Phase I/II clinical study on safety and antivascular effects of paclitaxel encapsulated in cationic liposomes for targeted therapy in advanced head and neck cancer

Abstract

Infusions of ET seem to be safe and further phase II and III studies are warranted to prove efficacy in the treatment of HNSCC.

Nanomedicine review: clinical developments in liposomal applications

“…Because of the paclitaxel's (PTX) insolubility in water, polyethoxylated castor oil (Cremophor EL) and dehydrated ethanol in a 1:1 (v/v) ratio are used as formulation vehicles, although it has toxic effects, such as hypersensitivity reactions, hyperlipidemia and neurotoxicity (Bulbake et al 2017;Xu et al 2013;Slingerland et al 2017;Ahn et al 2014;Graziani et al 2017;Strieth et al 2013). To avoid these drawbacks, many Cremophor-free liposomal paclitaxel (LPTX) formulations have been approved by FDA, such as (1) LEP-ETU, a conventional cationic nanosome with a size of about 150 nm (Slingerland et al 2017); (2) EndoTAG ™ -1, a cationic liposome formulation of lipid-embedded paclitaxel, which interacts with negatively charged tumor endothelial cells lessening their tumor blood supply (Strieth et al 2013;Awada et al 2014;Haas et al 2012;Ignatiadis et al 2016); and (3) Lipusu ® (Sike Pharmaceutical Co. Ltd., Nanjing, Jiangsu, P.R. China), a formulation approved in China prepared by using film dispersion methods followed by a lyophilization technique (Xu et al 2013;Slingerland et al 2017;Ahn et al 2014;Graziani et al 2017;Strieth et al 2013;Awada et al 2014;Haas et al 2012;Ignatiadis et al 2016;Ye et al 2013).…”

“…To avoid these drawbacks, many Cremophor-free liposomal paclitaxel (LPTX) formulations have been approved by FDA, such as (1) LEP-ETU, a conventional cationic nanosome with a size of about 150 nm (Slingerland et al 2017); (2) EndoTAG ™ -1, a cationic liposome formulation of lipid-embedded paclitaxel, which interacts with negatively charged tumor endothelial cells lessening their tumor blood supply (Strieth et al 2013;Awada et al 2014;Haas et al 2012;Ignatiadis et al 2016); and (3) Lipusu ® (Sike Pharmaceutical Co. Ltd., Nanjing, Jiangsu, P.R. China), a formulation approved in China prepared by using film dispersion methods followed by a lyophilization technique (Xu et al 2013;Slingerland et al 2017;Ahn et al 2014;Graziani et al 2017;Strieth et al 2013;Awada et al 2014;Haas et al 2012;Ignatiadis et al 2016;Ye et al 2013). Even Cremophor-free liposome-like formulations, such as Genexol-PM, a polymeric micelle formulation of paclitaxel (Samyang Co., Seoul Korea) (Ahn et al 2014), and PTX-LDE, a lipid core nanoparticle with encapsulated paclitaxel that binds to low-density lipoprotein receptors of cancer cells and concentrates in the tumor tissues (Graziani et al 2017).…”

Nanoparticles and nanofibers for topical drug delivery

“…Currently, several liposome-based drug delivery formulations are in clinical use for treating cancer, including melanoma [96]. Several other liposomal carriers for chemotherapeutic drugs are currently in clinical trials [97]. Moreover, major advances with cationic liposomes have led to the successful delivery of small interfering RNA (siRNA) [98].…”

Recent Clinical Developments of Nanomediated Drug Delivery Systems of Taxanes for the Treatment of Cancer

“… 59 1,2 dioleoyl-3-trimethylammonium-propane (DOTAP) and 1,2 dioleoyl-sn-glycero-3-phosphocholine (DOPC) are used to construct EndoTAG-1 which encapsulates paclitaxel. 60 , 61 The size of the EndoTAG-1 typically ranges between 180 and 200 nm. 60 Cationic liposomes have been proven to selectively accumulate within the tumor vascularization.…”