Novel proteins and methods for producing the proteins

Abstract

A protein which inhibits osteoclast differentiation and/or maturation and a method for producing the protein. The protein is produced by human embryonic lung fibroblasts and has a molecular weight of about 60 kD and about 120 kD under non-reducing conditions and about 60 kD under reducing conditions on SDS-polyacrylamide gel electrophoresis. The protein can be isolated and purified from the culture medium of fibroblasts. Furthermore, the protein can be produced by gene engineering. The present invention includes cDNA for producing the protein by gene engineering, antibodies having specific affinity for the protein or a method for determining protein concentration using these antibodies.

1 - 31 . (canceled)  
     
     
         32 . A polypeptide, having at least one biological activity selected from the group consisting of improving decreased bone mass, inhibiting differentiation of osteoclasts, inhibiting maturation of osteoclasts, and inhibiting formation of osteoclasts, wherein said polypeptide is encoded by a nucleic acid selected from the group consisting of: 
 a) the nucleic acid of SEQ ID NO:6; and    b) nucleic acids which hybridize with the nucleic acid of SEQ ID NO:6 at 65° C. overnight in a hybridization buffer.    
     
     
         33 . A purified and isolated polypeptide comprising human OCIF.  
     
     
         34 . A purified and isolated polypeptide comprising human OCIF and having the amino acid sequence as shown in SEQ ID NO:5, or a substitution or deletion mutant thereof.  
     
     
         35 . The polypeptide of  claim 33  having the amino acid sequence as shown in SEQ ID NO:5 from residues 22-401.  
     
     
         36 . The polypeptide of  claim 33  which is characterized by being a product of expression of an exogenous DNA sequence.  
     
     
         37 . The polypeptide of  claim 36  wherein the DNA is cDNA or genomic DNA.  
     
     
         38 . A pharmaceutical composition comprising a therapeutically effective amount of OCIF in a pharmaceutically acceptable carrier, solubilizer, and/or stabilizer.  
     
     
         39 . A pharmaceutical composition comprising an isolated polypeptide consisting of the amino acid sequence as shown in SEQ ID NO:4 from residues 1-380, and a pharmaceutically acceptable carrier, solubilizer and/or stabilizer.  
     
     
         40 . A pharmaceutical composition comprising an isolated polypeptide consisting of the amino acid sequence as shown in SEQ ID NO:5 from residues 1-401, and a pharmaceutically acceptable carrier, solubilizer and/or stabilizer.  
     
     
         41 . The pharmaceutical composition of  claim 38  wherein the OCIF is human OCIF.  
     
     
         42 . An osteoclastogenesis inhibitory factor dimer consisting of osteoclastogenesis inhibitory factor monomers.