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Investigators presenting today at the annual American Association for the Study of Liver Diseases (AASLD) meeting being held in Chicago concluded that extended lamivudine therapy appears to maintain persistent suppression of the hepatitis B virus (HBV) in most patients for at least one year. Lamivudine is not yet approved for the treatment of chronic hepatitis B.
Today's interim results, presented by Dr. Jules Dienstag, were observed from 23 patients with chronic hepatitis B who had participated in earlier Phase II lamivudine trials for one or three months duration, and who were still positive for hepatitis e antigen (HBeAg) and HBV DNA. In today's reported study, these patients received extended retreatment with lamivudine (100 mg orally, once-daily) for a mean duration of 59 weeks.
Persistent HBV DNA suppression was observed in 87% (20 of 23) of evaluable patients. Nine of 23 (39%) patients lost detectable HBeAg, five of whom (22%) acquired anti-HBe antibodies, with two patients (9%) having lost HBsAg.
Overall, lamivudine was well tolerated, although one patient experienced transient elevations of CPK enzyme of indeterminate significance. Approximately one-third of patients experienced transient, mild ALT elevations generally in the second or third month of treatment.
Three patients in the study were reported to have developed resistance to lamivudine. These breakthroughs were subclinical. As with other viral infections, some degree of resistance is a common feature of anti-infective drug therapy, including antivirals such as lamivudine. Therefore, these observations of lamivudine resistance were not unexpected.
While these data are encouraging, definitive conclusions about the clinical profile of lamivudine as a treatment for hepatitis B can only be drawn after randomized, placebo-controlled Phase III trials are concluded. The majority of these Phase III trials are for durations of one year and will evaluate liver histology as a main endpoint. These studies, currently underway, have enrolled over 1,000 patients in 22 countries around the world, including the Far East, North America and Europe.
Lamivudine is also the subject of several other disclosures at the AASLD meeting ongoing in Chicago. Notably, investigators reported today that in a Phase II open-label study, 100 mg lamivudine treatment given once-daily for up to 52 weeks to 48 patients with documented recurrence of hepatitis B virus infection post-liver transplantation appears to be a safe and potentially effective therapy for post-orthotopic liver transplantation recurrence of hepatitis B virus.
Lamivudine was discovered by BioChem Pharma and licensed to Glaxo (now Glaxo Wellcome) in 1990. Under the terms of the agreement, BioChem will receive a royalty based on sales and Glaxo Wellcome has the right to develop, manufacture and sell lamivudine worldwide subject to special arrangements in Canada, where a Glaxo Wellcome-BioChem partnership exists.
BioChem Pharma, soon to mark its tenth anniversary, is an international biopharmaceutical company dedicated to the research, development and commercialization of innovative products for the prevention, detection and treatment of human diseases. The Company's shares are traded on the Montreal and Toronto Stock exchanges (BCH) and on the NASDAQ (BCHXF).
CONTACT: BioChem Pharma Inc. Christine Lennon, 514/978-7771 Cellular for Sunday, Nov. 10 only: 514/231-0987
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