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ANTISENSE DRUG DEMONSTRATES SUBSTANTIAL REDUCTION OF VIRAL LOAD IN PATIENTS WITH DRUG RESISTANT HEPATITIS C VIRUS

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    ANTISENSE DRUG DEMONSTRATES SUBSTANTIAL REDUCTION OF VIRAL LOAD IN PATIENTS WITH DRUG RESISTANT HEPATITIS C VIRUS CARLSBAD, Calif., June 18 /PRNewswire/ -- In
    Message 1 of 1 , Jul 12 11:44 AM
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      ANTISENSE DRUG DEMONSTRATES SUBSTANTIAL REDUCTION OF
      VIRAL LOAD IN PATIENTS WITH DRUG RESISTANT HEPATITIS C
      VIRUS

      CARLSBAD, Calif., June 18 /PRNewswire/ -- In a Phase
      I/II clinical trial, ISIS 14803 demonstrated
      dose-dependent antiviral activity, decreasing viral
      titers, or level of virus in blood, in patients with
      drug resistant chronic Hepatitis C Virus (HCV). All
      patients in the clinical study had the most common and
      drug resistant form of HCV, genotype 1, and all but
      one patient had failed previous interferon-based
      therapy. Results from this study were reported at the
      American Association for the Study of Liver Diseases'
      Single Topic Conference on Hepatitis C this weekend in
      Chicago, by John G. McHutchison, M.D., Medical
      Director, Liver Transplantation, Division of
      Gastroenterology/Hepatology, of the Scripps Clinic in
      La Jolla, California. ISIS 14803 is an antisense drug
      that inhibits HCV replication and is being developed
      by HepaSense(TM), Ltd., a joint venture of Isis
      Pharmaceuticals, Inc. (Nasdaq: ISIP) ("Isis") and Elan
      Corporation plc. (NYSE: ELN) ("Elan"), of Dublin,
      Ireland.

      "The anti-HCV activity demonstrated by this drug at
      this early stage of clinical development is
      impressive. In the trial, we observed responses in
      patients who were resistant to currently available
      treatments," said Dr. McHutchison. "While this study
      involved a small number of patients, we are encouraged
      by these early results."

      In the study, 11 patients with genotype 1 HCV, 10 of
      whom had failed interferon or interferon and ribavirin
      therapy, were treated with escalating doses of up to 2
      mg/kg intravenously of ISIS 14803, three times a week,
      for one month. Three patients received 0.5 mg/kg,
      three were treated with 1.0 mg/kg and five were given
      2.0 mg/kg, of ISIS 14803. Two of four evaluable
      patients in the 2 mg/kg group had greater than one log
      (1.4 and 1.5 log), or 30-fold, decrease in viral
      titers. A third patient receiving 2mg/kg experienced a
      half log, or three-fold, reduction. A fourth patient,
      who received 0.5 mg/kg, experienced a 0.7 log
      reduction in viral titers. Responses developed after
      several doses of ISIS 14803 and persisted for a range
      of 20 to 50 days. In most cases, the responses were
      associated with a transient liver enzyme "flare," or
      an increase in alanine aminotransferase (ALT).

      ISIS 14803 was well tolerated in the Phase I/II
      clinical trial. Adverse events reported were minor and
      non-specific. ALT flares were not accompanied by
      changes in bilirubin, albumin, or prothrombin time,
      which are measures of liver synthetic function. Liver
      biopsy results obtained during an ALT flare did not
      show evidence of drug-related liver toxicity.

      "Although the number of patients studied to date is
      small, we believe ISIS 14803 may prove to be important
      in the treatment of chronic HCV. In this trial, after
      a short course of therapy, we observed considerable
      viral reduction in drug resistant patients with high
      viral titers. Those reductions appear to correlate
      with drug dose," said F. Andrew Dorr, M.D., Isis' Vice
      President and Chief Medical Officer. "Based on the
      results of this study, we plan to continue to evaluate
      the potential of ISIS 14803 in single-agent trials, in
      combination studies with pegylated interferon and
      ribavirin as well as through studies that will look at
      longer-term dosing with both intravenous and
      subcutaneous administration."

      Studies of the subcutaneous delivery of ISIS 14803 are
      currently being conducted. Clinical trials of ISIS
      14803 using Elan's MEDIPAD(TM) Drug Delivery System, a
      minimally invasive microinfusion pump, are planned for
      the future. In January 2000, Isis and Elan formed
      HepaSense to jointly develop ISIS 14803 to treat
      patients with chronic HCV.

      Hepatitis C causes chronic inflammation of the liver
      that can go undetected for months or years but is
      frequently progressive, resulting in life-threatening
      impairment of liver function. Persistent liver
      inflammation causes ongoing injury to the cells of the
      liver. If left untreated, it can lead to liver
      scarring called cirrhosis, liver failure, possibly
      liver cancer and death due to the complications of
      these hepatic insults. Liver complications of chronic
      HCV infections are the most frequent indication for
      liver transplantation.

      According to the National Institute of Diabetes,
      Digestive and Kidney Diseases (NIDDK), HCV is one of
      the most important causes of chronic liver disease in
      the U. S. It accounts for approximately 20 percent of
      acute viral hepatitis, 60 to 70 percent of chronic
      hepatitis, and 30 percent of cirrhosis, end-stage
      liver disease, and liver cancer. Nearly four million
      Americans, or 1.8 percent of the U.S. population, have
      antibody to HCV (anti-HCV), indicating ongoing or
      previous infection with the virus. There are at least
      6 major genotypes and more than 50 subtypes of HCV.
      Genotypes 1a and 1b are the most common in the U.S.
      Genotypes 2 and 3 are present in approximately 30
      percent of patients. There is little difference in the
      severity of disease or outcome of patients infected
      with different genotypes. However, patients with
      genotypes 2 and 3 are more likely to respond to alpha
      interferon treatment. HCV causes an estimated 8,000 to
      10,000 deaths annually in the U.S.

      Isis will conduct a live webcast conference call to
      discuss this release on Monday, June 18, at 10:30 am
      Eastern time. To participate over the Internet, go to
      www.streetfusion.com. A replay of the webcast will be
      available at this address for up to 90 days.

      Isis Pharmaceuticals, Inc. is exploiting its expertise
      in RNA to discover and develop novel human therapeutic
      drugs. The company has commercialized its first
      product, Vitravene(TM) (fomivirsen), to treat
      CMV-induced retinitis in AIDS patients. In addition,
      Isis has 11 products in its development pipeline, with
      two in late-stage development and four in Phase II
      human clinical trials. ISIS 3521, an inhibitor of
      PKC-alpha, is in Phase III trials for non-small cell
      lung cancer. Isis is preparing to initiate a Phase III
      program for ISIS 2302 (alicaforsen), an ICAM-1
      inhibitor, in Crohn's disease. Isis has a broad patent
      estate, as the owner or exclusive licensee of over 780
      issued patents worldwide. Isis' GeneTrove division
      uses antisense to assist pharmaceutical industry
      partners in validating and prioritizing potential gene
      targets through customized services and access to an
      extensive gene function database. Ibis
      Therapeutics(TM) is a division focused on the
      discovery of small molecule drugs that bind to RNA.

      ISIS PHARMACEUTICALS, INC - http://www.isip.com/


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