The present invention relates, first, to the discovery, identification, and characterization of novel
nucleic acid molecules, that are associated with PBC, Sjögren'
s syndrome, scleroderma, SLE, autoimmune
thyroiditis and various other
connective tissue disorders. The novel
nucleotide sequences of the present invention are retroviral in origin and are indicative of a PBC
retrovirus which bears a strong correlation with PBC. The present invention is based, in part, on the Applicant's data which is the first evidence to suggest that PBC patient's tissue may harbor a transmissible agent. The association of a retroviral
infectious agent with PBC was first demonstrated by Applicants
in vitro by co-culture of periportal
lymph nodes derived from patients at time of
transplantation and healthy biliary
epithelium cells. The Applicant's discoveries as described herein, report the characterization of PBC-associated
infectious agent as retroviral as demonstrated by
electron microscopy and immunoblot reactivity. In addition, Applicants have characterized novel
nucleotide sequences which are associated with the PBC-associated
retrovirus.