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Clinical Program
PhytoCeutica’s core focus
is getting the first botanical-based prescription drug approved by
the FDA. The FDA’s recent publication
Guidance
for Industry Botanical Drug Products provides an overarching
description of the regulatory pathway botanical drugs must take to
gain regulatory prescription approval.
This framework is similar to that for synthetic or highly purified
drugs:
Investigational New Drug Application (IND)
Phase I
Phase II
Phase III
New Drug Application (NDA)
However, the details requisite
for a successful navigation of this pathway remain undefined.
PhytoCeutica will work closely with the FDA as its lead product,
PHY906, makes its way through the various clinical phases.
An Investigational New Drug Application (IND) for PHY906 was
filed May 2001. To date, 2
clinical trials—in
colorectal and
primary liver cancers--have been initiated under this IND.
Future trials are planned for Q3/Q4 2005. |
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PhytoCeutica, Inc. 5 Science Park, Suite
13 New Haven, CT 06511
Phone: 203-777-3462 Fax: 203-777-3538 E-mail: info@phytoceutica.com |
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