Treatment with anti-alpha2 integrin antibodies

Abstract

The invention relates to a formulation of an anti-α2 integrin antibody for administration to a patient, which is suitable for the treatment of cancer.

1 . A formulation for administration to a subject in need thereof, comprising:
 a) an anti-α2 integrin antibody;   b) about 0.03% Tween-80; and   c) phosphate buffered saline.   
     
     
         2 . The formulation of  claim 1 , wherein the anti-α2 integrin antibody comprises a heavy chain variable region and a light chain variable region, the heavy chain variable region comprising complementary determining regions (CDRs) comprising the amino acid sequences of SEQ ID NOS: 1, 2, and 3, and the light chain variable region comprising CDRs comprising the amino acid sequences of SEQ ID NOS: 112, 5, and 6. 
     
     
         3 . The formulation of  claim 2 , wherein the anti-α2 integrin antibody comprises a heavy chain comprising the amino acid sequence of SEQ ID NO: 187 and a light chain comprising the amino acid sequence of SEQ ID NO: 188. 
     
     
         4 . The formulation of  claim 1 , wherein the anti-α2 integrin antibody is present at a concentration from about 0.5 mg/ml to about 5 mg/ml. 
     
     
         5 . The formulation of  claim 1 , wherein the formulation is a liquid formulation. 
     
     
         6 . The formulation of  claim 1 , wherein the formulation is a lyophilized formulation. 
     
     
         7 . The formulation of  claim 1  for use in the treatment of a cancer selected from the group consisting of: squamous cell cancer, lung cancer including small-cell lung cancer, non-small cell lung cancer, adenocarcinoma of the lung, and squamous carcinoma of the lung, cancer of the peritoneum, hepatocellular cancer, gastric or stomach cancer including gastrointestinal cancer, pancreatic cancer, glioblastoma, cervical cancer, ovarian cancer, liver cancer, bladder cancer, hepatoma, breast cancer, colon cancer, colorectal cancer, endometrial or uterine carcinoma, salivary gland carcinoma, kidney or renal cancer, liver cancer, prostate cancer, vulval cancer, thyroid cancer, hepatic carcinoma and various types of head and neck cancer, as well as B-cell lymphoma including low grade/follicular non-Hodgkin's lymphoma (NHL); small lymphocytic (SL) NHL; intermediate grade/follicular NHL; intermediate grade diffuse NHL; high grade immunoblastic NHL; high grade lymphoblastic NHL; high grade small non-cleaved cell NHL; bulky disease NHL; mantle cell lymphoma; AIDS-related lymphoma; and Waldenstrom's Macroglobulinemia; chronic lymphocytic leukemia (CLL); acute lymphoblastic leukemia (ALL); Hairy cell leukemia; chronic myeloblastic leukemia; and post-transplant lymphoproliferative disorder (PTLD), as well as abnormal vascular proliferation associated with phakomatoses, edema such as that associated with brain tumors, Meigs' syndrome, melanoma, mesothelioma, multiple myeloma, fibrosarcoma, osteosarcoma, and epidermoid carcinoma. 
     
     
         8 . A kit comprising a container comprising the formulation of  claim 1  and instructions for the administration and use of the formulation. 
     
     
         9 . The formulation of  claim 1 , wherein the formulation is administered to a subject to deliver from about 0.1 to about 100 mg/kg of the antibody. 
     
     
         10 . The formulation of  claim 9 , wherein the formulation is administered to a subject to deliver about 1 to about 20 mg/kg of the antibody. 
     
     
         11 . The formulation of  claim 10 , wherein the formulation is administered to a subject to deliver about 3 to about 10 mg/kg of the antibody.