bibliography :::

SPK-843 new antifungal agent


SPK-843 ::: DOCUMENTATION


   Chemistry and Pharmacy
   In vitro and in vivo antifungal activity
   Pharmacodynamic and safety studies
   Pharmacokinetic tests
   Toxicology and mutagenicity

Chemistry and pharmacy

45a. DMF of drug substance SPK-843
45b. Chemical and Pharmaceutical Documentation of drug product SPK-843

In vitro and in vivo antifungal activity

46. Rimaroli C., Bruzzese T.
In vitro activity of a new polyene, SPK-843, against yeasts.
Antim.Ag.Chemother., 42, 11, 3012, 1998
47. Summary of the communication presented at the 5th ASM Conference on Candida and Candidiasis - March 1-4, 1999 - Charleston, South Carolina -USA
(Rimaroli C., Bruzzese T. - In vitro activity of SPK-843 against Candida sp.)
47a. Rimaroli C., Bruzzese T.
Overview of SPK-843 in vitro activity against filamentous fungi.
Chemotherapy, 46, 28, 2000
47b. Summary of the communication presented at the 5th Congress of the ECMM – June 3-6, 1999 – Dresden – Germany
(Rimaroli C., Bruzzese T. – In vitro activity of SPK-843 against filamentous fungi)
47c. Summary of the communication presented at the International Meeting on ACCP -
October 27-30, 1999 – Santa Margherita Ligure – Portofino (Genova) Italy
(Rimaroli C, Bruzzese T. – In vitro activity of a new polyene, SPK-843)

47d. Strippoli V., D’Auria F.D., Simonetti G., Bruzzese T, and Simonetti N.
Anticandidal activity of SPK-843, a new polyenic drug.
J.Antimicr.Chemother., 45, 235, 2000
47e. Communication presented at the 40th ICAAC – Toronto, Canada , 2000
(Senda H., Maejima T. et al. - Kaken Pharma. Co. – SPK-843, a new polyene antibiotic with potent in vitro activity and a strong fungicidal effect – Poster 1093)
48. Kaken Pharm.Co. (Maejima T. et al.)
Comparative activity of SPK-843 on systemic fungal infections in mice.
Kaken Bim. Report - February 1997

49. Kaken Pharm.Co. (Maejima T. et al. )
Pharmacology : Systemic infections / Pulmonary infections
Meeting Kyoto - May 22-23,1997
May 24, 2001
50. Kaken Pharm.Co. (Maejima T. et al. )
Pharmacology : Efficacy of SPK-843 on systemic infection caused by
Candida albicans KSG-27 in normal Wistar rats.
Kaken Report - September 1997
51. Kaken Pharm.Co. (Maejima T. et al. )
Pharmacology.
Kaken Bim. Report - December 1997
52. Kaken Pharm.Co. (Maejima T. et al. )
Pharmacology.
Kaken Bim.Report - February 1998
53. Kaken Pharm.Co. (Senda H. et al. )
Pharmacology.
Kaken Bim.Report April 1998 and November 1998
53a. Kaken Pharm.Co. (Senda H.)
Pharmacology/Abstracts on Antifungal activity and therapeutic effect of SPK-843.
53b. Communication presented at the 40th ICAAC – Toronto, Canada , 2000
(Senda H., Maejima T. et al. - Kaken Pharma. Co. – Potent effect of SPK-843, on experimental candidiasis and pulmonary aspergilloses - Poster 1094)
53c. Kaken Pharm.Co. (Senda H.)
Efficacy Pharmacology of SPK-843 – Final Report

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Pharmacodynamic and safety studies

54. SPA - Pharmacology and Toxicology Dept.
Safety Pharmacology Studies
February 1999

Pharmacokinetic tests

55. Summary of the communication presented at the XIIIth Int.Congress of Pharmacology - 26 - 31 July 1998, Munchen (Germany)
(Bonabello A., Galmozzi M.R., Buffa G., Bruzzese T. - Rat serum and tissue distribution of SPK-843 , a new semisynthetic polyene antibiotic).

55a. Bruzzese T. , Galmozzi M.R., Buffa G., Sala P. and Bonabello A.
Pharmacokinetics in rats of N-dimethylaminoacetyl-Partricin A 2- dimethylaminoethylamide diascorbate (SPK-843)
Chemotherapy, 47, 77, 2001
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Toxicology and mutagenicity

56. SPA - Pharmacology and Toxicology Dept.
Acute toxicity data (rats and mice)
SPA Report - December 1996
57. Kaken Pharm.Co. (Yoshida M.)
Preliminary single dose toxicity study of SPK-843 by intravenous administration in rats. Study No. ST 960405.
57a. Kaken Pharm.Co.
A single dose intravenous toxicity study of SPK-843 in rats - Study No. SQT 033 Final report - January 30,1998 - June 10, 1998
57b. Kaken Pharm.Co. (Akira Ito)
A 4-week intravenous toxicity study of SPK-843 in rats followed by 4-week recovery period - Study N. SRT003 . Final Report - October 30, 1998

58. Kaken Pharm.Co. (Tsusaki H.)
A single dose intravenous infusion toxicity study of SPK-843 in Cynomolgus monkeys -Study number SBL 73-69. February 23, 1998.

59. Kaken Pharm.Co. (Tsusaki H.)
A 2-week intravenous infusion toxicity study of SPK-843 in Cynomolgus monkeys - Study number SBL 73-70 . March 27, 1998.

60. Kaken Pharm.Co.
Toxicological study / 4 weeks in monkey : Summary
Meeting Milan - November 23-24, 1998
60a. Kaken Pharm.Co (Hideshi Tsusaki)
A 4-week intravenous infusion toxicity study of SPK-843 in Cynomolgous monkeys followed by a 4-week recovery period. - Study No. SBL 73-71 - November 4, 1998

60b. Kaken Pharm.Co.(Junichi Yoshida)
Chromosomal aberration test of SPK-843 in CHL/IV cells - Study No. SRT 009 - Final Report - September 30, 1998

60c. Kaken Pharm.Co.(Junichi Yoshida)
Reverse mutation test of SPK-843 in bacteria - Study No.SRT 006 - Final Report July 31, 1998

60d. Kaken Pharm.Co.(Junichi Yoshida)
Peripheral blood micronucleus test in mice administered SPK-843 intravenously
Study No. SRT007 – Final Report -August 14, 1998
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