Strategy and planning for chemopreventive drug development: clinical development plans II.
Kelloff GJ,
Crowell JA,
Hawk ET,
Steele VE,
Lubet RA,
Boone CW,
Covey JM,
Doody LA,
Omenn GS,
Greenwald P,
Hong WK,
Parkinson DR,
Bagheri D,
Baxter GT,
Blunden M,
Doeltz MK,
Eisenhauer KM,
Johnson K,
Knapp GG,
Longfellow DG,
Malone WF,
Nayfield SG,
Seifried HE,
Swall LM,
Sigman CC.
Division of Cancer Prevention and Control (DCPC), National Cancer Institute (NCI), Bethesda, MD 20892, USA.
This is the second publication of Clinical Development Plans from the National Cancer Institute, Division of Cancer Prevention and Control, Chemoprevention Branch and Agent Development Committee. The Clinical Development Plans summarize the status of promising chemopreventive agents regarding evidence for safety and chemopreventive efficacy in preclinical and clinical studies. They also contain the strategy for further development of these drugs, addressing pharmacodynamics, drug effect measurements, intermediate biomarkers for monitoring efficacy, toxicity, supply and formulation, regulatory approval, and proposed clinical trials. Sixteen new Clinical Development Plans are presented here: curcumin, dehydroepiandrosterone, folic acid, genistein, indole-3-carbinol, perillyl alcohol, phenethyl isothiocyanate, 9-cis-retinoic acid, 13-cis-retinoic acid, l-selenomethionine and 1, 4-phenylenebis(methylene)selenocyanate, sulindac sulfone, tea, ursodiol, vitamin A, and (+)-vorozole. The objective of publishing these plans is to stimulate interest and thinking among the scientific community on the prospects for developing these and future generations of chemopreventive drugs.
PMID: 9154168 [PubMed - indexed for MEDLINE]