Important note: Information in this article was accurate in 1996. The state of the art may have changed since the publication date.
PR Newswire, 810 Seventh Avenue, New York, NY 10019 - Tuesday, 12 November 1996.
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 improvement 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 American Liver 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.
SciClone Pharmaceuticals is an international biopharmaceutical company engaged in the acquisition, development and commercialization of pharmaceuticals worldwide. SciClone's focus is on therapeutics for diseases that are chronic and life-threatening, including hepatitis B and C, immune system disorders and cancer.
CONTACT: Mark Culhane, Chief Financial Officer of SciClone Pharmaceuticals, Inc., 415-358-3456/ 09:10 EST
Copyright (c) 1996/PR NewsWire. Reproduced with permission. Reproduction of this article (other than one copy for personal reference) must be cleared through the Permissions Desk, PR Newswire, 810 Seventh Avenue, New York, NY 10019.
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