COUNTY OF SAN MATEO

Inter-Departmental Correspondence

San Mateo Medical Center

DATE:

May 20, 2004

BOARD MEETING DATE:

June 8, 2004

TO:

Honorable Board of Supervisors

FROM:

Nancy J. Steiger, Chief Executive Officer, San Mateo Medical Center

SUBJECT:

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

Recommendation

Adopt a resolution authorizing the President of the Board to accept an increase to the grant from the SciClone Pharmaceuticals, Inc. and to execute an Amendment to the Agreement 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.

On August 5, 2003, your Board accepted a grant from SciClone in the amount of $101,500 from SciClone Pharmaceuticals, Inc. and approved an agreement 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.

Discussion

Due to the increased cost of patient care and lab work relating to this study, SciClone is awarding an additional $1,000 per patient enrolled into the study. This will add an additional $10,000 to the original agreement.

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 agreement to conduct the research remains the same, from June 19, 2003 through June 19, 2006. This total amount of the award is increased by $10,000, from $101,500 to $111,500. 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.