Category Archives: Nanomedicine

17.8 Commentary on Hurdles in Clinical Translation of Various Nanotechnology Products

Research regarding nanoconstructs development in the cancer treatment field has witnessed a noticeable increase after discovery of the EPR effect. However, the number of anticancer drugs that actually reached the market was considered extremely low, as out of 200,000 anticancer drugs only 15 made it by 2017 (Greish et al., 2018). The reasons why most of the nanomedicines cannot even reach the market are the hardship or inability to maintain detailed characterization of these products, unsuccessful manufacturing on large scales, and issues in their safety and efficacy. These hurdles require many developmental processes to overcome them including a precise understanding of every component and all the possible interactions between them, determination of key characteristics to understand in which possible ways they affect performance, and the extent of it. If key characteristics can be replicated under manufacturing conditions (scaling up), the efficacy of targeting at the site of action and their stability and sterility can be enhanced and/or assessed (Desai, 2012). The majority of these hurdles are summarized in Table 17.5 (Tinkle et al., 2014).

Table 17.5. Major Hurdles That Face the Commercialization of Nanomedicine

Lack of standard nano nomenclature: imprecise definition for nanomedicines

Currently used compounds/components for nanodrug synthesis often pose problems for large-scale good manufacturing (cGMP) production

Lack of precise control over nanoparticle manufacturing parameters and control assays

Lack of quality control: issues pertaining to separation of undesired nanostructures (byproducts, catalysts, starting materials) during manufacturing

Reproducibility issues: control of particle size distribution and mass

Scalability complexities: enhancing the production rate to increase yield

High fabrication costs

Lack of rational preclinical characterization strategies via multiple techniques

Biocompatibility, biodistribution and toxicity issues: lack of knowledge regarding the interaction between nanoparticles and biosurfaces/tissues

Consumer confidence: the publics general reluctance to embrace innovative medical technologies without clearer safety or regulatory guidelines

The relative scarcity of venture funds

Ethical issues and societal issues are hyped up by the media

Big Pharmas continued reluctance to seriously invest in nanomedicine

Patent review delays, patent thickets, and issuance of invalid patents by the US Patent and Trademark Office

Regulatory uncertainty and confusion due to baby steps undertaken by US Food and Drug Administration: a lack of clear regulatory/safety guidelines

One of the major concerns related to NPs is their potential incompatibility and toxicity. Studies showed that inhaling NPs can cause pulmonary inflammation as well as inducing endothelial dysfunction that might lead to further complications in the cardiovascular system. A study for evaluation of iron oxide toxicity showed that monocyte-mediated dissolution and phagocytosis of the NPs have caused severe endothelial toxicity by initiating oxidative stress. Nanomaterials used in oral DDS have been shown to accumulate in hepatic cells, which might induce the immune response and eventually cause permanent damage to the liver. The accumulation of NPs in cells has been found to cause cancer by transforming cells into the tumorous state (Jain et al., 2018; Riehemann et al., 2009). Thus, handling these nanosystems requires special equipment and caution, which increases the cost of the production process and requires further investigations of the safety of nanomaterials to have a better understanding and optimize safety during manufacturing (Hammed et al., 2016). Production of NPs in the laboratory often requires complex, multistep synthesis processes to yield the nanomaterials with the required properties. Aside from the complexity of the process, controlling conditions such as temperature and concentrations precisely is significant to achieve homogeneity of NPs in terms of desired characteristics. However, retaining temperature and concentration in large systems is harder to achieve resulting in NPs with different characteristics (Gomez et al., 2014).

NPs tend to aggregate forming clusters with several microns in size. Aggregation of NPs alters their characteristics such as reactivity, transport, toxicity, and risk in the environment. Dissolution reduces when aggregation occurs due to the decrease in available surface area that will eventually reduce the activity of NPs. For example, dechlorination rate of CT (carbon tetrachloride) by magnetite NPs has shown to decrease when aggregation of the NPs increases resulting in an inverse relationship between dechlorination rate of carbon tetrachloride and aggregation of magnetite NPs (Hotze et al., 2010; Hou and Jafvert, 2009).

All these requirements are extremely important because the majority of the nanomedicines have failed to reach the commercialization step even though their efficacy in animal models was considerably high. Due consideration must be given regarding the several difficulties such as their low targeting, low safety, low efficacy, heterogeneity of disease between individuals, inability to scale-up successfully, and unavailability in determining a convenient characterization methods (Agrahari and Agrahari, 2018; Hare et al., 2017; Kaur et al., 2014). These hurdles that face the research process of accelerated translation are summarized in Fig. 17.8 (Satalkar et al., 2016).

Figure 17.8. Major issues that face accelerated translation process of nanoparticles.

Therefore, more understanding in all aspects of nanomedicine production, characterization, and clinical processes must be fulfilled to control and improve the development processes, and increase the efficacy of the translational methods. Other significant hurdles hindering clinical translation are the insignificant incentives regarding technology transfer, as well as socioeconomic uncertainties along with the safety problems faced. In the majority of cases, consideration of commercialization aspects in early stages of development is hardly even considered thus eliminating the market-oriented development (Rsslein et al., 2017).

Nanomedicines face tough, challenging concerns when it comes to determining the applicable analytical tests in terms of chemical, physical, or biological characterization. This is mainly achieved due to their complex nature in comparison with other pharmaceutical products. Hence, there is a need for more complex and advanced levels of testing to ensure a full accurate characterization of nanomedicine products. Quantification of each component of nanomedicine is considered essential alongside the identification and evaluation of interactions between them. For more possibility in achieving successful manufacturing processes with reproducibility, these products should be investigated and understood more during the early developmental stages to identify their key characteristics. The challenges for nanomedicine during scale-up and manufacturing are considered relatively unique because other pharmaceutical manufacturing processes systems are not three-dimensional multicomponent in nature on the nanometer scale. Therefore, a certain series of obstacles in the scale-up process is required. To reach the desired safety, pharmacokinetic and pharmacodynamic parameters to produce the therapeutic effect are needed. These are further determined by the proper selections of the essential components, determination of the critical manufacturing steps, and key characteristics identification. Several methods of orthogonal analysis are essential for in-process quality controls of nanoparticle products and any deviations from key parameters could result in a significant negative impact on both the safety and efficacy of nanomedicines (Desai, 2012).

Each step in the manufacturing process of NPs must be understood extensively with the need of experienced technicians. The development process also requires more enhancements in both complexity and cost. Inadequate data regarding scaling-up processes of nanomedicine products is a major concern in the commercialization step as there are only a few reports supporting scaling-up developments. Many formulation methods have been developed for manufacturing nanomedicine products. The most common methods are nanoprecipitation and emulsion-based approaches. Generally, formulations are prepared either by precipitating the dissolved molecules (bottom-up method) or by reducing the size of larger drug particles (top-down method). Removal of the solvent in the bottom-up method is not an easy process and it cannot be controlled well either, thus explaining why this method is less often applied in industrial manufacturing (Agrahari and Agrahari, 2018; Vauthier and Bouchemal, 2009). Investments in innovative projects face several issues with the major one being the knowledge that should be obtained from the innovation. Its confidentiality is easily breached when a company uses that knowledge as it cannot prevent other companies from using it. Thus, investors are not attracted to this type of project because the total return on the investment cannot be easily appropriated (Morigi et al., 2012).

The complexities in formulating nanoproducts on large scales are due to the inability of optimization of formulation processes and achieving reproducibility. Whereas formulation steps including size reduction, homogenization, centrifugation, sonication, solvent evaporation, lyophilization, extrusion, and sterilization can be easily optimized on small-scales, its still a challenging process on large-scales. Accordingly, variations between batches cannot be controlled sufficiently thereby limiting the possibility of nanomedicine to get through commercial translation (Anselmo et al., 2017; Desai, 2012).

Another problem is that even slight changes in either the formulation or the manufacturing process can have a significant effect on the nanomedicine physiochemical properties (crystallinity, size, surface charge, release profile), which will ultimately influence the therapeutic outcome. Most of the pharmaceutical industrial facilities cannot manufacture nanomedicines because of the lack of the right equipment for the process. As nanomedicine manufacturing usually involves the use of organic solvents, the ability to correctly process and handle nanoproducts is crucial to control their safety and sterility (Anselmo et al., 2017; Desai, 2012; Kaur et al., 2014). These steps require an expensive and complicated equipment, well-trained staff, and precise control to get the required product in the right quality (Desai, 2012; Kaur et al., 2014; Ragelle et al., 2017).

To date, only 58 nanoformulations are approved based on their clinical efficacy but only a quarter of them are meant for cancer treatment. Majority of the nanoformulations could not even be reproduced successfully due to several factors including the study design, overall analysis, protocols, data collection, and the quality and purity of materials used. Besides, the poor establishment of the correlation and prediction of safety and efficacy of the nanomedicine on patients hinders the successful DDS. Targeting and drug accumulation of anticancer drugs in the site of action is considered relatively poor in mouse models. Many nanoformulations were faced with failure in different clinical trial phases. Some of them got approved but then withdrawn from the market such as peginesatide. Unfortunately, the increased failures will most probably affect the development movement in the pharmaceutical industry (Greish et al., 2018).

At the present time, regulatory agencies such as the FDA and EMEA are examining every new nanomedicine on a product-by-product basis. They are considered a unique category due to the fact that there are no true standards in their examination process (Desai, 2012). Two of the major regulatory issues that emerged at the start of nanomedicine is the lack of scientific experts in the FDA and the difficulty in classifying the product (Morigi et al., 2012). The unique characteristics of nanomedicines are directly related to their regulation hurdles, which is the same as other pharmaceutical systems such as liposomes and polymeric systems (Sainz et al., 2015).

Researchers keep investigating nanomedicines when attached to prodrugs, drugs, tracking entities, and targeting molecules. Development of robust methods and assays in quality control of nanomedicines are required for more effective monitoring and characterizations. Also, estimation of their overall performance in releasing drugs, binding to proteins, and the specificity in cellular uptake must be considered (Sainz et al., 2015; Tinkle et al., 2014).

Nanomedicine products are both complex and diverse requiring explanation of challenges to have a clear definition and an effective regulation. The lack of regulatory guidelines for these products hinders their clinical potential. Drug regulatory authorities must keep up with the rapid pace of the knowledge and technological development as they play a major role translating nanomedicines towards the market. The European Medicines Agency (EMEA) and the FDA have different requirements in evaluating new nanomedicines as well as different definitions regarding nanomedicine. Agreeing on specific regulatory procedures internationally is very important to ease the translational researches of nanomedicines. Also, better long-term monitoring of toxicity should be achieved by prolonging postmarketing surveillance especially for a patient with chronic diseases (Sainz et al., 2015; Tinkle et al., 2014).

Nanomedicines just like any other pharmaceutical formulations must offer higher value to patients to become commercially successful, and have better efficacy and safety. New nanomedicine products follow the same steps in clinical trials as other drugs. It starts with preclinical tests, then be submitted to get the IND (investigational new drug) approval and following that it enters the three stages of clinical trials, one after another to evaluate safety and efficacy of the new drug (Agrahari and Agrahari, 2018).

In recent years, toxicities caused by nanomedicines have drawn attention and been recognized to be unique to nanoparticulate systems. Hence, a minimum set of measurements for the nanoparticle like surface charge, size, and solubility are monitored so as to predict the possible toxicity of NPs. Besides, NPs can stimulate the immune system by acting as an antigen. Immunogenicity is mainly affected by the size of the nanoparticle, its surface characteristics, hydrophobicity, charge, and solubility. Hematologic safety concerns have also been observed such as hemolysis and thrombogenicity (Desai, 2012).

In vivo and in vitro studies provide the proper characterization of the interactions between the product and the biological system. The problem is that the data attained from current toxicity tests are not from clinical trials and it cannot always be extrapolated to humans. Monolayers of cell cultures are currently used to characterize immunogenicity, drug release, cellular uptake, and toxicity. However, the cellular uptake process of nanoformulations is majorly influenced by physicochemical characteristics. Thus, 3D cell systems will probably provide better outcomes (Gupta et al., 2016). More caution should be given when handling any nanosized powder due to the ability of such particles to penetrate the skin and because it can also show pulmonary toxicity (Agrahari and Hiremath, 2017; Nel et al., 2006).

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Wiley Interdiscip Rev Nanomed Nanobiotechnol. 2020 Jul 22:e1654. doi: 10.1002/wnan.1654. Online ahead of print.

ABSTRACT

Lung cancer is considered to cause the most cancer-related deaths worldwide. Due to the deficiency in early-stage diagnostics and local invasion or distant metastasis, the first line of treatment for most patients unsuitable for surgery is chemotherapy, targeted therapy or immunotherapy. Nanocarriers with the function of improving drug solubility, in vivo stability, drug distribution in the body, and sustained and targeted delivery, can effectively improve the effect of drug treatment and reduce toxic and side effects, and have been used in clinical treatment for lung cancer and many types of cancers. Here, we review nanoparticle (NP) formulation for lung cancer treatment including liposomes, polymers, and inorganic NPs via systemic and inhaled administration, and highlight the works of overcoming drug resistance and improving cancer immunotherapy. This article is categorized under: Therapeutic Approaches and Drug Discovery > Nanomedicine for Oncologic Disease.

PMID:32700465 | DOI:10.1002/wnan.1654

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Nanomedicine in lung cancer: Current states of overcoming drug resistance and improving cancer immunotherapy - DocWire News

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Nanomedicine Market Table of Contents

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Nanomedicine Market 2019 by Rising-Trends, Growth Analysis, Industry Share, Product Types, User-Demand, Business Strategy and Comprehensive Valuation...

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Global Nanomedicine Market Report provides an overview of the market based on key parameters such as market size, sales, sales analysis and key drivers. The market size of the market is expected to grow on a large scale during the forecast period (2019-2026). This report covers the impact of the latest COVID-19 on the market. The coronavirus epidemic (COVID-19) has affected all aspects of life around the world. This has changed some of the market situation. The main purpose of the research report is to provide users with a broad view of the market. Initial and future assessments of rapidly changing market scenarios and their impact are covered in the report.

The global nanomedicine market was valued at $111,912 million in 2016, and is projected to reach $261,063 million by 2023, growing at a CAGR of 12.6% from 2017 to 2023.

The drug delivery segment accounted for nearly two-fifths share of the global market in 2016.

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Nanomedicine is an application of nanotechnology that deals in the prevention & treatment of diseases in humans. This technology uses submicrometer-sized particles for diagnosis, treatment, and prevention of diseases. Nanomedicines are advantageous over generic drugs in several aspects such as, to reduce renal excretion, improve the ability of drugs to accumulate at pathological sites, and enhance the therapeutic index of drugs. Thus, nanomedicine is used in a wide range of applications that include aerospace materials, cosmetics, and medicine.

The global market is driven by increase in the development of nanotechnology-based drugs, advantages of nanomedicine in various healthcare applications, and growth in need of therapies with fewer side effects. However, long approval process and risks associated with nanomedicine (environmental impacts) restrain the market growth. In addition, growth of healthcare facilities in emerging economies is anticipated to provide numerous opportunities for the market growth.

The vaccines segment is expected to register a significant CAGR of 13.2% throughout the forecast period. The treatment segment accounted for about fourth-sevenths share in the global market in 2016, accounting for the highest share during the forecast period. This is due to the high demand for therapeutics among patient and rise in the incidence of chronic diseases.

The neurological diseases segment is expected to grow at the highest CAGR of 13.9% during the forecast period, owing to high demand for brain monitoring & treatment devices and drugs. The oncological diseases segment accounted for the highest revenue in 2016, with one-third share of the global market, and is expected to maintain its dominance throughout the forecast period.

In 2016, Asia-Pacific and LAMEA collectively accounted for about one-fourth share of the global market, and is expected to continue this trend due to increased adoption of nanomedicines, especially in China, India, and the other developing economies. In addition, rise in investments by key players in the field of nanomedicines is key driving factor of the Asia-Pacific market.

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SHELTON, CT / ACCESSWIRE / July 21, 2020 / NanoViricides, Inc. (NYSE American:NNVC) (the "Company") a global leader in the development of highly effective antiviral therapies based on a novel nanomedicines platform, today announced that Anil R. Diwan, PhD, President and Executive Chairman of the Company, will participate in the "B. Riley FBR Virtual Infectious Disease Summit - Therapeutics Day" on Tuesday, July 21, 2020. The Conference is organized by B. Riley FBR, Inc. (https://brileyfbr.com/).

Dr. Diwan is invited to participate in Panel #3 at 2020 at 2:10 p.m. ET, entitled "Taming the Severe Disease Presentations". He will briefly discuss the Company's novel nanomedicines platform and the Company's progress in the lead IND-ready candidate for the treatment of shingles rash, NV-HHV-101, as well as in developing a drug candidate against SARS-CoV-2, the cause of COVID-19 global pandemic.

The Company believes that it is close to selecting a clinical candidate worthy of advancing into human clinical trials for the treatment of SARS-CoV-2 infection, based on (i) cell culture effectiveness studies against multiple circulating coronaviruses that employ different cell surface receptors, (ii) a lethal lung infection animal model effectiveness study using hCoV-NL63 infection (a coronavirus that uses the same receptor, ACE2, as SARS-CoV-2, and produced similar disease in the animal model), and (iii) preliminary safety studies in animal model at maximum feasible dosage levels. The Company has disclosed its findings from these studies in previous press releases.

Prior to filing for human clinical trials, NanoViricides plans on conducting studies, towards clinical candidate selection, to further determine the effectiveness against SARS-CoV-2, perform additional drug development studies as may be necessary, and request a pre-IND Meeting with the US FDA for regulatory guidance.

The Company is also working with its regulatory consultants on completing an IND with the US FDA to advance its lead drug candidate NV-HHV-101 into human clinical trials for topical dermal treatment of Shingles rash as the initial indication. In particular, the Company is working on finalizing the clinical trials plan for the anticipated human clinical trials for shingles rash treatment. The Company is also in the process of finalizing clinical trial sites. This process has been adversely affected by the current global COVID-19 pandemic, and in particular, its effects across the USA.

Importantly, nanoviricides are designed to act by a novel mechanism of action, trapping the virus particle like the "Venus-fly-trap" flower does for insects. Antibodies, in contrast, only label the virus for other components of the immune system to take care of. It is well known that the immune system is not functioning properly at least in severe COVID-19 patients.

Additionally, it is well known that viruses escape antibody-drugs via mutations. The Company's "nanoviricide" drug candidates, in contrast, are designed to be broad-spectrum, and therefore virus escape by mutations is expected to be unlikely.

The market size for the treatment of shingles is estimated at approximately one billion dollars by various estimates. These estimates take into account the Shingrix vaccine as well as existing vaccines. About 500,000 to 1 million cases of shingles occur in the USA alone every year.

The market size for our immediate target drugs in the HerpeCide program is variously estimated at billions to tens of billions of dollars. The Company believes that its dermal topical cream for the treatment of shingles rash will be its first drug heading into clinical trials. The Company believes that additional topical treatment candidates in the HerpeCide program, namely, HSV-1 "cold sores" treatment, and HSV-2 "genital ulcers" treatment are expected to follow the shingles candidate into IND-enabling development and then into human clinical trials. These additional candidates are based on NV-HHV-101, thereby maximizing return on investments and shareholder value.

The Company develops its class of drugs, that we call nanoviricides, using a platform technology. This approach enables rapid development of new drugs against a number of different viruses. A nanoviricide is a "biomimetic" - it is designed to "look like" the cell surface to the virus. The nanoviricide technology enables direct attacks at multiple points on a virus particle. It is believed that such attacks would lead to the virus particle becoming ineffective at infecting cells. Antibodies in contrast attack a virus particle at only a maximum of two attachment points per antibody.

In addition, the nanoviricide technology also simultaneously enables attacking the rapid intracellular reproduction of the virus by incorporating one or more active pharmaceutical ingredients (APIs) within the core of the nanoviricide. The nanoviricide technology is the only technology in the world, to the best of our knowledge, that is capable of simultaneously (a) attacking extracellular virus to break the reinfection cycle, and (b) disrupting intracellular production of the virus, thus enabling complete control of a virus infection.

About NanoViricidesNanoViricides, Inc. (www.nanoviricides.com) is a development stage company that is creating special purpose nanomaterials for antiviral therapy. The Company's novel nanoviricide class of drug candidates are designed to specifically attack enveloped virus particles and to dismantle them. Our lead drug candidate is NV-HHV-101 with its first indication as dermal topical cream for the treatment of shingles rash. The Company is in the process of completing an IND application to the US FDA for this drug candidate. The Company cannot project an exact date for filing an IND because of its dependence on a number of external collaborators and consultants, and the effects of recent COVID-19 restrictions.

The Company is also developing drugs against a number of viral diseases including oral and genital Herpes, viral diseases of the eye including EKC and herpes keratitis, H1N1 swine flu, H5N1 bird flu, seasonal Influenza, HIV, Hepatitis C, Rabies, Dengue fever, and Ebola virus, among others. NanoViricides' platform technology and programs are based on the TheraCour nanomedicine technology of TheraCour, which TheraCour licenses from AllExcel. NanoViricides holds a worldwide exclusive perpetual license to this technology for several drugs with specific targeting mechanisms in perpetuity for the treatment of the following human viral diseases: Human Immunodeficiency Virus (HIV/AIDS), Hepatitis B Virus (HBV), Hepatitis C Virus (HCV), Rabies, Herpes Simplex Virus (HSV-1 and HSV-2), Varicella-Zoster Virus (VZV), Influenza and Asian Bird Flu Virus, Dengue viruses, Japanese Encephalitis virus, West Nile Virus and Ebola/Marburg viruses. The Company has executed a Memorandum of Understanding with TheraCour that provides a limited license for research and development for drugs against human coronaviruses. The Company intends to obtain a full license and has begun the process for the same. The Company's technology is based on broad, exclusive, sub-licensable, field licenses to drugs developed in these areas from TheraCour Pharma, Inc. The Company's business model is based on licensing technology from TheraCour Pharma Inc. for specific application verticals of specific viruses, as established at its foundation in 2005.

This press release contains forward-looking statements that reflect the Company's current expectation regarding future events. Actual events could differ materially and substantially from those projected herein and depend on a number of factors. Certain statements in this release, and other written or oral statements made by NanoViricides, Inc. are "forward-looking statements" within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934. You should not place undue reliance on forward-looking statements since they involve known and unknown risks, uncertainties and other factors which are, in some cases, beyond the Company's control and which could, and likely will, materially affect actual results, levels of activity, performance or achievements. The Company assumes no obligation to publicly update or revise these forward-looking statements for any reason, or to update the reasons actual results could differ materially from those anticipated in these forward-looking statements, even if new information becomes available in the future. Important factors that could cause actual results to differ materially from the company's expectations include, but are not limited to, those factors that are disclosed under the heading "Risk Factors" and elsewhere in documents filed by the company from time to time with the United States Securities and Exchange Commission and other regulatory authorities. Although it is not possible to predict or identify all such factors, they may include the following: demonstration and proof of principle in preclinical trials that a nanoviricide is safe and effective; successful development of our product candidates; our ability to seek and obtain regulatory approvals, including with respect to the indications we are seeking; the successful commercialization of our product candidates; and market acceptance of our products. FDA refers to US Food and Drug Administration. IND application refers to "Investigational New Drug" application. CMC refers to "Chemistry, Manufacture, and Controls". ]

Contact:NanoViricides, Inc.info@nanoviricides.com

Public Relations Contact:MJ ClyburnTraDigital IRclyburn@tradigitalir.com

SOURCE: NanoViricides, Inc.

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