Arrowhead Research Corporation, a biopharmaceutical company developing targeted RNAi therapeutics, announced new data on its lead product ARC-520 from a test with a chimpanzee, which was recently presented at the 2013 AASLD Annual Meeting. Robert E. Lanford, Ph.D. at the Texas Biomedical Research Institute gave the presentation, which was selected as one of the top poster presentations among all presented abstracts.
Approximately 350 million people worldwide are infected with Hepatitis B (HBV), which causes cirrhosis of the liver and primary liver cancers. ARC-520 is composed of 2 types of cholesterol-conjugated siRNAs and the hepatocyte-targeted membrane-lytic Dynamic Polyconjugate (DPC) delivery vehicle and it is designed to reduce the expression of HBV-DNA that is critical for its survival.
In the study, ARC-520 was dosed in a single chimpanzee chronically infected with HBV since 1979. Researchers measured the levels of such as HBV-DNA, hepatitis B s-antigen and e-antigen (HBsAg and HBeAg), cytokines in serum to evaluate activity and safety of ARC-520.
Read more Texas BioMed articles here:
[feed url=”http://bionews-tx.com/news/news-tags/texas-biomedical-research-institute/feed” number=”5″ ]
HBV-DNA levels dropped by 17-fold by day 4, 36-fold following the second dose, and returned to the baseline by day 43. HBeAg levels declined by more than one log by day 4 and returned to baseline by day 43. HBsAg levels declined 5.2-fold by day 29 and did not return to baseline until day 71. In addition, alanine transaminase (ALT) levels in serum increased, coincident with the nadir of circulating HBsAg.
“This study would have been important if ARC-520 just demonstrated safe and effective HBsAg reduction because this is thought to be a necessary step in achieving a functional cure,” said Dr. Lanford. “What is really exciting about these data, however, is that we appear to have seen immune de-repression, the next step toward HBsAg seroconversion and functional cure. The timing of the ALT rise and associated increases in key chemokine/cytokine mRNAs suggest that they were related to the therapy-induced reduction in circulating HBsAg and represented an immunological event.”
Researchers are currently preparing for a Phase-2a clinical trial in patients with chronic HBV infection.