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, 15 October 1996.
The randomized and controlled clinical trial was designed to evaluate the efficacy and safety of thymosin alpha 1 treatment in patients who were hepatitis B virus DNA ("HBV DNA") positive and hepatitis B e antibody ("HBeAb") positive (mutant type of virus), a commonly seen form of hepatitis in the Mediterranean region. This form of hepatitis is characterized by a progressive and relapsing course with fluctuations of viral replication and a poor response to alpha interferon therapy.
A total of 33 patients were enrolled and randomly assigned to receive either thymosin alpha 1 (0.9 mg per m(2) -- approximately 1.6 mg) twice weekly for six months (17 patients), or alpha interferon (5 million units) three times weekly for six months (16 patients). In addition, 15 clinically similar patients who had never been treated with alpha interferon were used as historical controls. All patients were hepatitis B surface antigen ("HBsAg") positive, HBV DNA positive, HBeAb positive and had elevated ALT levels. At entry, the two treated groups and the historical controls were comparable with respect to age, sex, biochemical, histological and serological parameters. The protocol called for six months of treatment followed by six months of observation. Complete response was defined as ALT normalization and HBV DNA loss.
After six months of observation following treatment, complete response was observed in seven of the 17 patients (41.2 percent) in the thymosin alpha 1 treatment group, four of 16 patients (25 percent) in the alpha interferon treatment group, and 1 of 15 patients (6.7 percent) in the historical control group. At the completion of the 12 month study, the response rate of the thymosin alpha 1 treated group, but not of the alpha interferon treated group, was statistically significantly higher than the response rate of the control group (41.2 percent versus 6.7 percent) p < 0.05. The researchers reported that, "unlike alpha interferon, thymosin alpha 1 was well-tolerated in all patients and seems to induce a gradual and more sustained ALT normalization and HBV DNA loss." The researchers concluded that "thymosin alpha 1 appears to be a safe and effective alternative treatment for HBeAb positive chronic hepatitis."
Additional Trial Results Reported in the "Journal of Viral Hepatitis"
Separately, SciClone reported that a second team of researchers in Italy, led by Dr. Guido Rasi of the Institute of Experimental Medicine in Rome reported the results of an open label trial to study the efficacy of combination therapy using thymosin alpha 1 and low dose natural alpha interferon in 15 patients with chronic hepatitis B, including 11 patients who had previously failed standard alpha interferon therapy. The results were published in the current issue of the "Journal of Viral Hepatitis."
All 15 enrolled patients were HBsAg and HBV DNA positive and had elevated ALT levels. Patients were treated for six months and followed for an additional 12 months. Patients received 3 million units of natural alpha interferon twice weekly (compared to standard alpha interferon therapy in Europe, of 15 - 30 million units weekly) and 1 mg of thymosin alpha 1 twice weekly. Sustained response at 18 months was defined as the absence of HBV DNA and normal or near normal ALT levels.
At the conclusion of the 18 month study, Dr. Rasi observed sustained response in nine of the 15 patients (60 percent), including six of 11 patients (55 percent) who had previously not responded to standard alpha interferon treatment. Of the nine responders, five patients (55.6 percent) seroconverted to HbeAg negative status and two patients were HbeAg negative at entry. In addition, six of the nine patients (66.7 percent) responding achieved HBsAg negative status, a long-term marker of clearance in hepatitis B and one of the final markers to clear in achieving long-term sustained remission.
"We are pleased to see these studies published in important medical journals," stated Donald R. Sellers, President and Chief Executive Officer. He added "These studies add to the growing body of clinical data demonstrating that thymosin alpha 1 is a competent hepatitis B therapy that is safe and virtually side-effect free."
Thymosin alpha 1, SciClone's lead product, is a synthetically produced immunomodulator that the Company believes stimulates the immune system's disease-fighting properties. SciClone markets thymosin alpha 1 under the trade name ZADAXIN(R) thymosin alpha 1. In addition to hepatitis B, thymosin alpha 1 is also under investigation as a treatment for hepatitis C and HIV. SciClone has received licenses to market thymosin alpha 1 as a treatment for hepatitis B in the Peoples Republic of China, the Republic of the Philippines and Singapore. SciClone has thymosin alpha 1 new drug applications under review in six countries and plans to file approximately 12 additional thymosin alpha 1 new drug applications to market thymosin alpha 1 in Asia, the Middle East and Latin America prior to the end of 1996.
The statements made in this press release contain certain forward-looking statements related to the filings of new drug applications, pending new drug applications under review and conclusions regarding the results of clinical studies 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 & 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 or 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
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