Activated protein c variants with normal cytoprotective...

A - Human Necessities – 61 – K

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A61K 38/36 (2006.01) A01N 1/02 (2006.01) C12P 21/02 (2006.01)

Patent

CA 2531695

Variants (mutants) of recombinant activated protein C (APC) or recombinant protein C (prodrug, capable of being converted to APC) that have substantial reductions in anticoagulant activity but that retain normal levels of anti- apoptotic activity are provided. Two examples of such recombinant APC mutants are 3K3A-APC and 229/230-APC. APC variants and prodrugs of the invention have the desirable property of being cytoprotective (anti-apoptotic effects), while having significantly reduced risk of bleeding. The invention also provides a method of using the APC variants or prodrugs of the invention to treat subjects who will benefit from APC's cytoprotective activities that are independent of APC's anticoagulant activity. These subjects include patients at risk of damage to blood vessels or tissue in various organs caused, at least in part, by apoptosis. At risk patients include, for example, those suffering (severe) sepsis, ischemia/reperfusion injury, ischemic stroke, acute myocardial infarction, acute or chronic neurodegenerative diseases, or those undergoing organ transplantation or chemotherapy, among other conditions. Methods of screening for variants of recombinant protein C or APC that are useful in accordance with the invention are also provided.

La présente invention concerne des variant (mutants) de recombinaison de protéine C activée (APC) ou de protéine C de recombinaison (promédicament capable d'être transformé en APC) qui possède des réductions importantes d'activité anticoagulante mais qui conserve des niveaux normaux d'activité anti-apoptotique. Deux exemples de ses mutants APC de recombinaison sont 3K3A-APC et 229/230-APC. Des variants APC et des promédicaments de cette invention possèdent la propriété recherchée de cytoprotection (effets anti-apoptotique), tout en présentant un risque de saignement considérablement réduit. Cette invention concerne aussi une technique d'utilisation de ces variant APC ou de ces médicaments permettant de traiter des sujets qui pourront bénéficier des activités cytoprotectrices de ces APC, lesquelles sont indépendantes de l'activité anticoagulante des APC. ces sujets comprennent des patients présentant un risque de dégradation des vaisseaux sanguins ou de tissus de divers organes causée, au moins en partie, par l'apoptose. Ces patients à risque comprennent, par exemple, ceux qui souffrent de septie (grave), de blessures d'ischémie/transfusion, d'attaque ischémique, d'infarctus du myocarde aigu, de maladies neurodégénératives aiguës ou chroniques ou ceux qui subissent une transplantation d'organes ou une chimiothérapie, parmi d'autres pathologies. Cette invention concerne aussi des techniques de recherche de variants de protéines C de recombinaison ou d'APC qui sont utiles dans le cadre de cette invention.

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