ZADAXIN U.S. Hepatitis C Trial Statistically Significant
SAN MATEO, Calif., Nov. 12, 1996 -- SciClone Pharmaceuticals,
Inc. reported today that the results of its 103 patient randomized,
double-blind and placebo-controlled U. S. chronic hepatitis C trial
were presented by the principal investigator, Kenneth Sherman,
M.D., Ph.D., of the Univeristy of Cincinnati at the annual meeting
of the American Association for the Study of Liver Diseases (AASLD)
being held in Chicago.
The combination of Zadaxin and alpha interferon demonstrated
statistically significant higher efficacy than single agent alpha
interferon, the only currently FDA-approved therapy for chronic
hepatitis C. Among evaluable patients, biochemical response was
observed in 41.9 percent of patients treated with the combination
therapy of Zadaxin plus alpha interferon, 16.6 percent among
patients treated with alpha interferon only and 2.7 percent among
the patients who received placebo. The results of the combination
therapy versus single-agent interferon was statistically
significant at p=0.022, while the results of the combination
therapy versus placebo was statistically significant at
p=0.0001.
Among patients with genotype 1a or 1b, the researchers observed
complete response in 31 percent of the patients treated with the
combination therapy, compared with 12 percent among patients
treated with single-agent interferon. Of the evaluable patients,
over 50 percent were genotype 1a or 1b, and the remainder were
genotypes 2, 3, and 4 or were mixed genotypes. Published data on
the treatment of hepatitis C indicates that genotypes 1a and 1b are
the most resistant to current forms of treatment. Among patients
with other genotypes the researchers observed complete response in
50 percent of patients treated with combination therapy compared
with 25 percent among patients treated with single-agent
interferon.
Dr. Sherman commented, "In both treatment groups the sustained
response is consistent with other recent hepatitis C trials and
current therapy. The statistically significant response to the
thymosin-interferon combination therapy during our six month
treatment phase suggests that longer therapy should confirm
previous pilot studies showing a high rate of sustained response
after twelve months of treatment. Our preliminary retreatment data
supports this concept." Dr. Sherman added, "One of the most
important findings was the degree of improve- ment in liver
biopsies. The histologic improvement demonstrates that the
combination treatment has a measurable clinical effect."
The histologic data showed that only the combination therapy
demonstrated statistically significant higher efficacy than placebo
at reducing histologic activity. The mean Knodell score change in
the patients treated with combination therapy was -2.5, compared to
a mean change of 0 for patients treated with placebo (p<0.05).
Patients treated with single-agent interferon did not demonstrate a
statistically significant improvement in histology versus patients
treated with placebo.
The virologic data showed that the combination treatment
demonstrated statistically significant reduction in the level of
hepatitis C serum viral RNA (HCV RNA) from baseline levels.
Patients treated with combination therapy achieved reductions in
HCV RNA from 9.5 Meq/ml at baseline to 3.5 Meq/ml at the end of
treatment (p<0.05). Patients treated with single-agent
interferon or placebo did not achieve statistically significant
reductions in HCV RNA compared to baseline.
The Centers for Disease Control estimate that 3.9 million
Americans are infected with the hepatitis C virus, and the
AmericanLiver Foundation estimates that an additional 170,000 new
cases are reported each year. Hepatitis C can cause chronic liver
problems and cirrhosis and is believed to facilitate the
progression of liver cancer.
In addition to hepatitis C, Zadaxin is also under investigation
as a treatment for hepatitis B and HIV. SciClone has received
licenses to market Zadaxin as a treatment for hepatitis B in China,
the Philippines and Singapore. SciClone has filed new drug
applications for permission to market Zadaxin in Hong Kong, India,
Indonesia, Malaysia, Mexico and Cyprus. The company expects to file
additional applications in foreign markets prior to the end of
1996.
The statements made in this press release contain certain
forward looking statements, including statements regarding the
effects of longer therapy, that involve a number of risks and
uncertainties. Actual events or results may differ from the
company's expectations. In addition to the matters described in
this release, future actions by the Food and Drug Administration or
equivalent regulatory authorities in foreign countries, results of
pending or future clinical trials, as well as the risk factors
listed from time to time in the company's SEC reports, including
but not limited to its Annual Report on Form 10-K, may affect the
actual results achieved by the company.
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