COUNTY OF SAN MATEO

Inter-Departmental Correspondence

San Mateo Medical Center

 

DATE:

July 27, 2005

BOARD MEETING DATE:

August 16, 2005

SPECIAL NOTICE/HEARING:

None

VOTE REQUIRED:

Majority

 

TO:

Honorable Board of Supervisors

FROM:

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

SUBJECT:

Agreement with Idenix Pharmaceuticals, Inc.

 

RECOMMENDATION:

Adopt a Resolution:

 

1)

Accepting a grant from the Idenix Pharmaceuticals in the amount not to exceed $94,560 to conduct a clinical trial evaluating the combination of Pegylated Interferon Alfa plus Valopicitabine (NM283) in Treatment- Naïve Patients with Chronic Hepatitis C.

 

2)

Authorizing the execution of an Agreement with Idenix Pharmaceuticals, Inc., to conduct the clinical trial for the term July 20,2005 until the trial is completed, in an amount not to exceed $94,560

 

VISION ALIGNMENT:

Commitment: Ensure Basic Health and Safety for All

Goal(s): Provide residents access to healthcare and preventive care

The agreement contributes to this commitment and goal by continuing to pursue efforts to expand prevention activities through research and clinical studies. This study will evaluate the Combination of Pegylated Interferon Alfa plus Valopicitabine (NM283) in Treatment Naïve Patients with Chronic Hepatitis C.

 

Performance Measure(s):

Measure

FY 2005-06
Projected

FY2006-07

Projected

Number of patients enrolled in the clinical trial

10

10

Percent of enrolled patients completing trial with a positive outcome

75%

75%

A maximum of 10 patients will be enrolled in the study and followed over a two-year period. It is the goal that by the conclusion of the study, that 75% of enrolled patients will have a positive outcome from the medications provided in this study.

BACKGROUND:

The Clinical Trials and Research Unit of the San Mateo County Health 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. 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 combination drug treatment.

 

DISCUSSION:

In May 2005 Idenix Pharmaceuticals, Inc. contacted the Clinical Trials and Research Unit to participate in a clinical trial for patients with Hepatitis C. On June 20, 2005, Idenix Pharmaceuticals, Inc notified the County that our site was selected to participate in the clinical trial. The County will receive up to $94,560 for fiscal year 2005-2006, if we are able to enroll 10 patients into the study.

The primary purpose of this study is to Evaluate the Combination of Pegylated Interferon Alfa plus Valopicitabine (NM283) in Treatment-Naïve Patients with Chronic Hepatitis C.

 

FISCAL IMPACT:

The grant from Idenix Pharmaceuticals, Inc will not exceed $94,560. Funds will be included in the September budget revision. The term of the agreement is July 20, 2005 until the trial is completed. 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.