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.

Keywords:

• cancer
• nanodrug
• nanoformulated drug
• nanoformulation
• nanomedicine
• nanooncology
• nanoparticle
• nanopharmaceuticals

Acknowledgement

EA was in charge of the overall supervison of the paper and wrote most of it. Mickael Durand-Dubief, Chalani Mandawala and Raphael Lefèvre helped with the scientific aspects while Pierre Grand-Dewyse contributes on financial issues.

Disclaimer

The authors have made their best effort to report correct data in this review based on previously published reports but the authors cannot guarantee that no errors exist.

Financial & competing interests disclosure

All authors were employees of Nanobacterie when the article was written. The authors have no other relevant affiliations or financial involvement with any organization or entity with a financial interest in or financial conflict with the subject matter or materials discussed in the manuscript apart from those disclosed.

Key issues

• Nanoformulated drugs are very divers, present less toxicity than their non-nanoformulated counterparts and are characterized by specific biodistribution properties in the organism due to their small sizes.

• Nanoformulated drugs can usually target tumors through the enhanced permeability and retention effect, which leads to a larger concentration of drugs in the tumor compared with their non-nanoformulated counterparts.

• The activity of several of these drugs can be activated on demand by an external source of energy (magnetic field or x-ray), leading to a controlled therapy.

• Regulation is currently emerging to allow the development of these drugs.

• Small companies have recently appeared that develop these drugs.