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Further Phase II Data
Further Phase II Data.
About this update from Immupharma Plc
[{"type":"text","content":"\n Immupharma PLC\n30 October 2006\n\n\nFor Immediate Release 30 October 2006\n\n\n ImmuPharma announces further data from its IPP- 201101 phase II Lupus trial\n showing significant clinical improvement in patients\n\n\nImmuPharma PLC (LSE:IMM), the specialist drug discovery and development company,\nannounced today further data from its phase II trial with IPP-201101 for Lupus.\nPatients who received IPP-201101 on only 3 occasions, 2 weeks apart,\ndemonstrated a significant clinical improvement in their condition in addition\nto the decrease of their biomarkers.\n\nImmuPharma announced on 17 October 2006 that the phase II trial of IPP-201101\nmet its primary end-points. The study was designed to measure biomarkers,\nincluding reduction in anti-dsDNA auto-antibodies and increase in IL-10. The\nstudy was not expected to show significant clinical improvement, primarily due\nto its short treatment duration. Many of the patients that were treated with\nthe drug showed reduction in their auto-antibodies and showed also significant\nimprovement in their condition.\n\nPhase II clinical highlights:\n\n • IPP-201101 significantly improved the clinical status of a number of the\n patients treated.\n • 50 % of the patients in one of the two dose groups showed a reduction of\n at least 50 % of their SLEDAI score, a specific scale used to measure the\n condition of Lupus patients.\n • It appears that a correlation exists, with this drug, between the decrease\n of the SLEDAI scores and the decrease of the surrogate markers (anti-dsDNA\n auto-antibodies) which could reach statistical significance with a larger\n number of patients.\n • Establishing such a correlation was one of the key objectives of the Phase\n II/III trial as discussed with the FDA earlier this year (see ImmuPharma\n announcement of 2 October 2006).\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 involved in the\npathogenesis of the disease. The clinical profile of Lupus patients is generally\nassessed by standardized scales such as SLEDAI (SLE Disease Activity Index): the\nlower the score, the better the condition of the patient. During this Phase II\nstudy, the SLEDAI scores were assessed on multiple occasions even though the\nstudy was not designed or powered to demonstrate...