SciClone Pharmaceuticals, Inc. (SCLN) And Sigma-Tau Announce Positive Interim Survival Data From Large Phase 2 Malignant Melanoma Trial; Stock Up 43%

SAN MATEO, CA-Dec 22, 2006- SciClone Pharmaceuticals, Inc. and Sigma-Tau S.p.A. today announced positive interim survival data from a large phase 2 trial treating patients with stage IV malignant melanoma, the most advanced form of this cancer. Data from the first four arms of this ongoing five-arm trial showed that the addition of 3.2 mg of ZADAXIN® (thymalfasin or thymosin alpha 1) to standard dacarbazine (DTIC) chemotherapy increased the median survival to 10.2 months. These data compare favorably to the median survival of 6.6 months for patients treated with DTIC chemotherapy with interferon alpha. DTIC is the only approved therapy in the United States for the treatment of advanced melanoma. In addition, data show patients treated with thymalfasin and DTIC chemotherapy without interferon alpha achieved
more than double the overall tumor response as compared to the control group, consistent with previously reported interim results. SciClone and Sigma-Tau expect to present detailed clinical results from this trial including statistical analyses at the upcoming ASCO meeting.


"Based on the strength of these data, we and Sigma-Tau plan to meet with U.S. and European regulatory authorities to discuss a phase 3 clinical trial design using ZADAXIN and DTIC chemotherapy," commented Friedhelm Blobel, Ph.D., Chief Executive Officer of SciClone Pharmaceuticals, Inc. "We are pleased that the addition of ZADAXIN to the current standard of care may offer survival benefits to patients diagnosed with this life-threatening cancer."

"We are excited to observe the positive effects on survival and overall tumor response when ZADAXIN is added to standard DTIC chemotherapy in treating patients with malignant melanoma," commented Roberto Camerini, M.D., Research and Development for Sigma-Tau S.p.A. "Current therapy for the advanced stages of this cancer provides minimal survival benefit for the patient. We are particularly encouraged of the prospect of improving patient survival with the addition of thymalfasin, a drug shown to be safe and well tolerated in several other clinical settings."

The market impact on these results should be rather large if in the end, if it's approved for all stages of melanoma and other cancers. Melanoma is roughly responsible for nearly 80% of all cancer deaths.

Thymalfasin is the synthetic version of thymosin alpha 1, a substance found naturally in the circulation and produced in the body's thymus gland. Thymosin stimulates the immune system by affecting T cells and NK cells, which are the body's most potent defense against infectious diseases and tumor cells. It is this ability to act as an immunomodulator that makes ZADAXIN a promising therapy for such a wide variety of clinical conditions. Stimulation of the immune system in this way is tricky however, and requires careful dosing regimens that can stimulate the immune system but not over produce the inflammatory response.

NASDAQ:SCLN- in late afternoon trading is up to $3.23 (up 97 cents a share)