Anti-integrin .alpha..nu..beta.3 antibody formulations and...

A - Human Necessities – 61 – K

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A61K 39/395 (2006.01) C07K 16/28 (2006.01)

Patent

CA 2512174

The present invention provides liquid formulations of antibodies or antibody fragments that immunospecifically bind to integrin .alpha..nu..beta.3 , which formulations exhibit stability, low to undetectable levels of aggregation, and very little to no loss of the biological activities of the antibodies or antibody fragments, even during long periods of storage. In particular, the present invention provides liquid formulations of antibodies or fragments thereof that immunospecifically bind to integrin .alpha..nu..beta.3 , which formulations are substantially free of surfactant, inorganic salts, and/or other common excipients. Furthermore, the invention provides methods of preventing, treating or ameliorating an inflammatory disorder, an autoimmune disorder, a disorder associated with aberrant expression and/or activity of integrin .alpha..nu..beta.3, a disorder associated with abnormal bone metabolism, a disorder associated with aberrant angiogenesis or cancer utilizing the liquid formulations of the present invention.

La présente invention concerne des préparations liquides d'anticorps ou de fragments d'anticorps qui se lient de manière immunospécifique à l'intégrine .alpha.¿??.beta.¿3? et qui présentent une certaine stabilité, des niveaux d'agrégation faibles voire indécelables, et très peu voire pas de perte des activités biologiques des anticorps ou des fragments d'anticorps, même durant de longues périodes de stockage. Notamment, cette invention a pour objet des préparations liquides d'anticorps ou de fragments associés qui se lient de manière immunospécifique à l'intégrine .alpha.¿??.beta.¿3? et qui sont pratiquement exemptes d'agent de surface, de sels minéraux et/ou d'autres excipients communs. De plus, ladite invention a trait à des méthodes de prévention, de traitement ou d'amélioration d'un trouble inflammatoire, d'un trouble auto-immun, d'un trouble lié à l'expression aberrante et/ou à l'activité de l'intégrine .alpha.¿??.beta.¿3?, d'un trouble associé à un métabolisme osseux anormal, d'un trouble lié à une angiogenèse aberrante ou à un cancer, au moyen desdites préparations liquides de cette invention.

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