Pharming recombinant human C1 inhibitor: Results in pre-clinical
ischaemic reperfusion model confirm
(Thomson Reuters ONE) - Leiden, The Netherlands, October 22, 2009. Biotech company PharmingGroup NV ("Pharming" or "the Company") (NYSE Euronext: PHARM)announced today publication of a preclinical study showing thebenefit of using recombinant human C1 inhibitor (rhC1INH) in ischemicbrain injury. The results support the potential for development ofthe product for treatment of so-called ischemia-reperfusion injuries,in order to improve the outcome in a variety of indications, such asAcute Myocardial Infarction (AMI), Stroke and Delayed Graft Function(DGF) after Organ Transplantation.Because of its multiple anti-inflammatory effects, C1 inhibitor(C1INH) may be an effective drug for the treatment and prevention ofischemia-reperfusion injury. In a preclinical stroke model, Pharmingexplored the efficacy of rhC1INH on ischemic brain injury incomparison with plasma derived C1 inhibitor (pdC1INH). The resultsshow that rhC1INH markedly reduced cerebral damage when administeredup to as late as 18 hours after the ischemic episode. Furthermore,rhC1INH appeared to be remarkably more effective than pdC1INH inreducing the size of the brain infarcts. An explanation for thisdifference between rhC1INH and plasma derived C1INH is that, unlikeplasma derived C1INH, rhC1INH binds to mannose binding lectin (MBL)and attenuates the inflammatory damage mediated by this proteinduring ischemia-reperfusion injury."By reducing the tissue damage in ischemic injuries, Pharming'srhC1INH product could set a new standard in the treatment ofblockbuster indications such as DGF, AMI and Stroke," said Dr. BrunoGiannetti, Chief Operations Officer of Pharming. "The results of thestudy are particularly promising because the window of opportunity toinitiate treatment was 18 hours compared to less than 3 hours forplasma derived product, and this time window is of criticalimportance for clinical applications."Pharming performed the study in collaboration with researchers fromthe Mario Negri Institute for Pharmacological Research in Milan,Italy. The results are published by Dr De Simoni (Annals of Neurology2009 Sep;66(3):332-42) The findings of these studies also form thebasis for a patent application of Pharming.Pharming is currently focussing on the development of rhC1INH for thetreatment of acute attacks of hereditary angioedema (Rhucin®). Thisincludes all types of attacks, i.e. abdominal attacks, facial attacksand peripheral attacks. Pharming submitted its MarketingAuthorization Application (MAA) for Rhucin to EMEA in September 2009.According to the standard timetable of the Centralized Procedure,Pharming may expect the adoption of the final CHMP opinion within atotal of 210 days review time (excluding any clock-stops), which isthe second half of next year. More information on this procedure canbe found on www.emea.europa.eu.About transplantation and ischemiaIn the United States alone, over 79,000 patients are waiting for anorgan transplant. Each month, nearly 3,000 new patients are added tothis waiting list. However, only 25,000 solid organs are availableand transplanted each year, including kidney, liver, lung and hearttransplants. In addition, complications may arise following organtransplantation, such as Antibody Mediated Rejection (AMR), whichcauses acute loss of the transplant, and DGF, which results fromischemia-reperfusion injury of the transplanted kidney, and isassociated with an increased rejection rate and graft failure.Ischemia occurs when the blood supply to a tissue is interrupted.Restoration of blood supply is a logic treatment but has to beapplied early as it otherwise induces severe inflammatory damage tothe jeopardized tissue. Ischemia-reperfusion injury is involved invarious diseases including cardiovascular diseases and kidneytransplantation.About Pharming Group NVPharming Group NV is developing innovative products for the treatmentof genetic disorders, ageing diseases, specialty products forsurgical indications, and nutritional products. Pharming's leadproduct Rhucin® for acute attacks of Hereditary Angioedema has passedclinical development stage and the Market Authorization Applicationis under review with EMEA. Prodarsan® is in early stage clinicaldevelopment for Cockayne Syndrome and lactoferrin for use in foodproducts The advanced technologies of the Company include innovativeplatforms for the production of protein therapeutics, technology andprocesses for the purification and formulation of these products, aswell as technology in the field of DNA repair (via DNage). Additionalinformation is available on the Pharming website,http://www.pharming.com.This press release contains forward looking statements that involveknown and unknown risks, uncertainties and other factors, which maycause the actual results, performance or achievements of the Companyto be materially different from the results, performance orachievements expressed or implied by these forward lookingstatements.Contact:Ms. Marjolein van Helmond, Pharming Group NV, T: +31 (0)71 52 47 431or +31 (0)6 109 299 54http://hugin.info/132866/R/1349595/325280.pdfThis announcement was originally distributed by Hugin. The issuer is solely responsible for the content of this announcement.
Bereitgestellt von Benutzer: hugin
Datum: 22.10.2009 - 18:30 Uhr
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