Interference No. 102,408
positive was accepted as an indication that a compound had
anti-cancer activity (CR285,
¶ 2).
According to Durr (CR286, ¶ 3):
During 1984 at Lederle, the standard procedure
for carrying out the P 388 test was as follows:
The animals used were BDF 1 mice, all of one
sex, weighing a minimum of 17 g and all with a 3 g
weight range. There were 5 or 6 mice per test
group. The tumor transplant was by intraperitoneal
injection of 0.5 ml of diluted ascitic fluid
containing 10 cells of lymphocytic leukemia P 388.6
The test compounds in 0.5 ml of 0.2% Klucel in
normal saline were administered intraperitoneally on
days 1, 5 and 9 after tumor implantation, at the
indicated doses. The mice were weighed and the
survivors recorded on a regular basis for up to 30
days. The ratio of survival time for treated
(T)/control (C) animals times 100 was calculated. A
score of 125 or greater is an indication that the
compound was active in the P 388 test. [Compare
CR291.]
Exhibit B attached to the Durr declaration is said to
report the results of a P 388 test carried out on compound
"285605 (12459B 47A)." See CR287, ¶ 7; CR292. The exhibit
bears the following dates: (1) “DATE 6/20/84”, (2) “Data
Entered 7/27/84,” (3) "A.J. Hauss 9/25/84," and (4) “9/27/84
H.L. Lindsay.”
Additionally, junior party Child relies on the
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