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February 26, 2013
09:02 EDTARWRArrowHead Research to publish data of ARC-520 study
Arrowhead Research announced the publication of data demonstrating multi-log reductions in hepatitis B viral DNA and proteins lasting over 30 days after a single injection in animal models. This suggests that Arrowhead's RNAi-based candidate ARC-520 has the potential to treat chronic hepatitis B virus infection in a fundamentally different manner, with the goal of achieving a functional cure. The paper, entitled "Hepatocyte-targeted RNAi therapeutics for the treatment of chronic hepatitis B virus infection," by Wooddell et al, was published online ahead of print in the journal Molecular Therapy. In the publication, Arrowhead scientists describe the use of a novel Dynamic PolyConjugate technology to deliver small interfering RNAs designed against the hepatitis B virus.
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November 16, 2015
11:09 EDTARWRArrowhead says data shows ARC-520 can produce reductions of HBV antigens
Arrowhead Research Corporation presented data from a Phase 2a clinical study at The AASLD Liver Meeting 2015 demonstrating that ARC-520, its lead drug candidate against chronic hepatitis B infection, effectively reduced HBV viral antigens derived from cccDNA. HBV surface antigen was reduced substantially with a maximum reduction of 1.9 logs and a mean maximum reduction of 1.5 logs in treatment naive e-antigen-positive patients. This direct antiviral effect was still evident 57 days after a single dose. These data strongly support advancement of ARC-520, and Arrowhead has initiated multiple studies aimed at producing a functional cure of HBV. In this presentation, Dr. Yuen and co-authors show that in the Heparc-2001 clinical study, ARC-520 in combination with entecavir achieved maximum reductions of HBsAg, HBV DNA, HBeAg, and core-related antigen of 1.9 logs, 4.3 logs, 1.7 logs, and 1.2 logs, respectively. Consistent with findings from Arrowhead's chimpanzee study, also presented at AASLD, variations in viral antigen reduction indicated that patients previously treated with chronic entecavir and patients that were treatment-naive and negative for HBeAg likely had lower levels of cccDNA derived mRNA transcripts. As such, HBeAg-positive treatment naive patients experienced a greater relative reduction in HBsAg than patients that were HBeAg-negative or treatment experienced. One transitional patient in cohort 7 was HBeAg-positive at baseline and became HBeAg-negative at days 3 to 43. This patient experienced an intermediate response initially, however HBsAg continued to trend downward through day 57, the last time-point available. ARC-520 was well tolerated with no serious adverse events, no dose limiting toxicities, no discontinuations due to medication AEs, and a modest occurrence rate of AEs that were all deemed unrelated to study drug by the principal investigator. No AE occurred more than once. There were no AEs amongst 10 patients receiving placebo. There was a low occurrence rate of abnormal laboratory tests, with no observed relationship to timing or dose.
08:27 EDTARWRArrowhead to hold an analyst and investor reception
Management hosts an Analyst and Investor Reception to discuss ARC-520 and key data presented at the 66th Annual Meeting of AASLD in San Francisco on November 16 at 9:30 pm. Webcast Link
November 15, 2015
18:28 EDTARWRArrowhead reports data on anti-hepatitis B effects of ARC-520 in chimpanzees
Arrowhead announced the presentation of data demonstrating that ARC-520, its drug candidate against chronic hepatitis B infection, leads to "robust, sustained anti-viral effects in chimpanzees with chronic HBV," according to the company. Arrowhead also reported a new discovery that HBV DNA integrated into the host genome is "likely an important source of HBV surface antigen production, particularly in chimps that are negative for hepatitis B e-antigen." ARC-520 led to a drop in circulating HBsAg, with the degree of HBsAg reduction correlating with HBeAg status. HBeAg-positive and negative chimps demonstrated HBsAg reductions of 96.8%-99.8% and 68.4%-87.4%, respectively, with an intermediate response in a chimp transitioning from HBeAg positive to negative. In addition, one chimp seroconverted for HBeAg during ARC-520 therapy and had a sustained virologic response with respect to HBeAg, HBV DNA, and HBsAg. This persisted off therapy and through at least 32 weeks after ARC-520 and NUC therapy was removed. A second chimp demonstrated effects consistent with immunologic reactivation. Arrowhead also found that the predominant form of liver HBV DNA differed in HBeAg-negative versus HBeAg-positive chimps. Most HBV DNA in HBeAg-positive chimps was cccDNA, while less than 5% of HBV DNA in HBeAg-negative chimps was cccDNA. In addition, HBV RNA profiles in HBeAg-negative chimps were consistent with transcripts arising from integrated DNA. "These data and others, strongly suggest that integrated DNA is likely an important source of HBsAg production in HBeAg-negative chimps," claimed the company. "Direct confirmatory data" was obtained by treating HBeAg negative chimps with a siRNA designed to target transcripts originating from integrated HBV DNA. Up to an additional 99% of HBsAg knockdown was achieved, resulting in overall relative knockdown levels similar to those observed using ARC-520 in HBeAg-positive chimps. Arrowhead said it has incorporated one of these RNAi triggers and one targeting predominantly cccDNA derived transcripts into a new complementary drug candidate, ARC-521, that is planned to be in clinical trials in 2016. The company noted it plans to present additional data at the Hep Dart conference in December demonstrating that two of four HBeAg-positive chimps exhibited signs of immune reactivation, "which is believed to be a necessary step toward achieving a functional cure of HBV."

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