COUNTY OF SAN MATEO

Inter-Departmental Correspondence

San Mateo Medical Center

DATE:

July 18, 2003

BOARD MEETING DATE:

August 5, 2003

TO:

Honorable Board of Supervisors

FROM:

Nancy J. Steiger, Chief Executive Officer

SUBJECT:

Acceptance of a Grant Award from the SciClone Pharmaceuticals, Inc. and Agreement with SciClone Pharmaceuticals, Inc. to Conduct Research to Study the Safety and/or efficacy of Zadaxin

Recommendation

Adopt a resolution to accept a grant from the SciClone Pharmaceuticals, Inc. and to execute an agreement with SciClone Pharmaceuticals, Inc. to conduct a research to study the safety and/or efficacy of ZADAXIN (thymalfasin) Thymosin alpha 1, Infection (the Study Drug) for patients with compensated Cirrhosis due to chronic Hepatitis C.

Background

The Clinical Trials and Research Unit of the San Mateo Medical Center was established by the Health Services Agency in 2000 in order to provide a mechanism and infrastructure for the conduct of clinical treatment trials and medical or psychosocial research projects for the benefit of the residents of San Mateo County. A preliminary assessment by the unit staff identified Hepatitis C as a problem affecting many of the County's patients with HIV. The Clinical Trials and Research Unit discovered that patients are not responding to the current drug treatments. This trial will evaluate patient's response to this new drug treatment.

Discussion

In May 2003 SciClone Pharmaceuticals, Inc. contacted the Clinical Trials and Research Unit to participate in a Multicenter Double-Blinded Study for patients with compensated Cirrohosis due to chronic Hepatits C. On June 3, 2003, the SciClone Pharmaceuticals, Inc. notified the County that our site was selected to participate in the clinical trial.
The County will receive $101,500 for fiscal years 2003-2006 to fund this trial.
The primary purpose of this study is to access the safety and effectiveness of 12 months treatment with thymosin alpha 1 in combination with PEG-INF alpha-2a in adult patients with compensated Cirrhosis due to chronic Hepatitis C already treated with, and not responding to, IFN monotherapy or IFN plus ribavirin combination therapy.

Outcome Objectives

The following outcome objectives related to this project will be measured in 2003-2006 using an Evaluation Work Plan included in the grant proposal:

Outcome Measures

(at end of first year)
2003-2004
Objectives

Percentage of project client goal (10 persons) recruited and assessed.
100%

Percentage of project client's dosage comparisons completed.
100%

Percentage of project clients with positive response to trial medications.
25%

Vision Alignment

This agreement keeps the commitment to Ensure Basic Health and Safety for All and goal number 5: Provide residents access to healthcare and preventive care. The agreement contributes to this commitment by providing a mechanism for a study to access the safety and effectiveness of Zadaxin for patients with compensated Cirrhosis due to chronic Hepatitis C.

Fiscal Impact

The term of this agreement is from June 19, 2003 through June 19, 2006. This total amount of the award is $101,500. Administrative oversight, technical assistance, and project monitoring will be provided by existing Clinical Trials and Research staff. There is no net county cost associated with this project.