Phase II study of NK105, a paclitaxel-incorporating micellar nanoparticle as second-line treatment for advanced or recurrent gastric cancer.

Chin, Koei; Kato, K.; Yoshikawa, T.; Yamaguchi, Kazuhisa; Esaki, Tetsuo; Tsuji, Yoshiaki; Sakai, Keisuke; Kimura, Masashi; Ikeda, Rie; Matsumura, Y

doi:10.1200/jco.2010.28.15_suppl.4041

Cited by 10 publications

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“…PEGylated proteins, antibodies, and most recently aptamers have been particularly successful, and several PEG-aptamers are undergoing clinical evaluation as treatments for age-related macular degeneration, cancer, diabetic nephropathy, and coronary disease (reviewed in ref ). Block copolymer micelles (e.g., the PEG-poly(aspartate) block copolymers) incorporating drug by either chemical conjugation or physical entrapment (20–100 nm) are undergoing phase I/II studies as anticancer agents, e.g., micelles containing cisplatin (NC-6004), , oxaliplatin (NC-4106), and paclitaxel (NK-105) , (reviewed in ref ). In a phase II study in patients with advanced gastric cancer after failure of first-line chemotherapy NK105 (150 mg paclitaxel-equiv/m 2 every 3 weeks) there were 2 complete responses and 12 partial responses in 56 evaluable patients with good tolerability.…”

Section: The Future: Nanomedicines Of Tomorrow?mentioning

confidence: 99%

“…Block copolymer micelles (e.g., the PEG-poly(aspartate) block copolymers) incorporating drug by either chemical conjugation or physical entrapment (20–100 nm) are undergoing phase I/II studies as anticancer agents, e.g., micelles containing cisplatin (NC-6004), , oxaliplatin (NC-4106), and paclitaxel (NK-105) , (reviewed in ref ). In a phase II study in patients with advanced gastric cancer after failure of first-line chemotherapy NK105 (150 mg paclitaxel-equiv/m 2 every 3 weeks) there were 2 complete responses and 12 partial responses in 56 evaluable patients with good tolerability.…”

Section: The Future: Nanomedicines Of Tomorrow?mentioning

confidence: 99%

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Nanomedicine(s) under the Microscope

2011

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Depending on the context, nanotechnologies developed as nanomedicines (nanosized therapeutics and imaging agents) are presented as either a remarkable technological revolution already capable of delivering new diagnostics, treatments for unmanageable diseases, and opportunities for tissue repair or highly dangerous nanoparticles, nanorobots, or nanoelectronic devices that will wreak havoc in the body. The truth lies firmly between these two extremes. Rational design of "nanomedicines" began almost half a century ago, and >40 products have completed the complex journey from lab to routine clinical use. Here we critically review both nanomedicines in clinical use and emerging nanosized drugs, drug delivery systems, imaging agents, and theranostics with unique properties that promise much for the future. Key factors relevant to the design of practical nanomedicines and the regulatory mechanisms designed to ensure safe and timely realization of healthcare benefits are discussed.

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Section: The Future: Nanomedicines Of Tomorrow?mentioning

confidence: 99%

Section: The Future: Nanomedicines Of Tomorrow?mentioning

confidence: 99%

Nanomedicine(s) under the Microscope

2011

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“…35 In a subsequent Phase 2 study, the dose was reduced to 150 mg/m 2 PTX q3w with a 30-min intravenous infusion. 36 Comparison of the PK data shown in Table 5 indicates very similar behavior for Genexol-PM and Taxol, suggesting that the higher MTD and reduced occurrence of adverse effects observed for the micelle formulation are mainly related to the absence of Cremophor EL. Similar to the observation for LEP-ETU liposomes, the data does not indicate enhanced stability of Genexol-PM over Taxol in the blood stream.…”

Section: What Nanomedicines In the Clinic Right Now Really Form Nanoparticles?mentioning

confidence: 86%

“…NK105 was administered intravenously as a 1‐h infusion q3w without premedication, and a MTD of 180 mg/m 2 was determined in a Phase 1 study involving 19 patients . In a subsequent Phase 2 study, the dose was reduced to 150 mg/m 2 PTX q3w with a 30‐min intravenous infusion . Comparison of the PK data shown in Table indicates very similar behavior for Genexol‐PM and Taxol, suggesting that the higher MTD and reduced occurrence of adverse effects observed for the micelle formulation are mainly related to the absence of Cremophor EL.…”

Section: What Nanomedicines In the Clinic Right Now Really Form Nanoparticles?mentioning

confidence: 99%

What nanomedicine in the clinic right now really forms nanoparticles?

Svenson

2014

WIREs Nanomed Nanobiotechnol

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Some researchers believe nanomedicine will revolutionize healthcare and medicine through transformative new therapeutic tools. Nanocarriers, utilized to transport actives to the target site, are constructed from a wide range of materials. Nanocarriers can be grouped into self-assembling (liposomes, micelles), processed (nanoparticles, emulsions), and chemically bound (dendrimers, silica-based carriers, carbon nanotubes) structures. A review of nanomedicines on the market and in clinical translation reveals that the vast majority is based on liposomes, polymeric micelles, and nanoparticles. The increasing presence of these novel nanomedicines raises the question what nanomedicines in the clinic right now really form nanoparticles, i.e., are improvements we see from nanomedicines structure-related or do they result from improved formulations? Do we even have sufficient data to address this question? The formation of nanocarriers is usually confirmed in vitro but little if any in vivo (let alone clinical) information is available. Given the large number of nanomedicines on the market and under clinical evaluation one clearly cannot expect to find a 'one size fits all' answer. Therefore, two case studies are discussed: the paclitaxel formulation Taxol® and its nanomedicine companions LEP-ETU (liposome), Genexol®-PM and NK105 (micelles), and Abraxane® (nanoparticle). Published pharmacokinetic data is utilized to find differences indicating nanocarrier delivery. The second case study involves structurally related camptothecin-polymer conjugates CRLX101 (nanoparticles) and XMT-1001 (prodrug). Structural differences are evaluated to discuss the different aggregation behavior. This opinion can only serve as first attempt to find a more general answer; clearly more data is needed from future studies.

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“…4 Results of clinical trial studies of NK105 showed that it was well tolerated 5 and efficacious in patients with gastric cancers. 6 Another polymeric micelle formulation of PTX is Genexol-PM ® (Samyang Pharmaceuticals, Daejeon City, Korea), 7 amphiphilic micelleforming diblock copolymers of poly(D,L-lactide) and poly(ethylene glycol), and PTX incorporated within the core. A Phase I clinical trial study showed that Genexol-PM delivered higher PTX drug doses without additional toxicity, 8 and it also had a better response rate in patients with metastatic breast cancer 9 compared with Taxol.…”

Section: Introductionmentioning

confidence: 99%

Novel free paclitaxel-loaded poly(L-γ-glutamylglutamine)–paclitaxel nanoparticles

Van¹,

Yu²,

Yang³

2011

IJN

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The purpose of this study was to develop a novel formulation of paclitaxel (PTX) that would improve its therapeutic index. Here, we combined a concept of polymer–PTX drug conjugate with a concept of polymeric micelle drug delivery to form novel free PTX-loaded poly(L-γ-glutamylglutamine) (PGG)–PTX conjugate nanoparticles. The significance of this drug formulation emphasizes the simplicity, novelty, and flexibility of the method of forming nanoparticles that contain free PTX and conjugated PTX in the same drug delivery system. The results of effectively inhibiting tumor growth in mouse models demonstrated the feasibility of the nanoparticle formulation. The versatility and potential of this dual PTX drug delivery system can be explored with different drugs for different indications. Novel and simple formulations of PTX-loaded PGG–PTX nanoparticles could have important implications in translational medicines.

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Phase II study of NK105, a paclitaxel-incorporating micellar nanoparticle as second-line treatment for advanced or recurrent gastric cancer.

Cited by 10 publications

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Nanomedicine(s) under the Microscope

Nanomedicine(s) under the Microscope

What nanomedicine in the clinic right now really forms nanoparticles?

Novel free paclitaxel-loaded poly(L-γ-glutamylglutamine)–paclitaxel nanoparticles

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Phase II study of NK105, a paclitaxel-incorporating micellar nanoparticle as second-line treatment for advanced or recurrent gastric cancer.

Cited by 10 publications

References 0 publications

Nanomedicine(s) under the Microscope

Nanomedicine(s) under the Microscope

What nanomedicine in the clinic right now really forms nanoparticles?

Novel free paclitaxel-loaded poly(L-&gamma;-glutamylglutamine)&ndash;paclitaxel nanoparticles

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Product

Resources

About

Novel free paclitaxel-loaded poly(L-γ-glutamylglutamine)–paclitaxel nanoparticles