof of\n Concept\n\n • Excellent safety and tolerability profile\n\n • An US IND is expected to be filed in Q1 2007 for the Phase II/III program\n\nThis study in Lupus patients was a proof of concept, dose ranging, safety,\nmulti-centre European study. The proof of concept was assessed by measuring the\ndecrease of anti dsDNA antibodies as a surrogate marker for efficacy and IL10, a\ncytokine, to ascertain its mechanism of action. The drug was administered 3\ntimes by subcutaneous injections 2 weeks apart at doses of 200(micro)g and 1000\n(micro)g and the patients were monitored one month after treatment stop.\nClinical parameters were also assessed but have not been fully evaluated yet.\n\nDr Robert Zimmer, President & Chief Scientific Officer said: 'We are very\npleased by these results. They are in line with our preclinical results and\nconfirm our view on the global mechanism of action of IPP-201101. Importantly it\npaves the way for the Phase II/III study in Europe and the US as discussed with\nthe ...