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                  <text>E

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June l5, i970
Dr. Wilma Harrison

Geigy Pharmaceuticals
Ardsiey, New York
Dear Wilma,

Following our discussion of June i0, i am pleased to include
reports of our studies of GP 4l299. The clinical report,
dated June i, l970 (iV: 6-l0-70) summarizes the data to May l, I970
with supplements to June i. As we discussed, these clinical trials
will continue to the limit of the available supply of GP 4l299.
You indicated that IOOO additional capsules will be shipped, and we
two interim

estimate this to be sufficient to add

3

additional subjects.

will complete these trials during the next 8-l0 weeks and
submit, in September, a final report with the case records, Gelgy
report forms and laboratory summaries.
We

report (ll: 6-i5-70) describing
4i299. it is clear that the EEG profile,
at single 75 mg doses, ls readily distinguished from placebo and most
resembles the drug, doxepin. For a definitive bio-classification
study, i would recommend an oral EEG comparison against doxepln,
chlordlazepoxide, imlpramine and placebo.
am

i

the

EEG

also enclosing

classification of

an interim
GP

clinical trials in progress, we would also suggest
clinical trial of GP 4l299. i am pleased with the
present pilot data which indicates that 225~300 mg/day is well
tolerated, clinically effective and safe in our laboratory tests; and
that the target symptom is overt anxiety. From the EEG profile, i
would suggest that measures of depressive mood be added and patients
with manifest depression be included in the trial. A protocol for such
a clinical study will be prepared in September.
Based on the
a more definitive

i

trust these data are useful,

Your comments on

grateful for your cOOperation.'
these interim reports will be welcome.
and

i

am

Sincerely yours,
Fink, M.D.
Professor of Psychiatry

Max

MFtkf

enc.

interim reports

#2
#3

(iv: 6-i0~70iand

(ii:

6~l5-70)

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