Nystatin LF (Aronex/Abbott).
Nystatin LF (Nyotran) is a liposomal, intravenous nystatin formulation under development by Aronex, under license from the MD Anderson Cancer Research Center, as a systemic antifungal agent against strains including Aspergillus and Candida. Like amphotericin, nystatin is a polyene derivative that binds to ergosterol, a fungal cell membrane component, creating a pore in the membrane and thus killing the cell. Nystatin is an established antifungal agent, but is restricted to topical use as it is ineffective orally and severely toxic when administered iv [187583], [187589]. It has demonstrated good, broad in vitro antifungal activity against clinically relevant filamentous fungi [319465], including fungi resistant to fluconazole and amphotericin B products [264505], [2869821, [287790], 1289522]. The company is also conducting a phase III trial to evaluate its efficacy against cryptococcal meningitis [305531], [334156]. Aronex filed for approval of nystatin LF in Spain in December 1997 [272986] and expected to file an NDA in the US by the end of 1999 1311208], [342003]. However, in an effort to ensure that its US and European filings contained data from the phase III cryptococcal meningitis trial in its entirety, Aronex's marketing partner requested that all the 70-day data be gathered prior to unblinding this study. The filing had initially been based on interim data at the 14- and 21-day endpoint 1344887]. In September 2000, the company anticipated an NDA filing in the US in the fourth quarter of 2001 1382861], 1387947]. In December 1997, Aronex, together with Grupo Ferrer Internacional, filed an MAA in Spain seeking approval for Nyotran for the treatment of systemic fungal infections. Aronex intended to follow the filing with additional filings in other European countries 1272986]. In 1997, a commercialization agreement was signed with Ferrer for Spain and Portugal, with Aronex intending to form other such partnerships throughout Europe and Asia 1248346]. In November 1998, Aronex signed a licensing collaboration with Abbott Laboratories for the worldwide rights to nystatin LF [305531].
Arikan
S
S
Hacettepe University Medical School, Department of Microbiology and Clinical Microbiology, Ankara, Turkey. sarikan@metu.edu.tr
Rex
J H
JH
D000935:Antifungal Agents / Q000008:administration & dosage*; D002986:Clinical Trials as Topic; D004337:Drug Carriers; D006801:Humans; D008081:Liposomes; D009761:Nystatin / Q000008:administration & dosage* / Q000378:metabolism / Q000494:pharmacology; D013329:Structure-Activity Relationship
D000935:Antifungal Agents; D004337:Drug Carriers; D008081:Liposomes; D009761:Nystatin