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February 5, 2007:
Ipca files to DCGI - India First Investigational
New Drug Application (INDA) in
collaboration with
Central Drug Research
Institute (CDRI), Lucknow
Ipca Laboratories Limited
has entered into a collaborative agreement with CDRI
Lucknow to develop novel antimalarial drugs. The investigational compound
CDRI-97/98 is a synthetic trioxane; a new chemical entity co-developed by
CDRI and licenced to Ipca. The pre-clinical development of this compound
was carried out at CDRI and Chemical Research Division of Ipca. The IND
application was compiled by Medical Affairs and Clinical Research
Department of Ipca and is being filed to DCGI's Office for seeking
approval to conduct Phase-I (first in human) studies.
This
development is a major milestone in history of Ipca as this is the first
new chemical entity of Ipca. Successful development of this molecule will
result in availability of new therapeutic armamentarium in treatment of
resistant falciparum malaria.
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