Perspectives on the Future of Nanomedicine to Impact Patients: An Analysis of US Federal Funding and Interventional Clinical Trials

Abstract

The US and governments around the world, and companies, have made a considerable investment in nanomedicine, and there have been important discoveries. Nevertheless, there has been considerable debate as to whether the investment, both in money and in time, has been worth it. That question is not yet definitively answerable. However, investigators (and investors) might also wonder if the efforts in nanomedicine are likely to continue at the same pace as over the past decade. For this paper, an analysis was done by searching Medline, RePORT, the DOD (CDMRP), the NSF, and ClinicalTrials.gov. The major findings from the analysis are as follows: (1) The number of journal articles on the subject of nanomedicine continues to steadily rise and the areas "Drug Carriers" and "Drug Delivery Systems" are experiencing particularly rapid growth.(2) The level of funding from the Department of Health and Human Services (NIH and others) for indications other than cancer has been greater than that for cancer. (3) Funding for applications in HIV/AIDS has been strong. (4) Most of the cancers are being impacted. (5) The number of clinical trials are more highly focused in breast, skin, metastatic, and ovarian cancers, though the noncancer indications of pain and infections are also highly represented. The trials are primarily in Phases I and II, suggesting a long horizon before translating to a high impact on patients. (6) The vast majority of the clinical trials are for the evaluation of established nanomedicine formulations (liposomes and nab-paclitaxel/Abraxane) in combination with other therapies. Nevertheless, the number of clinical trials with other nanomedicine formulations has been increasing since 2009. Relatively few of the trials are for micelles or dendrimers. Taken as a whole, the analysis provides a picture that nanomedicine continues to be highly funded and highly studied but with few recent breakthroughs. Nanomedicine has yet to provide the "silver bullet" for therapy in cancer or other diseases, and it remains unclear whether it ever will.

Recent Advances in Nanomaterials Development for Nanomedicine and Cancer

“…199 Abraxane, a nanoscale albumin-bound paclitaxel, was the first protein-based nanotherapeutic approved by the FDA in 2005 to treat metastatic breast cancer and then, for nonsmall cell lung and pancreatic cancers. 197 In addition to albumin, other proteins such as gelatin, zein, and milk proteins of βlactoglobulin and casein have also been approved by the FDA for pharmaceutical and biomedical applications. 163 Ontak, a recombinant fusion protein of diphtheria toxin and interleukin-2, is one of the first actively targeted therapeutic nanoplatforms approved by the FDA to treat cutaneous T cell lymphoma cells.…”

“…Nanoscale drugs and nanomaterials integrated therapeutics have been increasingly considered over the last two decades in the pharmaceutical industry . These nanobased products have been extensively reviewed in some recent reports. − As mentioned in the previous sections, some FDA-approved drug delivery nanosystems are currently used to treat various diseases. Cancer is the main focus of studies, and the liposomal nanoformulations are of great interest for this aim.…”

Nanomedicine-based drug delivery towards tumor biological and immunological microenvironment

“…Currently, there are several anticancer nanomedicines approved by the U.S. Food and Drug Administration (FDA), such as Doxil (doxorubicin liposomes), DaunoXome (daunorubicin liposomes) and Abraxane (paclitaxel albumin-bound nanoparticles) 24 , 25 , 26 , 27 . A list of nanomedicines currently under clinical trial can be found in a recent published review 28 . However, the heterogeneity of tumors can lead to low therapeutic efficacy, acquired resistance and side effects 29 .…”

Quantification of Cellular Drug Biodistribution Addresses Challenges in Evaluating In Vitro and In Vivo Encapsulated Drug Delivery

“…Despite the promise of nanoencapsulated delivery, nanotherapeutics have overall been far less successful in the clinic than originally hypothesized. [ 8–11 ] Discouragingly, understanding the mechanisms of failure has been challenging. Foremost, the pharmacokinetics of nanomaterial in vivo is complicated and difficult to predict.…”