SOURCE: SciClone Pharmaceuticals, Inc.

September 18, 2006 06:30 ET

SciClone and Sigma-Tau Present Encouraging Interim Phase 2 Metastatic Malignant Melanoma Response Data

Data Presented at Joint Perspectives in Melanoma X and the Third International Melanoma Research Congress

SAN MATEO, CA -- (MARKET WIRE) -- September 18, 2006 -- SciClone Pharmaceuticals, Inc. (NASDAQ: SCLN) and Sigma-Tau S.p.A today reported interim data showing that the addition of ZADAXIN® to standard dacarbazine (DTIC) chemotherapy, with or without interferon alpha in patients, with stage IV, the most advanced form of malignant melanoma, achieved double the overall tumor response as compared to the control group. Additional results from this trial, including preliminary survival data for the first four arms of this trial, are expected prior to the end of the year.

"We are pleased that the addition of ZADAXIN at all tested doses increases tumor response for these patients with metastatic malignant melanoma, and that the response has been maintained since we first reported interim data from this trial in December 2005," said Alfred R. Rudolph, M.D., Chief Operating Officer of SciClone Pharmaceuticals, Inc. "Importantly, we intend to look at the survival and tumor response data together in early 2007 to determine the optimal dose and design for our planned phase 3 trial, targeting regulatory approvals in the U.S. and Europe."

Interim results from the ongoing phase 2 clinical trial were presented on Saturday, September 16, 2006 at the joint Perspectives in Melanoma X and the Third International Melanoma Research Congress in Noordwijk, The Netherlands. The data include 463 of the total 485 patients in this 5-arm, phase 2 clinical trial. All 463 patients have been evaluated according to RECIST criteria for overall tumor response, which includes partial and complete responses. All patients enrolled in the trial were diagnosed with stage IV metastatic malignant melanoma.

These interim data showed that all patients in the treatment arms containing ZADAXIN had a higher response than those in the control arm. Of the 99 patients treated with 3.2 mg of ZADAXIN in combination with DTIC, 12.1% achieved an overall response (complete and partial response), which was more than double the 5.3% response for the 95 patients in the control arm. Of the 97 patients treated with 3.2 mg of ZADAXIN, DTIC, and low-dose interferon alpha, 10.3% showed an overall response; and of the 97 patients receiving 1.6 mg of ZADAXIN, DTIC and low-dose interferon alpha, 7.2% showed an overall response. All patients in the fifth arm, treated with 6.4 mg ZADAXIN, DTIC and low-dose interferon, will complete the treatment and follow-up period by February 2007. To date, 75 patients in this arm have completed therapy and follow-up, and have shown an 8% overall response. The adverse events observed to date in this trial are consistent with those expected for this group of patients treated with DTIC and interferon alpha.

"These data confirm our excitement about ZADAXIN and its potential to offer a therapeutic benefit for the patients suffering from metastatic melanoma," commented Roberto Camerini, M.D., Research and Development for Sigma-Tau S.p.A. "This is a patient population in desperate need of new therapeutics to treat this deadly disease, and we believe that ZADAXIN would offer increased response rates without additional side effects."

About the Malignant Melanoma Trial

SciClone's European partner, Sigma-Tau, is conducting a large, multi-center, open-label phase 2 trial in Europe evaluating different dose levels of ZADAXIN in combination with DTIC chemotherapy with and without low-dose interferon alpha as a first-line treatment for patients with stage IV malignant melanoma. Most of these stage IV patients have visceral metastases and the remaining patients have lung metastases and skin or lymph node metastases.

The trial's primary endpoint is overall tumor response. Secondary endpoints include overall survival, duration of response, time to disease progression and immunological response. Additional data, including preliminary survival information on all patients in the first four arms, are expected by the end of 2006.

ZADAXIN received Orphan Drug Status in the United States for stage IIb through stage IV malignant melanoma in March 2006.

About Malignant Melanoma

The American Cancer Society estimates that this year in the United States approximately 7,700 deaths will occur from melanoma. Melanoma is classified as stage IV, the most advanced form, once the cancer has spread beyond the skin to a distant site. Common treatments for stage IV patients include chemotherapeutic agents, like DTIC, and immunotherapy, including interferon alpha. However, none of these therapies are effective at extending overall patient survival, which at this stage is typically only about six to nine months. Response to treatment largely depends upon the stage of melanoma, disease site and the extent to which the cancer has spread.

About ZADAXIN

ZADAXIN is a novel compound with immunomodulatory effects that facilitates the body's immune response to fight viruses and certain cancers. The compound is a synthetic version of the naturally occurring peptide thymosin alpha 1, generically referred to as thymalfasin. ZADAXIN promotes T-cell maturation as well as increases the response of the immune system, with both functions playing an important role in eradicating virally infected and cancer cells. ZADAXIN appears to be well tolerated, with few reports of significant side-effects or toxicities associated with its use.

About SciClone

SciClone Pharmaceuticals is a biopharmaceutical company engaged in the development of therapeutics to treat life-threatening diseases. SciClone's lead product ZADAXIN is currently being evaluated in late-stage clinical trials for the treatment of malignant melanoma and hepatitis C. ZADAXIN is approved for sale in select markets internationally, most notably in China where SciClone has an established sales and marketing operation. A key part of SciClone's strategy is to leverage its advantage in China by in-licensing or acquiring the marketing rights to other products, such as the DC Bead, to broaden its portfolio in this rapidly growing pharmaceutical market. SciClone's other drug development candidate is SCV-07, currently in early clinical development in the U.S. for the treatment of viral and other infectious diseases. For more information about SciClone, visit www.sciclone.com.

The information in this press release contains forward-looking statements including our expectations and beliefs regarding progress and results of our clinical trials. Words such as "expects," "plans," "believe," "may," "will," "anticipated," "intended" and variations of these words or similar expressions are intended to identify 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 the progress of ongoing and proposed trials and studies for ZADAXIN, unexpected adverse results to patients, future actions by the U.S. Food and Drug Administration or equivalent regulatory authorities in China and Europe and the fact that experimental data and clinical results derived from pre-clinical studies or from studies with a limited group of patients may not be predictive of the results of larger studies, as well as other risks and uncertainties described in SciClone's filings with the Securities and Exchange Commission.

Contact Information

  • Corporate contact:
    Richard Waldron
    Chief Financial Officer
    SciClone Pharmaceuticals, Inc.
    650-358-3437