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Title: Novel Drug Pradefovir Mesylate May Emerge as Treatment Option in Patients with Lamivudine-Resistant HBV Infection: Presented at HEP DART

"Novel Drug Pradefovir Mesylate May Emerge as Treatment Option in Patients with Lamivudine-Resistant HBV Infection: Presented at HEP DART"

By Bonnie Darves KOHALA COAST, HI -- December 15, 2005 -- A novel cytochrome, pradefovir mesylate P450 (PDV), might become a viable treatment option for patients with hepatitis B (HBV) who are resistant to standard treatment with lamivudine. Researchers presented study results on this new compound here on December 13[^th at the Frontiers in Drug Development for Viral Hepatitis HEP DART 2005 meeting.

Their research found that up to 50% of patients with chronic-hepatitis B with documented lamivudine resistance who received PDV had undetectable HBV DNA after 24 weeks of treatment.

Those results, combined with positive results from a larger trial comparing the relative safety and effectiveness of PDV versus lamivudine, have inclined researchers to purse a phase 3 study, said the study's lead author Wan-Long Chuang, MD, PhD, Professor, College of Medicine, Kaoshiung Medical University, Kaoshiung City, Taiwan.

"This drug may be useful in the future for lamivudine-resistant patients," Dr. Chuang said, adding that the drug, to date, has shown a good safety profile.

The study of 28 patients involved follow-up analysis of data from the randomised phase 2 multicenter study, which compared PDV to adefovir dipivoxil, an agent approved by the Food and Drug Administration for chronic HBV. This study's results were reported in November 2005 at the American Association for the Study of Liver Diseases annual meeting.

That study found that PDV was safe and well tolerated at doses of 5 mg to 30 mg daily, and demonstrated good anti-HBV activity compared to adefovir dipivoxil. Preclinical studies of the drug had found that pradefovir had a good liver-targeting yet kidney-sparing profile compared to adefovir dipivoxil.

After 24 weeks of treatment, eight lamivudine-resistant patients who took the 30 mg dose had undetectable HBV DNA, as did eight who received the 20 mg dose, Dr. Chuang said. Three patients who received the 10 mg dose had undetectable HBV DNA at the study end-point, however, suggesting that the efficacy in this patient population is likely dose related.

[Presentation title: Antiviral Activity of Pradefovir Mesylate in Patients with Lamivudine-Resistant HBV Infection: 24-Week Analysis from a Phase 2 Study, Abstract 030]

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