Press Releases
Isis Announces Antisense Targeting Of HBV Produces Dose-Dependent Reductions In Hepatitis B Virus In An Animal Model Of HBV
"Hepatitis B virus infection is a serious health problem that can lead to significant and potentially fatal health conditions, including cirrhosis, liver failure and liver cancer. Chronic HBV infection is one of the most common persistent viral infections in the world. Currently available therapies, although effective in reducing circulating HBV in the blood, do not efficiently inhibit HBV antigen production and secretion, which are associated with poor prognosis and increased risk of liver cancer," said Dr. Stefan Wieland, assistant professor of experimental virology at
These preclinical data, which will be presented by Dr.
"While chronic hepatitis B virus is currently treated with oral antiviral agents or injectable interferons, these treatments do not clear HBV and do not effectively clear HBV antigens from these patients. As a result, patients are unable to fully control HBV infection and achieve sustained disease remission. Many of these patients are at elevated risk for severe liver complications such as cirrhosis and primary liver cancer. By targeting and suppressing viral mRNAs in the liver, treatment with ISIS-HBVRx added to current therapies could result in greater viral inhibition and permit greater immune system activity against the virus," said
The Phase 1 study of ISIS-HBVRx is a randomized, placebo-controlled, dose-escalation study in approximately 30 healthy volunteers. This study is designed to evaluate the safety, tolerability, and pharmacokinetics of single and multiple doses of ISIS-HBVRx. ISIS-HBVRx, formerly referred to as ISIS-GSK3Rx, is an investigational drug that is designed to target viral mRNA and reduce the production of viral proteins associated with HBV infection and replication. ISIS-HBVRx is part of Isis' alliance with GSK. Isis will develop ISIS-HBVRx to completion of Phase 2 proof-of-concept, after which GSK has an exclusive option to in-license and further develop and commercialize ISIS-HBVRx. Isis has already earned
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Isis is exploiting its leadership position in antisense technology to discover and develop novel drugs for its product pipeline and for its partners. Isis' broad pipeline consists of 31 drugs to treat a wide variety of diseases with an emphasis on cardiovascular, metabolic, severe and rare diseases, including neurological disorders, and cancer. Isis' partner, Genzyme, is commercializing Isis' lead product, KYNAMRO®, in
This press release includes forward-looking statements regarding Isis' collaboration with GSK, the discovery, development, activity, therapeutic potential and safety of ISIS-HBVRx and the therapeutic potential of discovering a drug to treat chronic HBV infection. Any statement describing Isis' goals, expectations, financial or other projections, intentions or beliefs is a forward-looking statement and should be considered an at-risk statement. Such statements are subject to certain risks and uncertainties, particularly those inherent in the process of discovering, developing and commercializing drugs that are safe and effective for use as human therapeutics, and in the endeavor of building a business around such drugs. Isis' forward-looking statements also involve assumptions that, if they never materialize or prove correct, could cause its results to differ materially from those expressed or implied by such forward-looking statements. Although Isis' forward-looking statements reflect the good faith judgment of its management, these statements are based only on facts and factors currently known by Isis. As a result, you are cautioned not to rely on these forward-looking statements. These and other risks concerning Isis' programs are described in additional detail in Isis' annual report on Form 10-K for the year ended
In this press release, unless the context requires otherwise, "Isis," "Company," "we," "our," and "us" refers to
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SOURCE
For Isis Pharmaceuticals: D. Wade Walke, Ph.D., Vice President, Corporate Communications and Investor Relations, 760-603-2741, Amy Blackley, Ph.D., or Associate Director, Corporate Communications, 760-603-2772