Further Details on Phase 1a Study -- Safety and Pharmacokinetic Profile of ITMN-191
The Phase 1a placebo-controlled study of ITMN-191 was completed in May of 2007, enrolling a total of 64 healthy volunteers. Doses in this study ranged from less than 10% to many-fold higher than those that will be evaluated in the three dosage cohorts of the Phase 1b trial. The study results show that:
-- ITMN-191 was well tolerated in all doses evaluated in Phase 1a study.
-- No Serious Adverse Events (SAEs) were reported and no subject
discontinued the study due to an Adverse Event (AE).
-- All AEs in subjects receiving ITMN-191 were classified as mild (CTCAE
-- The most common AEs reported were gastrointestinal-related and
consisted of mild diarrhea and mild abdominal pain. These mild AEs
occurred predominantly in the highest dose group, a dose many-fold
higher than the doses planned in the Phase 1b study just begun.
-- No clinically significant laboratory abnormalities or changes in
electro-cardiograms were observed.
-- Food has a significant effect on the absorption of ITMN-191, with
higher AUC in patients who took ITMN-191 with a meal.
-- The pharmacokinetics of ITMN-191 were linear over the range of doses
planned in the Phase lb study.
InterMune is a biotechnology company focused on the research,
development and commercialization of innovative therapies in pulmonology
and hepatology. InterMune has a pipeline portfolio addressing idiopathic
pulmonary fibrosis (IP
|SOURCE InterMune, Inc.|
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