NCI, Yeast Manufacturer Sign Clinical Trial Agreement

NCI, Yeast Manufacturer Sign Clinical Trial Agreement

FRESNO, Calif.--The National Cancer Institute (NCI) signed a Clinical Trial Agreementwith Cypress Systems Inc. for the use of Cypress' SelenoExcell High Selenium Yeast. Thetrials may lead to a New Drug Application and a Biological License Application.

The Eastern Cooperative Oncology Group, lead by Daniel Karp, M.D., from Beth IsraelDeaconess Medical Center in Boston, will conduct the first clinical trial. Thedouble-blind, randomized, placebo-controlled Phase III trial is entitled,"Chemoprevention Trial of Selenium Supplementation in Persons at High Risk for LungCancer." Approximately 2,000 men and women will be enrolled; persons who have hadsurgery for early stage non-small cell lung cancer may participate.

Participants will be given SelenoExcell as a 2000 mcg tablet. Cypress will supply boththe SelenoExcell and the placebo yeast; the tablets will be formulated by Chatsworth,Calif.-based Natrol Inc.