ZADAXIN COMBINATION THERAPY SHOWS
71% SUSTAINED RESPONSE IN HEPATITIS B PATIENTS
San Mateo, CA, April 9, 2003 -- SciClone Pharmaceuticals (Nasdaq: SCLN) today announced the results of a study showing a 71% long-term sustained response rate for difficult to treat hepatitis B patients. These results were achieved after only one year of combination therapy with ZADAXIN and interferon alpha. This sustained response rate compares extremely favorably to 20% of patients using interferon alpha in combination with lamivudine and 10% of patients using interferon alpha alone.
All of the patients in this study were infected with HBeAg-negative hepatitis B, commonly referred to as precore mutant hepatitis B. This strain of the virus is extremely difficult to treat and is highly prevalent in the Mediterranean region. Recommended treatment for these patients is at least one year of therapy. However, a separate study showed that even with 24 months of interferon alpha therapy only 30% of these patients achieved a sustained response.
“ZADAXIN combination therapy has shown the ability to treat successfully some of the most difficult to treat hepatitis B patients,” commented Eduardo Martins, M.D., Ph.D., Vice President, Medical Affairs of SciClone Pharmaceuticals. “Achieving a sustained and durable response in the majority of patients within a reasonable treatment period is of significant benefit both for the patient and for the healthcare systems dealing with this potentially life-threatening disease.”
This recent study was conducted by a team led by Dr. Murat Saruc of the University of Nebraska Medical Center in Omaha, Nebraska and Celal Bayar University in Manisa, Turkey. The study was designed to show long-term efficacy of ZADAXIN in combination with interferon alpha in the treatment of patients infected with precore mutant hepatitis B. One of the primary goals of treatment, and the measure of sustained response in the study, is sustained suppression of hepatitis B viral replication and histological improvement.
In the study, 74% (20/27) of patients receiving 26 weeks of ZADAXIN in combination with interferon followed by 26 weeks of interferon monotherapy (a total of 52 weeks of therapy) showed a sustained response at 6 months post-treatment. 71% (19/27) of these patients showed a sustained response at 18 months post-treatment.
By comparison, 53% (8/15) of patients receiving 52 weeks of interferon in combination therapy with lamivudine followed by continuous lamivudine monotherapy showed a sustained response at 6 months post-treatment but only 20% (3/15) at 18 months post-treatment. 40% (4/10) of patients receiving 52 weeks of interferon monotherapy showed a sustained response at 6 months post-treatment but only 10% (1/10) at 18 months post-treatment.
Dr. Murat Saruc concluded, “Interferon alpha and ZADAXIN combination therapy results in significant virological and biochemical improvement compared with standard therapeutic regimens and is well tolerated.”
The abstract from this study was to be presented at the Annual European Association for the Study of Liver Disease (EASL) Conference to be held in Istanbul, Turkey. Unfortunately, the conference has been indefinitely postponed due to the war in Iraq.
Current Treatment Standards for Precore Mutant Hepatitis B
HBeAg-negative, or precore mutant, hepatitis B, is a mutant form of the virus which does not display on its surface the hepatitis B “e” antigen, the primary target for the immune response against the disease. In a recent consensus report, EASL states that patients with precore mutant hepatitis B require interferon alpha therapy for 12 to 24 months, which is two to three times the length of treatment for hepatitis B patients without this form of the virus. A study published this month in the medical journal Hepatology shows that even with 24 months of interferon alpha therapy, only 30% (30/101) of patients with precore mutant hepatitis B achieved a sustained response.
Importantly, interferon alpha causes severe toxicities, making patient compliance more difficult, and has an unfavorable treatment cost relative to its effectiveness. Lamivudine or adefovir, two additional hepatitis B therapies currently approved in Europe and the U.S., are recommended by EASL if interferon alpha is contraindicated, ineffective, or poorly tolerated. Long-term therapy with lamivudine or adefovir may lead to drug resistance, however, and make further therapy even more challenging.
About Hepatitis B
There are an estimated 350 million chronic hepatitis B carriers worldwide. The most widely used therapies for treating hepatitis B are lamivudine and interferon alpha. SciClone has recently completed a phase 3 clinical trial in Japan using ZADAXIN as a monotherapy for hepatitis B and expects to report data during the second quarter of 2003.
About ZADAXIN
ZADAXIN is a pure synthetic preparation of thymosin alpha 1, a substance which circulates naturally and is instrumental in the body’s immune response to fight viral infections and certain cancers. ZADAXIN has been approved for sale by the ministries of health in over 30 countries and is marketed in China and selected other countries outside the U.S. ZADAXIN has been administered to more than 10,000 patients in both clinical and commercial use, alone and in combination with anti-viral and anti-cancer drugs, without producing any reported ZADAXIN related significant side effects or toxicities.
About SciClone
SciClone Pharmaceuticals is a biopharmaceutical company engaged in the development of therapeutics to treat life-threatening diseases. Its lead product ZADAXIN is in several late-stage clinical trials, including two phase 3 hepatitis C clinical trials in the U.S., a recently completed phase 3 hepatitis B clinical trial in Japan, a phase 2 malignant melanoma clinical trial in Europe, and two phase 2 liver cancer trials in the U.S. In addition to ZADAXIN, SciClone’s drug development opportunities include SCV-07, a potentially orally available therapy to treat viral and infectious diseases, and products to address the protein-based disorder that causes cystic fibrosis.
The information in this press release contains forward-looking statements including expectations and beliefs regarding the timing of announcement of phase 3 hepatitis B clinical trial results and the potential of ZADAXIN. Words such as “expects,” “plans,” “believe,” “may,” “will,” “anticipated,” “intended” and variations of these words or similar expressions that may characterize future events are intended to identify forward-looking statements. In addition, to the extent that results of studies and other clinical data may imply or indicate what the actual results in larger patient populations may be, such statements may be forward-looking statements. These statements are not guarantees of future performance and are subject to risks, uncertainties and assumptions that are difficult to predict. Therefore, our actual results could differ materially and adversely from those expressed in any forward-looking statements as a result of various factors, including delays or unanticipated difficulties in analyzing or synthesizing data obtained from our phase 3 hepatitis B clinical trial, the statistical significance of data obtained from the clinical trial, the fact that results from studies with a limited group of patients may not be predictive of the results of larger studies and clinical and experimental data is not necessarily predictive of the efficacy and safety of ZADAXIN, as well as other risks and uncertainties described in SciClone’s filings with the Securities and Exchange Commission.
Corporate information contact:
Richard A. Waldron, CFO
650-358-3437
ZADAXIN COMBINATION THERAPY SHOWS 71% SUSTAINED RESPONSE IN HEPATITIS B PATIENTS
April 9, 2003
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