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The preclinical safety profile of imatinib was assessed in rats, dogs, monkeys and rabbits. Multiple dose toxicity studies revealed mild to moderate haematological changes in rats, dogs and monkeys, accompanied by bone marrow changes in rats and dogs. The liver was a target organ in rats and dogs. Mild to moderate increases in transaminases and slight decreases in cholesterol, triglycerides, total protein and albumin levels were observed in both species. No histopathological changes were seen in rat liver. Severe liver toxicity was observed in dogs treated for 2 weeks, with elevated liver enzymes, hepatocellular necrosis, bile duct necrosis, and bile duct hyperplasia. Renal toxicity was observed in monkeys treated for 2 weeks, with focal mineralisation and dilation of the renal tubules and tubular nephrosis. Increased blood urea nitrogen BUN ; and creatinine were observed in several of these animals. In rats, hyperplasia of the transitional epithelium in the renal papilla and in the urinary bladder was observed at doses 6 mg kg in the 13-week study, without changes in serum or urinary parameters. An increased rate of opportunistic infections was observed with chronic imatinib treatment. In a 39-week monkey study, no NOAEL no observed adverse effect level ; was established at the lowest dose of 15 mg kg, approximately one-third the maximum human dose of 800 mg based on body surface. Treatment resulted in worsening of normally suppressed malarial infections in these animals. Imatinib was not considered genotoxic when tested in an in vitro bacterial cell assay Ames test ; , an in vitro mammalian cell assay mouse lymphoma ; and an in vivo rat micronucleus test. Positive genotoxic effects were obtained for imatinib in an in vitro mammalian cell assay Chinese hamster ovary ; for clastogenicity chromosome aberration ; in the presence of metabolic activation. Two intermediates of the manufacturing process, which are also present in the final product, are positive for mutagenesis in the Ames assay. One of these intermediates was also positive in the mouse lymphoma assay. In a study of fertility, in male rats dosed for 70 days prior to mating, testicular and epididymal weights and percent motile sperm were decreased at 60 mg kg, approximately equal to the maximum clinical dose of 800 mg day, based on body surface area. This was not seen at doses 20 mg kg. A slight to moderate reduction in spermatogenesis was also observed in the dog at oral doses 30 mg kg. When female rats were dosed 14 days prior to mating and through to gestational day 6, there was no effect on mating or on number of pregnant females. At a dose of 60 mg kg, female rats had significant post-implantation foetal loss and a reduced number of live foetuses. This was not seen at doses 20 mg kg. In an oral pre- and postnatal development study in rats, red vaginal discharge was noted in the 45 mg kg day group on either day 14 or day 15 of gestation. At the same dose, the number of stillborn pups as well as those dying between postpartum days 0 and 4 was increased. In the F1 offspring, at the same dose level, mean body weights were reduced from birth until terminal sacrifice and the number of litters achieving criterion for preputial separation was slightly decreased. F1 fertility was not affected, while an increased number of resorptions and a decreased number of viable foetuses was noted at 45 mg kg day. The no observed effect level NOEL ; for both the maternal animals and the F1 generation was 15 mg kg day one quarter of the maximum human dose of 800 mg ; . Imatinib was teratogenic in rats when administered during organogenesis at doses 100 mg kg, approximately equal to the maximum clinical dose of 800 mg day, based on body surface area. 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1st dam BORISTOVA IRE ; : winner at 2 and placed 4 times; dam of 5 previous foals; 5 runners; 2 winners: LADY BEAR IRE ; 98 f. by Grand Lodge USA : 11 wins to 2004 at home and in Kingdom of Saudi Arabia and 204, 537 inc. Sunley Atalanta S., L., placed 2nd Dahlia S., L. and 3rd Kleenex Tissues Rosemary H., L. Enoiffos IRE ; 01 c. by Turtle Island IRE : winner at 2, 2003 in Italy and placed. Barton Flyer IRE ; 99 g. by Eagle Eyed USA : placed 3 times at 4, 2003. Shauban IRE ; 97 f. by Dolphin Street FR : placed at 2. 2nd dam Bold Meadows: 2 wins at 2 and 3 and placed twice inc. 2nd Blandford S., Gr.2; dam of 6 winners inc.: Judicial Field IRE ; g. by Law Society USA : 10 wins, 74, 936 viz. 4 wins at 2 and 3 and placed 9 times inc. 3rd Aer Rianta Shannon Challenge Race, L. and Ardilaun House Hotel Oyster S., L.; also 2 wins over hurdles and placed 9 times inc. 3rd Murphys Irish Stout Champion 4yo Hurdle, L. and The Ladbroke Extended H. Hurdle, L. and 4 wins over fences and placed 18 times. Bold Vision f. by Vision USA : placed at 2 viz. 3rd Dry Cane Sweet Solera S., L.; dam of 2 winners inc.: HARVARD HONOR NZ ; : 3 wins in New Zealand inc. Enterprise Homes Great Easter S., L., placed 3rd Smokefree Wellington S., Gr.3. Field of Vision IRE ; : 14 wins, 77, 176 inc. 11 wins and placed 43 times. Strawberry Beds IRE ; : 2 wins at 2 and 4 and placed 6 times. Burnley Al IRE ; 2-y-o gelding by Desert King IRE ; : in training. She also has a yearling filly by Desert Sun GB ; . 3rd dam SPARE FILLY by Beau Sabreur ; : 3 wins at 3 and 4 and placed 8 times; Own sister to SAMOTHRAKI; dam of 9 winners inc.: VAN HOUTEN: 12 wins in Italy and 140, 120, 000 lire inc. Premio Emanuele Filiberto, Gr.2, 3rd Gran Criterium, Gr.1, Premio Emilio Turati, Gr.1; sire. AFRICAN TUDOR: 12 wins at home and in Italy and 56, 918 inc. Premio Bereguardo, L., 4th Premio Omenoni, Gr.3. MANFILIA: 5 wins inc. Scottish & Newcastle Breweries H., L.; dam of 6 winners inc.: KILIJARO: Champion 2yr old filly in Ireland in 1978, Champion 3yr old sprinter in Europe in 1979, 14 wins at home, in France and in U.S.A. and $533, 100, 1, 225, 000 fr. and 34, 913 inc. Patrick S. Gallagher Phoenix S., Gr.1, Prix du Moulin de Longchamp, Gr.1 and Yellow Ribbon S., Gr.1; dam of Cossack Guard USA ; winner, 2nd Prix du Cadran, Gr.1 grandam of SHAME AUS ; won Sires' Produce S., Gr.1, The 1000 Guineas, Gr.1 third dam of OTHER VICTORY BRZ ; won Assoc. Bras. Criadores do Cavalo Corrida, Gr.3 ; . AFRICAN HOPE: 7 wins in France and 546, 000 fr. inc. La Coupe, Gr.3; sire. Stabled in Barn D Box 22 and citalopram.

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