07 Feb A selection of publications in nanomedicine by Pr J. Descotes
- Caster JM, Patel AN, Zhang T, Wang A (2017) Investigational nanomedicines in 2016: a review of nanotherapeutics currently undergoing clinical trials. WIRES Nanomed Nanobiotechnol. 9(1) e1416.
Since the introduction of liposomal doxorubicin in clinical practice (1995), approx. 50 nanoparticle-based drugs have been approved for therapeutic use. As it is rather difficult to get a clear picture of what is going on in the field of nanomedicines, this review is a useful source of information. Many of nanomedicines that are either approved or under clinical investigation, are nanoformulations of an existing active pharmaceutical ingredient (API), which allows for implementation of the shortened FDA 505(b) pathway approval process. Successful nanomedicines are by far novel formulations of highly toxic or poorly soluble API. Cancer chemotherapy and antimicrobial therapy are the two leading areas of nanoformulations under investigation.
The systemic toxicity of various anticancer drugs, such as paclitaxel, irinotecan, docetaxel or doxorubicin, is often treatment-limiting. Anticancer drug nanoformulations have been mostly successful in reducing toxicity, but not in increasing antitumor activity. At least, 18 anticancer drug nanoformulations are in clinical trials including liposomal preparations, polymer-drug conjugates, polymeric micelles, formulations of dendrimeric or inorganic (iron oxide, hafnium oxide or colloidal gold) nanoparticles.
Similarly, antimicrobial nanoformulations often demonstrated reduced toxicity potential of the API, but increased bacterial activity as well. Hundreds of antimicrobial formulations have been tested preclinically and of these, 15 are currently in clinical trials including liposomal and dendrimeric antibiotics, antimicrobial polymers, and inorganic (nanosilver) antimicrobials.
Furthermore, 30 nanoformulations are in clinical development in various medical areas including anesthetics, ophthalmic drugs, metabolic disorders, or CNS and autoimmune diseases. So far, clinical benefits achieved by nanoformulations have largely been reductions in toxicity. They are also expected to change the course of treated diseases dramatically. Thus, marked evolutions in the design and medical applications of nanomedicines can be expected in the next few years.
- Bawa R, Audette GF, Rubinstein I (2016) Handbook of Clinical Nanomedicine, 1. Nanoparticles, imaging, therapy, and clinical applications; Vol.2. Law, business, regulation, safety, and risk. Boca Raton: Pan Stanford & CRC Press, pp.3210.
This very extensive two-volume handbook is warmly recommended as this is probably the most comprehensive and relevant review to date, of critical aspects of nanomedicine. This is indeed a helpful tool for all those interested in the preclinical development, clinical applications and marketing of nanomedicines.
The first volume consists of 3 sections. Section I provides a definition of nanoscale technology, a description of the short history of nanomedicine, and expectations for rising avenues of nanomedicine development. In section II, many critical aspects of nanoparticles and nanodevices are addressed, e.g. the properties of nanoparticles, the design of nanopharmaceutical products, pharmaceutical nanomaterials, and nanoparticles for imaging. Section III reviews a fair number of clinical applications of nanomedicines, for instance nanodiagnostic tools, nanosimilars, transdermal drug nanodelivery, gene therapy, tissue engineering, cardiovascular diseases, cancer therapy, HIV treatment, and so forth.
The second volume consists of 4 sections. Section I is focused on intellectual property, patenting, licensing, commercialization issues, and technology transfer. The great merit of this section is to present notions very often unfriendly to scientists in quite a straightforward manner. Section II deals with regulatory issues and uncertainties as currently addressed by FDA, EPA and EMA, and offers thoughts on possible or anticipated evolutions in this area. Section III is centered on health, toxicity and risk of nanoparticles. Specific covered aspects include occupational health monitoring of workers in the nanotechnology industry, metrology of nanoparticles, management of environmental and health risk associated with nanoparticles, risk perception, nanotoxicology including in vitro and in vivo safety evaluation. Finally, Section IV is focused on ethical issues, perspectives and future implications of nanomedicine.Back