Immupharma Regulatory News (IMM)

30 Oct 2006 07:01

Immupharma PLC30 October 2006 For Immediate Release 30 October 2006 ImmuPharma announces further data from its IPP- 201101 phase II Lupus trial showing significant clinical improvement in patients ImmuPharma PLC (LSE:IMM), the specialist drug discovery and development company,announced today further data from its phase II trial with IPP-201101 for Lupus.Patients who received IPP-201101 on only 3 occasions, 2 weeks apart,demonstrated a significant clinical improvement in their condition in additionto the decrease of their biomarkers. ImmuPharma announced on 17 October 2006 that the phase II trial of IPP-201101met its primary end-points. The study was designed to measure biomarkers,including reduction in anti-dsDNA auto-antibodies and increase in IL-10. Thestudy was not expected to show significant clinical improvement, primarily dueto its short treatment duration. Many of the patients that were treated withthe drug showed reduction in their auto-antibodies and showed also significantimprovement in their condition. Phase II clinical highlights: • IPP-201101 significantly improved the clinical status of a number of the patients treated. • 50 % of the patients in one of the two dose groups showed a reduction of at least 50 % of their SLEDAI score, a specific scale used to measure the condition of Lupus patients. • It appears that a correlation exists, with this drug, between the decrease of the SLEDAI scores and the decrease of the surrogate markers (anti-dsDNA auto-antibodies) which could reach statistical significance with a larger number of patients. • Establishing such a correlation was one of the key objectives of the Phase II/III trial as discussed with the FDA earlier this year (see ImmuPharma announcement of 2 October 2006). IPP-201101 is a drug that specifically modulates the immune system of Lupuspatients by modifying the behaviour of some of the key cells involved in thepathogenesis of the disease. The clinical profile of Lupus patients is generallyassessed by standardized scales such as SLEDAI (SLE Disease Activity Index): thelower the score, the better the condition of the patient. During this Phase IIstudy, the SLEDAI scores were assessed on multiple occasions even though thestudy was not designed or powered to demonstrate clinical benefit as primaryendpoint due to the short treatment period. Dr. Robert Zimmer, President & Chief Scientific Officer said: "We could not haveexpected better results from this study with such a short period of treatment.We are absolutely delighted that we were able to demonstrate these clinicalimprovements in Lupus patients, paving the way for hopefully a very promisingand effective treatment for Lupus. This also gives us more confidence in theoutcome of the Phase II/III programme." For further information please contact: ImmuPharma PLC:Dimitri Dimitriou, Chief Executive Officer +44 20 7152 4080Richard Warr, Chairman +44 20 7152 4080Dr Robert Zimmer, President & Chief Scientific + 33 389 32 76 50Officer Buchanan Communications + 44 20 7466 5000Lisa BaderoonRebecca Skye Dietrich Notes to Editors: About ImmuPharma ImmuPharma PLC is a drug discovery and development company headquartered inLondon, UK and quoted on AIM of the London Stock Exchange (LSE:IMM). It hasresearch 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 centres and • lower risk of drug development and lower development costs ImmuPharma is a currently developing drug candidates for three different medicalconditions, each of which would represent a significant breakthrough in itsfield. The furthest advanced drug candidate targets Lupus, a disease for whichthere is currently no cure or specific treatment. The other two address moderateto severe pain (such as that experienced by cancer sufferers and post-operativepatients), and MRSA and similar severe hospital-acquired resistant infections. All three have significant sales potential as well as low marketing costs and arelatively low risk of development failure. One or more have the potential to befast-tracked by the US Food and Drug Administration according to "Guidance forIndustry: Fast Track Drug Development Programs - Designation, Development andApplication Review" issued July 2004 and could therefore obtain their marketauthorization 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. The products Treatment of Lupus (IPP-201101) This is a long-term treatment for Lupus, a chronic, life-threatening autoimmunedisease where the immune system attacks healthy cells. There is currently nocure and existing medications only treat the symptoms whereas ImmuPharma's drugcandidate has the potential to produce remission of the disease in a substantialproportion of patients. Based on independent forecasts, the value of ImmuPharma's Lupus drug isestimated to be "substantial" with peak annual sales forecast to generate inexcess of $4 billion. Severe pain relief (IPP-102199) ImmuPharma is developing a non-addictive compound for relieving moderate tosevere pain, such as experienced by cancer sufferers and post-surgical patients.Most existing treatments are opioid-based (explain) and tend to have seriousside effects. ImmuPharma's new treatment is based on met-enkephalin, the body'sinternal analgesic. IPP-102199 is being developed to have major advantages overmorphine such as longer pain relief duration and reduced side effects. Themarket for chronic opioids in the US currently exceeds $3.5 billion and isgrowing by more than 10 to 20 per cent a year. Antibiotic for MRSA and similar highly resistant infections (IPP-203101) This is a novel antibiotic to counter the effects of MRSA and other severehospital-acquired, resistant infections which affect some two million people inthe US, according to the US Centers for Disease Control and Prevention.ImmuPharma's drug candidate uniquely uses an electrical charge rather thanbiochemical methods against MRSA and other bacterial strains. It is hoped thisnovel approach will reduce their potential to become resistant. This information is provided by RNS The company news service from the London Stock Exchange