Immupharma Regulatory News (IMM)

26 Feb 2008 07:00

Immupharma PLC26 February 2008 For Immediate Release 26 February 2008 ImmuPharma PLC First Lupus patients dosed with IPP-201101 in phase IIb study ImmuPharma PLC (LSE:IMM), ("ImmuPharma" or the "Company"), the specialist drugdiscovery and development company, announces today that the first patients havebeen dosed in its phase IIb trial of IPP-201101 for the treatment of SystemicLupus Erythematosus. Assuming continued satisfactory patient recruitment withthe trial, headline efficacy data are expected in the summer of 2008 aspreviously indicated. The phase IIb clinical study is designed to evaluate the efficacy and safety ofIPP-201101 in patients with Systemic Lupus Erythematosus (SLE). The primaryobjective of the study is to assess the effect of subcutaneous IPP-201101 on thesigns and symptoms of disease activity in subjects with active SLE, over a12-week treatment period, compared to placebo. The phase IIb study has been designed as a multicenter, randomized,double-blind, placebo-controlled dose-ranging study to evaluate the safety,tolerability and efficacy of two doses of subcutaneous IPP-201101 plus standardof care, versus placebo plus standard of care in Subjects with SLE. The firstpatients have been dosed in Buenos Aires, Argentina. The study is beingconducted in 7 countries in 43 sites, across Europe and Latin America, and isexpected to enrol up to 204 patients. Dr Robert Zimmer, MD, PhD, President and Chief Scientific Officer of ImmuPharmasaid: "We are delighted to announce further progress in IPP-2011101 developmentwhile we believe more than ever that IPP-201101 will significantly improvetreatment options and the quality of life for SLE patients. IPP-201101represents a novel strategy for the treatment of SLE that has demonstratedencouraging potential in initial clinical studies. We are optimistic that thestudy will proceed well in the coming months and we look forward to reporting onour progress later this year." For further information please contact: ImmuPharma PLC:Dimitri Dimitriou, Chief Executive +44 20 7152 4080OfficerDr Robert Zimmer, President & Chief + 33 389 32 76 50Scientific OfficerRichard Warr, Chairman +44 20 7152 4080 Buchanan Communications + 44 20 7466 5000Lisa BaderoonRebecca Skye Dietrich Panmure Gordon & CoAndrew Burnett +44 151 243 0963 For company information, visit www.immupharma.com Notes to Editors: About ImmuPharma ImmuPharma PLC is a specialist drug discovery and development company (LSE:IMM).It has research operations in France (ImmuPharma (France) SA) and Switzerland(ImmuPharma AG). ImmuPharma is dedicated to the development of novel drugs,largely based on peptide therapeutics, to treat serious medical conditions suchas autoimmune diseases characterised by: * blockbuster potential in niche markets * low promotional costs in few specialised physicians and centresand * lower risk of drug development and lower development costs ImmuPharma is currently developing drug candidates for five different medicalconditions, each of which would represent a significant breakthrough in itsfield. The lead product candidate i targets Lupus, a disease for which there iscurrently no cure or specific treatment. The other four address cancer, moderateto severe pain (such as that experienced by cancer sufferers and post-operativepatients), MRSA and severe hospital-acquired resistant infections andinflammation / allergic disorders. All product candidates have significant sales potential as well as low marketingcosts and a relatively low risk of development failure. One or more have thepotential to be fast-tracked by the US Food and Drug Administration according to"Guidance for Industry: Fast Track Drug Development Programs - Designation,Development and Application Review" issued July 2004 and could therefore obtaintheir market authorization by 2010. Key to the potential success of ImmuPharma is its unique collaborative agreementwith Centre National de la Recherche Scientifique, France's scientific researchinstitution. This agreement grants ImmuPharma worldwide exclusive rights toexploit certain key discoveries. In addition to its three leading drug candidates, ImmuPharma has a drugdevelopment pipeline using its rights to a virtual chemical library of hundredsof thousands of molecules as well as an innovative technology for convertingpeptides to drug candidates. ImmuPharma has the option to commercialise its assets itself or to license themto other pharmaceutical companies at an earlier stage. This information is provided by RNS The company news service from the London Stock Exchange