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 Applications

This research may lead to the development of a standardized milk thistle product for treatment of liver diseases.

Agency
National Institute of Health (NIH)
Institute
National Center for Complementary & Alternative Medicine (NCCAM)
Type
Small Business Technology Transfer (STTR) Grants - Phase II (R42)
Project #
4R42AT000766-02
Application #
6603554
Study Section
Special Emphasis Panel (ZAT1-H (10))
Program Officer
Klein, Marguerite
Project Start
2001-09-20
Project End
2004-06-30
Budget Start
2002-07-15
Budget End
2003-06-30
Support Year
2
Fiscal Year
2002
Total Cost
$698,275
Indirect Cost
Name
Natural Pharmacia International, Inc.
Department
Type
DUNS #
City
Burlington
State
MA
Country
United States
Zip Code
01803