title: Cancer therapy using nanoformulated substances: scientific, regulatory and financial aspects.
abstract: Several nanoformulated anti-cancer substances are currently commercialized or under development. Pre-clinical and clinical results have revealed better properties, that is, larger efficacy and lower toxicity for these substances than for conventional anti-cancer treatments. Here, we review the development of several of these substances such as Marqibo, Myocet, Doxil, DaunoXome, MM398, MM302, Mepact, Versamune, Thermodox, Depocyt, Livatag, Abraxane, Eligard, Opaxio, Zinostatin Stimalamer (SMANCS), Pegasys and PegIntron, BIND-014, CRLX-101, Oncaspar, Neulasta, Aurimmune, Auroshell, AuNPs, Nanotherm, NanoXray, Magnetosome chains, Kadcyla (T-DM1), Ontak (DAB/IL2), Gendicine and Curcumin. We describe their specific properties, such as their stability, solubility, mean of administration or targeting, distribution, metabolism and toxicity. We discuss their categorization as medical devices or drugs, their fabrication process within a regulatory environment as well as intellectual property and financial aspects that are all essential to enable their industrial development.
authors.affiliation: a 1 Nanobacterie, Inc., 36 Boulevard Flandrin, 75116, Paris, France.|b 2 Université Pierre et Marie Curie, IMPMC, 4 place Jussieu, 75252, Paris, France.
authors.forename: Edouard
authors.initials: E
authors.lastname: Alphandéry
authors.affiliation: a 1 Nanobacterie, Inc., 36 Boulevard Flandrin, 75116, Paris, France.
authors.forename: Pierre
authors.initials: P
authors.lastname: Grand-Dewyse
authors.affiliation: a 1 Nanobacterie, Inc., 36 Boulevard Flandrin, 75116, Paris, France.|c 3 Institut de physique du globe de Paris, 1 rue Jussieu, 75238 Paris Cedex 05, France.
authors.forename: Raphael
authors.initials: R
authors.lastname: Lefèvre
authors.affiliation: a 1 Nanobacterie, Inc., 36 Boulevard Flandrin, 75116, Paris, France.|d 4 Muséum National d'histoire naturelle, IMPMC, 4 Place Jussieu, 75252, Paris, France.
authors.forename: Chalani
authors.initials: C
authors.lastname: Mandawala
authors.affiliation: a 1 Nanobacterie, Inc., 36 Boulevard Flandrin, 75116, Paris, France.
authors.forename: Mickael
authors.initials: M
authors.lastname: Durand-Dubief
mesh_terms: D000818:Animals; D000970:Antineoplastic Agents / Q000008:administration & dosage* / Q000009:adverse effects / Q000737:chemistry; D016503:Drug Delivery Systems; D015195:Drug Design; D004355:Drug Stability; D004335:Drug and Narcotic Control / Q000331:legislation & jurisprudence; D006801:Humans; D053758:Nanoparticles; D009369:Neoplasms / Q000188:drug therapy*; D012995:Solubility; D014018:Tissue Distribution
chemical_list: D000970:Antineoplastic Agents
keywords: cancer; nanodrug; nanoformulated drug; nanoformulation; nanomedicine; nanooncology; nanoparticle; nanopharmaceuticals