SciClone and Sigma-Tau Report Promising Interim Results From Phase 3 Hepatitis C Trial
Monday February 11, 6:30 am ET
FOSTER CITY, CA--(MARKET WIRE)--Feb 11, 2008 -- SciClone Pharmaceuticals, Inc. (NasdaqGM:SCLN - News) and Sigma-Tau S.p.A today reported promising blinded interim data from a large, randomized phase 3 clinical trial evaluating ZADAXIN® (thymalfasin) in combination with pegylated interferon alpha and ribavirin as a treatment for patients with hepatitis C virus (HCV) who have not responded to prior therapy with pegylated interferon alpha and ribavirin. Full unblinded data from the trial will be available in the third quarter of 2008.
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48 Week End of Treatment Response
The interim blinded HCV data show that at the end of 48 weeks of therapy, 171 out of 553 total patients, including both treatment and control group patients, responded to treatment. A response to treatment is defined as having no detectable HCV RNA circulating in the blood at the end of 48 weeks of therapy.
72 Week Sustained Virologic Response
Of the 171 patients who responded after 48 weeks of therapy, 150 patients have completed the 24-week follow up period (72 week observation) and 54 patients have achieved a sustained virologic response (SVR). Of the remaining 21 patients who responded at the end of therapy, 12 were HCV negative at week 60 (12-week follow-up observation period), and two had yet to reach the week 60 follow-up point. All patients will complete the observation period by the end of the second quarter 2008. While these data include both treatment and control group patients, SciClone and Sigma-Tau believe the trend is promising in light of other recent clinical trial results in non-responder HCV patients retreated with only pegylated interferon alpha and ribavirin which demonstrated SVR rates of 3 to 8% at the 72 week observation point. If the final results of this trial are positive, SciClone and Sigma-Tau plan to meet with the regulatory authorities in the United States and Europe to determine the most expeditious process to bring this therapy to the market.
"These interim HCV data are promising because, although we do not know the breakdown between thymalfasin treated and control group patients who have achieved an SVR, this is already a strong overall response for nonresponder patients. We look forward to reporting full data from this trial in the third quarter of 2008," said Mario Rizzetto, M.D., Professor of Gastroenterology, San Giovanni Battista Hospital, University of Torino, Italy, and lead investigator of the trial. "Thymalfasin's mechanism of action as an immune stimulator may prove to be ideal in the treatment of chronic hepatitis C, where the immune system is suppressed and cannot effectively fight the disease on its own."
"We believe that thymalfasin could represent an important advance in the treatment of hepatitis C patients and address a growing and acute unmet need. We estimate that nearly 1 million HCV patients in the United States alone have failed or will fail currently approved therapy, particularly those who have not responded to prior therapy," stated Friedhelm Blobel, Ph.D., President and Chief Executive Officer of SciClone Pharmaceuticals, Inc. "The treatment approach for HCV using a combination of thymalfasin together with pegylated interferon plus ribavirin is patent protected by SciClone in most major markets including the United States and Europe until 2021."
Thymalfasin Phase 3 Programs
"The information from these interim data is important in determining the optimal phase 3 development pathway for thymalfasin," noted Dr. Blobel. "In light of the promising interim data, we and Sigma-Tau are analyzing the many factors relative to our thymalfasin HCV and malignant melanoma programs."
In June 2007, SciClone reported positive phase 2 clinical trial results from Sigma-Tau's 488 patient study demonstrating thymalfasin met its primary endpoint in tumor response and, more importantly shows promise in extending survival for patients diagnosed with stage IV malignant melanoma. The companies are planning the design of a phase 3 melanoma trial and their regulatory strategy including a Special Protocol Assessment (SPA) to be filed with the Food and Drug Administration. Thymalfasin phase 3 clinical development and commercialization plans for HCV and melanoma have potentially significantly different timelines, costs, sizes of prospective addressable markets, competitive products and other factors. Consequently, before proceeding further with the melanoma trial, SciClone and Sigma-Tau will review the final 72 week results for the current HCV clinical trial in the third quarter of 2008 in order to determine the next steps for an optimal thymalfasin development program for the HCV and malignant melanoma indications. |
