Immupharma Regulatory News (IMM)

8 Jan 2008 07:00

Immupharma PLC08 January 2008 For Immediate Release 8 January 2008 ImmuPharma PLC ImmuPharma enters oncology with novel potential blockbuster drug for multiple cancer indications ImmuPharma PLC (LSE:IMM), ("ImmuPharma" or the "Company"), the specialist drugdiscovery and development company, announces today that, as part of its ongoingresearch collaboration with the Centre National de la Recherche Scientifique("CNRS"), France's scientific research institution, it has taken the rights forthe worldwide development and commercialization of a novel drug candidate forcancer.. The molecule, code-named IPP-204106, has a dual mechanism of action, acting bothin preventing angiogenesis as well as proliferation. IPP-204106 is a nucleolinantagonist, the lead molecule in a family of pseudopeptides designed to blockthe activity of a protein called nucleolin. Located essentially in the nucleusof normal cells where it is protected, nucleolin is much more abundant (often100 times more) at the surface of the cells which are proliferating as well asthe surface of active endothelial cells where it can be a target for antagonistpeptides. Cell surface expressed nucleolin is involved in the proliferation processes aswell as in cell transformation. It is also a receptor for many growth factorsand plays a key role in angiogenesis. Nucleolin antagonists have therefore bothanti-angiogenic and anti-proliferative properties. Preclinical data have shown that nucleolin antagonists inhibit the growth oftumours and metastasis in many cancer types. They prevent the implantation oftumours and block angiogenesis. They also inhibit the proliferation of certaintypes of leukaemia cells. Based on the mechanism of action nucleolin antagonistsare active as long as surface nucleolin is present, irrespective of the type ofcancer. Preliminary data have also shown the absence of toxicity. In addition to their efficacy as stand-alone agents, nucleolin antagonists mayalso have a use as selective carriers for cytotoxic drugs and the company hasfiled patents accordingly. ImmuPharma is planning to complete the formal preclinical development this yearwith a Phase I expected to start by year end. Dr Robert Zimmer, MD, PhD, ImmuPharma's Chief Scientific Officer, explained:"Most drugs for cancer are very toxic by default. IPP-204106 is a peptide-likemolecule and is not expected to show serious toxicity. If we were to assume thatproliferation, adhesion and angiogenesis can be blocked without major safetyissues a tremendous achievement in cancer treatment will be obtained." Dimitri Dimitriou, ImmuPharma's CEO added: "Entering oncology was a naturalprogression for ImmuPharma. Our business model of focusing in specialist areasdominated by huge unmet needs fits perfectly with oncology. Furthermore, thisexciting new drug candidate has a tremendous commercial potential if it meetsits target profile of preventing tumour growth as well as metastasis while beingnon-toxic." 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 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 pipeline 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 potential non-addictive compound for relievingmoderate to severe pain, such as experienced by cancer sufferers andpost-surgical patients. Most existing treatments are derived from the opiatemorphine and tend to have serious side effects. ImmuPharma's new treatment isbased on met-enkephalin, the body's internal analgesic. IPP-102199 is beingdeveloped to have major advantages over morphine such as longer pain reliefduration and reduced side effects. The market for chronic opioids in the UScurrently exceeds $3.5 billion and is growing by more than 10 to 20 per cent ayear. Antibiotic for MRSA and similar highly resistant infections (IPP-203101) This is a novel antibiotic to combat MRSA and other severe hospital-acquired,resistant infections which affect some two million people in the US, accordingto the US Centers for Disease Control and Prevention. ImmuPharma's drugcandidate is targeted at disrupting the membrane potential of the bacterialpathogens. It is hoped this novel approach will reduce their potential to becomeresistant. PLA2 inhibitor for inflammatory and allergic disorders (IPP-201007) Phospholipases A2 (PLA2s) are enzymes that catalyze the hydrolysis ofphospholipids. This catalytic reaction is essential in the production of lipidsduring various processes in the body, involving prostaglandins, leukotrienes,thromboxanes, platelet activation factor and others. In certain cases, suchlipids mediators cause allergic reactions and a number of inflammatoryconditions such as asthma and other respiratory disorders, rheumatoid arthritis,septic shock and acute pancreatitis are characterized by a significant increasein PLA2 activity. Inhibiting PLA2 can therefore reduce some of these allergic reactions andinhibitors of PLA2 have already been shown to have positive effect ininflammatory conditions. ImmuPharma believes this new molecule has potential inbecoming a drug for certain inflammatory conditions and intends to progress itsdevelopment. The drug could be in phase I trials as early as 2009. This information is provided by RNS The company news service from the London Stock Exchange