ZADAXIN Enters European Phase 2-3 Cancer Program

Source Press Release
Company SigmaSigma-Tau GroupSciClone Pharmaceuticals 
Tags Phase III, Phase II, Oncology
Date December 20, 2001

SciClone to Receive $2.7 MM Milestone from Sigma-Tau for U.S. Hepatitis C Trials

San Mateo, CA -- December 20, 2001 -- SciClone Pharmaceuticals  (Nasdaq: SCLN) today announced the initiation of a late-stage oncology clinical development program in Europe for ZADAXIN, SciClone’s lead immune system enhancer drug. The clinical program is being sponsored by Sigma-Tau S.p.A., SciClone’s exclusive partner for ZADAXIN in the European Union (EU). It begins with a Phase 2 trial program for malignant melanoma with patient enrollment planned during 2002. Pivotal Phase 3 trial design will be based on the Phase 2 results.

There is no proven life-prolonging therapy for late-stage (metastatic) malignant melanoma, the leading cause of skin cancer death, and the average current survival for a Stage IV patient is around 5 months. Sigma-Tau’s Phase 2 trials are based on the success of a smaller open label study conducted previously in the EU by independent researchers. In that study, reported in the peer-reviewed journal Melanoma Research (Volume 10, Issue 2, April 2000), 10 of 20 late-stage patients showed a complete or partial response when ZADAXIN was added to the current standard combination therapy, the anti-cancer drug dacarbazine (DTIC) and alpha interferon, and the median survival of the participating patients was approximately 11.5 months. This response rate is a clinically significant increase over the standard treatment’s historical efficacy. Sigma-Tau’s Phase 2 study plans to expand a similar combination therapy protocol and to also include a matched control group.

The SciClone and Sigma-Tau collaboration initially was formed to clinically develop and market ZADAXIN in Europe for the treatment of hepatitis C, based on pooled U.S. and European clinical data. SciClone’s expanded U.S. Phase 3 hepatitis C trials are now designed to provide the statistical basis required for both U.S. and European registration. Accordingly, Sigma-Tau has agreed to focus its European clinical resource commitments on funding a phase 2 and 3 clinical program for ZADAXIN targeting a cancer regulatory approval. The European oncology program also is intended to complement SciClone’s own Phase 2 cancer program for ZADAXIN in the U.S., currently comprised of two separate liver cancer studies.

Under the terms of the collaborative agreement, and in addition to funding the European oncology clinical program, Sigma-Tau has agreed to make $3.7 million in payments to SciClone to help fund the U.S. hepatitis C trials. SciClone expects to receive the initial $2.7 million milestone payment prior to the end of 2001 for work already completed in its U.S. hepatitis C trial program and to receive a $1 million milestone payment upon completion of U.S. patient enrollment. Sigma-Tau has exclusive rights for European Union clinical development, registration, marketing and sales of ZADAXIN. SciClone will receive revenues based on sales of finished form ZADAXIN to Sigma-Tau for distribution in Europe. SciClone retains all U.S. and other international rights to ZADAXIN.

"ZADAXIN is now in late stage clinical trial programs in the world’s three largest pharmaceutical markets, the U.S., Europe and Japan. More importantly, we are able to have human and financial resources applied to ZADAXIN’s promise as an oncology therapy without affecting SciClone’s commitment to the U.S. hepatitis C clinical program," said Donald R. Sellers, SciClone’s President and Chief Executive Officer. "The two U.S. phase 3 hepatitis C trials are designed to generate sufficient statistical basis for both U.S. and European registration. We are confident in the experience, abilities and competency of the Sigma-Tau research and development group as a solid platform from which to launch a well-managed European oncology clinical program. This initiative is expected to have spill-over benefits for SciClone’s U.S. clinical program in oncology.""

We are excited to give our contribution to the development of ZADAXIN for cancer indications," said Dr. Paolo Carminati, head of Research and Development at Sigma-Tau. "Sigma-Tau’s own research and development efforts are already strongly focused on oncology. Developing ZADAXIN’s potential as an oncology agent is a natural direction for Sigma-Tau to follow, particularly because the U.S. hepatitis C program is already underway. Both hepatitis C and cancer are very important therapeutic categories in Europe." 

ZADAXIN is a pure synthetic preparation of thymosin alpha 1, a peptide that occurs naturally in humans and is an immune system enhancer ("ISE") that helps stimulate, maintain and direct the body’s antiviral or anticancer responses. ZADAXIN has been administered to over 3,000 patients in clinical trials covering a broad range of diseases and to many thousands of patients commercially around the world, without adding to the side effect profile of combination therapies for infectious diseases and cancer. ZADAXIN is approved for sale in 25 countries, principally for the treatment of hepatitis B and hepatitis C, and also in certain countries as a vaccine adjuvant for patients with weakened immune systems and as an adjuvant to chemotherapy for the treatment of various cancers.

Sigma-Tau is a leading Italian pharmaceutical group with estimated revenues in excess of 500 million Euros for 2001 and over 2200 employees worldwide. Therapeutic areas on which the company’s research and development are focused include oncology, neurology, cardiovascular, gastroenterology, metabolism and immunology. Sigma-Tau has been engaged over the years also in the biotechnology sector. It has recently decided to further renew its commitment becoming the major shareholder of Tecnogen S.C.p.A., a biotech R&D and process development company, with expertise in the R&D and process development of proteins with pharmacological properties, monoclonal antibodies and peptidic combinatorial libraries mainly in oncology, immunology and CNS. Sigma-Tau has operating subsidiaries in Spain, Switzerland, the Netherlands, France, Germany and the United States. Sigma-Tau maintains a presence in all of the world’s major pharmaceutical markets through either licensees or representative offices. Press releases and corporate information from Sigma-Tau are available on the Internet at .

Source: Evaluate™
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