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Development of Standardized Milk Thistle Product

Award Information
Agency: Department of Health and Human Services
Branch: National Institutes of Health
Contract: PHS2001-2
Agency Tracking Number: 1R42AT000766-01
Amount: $221,244.00
Phase: Phase II
Program: STTR
Solicitation Topic Code: N/A
Solicitation Number: N/A
Solicitation Year: N/A
Award Year: 2001
Award Start Date (Proposal Award Date): N/A
Award End Date (Contract End Date): N/A
Small Business Information
115 MILL ST BELMONT, MA 02478-9106
United States
HUBZone Owned: No
Woman Owned: No
Socially and Economically Disadvantaged: No
Principal Investigator
 (617) 855-2038
Business Contact
Phone: (617) 855-2188
Research Institution

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

* Information listed above is at the time of submission. *

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