Appeal 2007-1615
Application 10/693,442
double blind, placebo controlled study. During the first two-stages of the
study . . . the safety, tolerability and pharmacokinetics of ascending single
doses [of P57] and of repeated dosing in healthy overweight volunteers
[were assessed]” (id.). “In the third phase, . . . the effects on calorie intake
in [ ] overweight men who took the compound or placebo twice daily for 15
days [were investigated]” (id.). “By the end of the study, men in the
treatment group achieved a 30% reduction in calorie intake, accompanied by
a significant reduction in body fat content by 1 kg” (id.). Habeck reports
that an independent consultant, responsible for advising researchers on the
dietary aspects of their clinical trials “agree[d] that the results of the proof-
of-principle study are very encouraging” and suggested “longer studies in
more people to demonstrate that this is a consistent effect[,] [since] [o]besity
is a chronic relapsing problem” (id.). Habeck also reports that the
researchers’ “next step will be to look at the dosing interval” (id.).
Van Heerden describes appetite suppressing extracts of Hoodia, a
pharmaceutical composition containing P57, a compound from the Hoodia
plant responsible for appetite suppression, and derivatives and analogs of
P57. Test rats given a single dose of an extract of Hoodia “on day 5 [of an
experiment described in Examples 1 and 2] displayed a substantially
diminished food intake over the next two days, while the control group did
not disclose a comparable reduced food intake. The food intake of the test
group returned to normal, and in fact increased from day 8 onwards” (Van
Heerden, col. 37, l. 50 to col. 38, l. 4). In other words, the appetite
suppressive effect of a single dose lasted 2 to 3 days, after which appetite
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