Effective dosages of an adenoviral-based biological delivery and expression system for use in the treatment of osteoarthritis in humans, and compositions comprising the same

A method of treating an osteoarthritis-affected joint of a human suffering from osteoarthritis or an osteoarthritic condition with a helper-dependent adenoviral vector, the method comprising

• administering by intra-articular injection to the osteoarthritis-affected joint of the human suffering from osteoarthritis or an osteoarthritic condition a pharmaceutical composition comprising, 0.7×1010 to 2.8×1012 genome copies (GC) of the helper-dependent adenoviral vector,
• wherein the helper-dependent adenoviral vector comprises a nucleic acid comprising:
• i) a sequence encoding a human interleukin-1 receptor antagonist (IL-1Ra) protein comprising the amino acid sequence of SEQ ID NO:
• 6,
• ii) left and right inverted terminal repeats,
• iii) an adenoviral packaging signal,
• iv) stuffer nucleic acid sequence that is non-viral and non-coding, and
• v) a NF-KB inducible promoter,
• wherein the expression of the nucleic acid sequence encoding the human IL-1Ra protein is regulated by the NF-KB inducible promoter, which NF-KB inducible promoter is located upstream of the reading frame of the nucleic acid sequence encoding the human IL-1Ra protein, and
• wherein the nucleic acid sequence of the nucleic acid comprising the sequence encoding the human IL-1Ra protein, the left and the right inverted terminal repeats, the adenoviral packaging signal, the stuffer nucleic acid sequence that is non-viral and non-coding, and the NF-KB inducible promoter, is at least 95% identical to the nucleic acid sequence of SEQ ID NO:
• 7.