Development of Standardized Milk Thistle Product

DESCRIPTION (Provided by applicant): The objective of this Phase I and II fast
track application is to develop a standardized milk thistle product and to
assure a quality controlled and reliable source for future basic and clinical
studies. Natural Pharmacia International, Inc, an established natural products
laboratory, has established an excellent consortial team to establish a
standardized milk thistle product following FDA guidelines. The key to the
success of this program as it has been conceived, is the cooperative efforts of
experts in botanical identification, cultivation, natural products chemistry,
chemical synthesis and analysis, quality assurance and control, toxicity
evaluation, bioavailability and pharmacokinetics analysis, in vitro and in vivo
liver disease models, formulation and regulatory issues including DMS (drug
master file) and IND (investigational new drug) filing. In addition, NPI
proposed an outstanding business plan, which includes the source of the milk
thistle seed extract, GMP manufacturing and packaging, storage, inventory, and
distribution of the standardized product and placebo in Phase III.
PROPOSED COMMERCIAL APPLICATION:
This research may lead to the development of a standardized milk thistle product for
treatment of liver diseases.