Chemistry: molecular biology and microbiology – Micro-organism – tissue cell culture or enzyme using process... – Recombinant dna technique included in method of making a...
Patent
1994-01-31
2000-02-01
Eisenschenk, Chris
Chemistry: molecular biology and microbiology
Micro-organism, tissue cell culture or enzyme using process...
Recombinant dna technique included in method of making a...
4241891, 4242251, 4242271, 4242261, 530324, G01N 3353, A61K 3929
Patent
active
060201673
DESCRIPTION:
BRIEF SUMMARY
The present invention relates to a composition comprising a polypeptide sequence prepared by recombinant DNA techniques and a carrier to provide a curing agent against chronic viral hepatic diseases. The invention relates to DNA sequences coding for said polypeptide sequences and to transfected cells for the expression of the same.
At least five different viruses, namely Hepatitis virus A, B, C, D and E, are able to trigger the clinical aspect of an acute hepatitis. Hepatitis A and E, which are transferred enterically, always heal, whereas hepatitis B, C (formerly called parenteral hepatitis Non-A Non-B), and D can progress into a chronic stage of inflammation, which in turn can result in liver cirrhosis and primary hepatocellular carcinoma.
There is relatively little data available on hepatitis C and D, on methods for the diagnosis and their treatment and on the respective viruses. The hepatitis D virus is a RNA virus which is known to be incomplete. Therefore, it needs a helper virus to develop in patients and is found only in individuals infected with HBV. Only very recently the hepatitis C virus has been detected, and an antibody test (anti-HCV) facilitating the diagnosis of chronic hepatitis C infections has been developed. However, there is an increasingly urgent need for a treatment to cure this disease.
The same holds true for chronic hepatitis B, a much better studied disease with respect to its recognition by immunological methods, its causative virus and the viral life cycle and DNA sequence. Patients are said to be chronic carriers of the hepatitis B virus if the viral DNA persists longer than ten weeks, the HBe-antigen (HBeAg) for more than 12 weeks, or if the hepatitis B surface-antigen (HBsAg) is persistent longer than six months.
Roughly three hundred million people are deemed to suffer from chronic hepatitis B, most of them living in the Far East.
For these people the main risk to be infected appears to be during or immediately after birth, since a chronically infected mother transfers the virus to her newborn. 90 percent of the children infected this way will become chronically infected, too, during later life. In the Western World infection occurs more commonly later in life, during childhood or even adulthood, mainly by a parenteral or sexual transmission. In these cases of hepatitis B infection after birth only five to ten percent of the infected become chronic carriers. The virus transferred, however, is not responsible for distinct reactions shown by infected people either to eliminate the virus or to retain it in the body lifelong. Consequently, it seems to be a matter of the immunological status that determines the future physical condition.
The HB-virion (Dane particle) is composed of different structural proteins, the core proteins and the surface (S) proteins. The latter are translation products of an open reading frame encompassing the coding sequence of three S-type domains, each of which starts with an ATG triplet capable of initiating translation in vivo. The domains are referred to as preS1, preS2 and S in the order of 5' to the 3' end of the molecule. There are six protein products derived from this ORF: a glycosylated and a non-glycosylated form of the major protein (gp27 and p24) translated from the S domain only (226 amino acids), a middle protein (281 amino acids) having one or two polysaccharide side chains (gp33 and gp36, respectively), that is encoded by the preS2- and S-region, and finally, both a glycosylated (gp42) and a non-glycosylated (p39) form of the large protein (389-400 amino acids, depending upon the viral serotype), which is formed by translation of preS1, preS2 and S. The core proteins are HBcAg and HBeAg, the latter one conceivably being a processing product of HBcAg.
The Dane particle, which is the infectious virion, comprises both core and surface proteins, whereas the filaments consist of a mixture of the six surface antigens. The S peptides alone assemble to form the so-called 20 nm particles, which are completely uninfectious.
Patients infected b
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Eisenschenk Chris
Medeva Holdings B.V.
Zeman Mary
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