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Category : Nanomedicine

Sleuths Uncover Web of Research Fraud in 400+ Papers From China – The Wire

Elisabeth Bik, the microbiologist and research integrity consultant noted for unearthing evidence of research misconduct, tweeted on February 21that she and some others had uncovered over 400 scientific papers that all share a very similar title layout, graph layout, and (most importantly) the same Western blot layout indicating an organised web of potential fraud. She also expressed concern that there might be hundreds of papers more, and that she and her collaborators may just have spotted the obviously fraudulent ones.

Western blotting is a technique that microbiologists employ to identify the proteins present in a tissue sample. As an analytical technique involving real-world materials, no two images of western blots are supposed to look alike, and similarities suggest the image may have been manipulated, inadvertently or otherwise.

Guided by this and similar giveaways, Bik, @SmutClyde, @mortenoxe and @TigerBB8 (all Twitter handles of unidentified persons), report as written by Bik in ablog post that the Western blot bands in all 400+ papers are all very regularly spaced and have a smooth appearance in the shape of a dumbbell or tadpole, without any of the usual smudges or stains. All bands are placed on similar looking backgrounds, suggesting they were copy-pasted from other sources or computer generated.

Bik also notes that most of the papers, though not all, were published in only six journals: Artificial Cells Nanomedicine and Biotechnology,Journal of Cellular Biochemistry,Biomedicine & Pharmacotherapy,Experimental and Molecular Pathology,Journal of Cellular Physiology, andCellular Physiology and Biochemistry, all maintained reputed publishers and importantly all of them peer-reviewed.

As a result, the discovery of the problem papers has prompted concerns about the ability of peer-review to check research misconduct in the scientific community.

Indeed, when Bik writes, Finding these fabricated images should not rely solely on the work of unpaid volunteers, she evidently means herself and her collaborators but her words also apply to peer-reviewers, who are unpaid for their work and often lack both the resources and the inclination to investigate each paper in close detail. As a result, peer-review is often not the insurmountable defence some proclaim it to be, nor are peer-reviewed journals as free of bogus science as they claim to be.

As Madhusudhan Raman, a postdoctoral scholar at the Tata Institute of Fundamental Research, Mumbai,wrote inThe Wire, any attempt to radically change the nature of peer-review must necessarily be accompanied by a change in the way the referees are compensated for their time and effort, especially within academia.

A PubPeer user who goes by Indigofera Tanganyikensis first identified the problem in two papers (thisandthis) both published by Chinese researchers. On February 17 this year, a little under a week before Bik published her blog post, two American researchers Jennifer A. Byrne and Jana Christopher published an articlediscussing similar research misconduct based on 17 papers they had discovered.

According to Bik, As it turns out, Byrne and Christophers publication describes the exact same set of papers that our small team of image forensics detectives had been working on in the past month.

These sleuths, as @SmutClydewrote on Leonid Schneiders blog, believe they have stumbled upon at least one paper mill. To quote (selectively) from Biks post,

A paper mill is a shady company that produces scientific papers on demand. They sell these papers to [people] who do not have any time in their educational program to actually do research. Authorships on ready-to-submit or already-accepted papers are sold to medical students for hefty amounts. Whether or not the experiments described in these papers has actually been performed is not clear. Some of these paper mills might have laboratories producing actual images or results, but such images might be sold to multiple authors to represent different experiments. Thus, the data included in these papers is often falsified or fabricated.

The mills seem to have been hired by Chinese clinicians affiliated to various medical colleges and hospitals in China (234 of the 400+ papers have been authored by people affiliated to institutions in Shandong province). The papers were all published between 2016 and 2020. @SmutClyde wrote that after they publicised their findings, including thedataset of papers they had identified as potentially fraudulent (and which they continue to update), an author of one of the papers wrote in:

Being as low as grains of dust of the world, countless junior doctors, including those younger [than] me, look down upon the act of faking papers. But the system in China is just like that, you cant really fight against it. Without papers, you dont get promotion; without a promotion, you can hardly feed your family. I also want to have some time to do scientific research, but its impossible. During the day, I have outpatient surgeries; after work, I have to take care of my kids. I have only a little bit time to myself after 10 pm, but this is far from being enough because scientific research demands big trunks of time. The current environment in China is like that.

Considering how the peer-review of all of those journals have failed, what the detectives have found effectively represents a large volume of unscientific data entering the scientific literature, funnelled predominantly by Chinese researchers who probably hired a paper mill to help meet the publishing requirements set by their respective institutions. Bik wrote that it is of great concern to see that this specific paper mill has successfully infected particular journals and that it is very alarming to see that journal editors do not appear to have noticed the similarities between dozens of papers published in their journals.

This said, the note from the unnamed Chinese author indicates the source of the problem is hardly new or even confined to China.

For example, until Prakash Javadekar, then the Union human resource development minister, said in mid-2017 that college teachers would not be required to undertake research to qualify for promotions, people who had not trained for research and have since been embedded in environments not properly equipped to support research were forced to conduct research, and publish papers.

Javadekar is to be loudly applauded and congratulated for taking this measure,Pushkar wrote forThe Wireat the time. The research requirement in the [Academic Performance Indicators] for college teachers was a travesty. All that it achieved was a proliferation of fake journals for college teachers to publish in.

Indeed, India has come to be known the fake journals capital of the world, partly as a result of requiring people who cannot undertake research to undertake research, and partly because research productivity has become one of the core measures of determining whether a country is a scientific superpower.

For another example, the journalNaturereportedthat Pakistans research output increased the most among all countries in the world by 21% in 2018, a feat that it dubbed a phenomenal success. However, as Anjum Altaf, former provost of Karachis Habib University and a famous teacher, subsequentlytoldThe Wire, The volume of third-rate publications in Pakistan has increased greatly simply because [Pakistans Higher Education Commission] introduced a tenure-track system and required publications for promotion.

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Sleuths Uncover Web of Research Fraud in 400+ Papers From China - The Wire

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ERC president ‘optimistic’ UK will stay in ‘irreplaceable’ fund – Times Higher Education (THE)

The UK gains benefits from the European Research Council that cannot be replaced, but there is good reason to be optimistic about the nation staying part of the programme despite Brexit, according to the funders new president.

The UK has been the number one [nation] in terms of funding received since the ERC was established in 2007, Mauro Ferrari toldTimes Higher Educationafter taking office last month. But the real benefit is bigger than that, he added.

Perhaps the biggest advantage of them all is that ERC grants strengthen the UKs position as a top destination for non-UK scientists, Professor Ferrari said. Think of all the great people that are in the UK with an ERC grant.

Science is all about people. You need the best people: you need to recruit them, you need to retain them. And I think the ERC has been a great instrument for the UK to do that.

Prestigious ERC grants for outstanding researchers, part of the European Unions wider framework programmes for research, have been described asmini-Nobel prizesand as the Champions League of research.

There is no certainty over whether the UK will seek to, or be allowed to, join the next framework programme, Horizon Europe, as an associated country when it starts in January 2021.

ERC grants are portable, but holders are expected to spend at least 50 per cent of their working time in an EU member state or associated country leading some in the UK to fear that the nation will miss out on attracting world-leading researchers if it does not associate to Horizon Europe.

While the UK will continue to attract and retain science talent, no matter what, because of its history and continuous investment, there is this bit that comes from the international connotation of the ERC that, I think, cannot be replaced, Professor Ferrari said.

His comments came as John Womersley, chief executive of the Science and Technology Facilities Council between 2011 and 2016, warns that there is great risk that the UK may choose not to associate to Horizon Europe.

Writing in THE, Professor Womersley now director-general of the European Spallation Source says that while UK-based researchers are keen to retain access to ERC funding, ministers are less likely to be keen on the two other larger pillars of Horizon Europe, covering challenge-based funding and the new European Innovation Council.

Professor Womersley warns that the EU is unlikely to allow cherry-picking of Horizon Europe, leading him to conclude that the UK was more likely to use the money it would otherwise contribute to the scheme tocreate a UK-based replacement for the ERC.

Asked by THE whether the UK could associate to the ERC, Professor Ferrari said that he cannot speculate on that. Thats the domain of a political negotiation, he said.

But given unanimous sentiment among UK and continental European scientists he had spoken with, he added: I would say there is good reason to be optimistic that some sort of reasonable construct will be reached that allows scientists to do their job in the best possible way.

ProfessorFerrari also discussed the ERCs role in building bridges between blue-sky research and innovation a link where he has personal experience as a pioneer of nanomedicine.

His 40-year academic career in the US began in engineering with a post at the University of California, Berkeley, then changed course following the death of his wife from cancer, after which heentered medical school at the age of 43to fight the disease.

Professor Ferrari retired as chief commercialisation officer at Houston Methodist Research Institute in 2019, but remains an affiliate professor with a lab at the University of Washington in Seattle.

I have returned [to Europe] for this job because I thought it was such an extraordinary and unique opportunity, he said.

The ERC, which evaluates proposals through international panels of leading scientists, is based on the principle that no individual, no agency, no office can actually envisage the future, what are the necessaryworld-changing breakthroughs in all of the fields of science, Professor Ferrari said. So we let scientists tell us.

Although European science is one of the global front-runners, he continued, there is no doubt about the fact that Europe has been lagging behind the United States when it comes to translation of great discoveries into innovation.

Professor Ferrari added that although the ERC by mandate is only doing blue-sky research, it has a role in addressing that by ensuring that research is best friends with innovation. We connect: we make sure our scientists are aware of whats happening in innovation, and make sure people on the innovation side are aware of what leading scientists are doing, he said.

john.morgan@timeshighereducation.com

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ERC president 'optimistic' UK will stay in 'irreplaceable' fund - Times Higher Education (THE)

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Oxford Performance Materials’ OsteoFab 3D Printed PEKK Technology Focus of Study Published in The Spine Journal – OrthoSpineNews

SOUTH WINDSOR, CONN. (PRWEB)FEBRUARY 17, 2020

Oxford Performance Materials, Inc. (OPM), an industry leader in advanced materials science and high-performance additive manufacturing (HPAM), announced today the publication of A Comparative Study of Three Biomaterials in an Ovine Defect Model: A TETRAfuse PEKK Study in The Spine Journal. 1,2,3 This study examined the in vivo material characteristics of polyetheretherketone (PEEK), titanium-coated PEEK, and 3D printed polyetherketoneketone (PEKK) in a sheep model. In comparison with PEEK, the PEKK implants displayed bone ingrowth, no fibrotic tissue formation, a significant increase in bony apposition over time, and a significantly higher push-out strength.

Conventionally, PEEK and Ti-coated PEEK have been used as standard biomaterials for implants like spinal interbody cages, but recent shortcomings in these materials have led to adoption of newer, more innovative technologies. Although PEEK shows an elastic modulus comparable to that of cortical bone, literature has illustrated that it consistently prompts a fibrotic and inflammatory tissue response, preventing it from integrating with host tissue. And while titanium exhibits similar osseointegrative properties when compared to PEKK, it is substantially stiffer than cortical bone and it is radiopaque, which makes bone fusion assessments difficult as the bone/implant interface is often obscured in post-operative imaging. With titanium coated PEEK implants, these drawbacks still exist but with the added risks of delamination of the titanium coating, subsidence, and the generation of wear debris.

The results reported by The Spine Journal were gratifying and support the comparative benefits of 3D printed PEKK implants that we have been hearing from surgeons for some time, now, said Scott DeFelice, CEO. OPMs OsteoFab technology platform is increasingly recognized as a best of solution for CMF and spinal implants, and we will be launching our unique 3D printed suture anchor product in the coming weeks.

3D printed PEKK delivers high mechanical integrity, radiographic visibility, and osseointegration, as well as inherent antibacterial characteristics.4 In this Spine Journal study, PEKK demonstrated a significantly higher push-out force when compared to PEEK at 8 and 16 weeks post-implantation and also had notably greater bone attachment following pushout when compared to PEEK and Ti-coated PEEK. From a histological standpoint, 3D printed PEKK also showed substantial bone growth. Within a 2mm radius of the implant, 3D printed PEKK exhibited the highest bone ongrowth percentage when compared to PEEK and Ti-coated PEEK at both the 8- and 16-week endpoints.

By directly comparing the three implant materials in an in vivo model, the study showed clear evidence of the performance characteristics at the bone-implant interface. In this instance, 3D printed PEKK presented a high propensity for bone-ingrowth, no radiographic interference, and a material structure that allowed for an increase of integration of cancellous bone into the implant. In a clinical scenario, 3D printed PEKK implants could improve the effectiveness of spinal fusion procedures by promoting osseointegration and decreasing the chance of complications associated with PEEK and Ti-coated PEEK.

Since 2013, OPM has been manufacturing patient-specific cranial and facial implant devices that have been distributed world-wide. In addition to over 2,300 craniomaxillofacial implants, OPM has 3D printed over 70,000 OsteoFab implants under a number of 510(k) clearances and just recently entered the sports medicine arena with a soft tissue fixation device. As the pendulum shifts away from traditional material solutions, OsteoFab 3D printed PEKK is proving to be a robust alternative with a rapidly growing user base.

About Oxford Performance Materials, Inc.

Oxford Performance Materials was founded in 2000 to exploit and commercialize the worlds highest performing thermoplastic, PEKK (poly-ether-ketone-ketone). OPMs Materials business has developed a range of proprietary, patented technologies for the synthesis and modification of a range of PAEK polymers that are sold under its OXPEKK brand for biomedical and industrial applications. The Company is a pioneer in 3D printing. OPM Biomedicals OsteoFab technology is in commercial production in numerous orthopedic implant applications, including cranial, facial, spinal, and sports medicine devices. OPM is the first and only company to receive FDA 510(k) clearance to manufacture 3D printed patient-specific polymeric implants and has six 510(k) clearances in its portfolio. OPM Industrial produces 3D printed OXFAB production parts for highly demanding applications in the energy, transportation and semiconductor markets. OXFAB structures offer significant weight, cost, and time-to-market reductions that are defined in a set of specified performance attributes in the exhaustive OPM B-Basis database, developed in conjunction with NASA. For more information, please visit:http://www.oxfordpm.com

Company Contact:Willow JohndrowDirector of Marketing860.656.9442

References1. Cheng, PhD B, Jaffee S, Swink I, Averick, PhD S, Horvath S, Zhukauskas, PhD R et al. A Comparative Study of Three Biomaterials in an Ovine Bone Defect Model: A TETRAfuse PEKK Study. The Spine Journal. 2019. doi: 10.1016/j.spinee.2019.10.0032. RESULTS paragraph from the Study abstract reads: PEKK implants demonstrated bone ingrowth, no radiographic interference, no fibrotic tissue membrane formation, significant increase in bony apposition over time, and significantly higher push-out strength compared to standard PEEK. The PEKK implant displayed bone growth characteristics comparable to Ti-coated PEEK with significant improvements in implant integrity and radiographic properties.3. Note: TETRAfuse is a Registered Trademark of RTI Surgical, Inc. and the tradename for RTIs spinal implants that are additively manufactured by Oxford Performance Materials, Inc. using OPMs proprietary OsteoFab technology platform. TETRAfuse was awarded a 2019 MedTech Breakthrough Award for Best New Technology Solution Orthopedics and a 2018 Spine Technology Award from Orthopedics This Week.4. Wang M, Bhardwaj B, Webster T; Antibacterial properties of PEKK for orthopedic applications. Intl Journal of Nanomedicine. 2017: 12 6471-6476.

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Oxford Performance Materials' OsteoFab 3D Printed PEKK Technology Focus of Study Published in The Spine Journal - OrthoSpineNews

Recommendation and review posted by Alexandra Lee Anderson

Nanomedicine Market by Key Manufacturers, Regions, Risk Analysis, Industry Share, Driving Factors, Deployment Policy, Innovative Technology, Product…

Global Nanomedicine Market report provides you with detailed insights, industry knowledge, market forecasts and analytics. The report on the global Nanomedicine industry also clarifies economic risks and environmental compliance. Global Nanomedicine market report assists industry enthusiasts including investors and decision makers to make confident capital investments, develop strategies, optimize their business portfolio, innovate successfully and perform safely and sustainably.

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Nanomedicine Market Segment by Regions

Asia-Pacific: China, Southeast Asia, India, Japan, Korea, Oceania

Europe: Germany, UK, France, Italy, Russia, Spain, Netherlands, Turkey, Switzerland

North America: United States, Canada, Mexico

Middle East & Africa: GCC, North Africa, South Africa

South America: Brazil, Argentina, Columbia, Chile, Peru

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Global Nanomedicine Market providing information such as company profiles, product picture, and specification, capacity, production, price, cost, revenue and contact information. Upstream raw materials and equipment and downstream demand analysis are also carried out. The Global Nanomedicine market development trends and marketing channels are analysed. Finally, the feasibility of new investment projects is assessed and overall research conclusions offered.

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1 Nanomedicine Industrial Chain Overview2 Global Nanomedicine Market Production & Consumption by Geography3 Nanomedicine Market Major Manufacturers Introduction4 Nanomedicine Market Competition Pattern5 Nanomedicine Product Type Segment6 Nanomedicine End-Use Segment7 Nanomedicine Market Forecast & Trend8 Nanomedicine Price & Channel9 Nanomedicine Market Drivers & Investment Environment10 Research Conclusion

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Nanomedicine Market by Key Manufacturers, Regions, Risk Analysis, Industry Share, Driving Factors, Deployment Policy, Innovative Technology, Product...

Recommendation and review posted by Alexandra Lee Anderson

How Nanomedicine is Going Green and Fighting Superbugs – CareDash News

Nanomaterials are materials with one dimension less than 100 nanometers. A nanometer is one-billionth of a meter. Professor Thomas Webster directs the Nanomedicine Laboratory at Northeastern University. His lab designs, synthesizes, and evaluates nanomaterials for various medical implant applications. CareDash CEO and Managing Editor Ted Chan interviewed Dr. Webster about nanotech innovation.

We focus on the synthesis, design, and evaluation of nanomaterials (that is, tubes, particles, etc. with dimensions usually less than 100 nm) in medicine. Specifically, we were the first group to demonstrate increased tissue growth (such as bone, cartilage, vascular, bladder, nervous system, etc.) on nanomaterials compared to conventional implants. We were also the first group to report decreased infection on nanomaterials compared to conventional implants, even without the use of drugs. We have also been pioneering the use of implantable nanosensors to detect disease, communicate such information to a handheld device, and kill the disease on-demand.

As just one example, we have a growing alarming number of antibiotic-resistant infections that are crippling our healthcare system. In fact, the U.S. Centers for Disease Control has predicted that more people will die from antibiotic-resistant infections than all cancers combined by 2050. We created this problem, and we can solve it. So, in simple terms, we are killing bacteria using nanoparticles, but not antibiotics. We can even kill antibiotic-resistant bacteria with nanoparticles, whereas antibiotics fail. Decreasing infection from any bacteria, especially antibiotic-resistant bacteria, will significantly increase health.

In addition to those medical advances mentioned above (implantable sensors, nanoparticles that can kill antibiotic-resistant bacteria, nanomaterials to increase tissue growth, etc.), I am particularly excited about green nanomedicine.

Green nanomedicine is where we can use natural materials to create medical devices and nanoparticles. This is important since a significant portion of the "plastic island" in the Pacific Ocean is composed of plastics from the medical community, yet very few people are studying green biomaterials or green nanomedicine. We are here at Northeastern Nanomedicine Laboratory. We have been creating green medical devices and green nanoparticles, which is saving our environment and are more effective in their function than the respective conventional materials.

Persistence. We have started over 13 companies with over 23 FDA approved implants. Research is hard enough, but getting the funding to commercialize your products is even harder. I have learned throughout my career in so many ways never to give up, and if you believe in technology, persist until it is saving human lives.

Dr. Webster is a Keynote Speaker at the 2ndBiomedical Engineering and Instrumentation Summit(BEIS 2020), a conference organized to promote awareness and enhance research in biomedical engineering. BEIS 2020 will be held on July 20-22, 2020, in Boston, MA.

Disclosure: CareDash is a media partner of the BEIS Summit at which Dr. Webster is a keynote speaker in 2020. Dr. Webster and CareDash have no financial affiliation.

You can also tweet us questions and comments@caredash.

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How Nanomedicine is Going Green and Fighting Superbugs - CareDash News

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Remyelination Potential of MS Therapy in Phase 2 Testing Evident in Animal Work, Study Says – Multiple Sclerosis News Today

Clene Nanomedicines remyelination therapy candidate, CNM-Au8, showed a robust ability to stimulate the production of new myelin and increase the number of myelin-wrapped nerve fibers in the brain and spinal cord of animals in models of demyelinating disease, allowing mice to recover motor skills, a study reports.

Such preclinical data support the efficacy of this potential treatment, now being tested in clinical trials with multiple sclerosis (MS) patients.

These early findings were reported in the study Nanocatalytic activity of clean-surfaced, faceted nanocrystalline gold enhances remyelination in animal models of multiple sclerosis, published in the journalNature Scientific Reports.

In MS, the immune system attacks myelin, the protective sheath around nerve fibers or axons. Myelin is essential for the fast transmission of electrical signals between neurons, and its loss (demyelination) damages the integrity of nerve cells and their ability to communicate with each other.

Finding therapies that promote remyelination the recovery of myelin is a high priority for MS, the researchers noted.Such treatments could potentially repair demyelinating lesions in the central nervous system (the brain and spinal cord), restoring function to nerve cells affected by the disease.

Most approved MS therapies dampen the immune systems activity to prevent further myelin damage. However, they cannot undo existing damage or replace the myelin sheaths that have been lost.

Clene Nanomedicines lead compound, CNM-Au8, is a potential remyelination therapy for MS and other neurodegenerative disorders, including Parkinsons disease, and amyotrophic lateral sclerosis (ALS).

CNM-Au8 is a solution of gold (Au) nanoparticles with apatented crystal structure, named a clean-surfaced nanocrystal (CSN). According to the company, these nanocrystals have properties that make them highly biologically active, allowing them to facilitate certain energy-related reactions within cells.

In the brain, both neurons and supporting cells, includingoligodendrocytesthat produce myelin, need substantial amounts of energy to work. In fact, the brain consumes more than 25% of the bodys metabolic resources in order to sustain the efficient flux of information through its vast network of nerve fibers.

CNM-Au8 is expected to enhance key metabolic reactions in neurons and oligodendrocytes so to increase energy reserves within these cells, while decreasing the harmful molecules naturally generated by the cells metabolism. This process, which Clene calls nanocatalysis, is thought to improve the survival and function of neurons, and to support the ability of oligodendrocytes to create new myelin.

CNM-Au8 has demonstrated a good safety profile in Phase 1 studies in healthy volunteers, and preclinical studies in animal models of MS and other diseasesindicate the therapyhas both remyelination and neuroprotection effects.

Several ongoing Phase 2 trials are evaluating CNM-Au8 in neurodegenerative diseases, including two studies in people with non-active, relapsing MS.

REPAIR-MS (NCT03993171) is an open-label Phase 2 trial assessing the safety, pharmacokinetics (availability of the therapy in the body) and pharmacodynamics (its effects) of differing oral doses of CNM-Au8 in 24 adults with relapsing-remitting MS (RRMS). This study is currently enrolling eligible patients at theUniversity of Texas Southwestern. More details can be foundhere. It is expected to conclude in the fall.

Another Phase 2 trial, called VISIONARY-MS (NCT03536559), is investigating the efficacy and safety of CNM-Au8 in up to 150 adults with RRMS, who have chronic vision problems due to lesions (chronic optic neuropathy). This study is also recruiting at nine sites across Australia, and is supported by the National Multiple Sclerosis Society. Contact and site information is available here. Results from VISIONARY-MS are expected in 2021.

Now, the preclinical work by researchers at Clene Nanomedicine, Northwestern University, and George Washington Universityprovides additional evidence supporting the ability of these gold nanocrystalsto promote remyelination in cell and animal models of MS.

We are gratified at the publication of these data. These results establish the rationale for our ongoing Phase 2 clinical trial, VISIONARY-MS, which is designed to demonstrate the efficacy of CNM-Au8 for the treatment of chronic optic neuropathy in patients with non-active relapsing MS, Robert Glanzman, MD, chief medical officer of Clene Nanomedicine, said in a press release.

Researchers found that oral delivery of CNM-Au8 to mice and rat models of demyelination led to robust remyelination activity in the brain and spinal cord, leading to higher numbers of myelin-wrapped axons. Study data also showed that CNM-Au8 resulted in a greater migration of oligodendrocytes to lesion sites, and increased myelin production.

The remyelination promoted by CNM-Au8 was also matched by a significant recovery of physical abilities in the mice, evaluated using different locomotor and fine motor tests.

Working on cells in lab dishes, known as in vitro assays, the scientists showed that treating oligodendrocyte precursor cells with CNM-Au8 stimulated their differentiation and maturation, and the expression of myelin-related markers.

The gold nanocrystals were seen to act via a novel energy metabolism pathway that speeds the conversion of NADH to NAD+, a critical factor for sensing and producing energy in cells. CNM-Au8 also increased the levels of adenosine triphosphate (ATP), a small molecule used as fuel by cells, and turned on genes related to myelin production, collectively resulting in functional myelin generation, the researchers reported.

These results further validate our entirely new approach using therapeutic gold nanocatalysts as a mechanism to support the cellular viability and enhanced function of neurons and oligodendrocytes, saidKaren Ho, PhD, one of the studys authors and director of Translational Medicine at Clene Nanomedicine.

CNM-Au8 is one of a limited number of drugs being developed which have demonstrated remyelination capabilities. We believe these data exemplify a strong step forward in the development of a treatment to improve function in the lives of more than one million people living with MS in the U.S., Ho concluded.

Ana is a molecular biologist with a passion for discovery and communication. As a science writer, she looks for connecting the public, in particular patients and healthcare providers, with clear and quality information about the latest medical advances. Ana holds a Ph.D. in Biomedical Sciences from the University of Lisbon, Portugal, where she specialized in infectious diseases, epigenetics, and gene expression.

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Patrcia holds her PhD in Medical Microbiology and Infectious Diseases from the Leiden University Medical Center in Leiden, The Netherlands. She has studied Applied Biology at Universidade do Minho and was a postdoctoral research fellow at Instituto de Medicina Molecular in Lisbon, Portugal. Her work has been focused on molecular genetic traits of infectious agents such as viruses and parasites.

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Remyelination Potential of MS Therapy in Phase 2 Testing Evident in Animal Work, Study Says - Multiple Sclerosis News Today

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How nanotechnology is transforming medicine and the future of biology – Cosmopolis

Nanotechnology will transform our lifes, our economy, our future. The book of the Oxford professor of biological physics, Sonia Contera, Nano Comes To Life: How Nanotechnology Is Transforming Medicine and the Future of Biology (Amazon.com, Amazon.co.uk, Amazon.de, Amazon.fr), explains why and how.

Nanotechnologies allow scientists to visualize, interact with, manipulate and create matter at the nanometer scale. Nanotechnology can manipulate the building blocks of life and, therefore, life itself because proteins and DNA are nano-size.

According to Sonia Contera, health and longevity will be affected. Nanoscale machines can target individual cancer cells and deliver drugs more effectively. Nanoantibiotics can fight resistant bacteria and makes it possible to engineer tissues and organs for research, drug discovery and transplantation.

Nanotechnology directly links the macroscopic world of our perceptions with the nanoscopic world of individual biomolecules. To restore humans to perfect health, we would need to know how molecules work in a specific environment, why and how they malfunction in a desease and who to reach them, target them, deactivate or activate them. To cure, we need to go from the macroscopic size of the doctor to the nanometer scale of biomolecules. Sonia Conteras book tries to show how far we have come so far.

Nanotechnology has attracted physical scientists to biology. In the last decades of the 20th century, artificial nanomaterials and the tools of nanotechnology came into existence. Physcial scientists sought to know how and why biology first constructed itself using nano-size building blocks in the medium of (salty) water. The coupling of physics and chemistry give rise to biological function. Scientists focused on using nanotechnologys methods to learn the workings of proteins, DNA and other important nano-size biomolecules. They became biological physicists. Others, more practical, saw opportunities to design nanomaterials that could be used to address disease, improving on current pharmacological treatments; they became nanomedicine scientists.

Cross-disciplinary activity led to the development of tools specifically built for studying biological processes and their nano-actors in physiological conditions. Nano-bioscientists eroded the boundaries between materials sciences, physics, chemistry and biology.

The last decades saw the emergence of quantitative biology. Physicists try to create mathematical models of biological processes. They try to predict the behavior of specific biological processes in the computer (in silico), without experiments. This shall allow to progressively abandon the trial-and-error methods of the traditional biological, medical and pharmacological sciences which are slow, costly and often lead to inefficient new drugs.

Biological physics, the help of algorithms, the analysis of biological big data and AI will lead to increasingly (more) accurate and smart models of life. However, knowing the workings of the building blocks (of life) is not enough to predict the behaviour of the whole: at larger scales, biology exhibits behaviors that the smaller constituents do not exhibit, or that cannot be explained from the relationships between their molecular building blocks. Sonia Contera explains that this is because complexly organized matter presents collective phenomena arising from cooperative interactions between the building blocks (these properties emerge). Examples are cellular movements, mechanical vibrations in the brain, electrical signaling across the membranes of cells, changes in the shape or stiffness, none of which can be predicted from just knowing the molecules that constitute a particular structure. For instance, nanotechnology would allow simultanously targeting the molecular, the cellular and the issue-level biology of a tumor.

Biology, mathematics, physics and engineering sciences used in nanotechnology will radically change, the way we find, interpret and treat disease. Nanotechnology will transform biology and medicine. Sonia Contera explores the complexity of biology, the birth of DNA technology, DNA nanorobotics, nanomedicine, recreating tissues and organs, addresses issues such as fear of technology, technology and equality. These are just a few take-aways from this substantial book written for non-specialists.

The author writes that we as human beings have no other choice than to mature to become part of the whole in a physical, economic and social sense. We have to advance into the construction of a new relationship with nature that allows our survival.

Sonia Contera: Nano Comes To Life: How Nanotechnology Is Transforming Medicine and the Future of Biology. Hardcover, Princeton University Press, November 2019, 216 pages. Order the book, the source for this article, from Amazon.com, Amazon.co.uk, Amazon.de, Amazon.fr.

For a better reading, quotations and partial quotations in this book review are not put between quotation marks.

Book review added on February 14, 2020 at 16:14 German time.

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How nanotechnology is transforming medicine and the future of biology - Cosmopolis

Recommendation and review posted by Alexandra Lee Anderson

NANOBIOTIX Announces Fast Track Designation Granted By U.S. FDA For Investigation of First-in-class NBTXR3 In Head and Neck Cancer – Business Wire

PARIS & CAMBRIDGE, Mass.--(BUSINESS WIRE)--Regulatory News:

NANOBIOTIX (Paris:NANO) (Euronext: NANO - ISIN: FR0011341205 the Company), a clinical-stage nanomedicine company pioneering new approaches to the treatment of cancer, today announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation for the investigation of NBTXR3 activated by radiation therapy, with or without cetuximab, for the treatment of patients with locally advanced head and neck squamous cell cancer who are not eligible for platinum-based chemotherapy.

Fast Track is a process designed to facilitate the development and accelerate the review of drugs for serious conditions and that have the potential to address unmet medical needs. The purpose is to expedite the availability of new treatment options for patients.

A product that receives Fast Track designation is eligible for1:

About NBTXR3

NBTXR3 is a first-in-class product designed to destroy tumors through physical cell death when activated by radiotherapy. NBTXR3 has a high degree of biocompatibility, requires one single administration before the first radiotherapy treatment session, and has the ability to fit into current worldwide radiotherapy radiation therapy standards of care. The physical mode of action of NBTXR3 makes it applicable across solid tumors such as lung, prostate, liver, glioblastoma, and breast cancers.

NBTXR3 is actively being evaluated locally advanced head and neck squamous cell carcinoma (HNSCC) of the oral cavity or oropharynx in elderly and frail patients unable to receive chemotherapy or cetuximab with limited therapeutic options. Promising results have been observed in the phase I trial regarding local control. In the United States, the company has started the regulatory process for the clinical authorization of a phase II/III trial in locally advanced head and neck cancers.

Nanobiotix is also running an Immuno-Oncology development program. The Company received FDA approval to launch a clinical trial of NBTXR3 activated by radiotherapy in combination with anti-PD-1 antibodies in locoregional recurrent (LRR) or recurrent and metastatic (R/M) HNSCC amenable to re-irradiation of the HN and lung or liver metastases (mets)from any primary cancer eligible for anti-PD-1.

The other ongoing NBTXR3 trials are treating patients with hepatocellular carcinoma (HCC) or liver metastases, locally advanced or unresectable rectal cancer in combination with chemotherapy, head and neck cancer in combination with concurrent chemotherapy, and prostate adenocarcinoma. Furthermore, the company has a large-scale, comprehensive clinical research collaboration with The University of Texas MD Anderson Cancer Center (9 new phase I/II clinical trials in the United States) to evaluate NBTXR3 across head and neck, pancreatic, thoracic, lung, gastrointestinal and genitourinary cancers.

About NANOBIOTIX: http://www.nanobiotix.com

Incorporated in 2003, Nanobiotix is a leading, clinical-stage nanomedicine company pioneering new approaches to significantly change patient outcomes by bringing nanophysics to the heart of the cell.

The Nanobiotix philosophy is rooted in designing pioneering, physical-based approaches to bring highly effective and generalized solutions to address unmet medical needs and challenges.

Nanobiotixs first-in-class, proprietary lead technology, NBTXR3, aims to expand radiotherapy benefits for millions of cancer patients. Nanobiotixs Immuno-Oncology program has the potential to bring a new dimension to cancer immunotherapies.

Nanobiotix is listed on the regulated market of Euronext in Paris (Euronext: NANO / ISIN: FR0011341205; Bloomberg: NANO: FP). The Companys headquarters are in Paris, France, with a US affiliate in Cambridge, MA, and European affiliates in France, Spain and Germany

1https://www.fda.gov/patients/fast-track-breakthrough-therapy-accelerated-approval-priority-review/fast-track

Disclaimer

This press release contains certain forward-looking statements concerning Nanobiotix and its business, including its prospects and product candidate development. Such forward-looking statements are based on assumptions that Nanobiotix considers to be reasonable. However, there can be no assurance that the estimates contained in such forward-looking statements will be verified, which estimates are subject to numerous risks including the risks set forth in the reference document of Nanobiotix registered with the French Financial Markets Authority (Autorit des Marchs Financiers) under number R.19-018 on April 30, 2019 (a copy of which is available on http://www.nanobiotix.com) and to the development of economic conditions, financial markets and the markets in which Nanobiotix operates. The forward-looking statements contained in this press release are also subject to risks not yet known to Nanobiotix or not currently considered material by Nanobiotix. The occurrence of all or part of such risks could cause actual results, financial conditions, performance or achievements of Nanobiotix to be materially different from such forward-looking statements.

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NANOBIOTIX Announces Fast Track Designation Granted By U.S. FDA For Investigation of First-in-class NBTXR3 In Head and Neck Cancer - Business Wire

Recommendation and review posted by Alexandra Lee Anderson

Nanomedicine Market to Witness Increasing Growth $261063 Million at CAGR of 12.6% In 2023 – PharmiWeb.com

UPDATE AVAILABLE ON-DEMAND

The globalnanomedicine marketwas 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.

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.

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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.

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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.

The Major Key Players Are:

Abbott Laboratories, CombiMatrix Corporation, General Electric Company, Sigma-Tau Pharmaceuticals, Inc., Johnson & Johnson, Mallinckrodt plc, Merck & Company, Inc., Nanosphere, Inc., Pfizer, Inc., and Teva Pharmaceutical Industries Ltd.

The other prominent players Are:

Celgene Corporation, UCB (Union Chimique Belge) S.A., AMAG Pharmaceuticals, Nanospectra Biosciences, Inc., Arrowhead Pharmaceuticals, Inc., Leadiant Biosciences, Inc., Epeius Biotechnologies Corporation, Gilead, and Cytimmune Sciences, Inc.

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Nanomedicine Market to Witness Increasing Growth $261063 Million at CAGR of 12.6% In 2023 - PharmiWeb.com

Recommendation and review posted by Alexandra Lee Anderson

3D printing and nanomedicine combined to combat HIV – TheRecord.com

WATERLOO A University of Waterloo researcher is combining 3D printing and his expertise in nanomedicine to create a novel way to protect women from getting HIV.

Emmanuel Ho, an associate professor in UW's School of Pharmacy, is developing an intra-vaginal ring that would provide precise doses of medication that could stop HIV infection at the site of transmission.

"This will empower women to protect themselves," Ho said.

The ring is made of medical-grade plastic with hollow tubing and tiny pores. Medicine loaded into the ring, which is placed in the vagina, is slowly released and absorbed by the body.

Ho is testing a combination of anti-HIV and anti-inflammatory drugs. Inflammation in the vagina increases the risk of acquiring HIV because inflammation draws the immune cells that are infected by the virus.

"If a woman has high levels of inflammation in the genital tract, then the probability of HIV infection is much higher," said Ho's collaborator Keith Fowke, professor and head of Medical Microbiology and Infectious Diseases at the University of Manitoba.

Releasing anti-inflammation medication directly could reduce the risk, and then the anti-HIV medication could combat the virus if a woman is infected.

"It's kind of like a two-pronged approach," Ho said.

Intra-vaginal rings with a similar shape and design, such as NuvaRing, have been approved for birth control and hormone replacement therapy.

However, Ho said a 3D printed model allows for more precise design and drug delivery. It's also cheaper and avoids the waste from traditional manufacturing where melted polymers are poured into a mould.

Ho's ring could be used for a variety of medications, including hormonal contraceptives. Delivering it to the site would reduce the amount of medication needed, which would mean fewer side-effects.

Condoms and anti-HIV treatment are available to prevent HIV infection. But social and cultural factors can impede condom use, no to mention availability in developing countries, and oral medications need to be taken daily.

The ring would offer a discrete, effective and convenient approach.

"This would be a new option," Ho said.

The research recently got a grant from the Canadian government to move onto animal testing with the University of Manitoba and the Centers for Disease Control and Prevention in the United States, bringing it one step closer to reality from concept.

Globally, infection rates are on the rise for HIV the virus that causes AIDS and kills one million people globally each year, according to UNAIDS.

"There's a definite need," Ho said.

jweidner@therecord.com

Twitter: @WeidnerRecord

jweidner@therecord.com

Twitter: @WeidnerRecord

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3D printing and nanomedicine combined to combat HIV - TheRecord.com

Recommendation and review posted by Alexandra Lee Anderson


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