Archive for October, 2020

Autologous Stem Cell Based Therapies Market Report Delivering Growth Analysis with Key Trends of Top Companies (2020-2026)

A comprehensive research study on the Autologous Stem Cell Based Therapies Marketwas recently published by Market Report Expert. This is an up-to-date report, covering the current COVID-19 impact on the market. The Coronavirus (COVID-19) has affected every aspect of life globally and thus altering the global market scenario. The changes in the market conditions are drastic. The swiftly changing market scenario and initial and future assessment of the impact on Autologous Stem Cell Based Therapies market is covered in the report.The Autologous Stem Cell Based Therapies Market report is a precise and deep-dive study on the current state that aims at the major drivers, market strategies, and imposing growth of the key players. Worldwide Autologous Stem Cell Based Therapies Industry also offers a granular study of the dynamics, segmentation, revenue, share forecasts, and allows you to make superior business decisions. The report serves imperative statistics on the market stature of the prominent manufacturers and is an important source of guidance and advice for companies and individuals involved in the Autologous Stem Cell Based Therapies industry.

The Global Autologous Stem Cell Based Therapies Market poised to grow from US$ XX million in 2020 to US$ XX million by 2026 at a compound annual growth rate (CAGR) of XX% during the projection period of 2020-2026.

An Outline of the Major Key Players covered in this Report:

Regeneus, Mesoblast, Pluristem Therapeutics Inc, U.S. STEM CELL, INC., Brainstorm Cell Therapeutics, Tigenix, Med cell Europe

Get Free LatestPDF Template of this Report(Including Covid-19 impact analysis on overall industry Forecast, Size, Share, CAGR and more.)@ https://www.marketreportexpert.com/report/Autologous_Stem_Cell_Based_Therapies_/13849/sample

Note: We can also provide market report in German/French Language.

The report puts together a succinct analysis of the growth drivers influencing the current business scenario across various regions and countries. Substantial information pertaining to the industry analysis size, share, application, and statistics are summed in the report in order to present a collaborative prediction. Additionally, this report encompasses a precise competitive analysis of major market players, innovative companies, and their strategies during the projection timeline.

The latest report on the Autologous Stem Cell Based Therapies Market consists of an analysis of this industry and its type, application, and other segments. As per the report, the market is estimated to gain significant returns and register substantial y-o-y growth during the forecast period of 2020-2026.

Majortype, primarily split into

Embryonic Stem CellResident Cardiac Stem CellsUmbilical Cord Blood Stem Cells

Major applications/end users, including

Neurodegenerative DisordersAutoimmune DiseasesCardiovascular Diseases

According to the report, the study offers details regarding the valuable estimations of the market such as market size, sales capacity, and profit projections. The report documents factors such as drivers, restraints, and opportunities that impacts the remuneration of this market.

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The research offers an analysis of the geographical landscape of the Autologous Stem Cell Based Therapies Market, which is divided into regions such as North America, Europe, Asia Pacific, South America, and the Middle East & Africa. The segment includes data about several parameters related to the regional contribution such as market share, application share, type share, key companies in respective regions, market share of key companies in regional market, growth rate and revenue of the regional market, sales, production, and consumption of the respective Autologous Stem Cell Based Therapies market.

Major Highlights of TOC Covers:

Autologous Stem Cell Based Therapies Market 2020, Autologous Stem Cell Based Therapies Market size, Autologous Stem Cell Based Therapies Market share, Autologous Stem Cell Based Therapies Market analysis, Autologous Stem Cell Based Therapies Market forecast, Autologous Stem Cell Based Therapies Market trends, Autologous Stem Cell Based Therapies Market Research report, Autologous Stem Cell Based Therapies application, Autologous Stem Cell Based Therapies Trends, Autologous Stem Cell Based Therapies Market growing CAGR, Autologous Stem Cell Based Therapies Market Competitive Landscape, Autologous Stem Cell Based Therapies Market Growth

Information related to the growth rate, revenue, sales, production, consumption, during the forecast period is included in the report. The Autologous Stem Cell Based Therapies Market report claims that the industry is projected to generate significant revenue and sales during the forecast period. The report consists of information related to the market dynamics such as challenges involved in this vertical, growth opportunities, and driving factors affecting the market.

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Autologous Stem Cell Based Therapies Market Size, Business Revenue Forecast, Leading Competitors And Growth Trends 2026| Regeneus, Mesoblast,...

The University of Manchester, part of the prestigious Russell Group of universities, has announced today a groundbreaking gene therapy partnership to ease the lifelong suffering of people with Hunter syndrome.

The University has agreed to a worldwide license and collaborative research funding agreement with AVROBIO, Inc., a leading clinical-stage gene therapy company with a mission to free people from a lifetime of genetic disease, based in Cambridge, Massachusetts, USA.

The significant partnership agreement is for the clinical development of an investigational lentiviral gene therapy for mucopolysaccharidosis type II (MPS II), or Hunter syndrome, a rare and deadly lysosomal disorder that primarily affects young boys.

Hunter syndrome, which affects an estimated one in 100,000 males worldwide, causes devastating complications throughout the body and brain, including severe cardiac and respiratory dysfunction, skeletal malformations and hearing impairment. Children with severe cases of Hunter syndrome typically show early symptoms in their toddler years and begin to regress developmentally around age six, losing basic motor skills and cognitive function.

The current standard of care is weekly enzyme replacement therapy (ERT), which can delay some complications but does not halt overall progression of the disease and has not been demonstrated to address cognitive issues. Even with ERT, people with Hunter syndrome face life-limiting symptoms and a significantly reduced life span.

The University of Manchester will sponsor the investigator-led Phase 1-2 clinical trial for Hunter syndrome which is expected to begin in 2021. The Hunter syndrome program was developed by Brian Bigger, a professor of cell and gene therapy at The University of Manchester. Professor Bigger has published preclinical data demonstrating that the introduction of the transgene with an optimised, proprietary tag has the ability to correct peripheral disease and normalise brain pathology.

Primary investigators for the clinical trial will be; Professor Robert Wynn, Consultant Paediatric Hematologist at the Royal Manchester Childrens Hospital and Dr. Simon Jones, Consultant Paediatric Physician for inherited metabolic diseases at the Willink Unit, Saint Marys Hospital and the Manchester Centre for Genomic Medicine.

We feel an enormous urgency to bring forward a treatment that may halt this deadly disease in its tracks, before symptoms emerge and before children lose their physical and cognitive skills, said Professor Bigger. We are delighted to be working with AVROBIO on this program. Both of our teams have deep experience running international clinical trials in other lysosomal disorders. AVROBIO also has a leading gene therapy platform, plato, which is designed to optimise the consistency, predictability and efficacy of its gene therapies and to enable efficient scaling for worldwide commercialization. By working together, we believe we can greatly accelerate development of this important program.

The investigational gene therapy, which will be called AVR-RD-05, involves ex vivo transduction of the patients own hematopoietic stem cells with a therapeutic transgene designed to express functional enzyme the patient needs to maintain cellular health, coupled to a proprietary protein tag that is designed to improve stability of the enzyme in the bloodstream and facilitate uptake by tissues from head to toe. When reinfused into the patient, the gene-modified stem cells are expected to engraft in the bone marrow and produce generations of daughter cells, each carrying the transgene. Those daughter cells are then expected to differentiate into macrophages, microglia and other components of the immune system and circulate throughout the body and central nervous system, potentially enabling widespread distribution of functional enzyme.

Geoff MacKay, AVROBIOs president and CEO said: The lentiviral gene therapy approach is well suited to treat a progressive and pervasive disease such as Hunter syndrome, which affects organs throughout the body and severely impairs cognitive function. If we treat children early, before their symptoms arise, we hope to prevent the tragic complications that rob these young children of their futures.

We believe our deep experience with investigational gene therapies for lysosomal disorders will enable us to efficiently move the program through clinical development in collaboration with Professor Brian Bigger, who has done tremendous work to develop and optimize this investigational gene therapy. Were proud to add this program to our leading lysosomal disorder pipeline and excited about its potential to change the lives of patients and families living with Hunter syndrome.

The University of Manchesters technology transfer office, The University of Manchester Innovation Factory and AVROBIO have negotiated the exclusive, worldwide license to the technology. Under the terms of the license, AVROBIO will pay The University of Manchester an upfront cash payment and additional payments based on the achievement of development and regulatory milestones. The company will pay The University a mid-single digit percentage royalty on annual net sales of licensed products. Additionally, under the collaborative research funding agreement, AVROBIO will cover budgeted clinical trial costs.

Andrew Wilkinson, CEO of the Universitys technology transfer company, The University of Manchester Innovation Factory said: We are delighted that AVROBIO will be working with teams from The University of Manchester and The University of Manchester Foundation Trust to develop a therapy for this debilitating genetic disease. AVROBIOs strategic focus on bringing new personalised gene therapies to the world along with their technical and commercial expertise in this area make them an excellent partner for the investigational Hunter syndrome gene therapy programme.

About Hunter syndrome

Hunter syndrome, also known as mucopolysaccharidosis type II (MPS II), is a lysosomal disorder caused by a mutation in the IDS gene that leads to a deficiency of the lysosomal enzyme iduronate-2-sulfatase (IDS), which is essential for breaking down large sugar molecules called glycosaminoglycans (GAGs, also known as mucopolysaccharides). Without functional IDS, toxic levels of GAGs build up throughout the body and central nervous system, causing a wide range of symptoms including cognitive decline and cardiac and respiratory dysfunction. The current standard of care is weekly enzyme replacement therapy, which may delay some symptoms but does not halt the overall progression of disease and does not cross the blood-brain barrier, an intricate web of protective tissue that selectively prevents macromolecules from entering the brain. Even with treatment, people with Hunter syndrome face life-limiting symptoms and a significantly reduced life span. The disorder affects an estimated 1 in 100,000 males worldwide; about two-thirds of cases have an early, severe progressive form.

About lentiviral gene therapy

Lentiviral vectors are differentiated from other delivery mechanisms because of their large cargo capacity and their ability to integrate the therapeutic gene directly into the patients chromosomes. This integration is designed to maintain the therapeutic genes presence as the patients cells divide, which potentially enables dosing of pediatric patients, whose cells divide rapidly as they grow. Because the therapeutic gene is integrated using the vector into patients own stem cells, patients are not excluded from receiving the investigational therapy due to pre-existing antibodies to the viral vector.

About The University of Manchester

The University of Manchester is a member of the prestigious Russell Group and one of the UKs largest single-site universities.

We have over 40,000 students, 12,000 staff and, with almost 480,000 former students from more than 190 countries, are home to the largest alumni community of any campus-based university in the UK. No fewer than 25 Nobel laureates have either worked or studied here.

We are thetop UK University for graduate employabilityaccording to The Times and Sunday Times Good University Guide; ranked 27th in the world in the QS World University Rankings (2020) and 6th in the UK. Were also listed as 8th in Reuters Top 100: Europe's most innovative universities (2019).

Visit http://www.manchester.ac.uk for further information or https://www.manchester.ac.uk/discover/vision/ for our latest strategic vision.

Link:
University of Manchester announces partnership with AVROBIO for Hunter syndrome gene therapy - PharmiWeb.com

David Z Wang and colleagues look at the latest advances in brain research and how they might affect treatment of brain disorders

The world has come a long way in solving the mystery of the brain, understanding its fundamental role in human consciousness and discovering methods to treat its disorders. In The Sacred Disease in ~430 BC, Hippocrates wrote that the brain served to house the ventricles, whose main purpose was to be a container and transit point for the breath or air (pneuma) from outside the bodythe force that brought to life our joys, pleasures, laughter, and grief. Thus, the brain was a reservoir for an animated substance that produced the human experience of consciousness and personality rather than the source of that activity itself.1 Our knowledge of the brain and its functional complexity remained at the level of three ventricles where our soul lies (Nemesius, da Vinci) for hundreds of years until modern neuroscience began to uncover the fine network of neuronal circuits that made up the solid substance of the brain.

With the advent of modern neuroimaging, the complex structure of the brain has been brilliantly revealed, and this has helped greatly in the treatment of many brain related disorders. Other articles in this series have provided updates on a wide range of topics, including neurodegenerative diseases, mental disorders, cerebrovascular diseases, epilepsy, monogenic neurological diseases, and in vivo brain function testing.23456 With help from gross anatomy to electronic microscopy, tissue staining to profiling, cell physiology, and synaptic chemistry, neuroscientists have elucidated the mechanisms and pathophysiology of many common brain diseases. For example, trinucleotide repeat expansion is now known to be responsible for many genetically inherited degenerative diseases such as Huntingtons disease, and amyloid precursor gene or presenilin gene mutations can cause Alzheimers disease.

On the other hand, despite centuries of discovery on mechanisms of brain disease, treatment options remain limited. Most treatments still provide only alleviation of symptoms, though recent breakthroughs in gene therapy such as onasemnogene abeparvovec-xioi to treat children with spinal muscular atrophy 7 and reperfusion therapy for acute ischaemic stroke hold the promise to truly revolutionise treatment for neurological disease. While options are available to modify disease expression with medicationssuch as in the treatment of Parkinsons disease, multiple sclerosis, and epilepsywe are far from curing them.

Entering the 21st century, perhaps we now have better ways to understand the mechanism of those brain disorders that are still a mystery and find the precise treatment. The key will likely be interdisciplinary research. Many ongoing brain health research programmes have already been multidimensional, combining neurobiology, physics, engineering, big data science, and artificial intelligence.

In the future, it is likely that humans will be able to live longer, and do so with augmented capabilities supported by machine-human interactions. One exciting advance is new ways of observing in vivo brain-wide activities at the cellular level. A real time, ultra-large scale, high resolution (RUSH) macroscope has recently been developed that can provide video-rate gigapixel imaging of biological dynamics at centimetre scale and micrometre resolution, with a data throughput of up to 5.1gigapixels a second.8 RUSH has enabled in vivo functional imaging of neural networks across the whole mouse brain at single dendrite resolution and brain-wide tracking of leucocytes during pathological processes, and the technology opens up a new horizon for large scale brain imaging to study various brain diseases at a systematic level.8

Another example is the better understanding of the precise number of brain cells needed to complete a particular task. By constructing an explicit model of face selective cells that could decode an arbitrary realistic face from face cell responses and predict the firing of cells in response to an arbitrary realistic face, Chao and colleagues identified that macaques require only 200 cells to remember a face.9 These findings have far reaching significance. For the first time, a specialised task of the brain can be attributed to a specific number and type of brain cells in a specific circuit. This may allow scientists to build artificial models of explicit brain functions and experiment with mechanisms of injury and repair at a cellular or molecular level. Such mapping may aid our understanding of brain function and recovery and guide the rebuilding of brain circuits or resection of dysfunctional brain cells rather than whole tissues. It may also help us pinpoint the cells and circuits that are responsible for addictive behaviours, from smoking to substance use disorders to gambling.

The common belief is that when a brain has been removed, brain death is imminent. However, such belief has recently been shattered. Sestan and colleagues collected brains of 6-8 month old pigs four hours after death and bathed them in specialised perfusate solutions. They found that brain cells and synapses of certain areas of brain began to recover and show signs of cellular activities.10 Their finding suggests that there may be a late window of treatment after onset of brain anoxia when brain tissue can recover, analogous to the benefit of late window thrombectomy. This discovery has taught us that brain cells can survive and recover after loss of circulation, and that favourable conditions may preserve a reservoir of resilient brain cells that are slow progressors to ischaemic necrosis.

Evidence is also emerging on how brain cells can adapt. A recent report of functional neuronal connectivity in adults without apparent loss of function after brain hemispherectomy sheds new light on brain plasticity. The study provides the first comprehensive analysis of whole brain functional connectivity across the full repertoire of resting state networks after hemispherectomy and shows preservation of resting state networks but an increase in internetwork connectivity with other functional brain networks. When hemispheric resection occurred in patients younger than 11, the retained hemisphere was able to protect the jeopardised functions by enhancing cellular interaction and synaptic activity.11

Artificial intelligence (AI) has been widely applied in clinical diagnosis and patient monitoring. Recent studies have attempted to classify or detect Alzheimers disease and other cognitive impairment,1213 acute neurological events,1415161718 focus of epilepsy, autism spectrum disorder, and attention deficit/hyperactivity disorder by using deep learning based algorithms. The data in these AI models include not only medical images but also clinical scores, in vitro diagnostic test results, and other functional and structure information.19202122232425 These studies showed high sensitivity and specificity from their test set, and work is ongoing on how to incorporate the routine use of these AI systems into a clinical setting.

The lack of a large dataset from multiple centres, the limited coverage of a disease spectrum, and unclear risk of using AI are major limitations of these blackbox systems. In contrast, Wang and colleagues have recently proposed a vascular aware unsupervised learning technique, VasNet,26 which provides the end users with explainable images, including both vascular structures and multidimensional features such as anatomical, physiological, biochemical, and cellular details. The enriched outputs could augment human decision making on treating vascular diseases and contribute to the emergence of the next generation of healthcare engineering.

The US Food and Drug Administration has already approved several automatic quantitative measurement software systems for disease classification (eg, NeuroQuant, Quantib, RAPID). Brain morphometry analysis software can automatically examine segments of brain tissue and detect minute changes. This technology can help early detection of degenerative brain diseases by comparing the results from individuals with a large dataset and images of healthy people. To take racial differences in the brain into account, some Asian companies have developed software based on datasets acquired from Asian populations (http://quant-health.com). Use of a deep learning based segmentation algorithm could improve the accuracy and test-retest stability in segmenting and measuring the volume of brain structure, abnormal lesions, perfusion deficit area, and other characteristics. The resulting quantified values could be used to assign a clinical score automatically, avoiding the variation arising from subjective measurement and interobserver inconsistency.

AI algorithms can also objectively analyse the data collected from a depth camera or wearable devices, assess behaviour, and evaluate facial expressions.272829 The quantified values produced would not be affected by the physicians experiences, and errors can be avoided since the spatial-temporal resolution of the hardware is much smaller than visual evaluation by humans. Such early detection may allow treatment of a disease before a person shows clinical signs of brain dysfunction. Quantified measurements can be used as biomarkers to monitor the progress of the disease and help evaluate the efficacy of precision therapy.

One of the potential ways of curing a brain disorder is to correct its diseased protein structure. Many neurological diseases are caused by misfolded proteins, including Huntingtons, Parkinsons, and Alzheimers disease. AlphaFold, a Google company, has successfully predicted a protein structure by using large genomic data. The 3D models of proteins that AlphaFold generates are far more accurate than any that have come beforemaking significant progress on one of the core challenges in biology. The ability to predict a proteins shape from its DNA sequence is useful to scientists because it is fundamental to understanding its role within the body, as well as diagnosing and treating diseases believed to be caused by protein misfolding.30

We have entered into an exciting new era of brain science research and discovery. With the advent of AI, advanced imaging, genomics, psychosocial analytics, and protein engineering we may be closer than ever to new precision medicine approaches to treat many brain disorders.

In the past decade, neuroscience and brain research have entered into a new era

It is now possible to understand brain physiology and pathophysiology better through direct and in vivo observation of live brain

In the coming years, artificial intelligence will likely be part of brain science and assist or replace certain brain function

Genetic or protein alterations may provide a cure for many brain disorders in the near future

Contributors and sources: DZW drafted the first manuscript. LHS, TYQ, and QHD critically reviewed and revised the manuscript. DZW is an expert in stroke clinical research. LHS is an expert in neuroscience research and stroke care quality improvement. TYQ is an expert in big data and artificial intelligence. QHD is an expert in brain research and artificial intelligence.

Competing interests: We have read and understood BMJ policy on declaration of interests and declare that we have no competing interest.

Provenance and peer review: Commissioned; externally peer reviewed.

This article is part of a series launched at the Chinese Stroke Association annual conferenceon 10 October 2020,Beijing, China.Open access fees were funded by the National Science and Technology Major Project. The BMJ peer reviewed, edited, and made the decision to publish these articles.

Gupta A, Ayhan M, Maida A. Natural image bases to represent neuroimaging data. Proceedings of 30th international conference on machine learning. Vol 28. Atlanta, GA. 2013:987-94.

Evans R, Jumper J, Kirkpatrick J, et al. De novo structure prediction with deep-learning based scoring. In: Thirteenth critical assessment of techniques for protein structure prediction. Abstracts, 1-4 December 2018.

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Decoding the brain through researchthe future of brain health - The BMJ

Cancer Gene Therapy Market report offers in-depth analysis of the industry size, share, major segments, and different geographic regions, forecast for the next five years, key market players, and premium industry trends. It also focuses on the key drivers, restraints, opportunities and industry challenges.

Growing prevalence of cancer with rising mortality rates will augment cancer gene therapy industry forecast in the coming years. Cancer therapies incorporated with genetically modified genes ai in blocking the growth of the tumors.

Efficient PCR and isothermal amplification technologies for detecting mutations and CRISPR gene editing tools are some technical developments. These advancements have led to innovations and ensured availability of advanced cancer gene therapies driving the industry trends.

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Estimates have stated that the global cancer gene therapy market value is likely to cross an annual valuation of USD 2.5 billion by 2025.

Technological developments are majorly fueling cancer gene therapy growth. Genetically modified genes which block tumor growth have been incorporated into recent cancer therapies. Efficient isothermal amplification techniques and PCR technology are transforming the way gene mutations are detected. Recent launch of CRISPR gene editing tools is claimed to help enhance the process of gene therapy development. These innovations and advancements in technology are anticipated to propel cancer gene therapy industry size.

The in-vivo segment is estimated to witness about 22% growth over the forecast period owing to its multiple offered benefits. In-vivo gene therapy consists of direct delivery of therapeutic genes into the target cell, a process which has shown effective results in cancer treatment. Viral vectors are delivered using in-vivo gene therapy which help in stopping the activity of tumor inducing genes and has exhibited positive results in clinical trials.

Biopharmaceutical firms held approximately 48% of the industry revenue share in 2018. Major firms such as Roche and Novartis are working on cancer gene therapies that have high adoption rate of both non-viral and viral vectors. These firms are also carrying out clinical trials that are favoring the demand for such vectors, consequently driving market growth.

Broadening awareness regarding the availability of advanced cancer therapies have stimulated the market for cancer gene therapy in China. Government initiatives and funds have encouraged researchers to carrying out extensive R&D activities linked to cancer gene therapy.

Meanwhile, on a global landscape, companies like Vigene Biosciences, Cobra, Uniqure, Sirion Biotech, Bluebird Bio, Caribou, Ziopharm, Finvector, Cellectis and Sarepta Therapeutics are leading the cancer gene therapy market. These firms are focusing on enhancing their market position through business strategies such as product launches, mergers and acquisitions, among others.

Browse full table of contents (TOC) of this report @ https://www.decresearch.com/toc/detail/cancer-gene-therapy-market

Partial Chapter of the Table of Content

Chapter 4. Cancer Gene Therapy Market, By Type

4.1. Key segment trends

4.2. Ex-vivo

4.2.1. Market size, by region, 2014 2025 (USD Million)

4.3. In-vivo

4.3.1. Market size, by region, 2014 2025 (USD Million)

Chapter 5. Cancer Gene Therapy Market, By Product

5.1. Key segment trends

5.2. Viral vectors

5.2.1. Market size, by region, 2014 2025 (USD Million)

5.2.2. Adenoviruses

5.2.2.1. Market size, by region, 2014 2025 (USD Million)

5.2.3. Lentiviruses

5.2.3.1. Market size, by region, 2014 2025 (USD Million)

5.2.4. Retrovirus

5.2.4.1. Market size, by region, 2014 2025 (USD Million)

5.2.5. Adeno associated virus

5.2.5.1. Market size, by region, 2014 2025 (USD Million)

5.2.6. Herpes simplex virus

5.2.6.1. Market size, by region, 2014 2025 (USD Million)

5.2.7. Vaccinia virus

5.2.7.1. Market size, by region, 2014 2025 (USD Million)

5.2.8. Others

5.2.8.1. Market size, by region, 2014 2025 (USD Million)

5.3. Non-viral vectors

5.3.1. Market size, by region, 2014 2025 (USD Million)

5.4. Others

5.4.1. Market size, by region, 2014 2025 (USD Million)

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Cancer Gene Therapy Market 2020 by industry trends, statistics, key companies growth and regional forecast - News by Decresearch

Strategic Acquisitions Lead to Innovations in Freezers and Bioproduction of Gene Therapies

Companies in the cryopreservation equipment market are focusing on strategic acquisitions to expand their product portfolio. For instance, BioLife - a manufacturer of cryopreservation freeze media, announced its acquisition of Custom Biogenic Solutions - a producer of cryopreservation equipment for the biotech industry, to expand its portfolio of liquid nitrogen laboratory freezers and other cryogenic equipment.

Strategic acquisitions have led to rise in investments in improving the technology of freezers. As such, freezers segment is expected to account for the highest revenue of the cryopreservation equipment market. The segment is projected to reach a value of ~US$ 3.5 Bn by the end of 2027. Companies are increasing efficacy of cloud-based monitoring systems that help in evaluating biologic sample storage conditions.

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Developments in cryogen techniques have led to innovations in liquid nitrogen laboratory freezers. As such, liquid nitrogen cryogen segment dominates the cryopreservation equipment market and is projected to reach a value of ~US$ 5.1 Bn by 2027. Companies are tapping into opportunities for the development of tools for bioproduction of cell and gene therapies.

Automated Systems in Sample-prep Support Cryo-em Analysis for Protein and Drug Discovery

The cryopreservation equipment market is witnessing innovations in advanced sample preparation systems. For instance, TTP Labtech - a manufacturer of products within sample management, announced the launch of its next-gen automated system for sample-prep. Companies are making efforts to innovate in cryogenic electron microscopy (cryo-EM) in advanced sample preparation systems. As such, sample preparation systems are projected for exponential growth in the cryopreservation equipment market.

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Innovations in sample-prep systems are paving the way for cryo-EM analysis, which is instrumental in protein research and drug discovery. High-quality foil grids in systems for cryo-EM analysis are increasingly replacing manual processes in the healthcare industry. Thus, stakeholders in biotechnology and research laboratories are benefitting from these advanced systems to assess structure of biomolecules and support protein research. Advanced sample-prep systems are pervasively replacing conventional methods of NMR (Nuclear Magnetic Resonance) and X ray crystallography. These systems offer areas for researchers to solve complex protein structures, which was not possible with conventional methods. Improved 3D imaging and high speed blot-free plunging are key attributes that are attracting research companies in the cryopreservation equipment market landscape.

Stem Cell Storage and New Cell Manufacturing Plants Create Income Sources for Companies

Emergence of new cell manufacturing plants is complementing the growth of the cryopreservation equipment market. For instance, Cellex Incorporated - a biotechnology company, announced the launch of its cell manufacturing plant in Cologne, Germany to produce advanced therapy medicinal products for cryopreservation and cell purification, among others.

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Companies in the cryopreservation equipment market are expanding their services in long-term cryo-storage of advanced therapy medicinal products. Thus, manufacturing innovative cell therapy products for cancer is beneficial for creating new income opportunities for manufacturers of cryopreservation equipment. However, growth of the stem cells industry is another driver of the cryopreservation equipment market growth. Growing awareness about stem cell storage at birth is gaining importance in the cryopreservation equipment market landscape.

Cutting-edge Sensor Technology Aids pH and Co2 Measurement in Benchtop Incubators

The cryopreservation equipment market is largely consolidated with three dominant players accounting for a combined share of ~66% of the cryopreservation equipment market. However, difficulty to establish the right culture environment and incubator conditions for laboratories and IVF clinics are some of the challenges faced by emerging players. Hence, manufacturers in the cryopreservation equipment market are increasing production capabilities to develop equipment that provide insights on pH measurement. For instance, Planer a supplier of controlled temperature products, innovated in PetriSenseST, a sensor that provides monitoring of pH and CO2 in benchtop incubators.

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Incubators type segment dominates the cryopreservation equipment market and is projected to reach a value of ~US$ 2.9 Bn by 2027. Hence, equipment companies are increasing technical expertise in sensor technology to support incubator applications in laboratories and IVF clinics. Portability and flexibility of petri dish-sized sensors is gaining application in laboratory equipment. Thus, manufacturers in the cryopreservation equipment market are expected to increase their scope for incremental opportunities by developing advanced sensor equipment to cater to the needs of end users in labs and clinics.

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Cryopreservation Equipment Market: Increase in Demand for Regenerative Medicines to Accelerate Market Growth - BioSpace

Latest published market study on Global Stem Cell and Progenitor Cell-based Therapeutics Market with + data Tables, Pie Chart, high level qualitative chapters & Graphs is available now to provide complete assessment of the Market highlighting evolving trends, Measures taken up by players, current-to-future scenario analysis and growth factors validated with Viewpoints extracted via Industry experts and Consultants.Stem Cell and Progenitor Cell-based Therapeutics Market presents point by point serious investigation including the market Share, Size, Future extension. This investigation classifies the worldwide Stem Cell and Progenitor Cell-based Therapeutics breakdown information by makers, area, type and applications, likewise examines the market drivers, openings and difficulties. The study breaks market by revenue and volume (wherever applicable) and price history to estimates size and trend analysis and identifying gaps and opportunities. Some are the players that are in coverage of the study are VitroBioPharma, ViaCyte, Inc., Vericel., U.S. Stem Cell, Inc., Stemedica Cell Technologies, Inc, etc.

Data Bridge Market Research analyses the Stem Cell and Progenitor Cell-based Therapeutics Market to grow at a CAGR of 9.4% in the above-mentioned forecast period. Increasing focus on stem research is anticipated to create new opportunity for the stem cell & progenitor cell based therapeutics market.

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Overview:

Increasing investment in the R&D and advancement in the stem cell based therapies is expected to enhance the market growth. Some of the other factors such as increasing public-private investments for advancement of stem cell therapies, development of infrastructure of stem cell banking & processing, and rising cases of Parkinson disease will affect the growth of this market.

Some of the factors such as improper guidelines associated with the product development and lack of skilled & trained professional for cell culture technology are hampering the growth of this market.

The Stem Cell and Progenitor Cell-based Therapeutics Market 2020 Document clearly explains what market definition, classifications, applications, engagements and market trends are for the Stem Cell and Progenitor Cell-based Therapeutics industry. The Global Stem Cell and Progenitor Cell-based Therapeutics Market Share analysis is provided for the international markets including development trends, competitive landscape analysis, and key regions development status. Development policies and plans are discussed as well as manufacturing processes and cost structures are also analyzed. This report also states import/export consumption, supply and demand Figures, cost, price, revenue and gross margins. For each manufacturer covered, this report analyzes their Stem Cell and Progenitor Cell-based Therapeutics manufacturing sites, capacity, production, ex-factory price, and revenue and market share in global market. This report studies the industry abilities for each geographical region based on the customer purchasing patterns, macroeconomic parameters, development rate, and market demand and supply states. What is more, it determines the impact of buyers, substitutes, new entrants, competitors, and suppliers on the market.

According to this report Global Stem Cell and Progenitor Cell-based Therapeutics Market will rise from Covid-19 crisis at moderate growth rate during 2020 to 2027. Stem Cell and Progenitor Cell-based Therapeutics Market includes comprehensive information derived from depth study on Stem Cell and Progenitor Cell-based Therapeutics Industry historical and forecast market data. Global Stem Cell and Progenitor Cell-based Therapeutics Market Size To Expand moderately as the new developments in Stem Cell and Progenitor Cell-based Therapeutics and Impact of COVID19 over the forecast period 2020 to 2027.

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Stem Cell and Progenitor Cell-based Therapeutics Market report provides depth analysis of the market impact and new opportunities created by the COVID19/CORONA Virus pandemic. Report covers Stem Cell and Progenitor Cell-based Therapeutics Market report is helpful for strategists, marketers and senior management, And Key Players in Stem Cell and Progenitor Cell-based Therapeutics Industry.

The Global Stem Cell and Progenitor Cell-based Therapeutics segments and Market Data Break Down are illuminated below:

By Disease Type (Parkinson Disease, Huntington Disease)

By Applications (Tissue Engineering, Stem Cells, Gene Therapy, Drug Discovery, Nanotechnology)

By End- Users (Pharmaceutical and Biotechnology Industries, Hospitals, Research Institutes, Biotechnology Companies, Others)

The report can help to understand the market and strategize for business expansion accordingly. In the strategy analysis, it gives insights from marketing channel and market positioning to potential growth strategies, providing in-depth analysis for new entrants or exists competitors in the Stem Cell and Progenitor Cell-based Therapeutics industry. This report also states import/export consumption, supply and demand Figures, cost, price, revenue and gross margins. For each manufacturer covered, this report analyzes their Stem Cell and Progenitor Cell-based Therapeutics manufacturing sites, capacity, production, ex-factory price, revenue and market share in global market.

List of TOP KEY PLAYERS in Stem Cell and Progenitor Cell-based Therapeutics Market Report are

Complete Report is Available (Including Full TOC, List of Tables & Figures, Graphs, and Chart) @ https://www.databridgemarketresearch.com/toc/?dbmr=global-stem-cell-and-progenitor-cell-based-therapeutics-market

Stem Cell and Progenitor Cell-based Therapeutics Industry 2020 Market Research Report provides exclusive vital statistics, data, information, trends and competitive landscape details in this niche sector. This reports provides current status for Stem Cell and Progenitor Cell-based Therapeutics market forecast till 2027. Likely, the report also focuses on global major manufacturers of Stem Cell and Progenitor Cell-based Therapeutics 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 is also carried out.

Stem Cell and Progenitor Cell-based Therapeutics Report covers the manufacturers data, including: shipment, price, revenue, gross profit, interview record, business distribution etc., these data help the consumer know about the competitors better. This report also covers all the regions and countries of the world, which shows a regional development status, including market size, volume and value, as well as price data.

Global Stem Cell & Progenitor Cell-Based Therapeutics Market Scope and Market Size

Stem cell & progenitor cell-based therapeutics market is segmented of the basis of disease type, application and end- users. The growth amongst these segments will help you analyse meagre growth segments in the industries, and provide the users with valuable market overview and market insights to help them in making strategic decisions for identification of core market applications.

On the basis of disease type, the stem cell & progenitor cell-based therapeutics market is segmented into Parkinson disease and Huntington disease.

The application segment of the stem cell & progenitor cell-based therapeutics market is divided into tissue engineering, stem cells, gene therapy, drug discovery, and nanotechnology.

On the basis of end- users, the stem cell & progenitor cell-based therapeutics market is segmented into pharmaceutical and biotechnology industries, hospitals, research institutes, biotechnology companies and others.

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The report offers in-depth assessment of the growth and other aspects of the Stem Cell and Progenitor Cell-based Therapeutics market in important countries (regions), including:

What the Stem Cell and Progenitor Cell-based Therapeutics Market Report Contains:

Organization profiles of the main rivals alongside their strategic activities and market shares.

Assurance and examination of the macro and microeconomic variables that influence the Global Market, as per the regional analysis.

Market Overview for the Global Stem Cell and Progenitor Cell-based Therapeutics Market and the identification of the market elements, including development drivers, limitations, difficulties, and potential opportunities for the market.

Assurance of various elements in charge of changing the market scene, rising future chances and assurance of driving players, which can influence the market on a territorial scale.

Market analysis for the Global Stem Cell and Progenitor Cell-based Therapeutics Market, with an aggressive scene and geographic examination on a worldwide and territorial scale.

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With tables and figures helping analyze worldwide Global Stem Cell and Progenitor Cell-based Therapeutics Market Forecast provides key statistics on the state of the industry and is a valuable source of guidance and direction for companies and individuals interested in the market.

The content of the study subjects includes a total of 15 CHAPTERS:

Chapter 1, to describe Stem Cell and Progenitor Cell-based Therapeutics product scope, market overview, market opportunities, market driving force and market risks.

Chapter 2, to profile the top manufacturers of Stem Cell and Progenitor Cell-based Therapeutics, with price, sales, revenue and global market share of Stem Cell and Progenitor Cell-based Therapeutics in 2018 and 2019.

Chapter 3, the Stem Cell and Progenitor Cell-based Therapeutics competitive situation, sales, revenue and global market share of top manufacturers are analyzed emphatically by landscape contrast.

Chapter 4, the Stem Cell and Progenitor Cell-based Therapeutics breakdown data are shown at the regional level, to show the sales, revenue and growth by regions, from 2010 to 2020.

Chapter 5, 6, 7, 8 and 9, to break the sales data at the country level, with sales, revenue and market share for key countries in the world, from 2010 to 2020.

Chapter 10 and 11, to segment the sales by type and application, with sales market share and growth rate by type, application, from 2010 to 2020.

Chapter 12, Stem Cell and Progenitor Cell-based Therapeutics market forecast, by regions, type and application, with sales and revenue, from 2020 to 2027.

Chapter 13, 14 and 15, to describe Stem Cell and Progenitor Cell-based Therapeutics sales channel, distributors, customers, research findings and conclusion, appendix and data source.

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Stem Cell and Progenitor Cell-based Therapeutics Market Market Size, Share, Industry Report by Growt - PharmiWeb.com

Santhera will hold a conference call today at 13:00 CEST, 12:00 BST, 07:00 EDT. Details are at the end of this statement.

Pratteln, Switzerland, October6, 2020 Santhera Pharmaceuticals (SIX: SANN) announces the discontinuation of its Phase 3 SIDEROS study with Puldysa (idebenone) in patients with Duchenne muscular dystrophy (DMD) who are in respiratory decline and receive concomitant glucocorticoid treatment. Data from an interim analysis conducted by the independent Data and Safety Monitoring Board (DSMB) concluded that the study was unlikely to meet its primary endpoint. As a consequence, Santhera will discontinue the study, withdraw the European marketing authorization application and end the global development program for Puldysa. The Company intends to initiate a restructuring plan for the business with a focus on retaining key functions for bringing DMD drug candidate vamorolone to patients and execute on its other pipeline programs.

Based on the now completed interim analysis which tested for efficacy, the DSMB has recommended the SIDEROS study be discontinued due to futility. The interim analysis was based on the primary endpoint of the study, the change of forced vital capacity % predicted (FVC%p) from baseline to 18 months of treatment. The outcome revealed that the probability of reaching the primary endpoint at the end of the study is too small to merit the continuation of the study. There were no safety concerns noted by the DSMB.

Santhera will stop the SIDEROS trial (including extension) and participants who are enrolled in the study will discontinue study medication and complete the studys follow-up evaluations. Furthermore, following up on the recommendation from the DSMB, Santhera will discuss the impact of ending the SIDEROS study on ongoing expanded access programs with the corresponding regulatory bodies.

"We would like to thank the patients and the families, as well as investigators and medical professionals, who participated in the SIDEROS study. Without their contributions we would not be able to advance DMD research, said Dario Eklund, Chief Executive Officer of Santhera. While this is obviously not the outcome we expected, all our efforts in DMD will now be focused on progressing the promising drug candidate vamorolone which we recently licensed from ReveraGen to its next inflection point, the readout of 6-month topline data from the pivotal VISION-DMD study planned for the second quarter of 2021.

In connection with this decision, Santhera intends to start a restructuring process, aligning its operations to focus on progressing vamorolone for DMD, lonodelestat for cystic fibrosis and other lung diseases and its discovery-stage gene therapy approach for congenital muscular dystrophy.

Conference CallSanthera will host a conference call today at 13:00 CEST / 12:00 BST / 07:00 EDT. Dario Eklund, CEO of Santhera, will discuss this update. Participants are invited to call one of the following numbers 10-15 minutes before the conference call starts (no dial-in code is required):Europe: +41 58 310 50 00UK: +44 207 107 06 13USA: +1 631 570 56 13

About Santhera Santhera Pharmaceuticals (SIX: SANN) is a Swiss specialty pharmaceutical company focused on the development and commercialization of innovative medicines for rare neuromuscular and pulmonary diseases with high unmet medical need. Santhera has an exclusive license for all indications worldwide to vamorolone, a first-in-class anti-inflammatory drug candidate with novel mode of action, currently investigated in a pivotal study in patients with DMD as an alternative to standard corticosteroids. The clinical stage pipeline also includes lonodelestat (POL6014) to treat cystic fibrosis (CF) and other neutrophilic pulmonary diseases, as well as omigapil and an exploratory gene therapy approach targeting congenital muscular dystrophies. Santhera out-licensed ex-North American rights to its first approved product, Raxone (idebenone), for the treatment of Leber's hereditary optic neuropathy (LHON) to Chiesi Group. For further information, please visit http://www.santhera.com.

Puldysa and Raxone are trademarks of Santhera Pharmaceuticals.

For further information please contact: public-relations@santhera.com orEva Kalias, Head External CommunicationsPhone: +41 79 875 27 80eva.kalias@santhera.com

Disclaimer / Forward-looking statements This communication does not constitute an offer or invitation to subscribe for or purchase any securities of Santhera Pharmaceuticals Holding AG. This publication may contain certain forward-looking statements concerning the Company and its business. Such statements involve certain risks, uncertainties and other factors which could cause the actual results, financial condition, performance or achievements of the Company to be materially different from those expressed or implied by such statements. Readers should therefore not place undue reliance on these statements, particularly not in connection with any contract or investment decision. The Company disclaims any obligation to update these forward-looking statements.

# # #

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Santhera to Discontinue Phase 3 SIDEROS Study and Development of Puldysa in Duchenne Muscular Dystrophy (DMD) and Focus on Vamorolone - GlobeNewswire

PITTSBURGH--(BUSINESS WIRE)--Krystal Biotech, Inc. (Nasdaq:KRYS) today announced the presentation of positive preclinical data supporting the ongoing development of KB301, an innovative, investigational therapy designed to reverse the decline of collagen in aging skin. The data will be presented at the American Society for Dermatologic Surgery (ASDS) 2020 Virtual Meeting to be held October 9-11, 2020.

The preclinical program evaluated KB301s ability to transduce clinically relevant skin cells, to express and secrete mature human COL3 in vitro, as well as to confirm proper tissue localization of the transgene without toxicity or systemic vector distribution in vivo.

Key findings from the poster presentation titled In Vitro and In Vivo Pharmacology of KB301, an HSV-1-Based Gene Therapy, for the Treatment of Superficial Skin Depressions include:

The above data presentation will be available on the Scientific Publications page of the Companys website at http://ir.krystalbio.com/select-scientific-publications.

About collagen type III and KB301

The skin is composed of collagen-rich connective tissue composed primarily of types I and III collagen fibrils. Age-related changes in skin are largely due to aberrant collagen homeostasis, caused both by intrinsic (e.g., passage of time, genetics) and extrinsic (e.g., chronic light exposure, pollution) factors, which leads to progressive loss of dermal collagen. KB301 is an investigational therapy designed to restore collagen homeostasis locally via directed expression of full-length human type III collagen gene (COL3A1), thereby reconstructing an optimal physiologic environment in the skin to treat wrinkles and other superficial skin defects. KB301 is manufactured in-house at Krystals fully functional GMP ANCORIS facility, located near corporate headquarters in Pittsburgh. If ultimately successful, KB301 and any additional aesthetic programs will be developed through our wholly-owned subsidiary Jeune, Inc.

About the PEARL-1 Trial

The Phase 1 trial will evaluate the safety, tolerability, and initial efficacy of KB301 injections. Approximately 22 patients will be enrolled across 3 cohorts. The initial, open-label cohort will evaluate the safety and tolerability of 2 different dose levels of KB301 in healthy buttock skin. Following dose selection enrollment will begin in Cohorts 2 and 3, which are double-blind, placebo-controlled, intra-subject evaluations of the safety and efficacy of KB301 in either shallow-to-moderately deep facial wrinkles or moderate-to-severe atrophic acne scars. More information about the PEARL-1 study is available at https://clinicaltrials.gov/ct2/show/NCT04540900.

About Krystal Biotech

Krystal Biotech, Inc. (NASDAQ:KRYS) is a gene therapy company dedicated to developing transformative medicines to treat diseases caused by protein or gene dysfunction. For more information, please visit http://www.krystalbio.com.

About Jeune, Inc.

Jeune, Inc. is the companys wholly-owned subsidiary, which was incorporated in 2019 for the purpose of undertaking preclinical studies for aesthetic skin conditions.

Forward-Looking Statements

Any statements in this press release about future expectations, plans and prospects for Krystal Biotech, Inc., including but not limited to statements about the development of Krystals product candidates, such as plans for the design, conduct and timelines of ongoing clinical trials of beremagene geperpavec (B-VEC), KB105, KB104, KB301 and KB407; the clinical utility of B-VEC, KB105, KB104, KB301 and KB407, and Krystals plans for filing of regulatory approvals and efforts to bring B-VEC, KB105, KB104, KB301 and KB407 to market; the market opportunity for and the potential market acceptance of B-VEC, KB105, KB104, KB301 and KB407; plans to pursue research and development of other product candidates; the sufficiency of Krystals existing cash resources; the unanticipated impact of COVID-19 on Krystals business operations, pre-clinical activities and clinical trials; and other statements containing the words anticipate, believe, estimate, expect, intend, may, plan, predict, project, target, potential, likely, will, would, could, should, continue, and similar expressions, constitute forward-looking statements within the meaning of The Private Securities Litigation Reform Act of 1995. Actual results may differ materially from those indicated by such forward-looking statements as a result of various important factors, including: the uncertainties inherent in the initiation and conduct of clinical trials, availability and timing of data from clinical trials, whether results of early clinical trials or trials will be indicative of the results of ongoing or future trials, uncertainties associated with regulatory review of clinical trials and applications for marketing approvals, the availability or commercial potential of product candidates including B-VEC, KB105, KB104, KB301 and KB407, the sufficiency of cash resources and need for additional financing and such other important factors as are set forth under the caption Risk Factors in Krystals annual and quarterly reports on file with the U.S. Securities and Exchange Commission. In addition, the forward-looking statements included in this press release represent Krystals views as of the date of this release. Krystal anticipates that subsequent events and developments will cause its views to change. However, while Krystal may elect to update these forward-looking statements at some point in the future, it specifically disclaims any obligation to do so. These forward-looking statements should not be relied upon as representing Krystals views as of any date subsequent to the date of this release.

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Krystal Biotech to Present Pre-clinical Data Highlighting KB301 for Aesthetic Indications at the ASDS 2020 Virtual Meeting - Business Wire

Grady Smith, 10, and Southfield resident Jessica Carroll were able to meet for the first time via Zoom in September at the DKMS Gala. Carroll was the bone marrow donor that helped save the boys life.

Photo provided by the Smith family

SOUTHFIELD If you were to take one look at 10-year-old Grady Smith, youd see a young boy who enjoys sports and school.

But the young Salem, New Hampshire, boy has been through more in 10 years than some people have in 50.

Grady was diagnosed with adrenoleukodystrophy, or ALD, back in 2018.

According to Boston Childrens Hospital, ALD is a rare genetic condition that causes the buildup of very long chain fatty acids in the brain. When the fatty acids accumulate, they destroy the protective myelin sheath around nerve cells, responsible for brain function. Without the myelin sheath, the nerves can no longer relay information to and from the brain.

Every single thing I read said, terminal, slow deterioration to death, one to five years, horrible, horrible death, Jillian Smith said. We just died. I havent been the same person since that day. It just changes you for the rest of your life.

With a diagnosis, Grady and his parents looked for options on how to help. Grady had a lesion with a Loes score which is a way of rating severity of 10. Scores range from 0-34.

His parents werent sure Grady would qualify for a bone marrow transplant because they usually only perform transplants for boys with scores of 9 and under. Grady was in luck, however, as Boston Childrens Hospital decided to move forward anyway.

The next move was to find a match for the boy, but that process could take weeks, months or even years. In Gradys case, it took just a few weeks.

Southfield resident Jessica Carroll registered as a potential bone marrow/blood stem cell donor with DKMS, a German bone marrow donor file, in 2014, but she didnt think much would come of it.

Four years later she got a call from the nonprofit organization letting her know that she was a match for a young boy. After some research, Carroll was totally on board with donating.

It was great knowing during that donation that this little bit that I went through was potentially saving somebodys life, Carroll said. Thats all I really cared about, was that I was helping somebody.

Grady was able to get his transplant in 2018.

According to his mother, Grady hasnt had any progression and has even made some recovery. Hes back in line with his academics and is playing sports again.

Grady has auditory processing issues, which make it hard for him to comprehend language and sound. His mother said he relies on reading lips to communicate.

Theres still a lot to it. It stopped the monster thats how we look at it but its not just so cut and dry, Jillian said. Hes a very rare outcome with his Loes score and with just how well hes doing. Hes just a really, really good boy. He works really hard to help bring awareness.

Carroll and the Smiths have talked via text, and they were able to meet virtually for the first time in September at the DKMS Gala.

For the Smiths and Carroll, the meeting was emotional. Grady was finally able to put a face to his donor, and vice versa for Carroll.

It was of course emotional, Carroll said. Being able to hear everything they went through, though, definitely made me so happy that I had chosen to register.

The Smiths and Carroll still talk periodically throughout the year, and Sept. 20 was the two-year anniversary of the transplant.

They are hoping to be able to meet in person soon, and the DKMS team wants to bring them to next years gala to help make that happen. However, they hope it will be sooner.

Throughout this journey with Grady, the Smiths have advocated, learned and spoken more about ALD.

Prior to Gradys birth, Massachusetts wasnt testing for ALD in newborns, but it has since started. New Hampshire wasnt either, but the Smiths got the state to add ALD to the newborn screening panel.

The next goal is to get more states to add the ALD screening. The family has also spoken at conferences to share Gradys story and have become big proponents of what DKMS has been able to do for not only their family, but families around the world.

I think a big thing, too, that we really want to get out there is bone marrow transplant or stem cell transplant, how easy it is, Jillian said. All people need to do is go on DKMSs website, and they can get a packet sent out to them. They just swab their cheeks, send it in and they could be saving anyones life, someone just like Grady.

According to the DKMS website, the organization is dedicated to the fight against blood cancer and blood disorders by creating awareness, recruiting bone marrow donors to provide a second chance at life, raising funds to match donor registration costs and supporting the improvement of blood cancer therapies by our own research.

Those looking for more information or wanting to register can visit dkms.org/en or call (212) 209-6700.

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Southfield woman meets boy she saved with bone marrow donation - C&G Newspapers

Boise State engineers have been awarded $315,000 from the National Science Foundation (NSF) to launch stem cell research into space.

Alexander Regner, masters student in materials science engineering, has been working on stem cell research for nearly three years. Through Regners research, he has studied the health and maintenance of bone and bone marrow.

As you exercise and move, your bone marrow stimulates cells, which is a vital part of maintaining health, according to Regner.

Thats why exercise is so good for you. We know all of this contributes to health and maintenance, but we dont actually know what it looks like mechanically to these cells, Regner said.

Regner and his associates Gunes Uzer, assistant professor of mechanical and biomedical engineering, and Aykut Satici, assistant professor of mechanical and biomedical engineering, have created a model to mimic the bone marrow mechanical environment and analyze what kind of mechanical environment is causing the cells to react in certain ways.

Regner uses a computer simulation that matches a 3D printed physical sample. This allows Regner to understand what the mechanical environment looks like so they can correlate the mechanical environment to the cellular response.

Through this research, Regner asks the big question, is there a different mechanical environment generated due to changes in bone architecture?

Gunes and Satici looked at Regners research and wanted to bring it to a bigger audience. Their new goal was to determine how stem cell research can benefit Earth. According to Gunes, space travel tends to produce tissue types and cell behavior that is similar to aging. This aging happens over a matter of weeks in space, as opposed to a matter of years on Earth.

We take one of these bone cells and we age them for a year or two. But obviously, these bones have a shelf life, Gunes said. Maybe we can do that in space in three weeks and do the experiment in space. Maybe we can learn more about how the bone mechanical environment contributes to the aging process. Thats really the project, take Alexs work and send it to space.

Saticis contribution to this research is from a different perspective, robotics. According to Satici, there needs to be mechanical vibrations applied to particular cells. To accomplish this, there needs to be a robotic mechanism to perform that motion in a consistent matter.

Center for the Advancement of Science in Space (CASIS) holds a subcontract with the International Space Station along with the National Science Foundation (NSF). Each year, they ask the question, what type of research can we perform in space that can teach us something about Earth and improve advanced science on Earth?

Regner, Gunes and Satici argued that they cannot properly age experiments on Earth, and proposed that space could be a good platform for their research. They wrote a grant proposal for their research, what they have done in the past, what they plan to do and who is a part of the research team.

Regner, Gunes and Satici also work closely with the University of Texas, Rensselaer Polytechnic Institute and Space Tango to complete this research.

Through this extensive research, Regner, Satici and Gunes emphasize the importance of working hard to accomplish ones goals.

Just because its fun to do, doesnt mean you are going to learn it. You have to persevere and do the dirty work. Try to improve yourself with any resources you can get, Satici said.

Regner advocates for students to continuously work hard to help solve modern problems. There are a lot of job opportunities in the STEM field, and many jobs that may not require a STEM background at all, like politics.

A lot of our modern problems we are dealing with are multidisciplinary things. It requires the involvement of everyone. Space flight, for example, you need people to understand not only the mechanics but make sure were safe while were doing it, Regner said. [There are] a lot of problems we are facing in the middle age. If youre interested in helping solve them, there are so many different opportunities to get involved. If you want to go into politics, we need people to advocate for science in politics to make sure that we have adequate funding and focused goals for where we are going and what we are doing.

Gunes hopes students who want to get involved and achieve their goals will start with volunteer work.

Go to a lab youre interested in and say Hey, I want to do volunteering involving research. Before you know it you start getting your masters, your Ph.D., and then you become a scientist. If youre interested in [science] then stop thinking about it and do it, Gunes said.

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Boise State engineers given the opportunity to send stem cell research into space - Boise State University The Arbiter Online

MINNEAPOLIS, Oct. 6, 2020 /PRNewswire/ --The National Marrow Donor Program (NMDP)/Be The Match today announced a collaboration with the Minnesota health system M Health Fairview and Marcus Center for Cellular Cures (MC3)/Carolinas Cord Blood Bank at Duke University (Duke) to offer cryopreservation services to transplant centers through the Be The Match BioBank. The collaboration brings together industry-leading expertise in cryopreservation and storage of patient-directed donor blood stem cell products to improve donor availability, collection quality, and ultimately, to provide a more reliable path to transplant for patients.

Through the Be The Match BioBank, blood stem cell donors will be able to donate bone marrow or peripheral blood stem cells (PBSC) for an intended patient on a timeline that is convenient for the donor. The cells are then cryopreserved and stored for the transplant center at no cost to them and shipped to coincide with initiation of the patient's conditioning regimen and optimal treatment timeline.

"We're excited to expand our partnership with Duke University by adding the expertise of physicians and researchers at M Health Fairview University of Minnesota Medical Center to continue to overcome logistical barriers to blood and marrow transplantation that might otherwise disrupt optimal patient care. Through the flexibility offered by the Be The Match BioBank, we believe we can provide transplant centers with a well-matched, available donor more often, and allow the transplant to occur at the best time for the patient," explained Steven Devine, MD, Chief Medical Officer, NMDP/Be The Match, and Associate Scientific Director, CIBMTR (Center for International Blood and Marrow Transplant Research). "The team at the Duke University lab was instrumental in the development of the Be The Match BioBank, as well as supporting donor product cryopreservation during the COVID-19 pandemic to ensure patients can continue to receive the transplants they need."

"We are proud to extend our partnership with the NMDP/Be The Match in a new way. Be The Match BioBank is an innovative way to remove barriers that otherwise may stand in the way of a patient's transplant," said Joanne Kurtzberg, MD, who leads the Marcus Center for Cellular Cures (MC3)/Carolinas Cord Blood Bank at Duke University.

"We are thrilled to be working with the NMDP/Be The Match to offer Be The Match BioBank. Through this partnership, transplant physicians can have confidence a high-quality bone marrow or PBSC product will be available from the donor they requested in the timeframe that works best for their patient," said David McKenna, MD, who leads the Molecular and Cellular Therapeutics program at M Health Fairview.

Be The Match BioBank can be used by any transplant center in the NMDP/Be The Match Network of more than 180 transplant centers worldwide. Blood stem cell donors are informed that the transplant center is requesting cryopreservation and provide consent prior to collection. Donors can also consent to having their donated cells made available to other searching patients in the unlikely event the intended patient is unable to proceed to transplant as planned.

To learn more about Be The Match BioBank, visit Network.BeTheMatchClinical.org/BioBank.

About the National Marrow Donor Program/Be The Match The National Marrow Donor Program/Be The Match is the global leader in providing a cure to patients with life-threatening blood and marrow cancers like leukemia and lymphoma, as well as other diseases. The organization manages the world's largest registry of potential blood stem cell donors and cord blood units. The NMDP/Be The Match partners with a global network to connect patients to their donor match for a transplant, and provides education and support for patients. Through Be The Match BioTherapies, the NMDP/Be The Match partners with cell and gene therapy companies to support the development and delivery of new therapies. The organization conducts research through its research program, CIBMTR (Center for International Blood and Marrow Transplant Research), in collaboration with Medical College of Wisconsin.

About M Health Fairview M Health Fairview is the newly expanded collaboration betweenthe University of Minnesota, University of Minnesota Physicians,and Fairview Health Services. The healthcare system combines the best of academic and community medicine expanding access to world-class, breakthrough care through its 10 hospitals and 60 clinics.

SOURCE Be The Match

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NMDP/Be The Match partners with M Health Fairview and Duke University cryopreservation labs to launch Be The Match BioBank - PRNewswire

By Dylan Adams News Editor

Timothy Ray Brown, the first known person to be cured of HIV, died on Sept. 29 at age 54 after battling cancer.

Timothy Ray Brown, a figurehead in the AIDS and HIV community, passed away surrounded by friends after a five-month battle with leukemia, stated Tim Hoeffgen, Browns partner.

Brown received a positive HIV diagnosis in 1995 while studying in Berlin.

In 2006, Brown was diagnosed with acute myeloid leukemia, which is a cancer that builds in the bone marrow and blood interfering with blood cell production. After bouts of infections from several rough rounds of chemotherapy, Browns leukemia came out of remission.

Due to leukemia in his bones, Brown required a stem cell transplant, a process that allows healthy stem cells to be introduced into a host to stimulate the immune system and healthy bone marrow growth. At the time, the survival rates for stem cell transplant were around fifty percent.

Doctors found a match to Browns genetic type, a donor with the CCR5 Delta 32 mutation, a protein that acts as a doorway to stop the HIV from infecting new cells. Three months after Brown stopped taking his HIV medication, doctors found he no longer had HIV in his blood.

After another round of stem cell treatment in February of 2008, Brown went through several near-death complications, almost going blind and becoming paralyzed but slowly recovering. His body was still successfully fighting off HIV.

In July 2012, the Timothy Ray Brown Foundation was created during the World AIDS Conference in Washington, DC. This foundation was built for Brown to show his support and work with medical institutions and scientists to develop a unifying cure and vaccination against HIV.

Brown would often donate large amounts of blood and tissue samples to researchers in the hope of progressing closer towards an HIV cure. According to his partner, Hoeffgen, Tims lifework was to tell his story about his HIV cure and become an ambassador of hope to those in need.

Doctors have since used Brown as a blueprint to work on a potential cure and vaccine for HIV. Most notably for the second person to ever be cured of HIV the London Patient, Adam Castillejo who went through similar stem cell transplants in 2019 before coming forward to the public.

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Excerpt from:
First Man Cured of AIDS Dies From Cancer - The Keystone Newspaper

When thinking about donating bone marrow, most will break out in a cold sweat.

The thought of needles, prodding and poking is enough to put anyone off from becoming a donor but Ndinae Muligwe, Sustainability and Donor Recruitment Coordinator for the South African Bone Marrow Registry (SABMR) explained that it is a less complicated and relatively painless process.

The SABMR was established in 1991 and is a non-profit organisation that conducts searches to find matching bone marrow donors for critically ill children and adults in South Africa who cannot find a match in their own families.

Bone marrow transplants help to treat and even sometimes cure illnesses like leukaemia, Non-Hodgkin lymphoma, bone marrow failure, and some genetic blood and immune-system disorders.

Ndinae explained that the likelihood of a donor finding a match is about one in 100 000. What is more concerning is that there are currently only around 74 000 local donors on the South African Bone Marrow Registry.

Although they do form part of the World Marrow Donor Association that represents about 38 million donors, there are not enough donors for the South African demographic.

Ethnicity plays a role when it comes to who is able to donate, and at the moment the numbers do not match the ethnic groups represented in South Africa. You are more likely to find a match within your own ethnic group.

But how do you become a donor and what is the process involved?

Ndinae said it is as easy as registering on the website. Of course there are some questionnaires to fill in and you will have to meet the criteria and be healthy.

The donating age has recently been lowered from 18 to 16 years of age, and applicants must be between 16 and 45 to register as a potential donor.

If you are eligible you will then be contacted by the SABMR to do a cheek swab free of charge.

Peripheral blood stem cell (PBSC) collection is the most likely way of collecting stem cells. These cells are found in your bone marrow and also the blood stream. A five-day course of growth factor or Granulocyte-Colony Stimulating Factors is given prior to the donation to encourage the stem cells to move from your marrow to your blood.

At the time of donation a needle is placed in one arm. The blood is then passed through a machine that collects the stem cells, and the remaining blood is returned to your body similar to donating blood platelets.

You do not have to pay for anything to make a tissue or blood donation of your bone marrow stem cells, the SABMR covers the cost of testing and collection.

Visitwww.sabmr.co.zafor more information.

Excerpt from:
Becoming a donor easier than you think - Randfontein Herald

NEW YORK, Oct. 08, 2020 (GLOBE NEWSWIRE) -- Bragar Eagel & Squire, P.C., a nationally recognized shareholder rights law firm, announces that a class action lawsuit has been filed in the United States District Court for the Southern District of New York on behalf of investors that purchased Mesoblast Limited (NASDAQ: MESO) securities between April 16, 2019 and October 1, 2020 (the Class Period). Investors have until December 7, 2020 to apply to the Court to be appointed as lead plaintiff in the lawsuit.

Click here to participate in the action.

Mesoblast develops allogeneic cellular medicines using its proprietary mesenchymal lineage cell therapy platform. Its lead product candidate, RYONCIL (remestemcel-L), is an investigational therapy comprising mesenchymal stem cells derived from bone marrow. In February 2018, the Company announced that remestemcel-L met its primary endpoint in a Phase 3 trial to treat children with steroid refractory acute graft versus host disease (aGVHD).

In early 2020, Mesoblast completed its rolling submission of its Biologics License Application (BLA) with the FDA to secure marketing authorization to commercialize remestemcel-L for children with steroid refractory aGVHD.

On August 11, 2020, the FDA released briefing materials for its Oncologic Drugs Advisory Committee (ODAC) meeting to be held on August 13, 2020. Therein, the FDA stated that Mesoblast provided post hoc analyses of other studies to further establish the appropriateness of 45% as the null Day-28 ORR for its primary endpoint. The briefing materials stated that, due to design differences between these historical studies and Mesoblasts submitted study, it is unclear that these study results are relevant to the proposed indication.

On this news, the Companys share price fell $6.09, or approximately 35%, to close at $11.33 per share on August 11, 2020.

On October 1, 2020, Mesoblast disclosed that it had received a Complete Response Letter (CRL) from the FDA regarding its marketing application for remestemcel-L for treatment of SR-aGVHD in pediatric patients. According to the CRL, the FDA recommended that the Company conduct at least one additional randomized, controlled study in adults and/or children to provide further evidence of the effectiveness of remestemcel-L for SR-aGVHD. The CRL also identified a need for further scientific rationale to demonstrate the relationship of potency measurements to the products biologic activity.

On this news, the Companys share price fell $6.56, or 35%, to close at $12.03 per share on October 2, 2020.

The complaint, filed on October 8, 2020, alleges that throughout the Class Period defendants made materially false and/or misleading statements, as well as failed to disclose material adverse facts about the Companys business, operations, and prospects. Specifically, defendants failed to disclose to investors: (1) that comparative analyses between Mesoblasts Phase 3 trial and three historical studies did not support the effectiveness of remestemcel-L for steroid refractory aGVHD due to design differences between the four studies; (2) that, as a result, the FDA was reasonably likely to require further clinical studies; (3) that, as a result, the commercialization of remestemcel-L in the U.S. was likely to be delayed; and (4) that, as a result of the foregoing, defendants positive statements about the Companys business, operations, and prospects were materially misleading and/or lacked a reasonable basis.

If you purchased Mesoblast securities during the Class Period and suffered a loss, have information, would like to learn more about these claims, or have any questions concerning this announcement or your rights or interests with respect to these matters, please contact Brandon Walker, Melissa Fortunato, or Marion Passmore by email at investigations@bespc.com, telephone at (212) 355-4648, or by filling out this contact form. There is no cost or obligation to you.

About Bragar Eagel & Squire, P.C.:Bragar Eagel & Squire, P.C. is a nationally recognized law firm with offices in New York and California. The firm represents individual and institutional investors in commercial, securities, derivative, and other complex litigation in state and federal courts across the country. For more information about the firm, please visit http://www.bespc.com. Attorney advertising. Prior results do not guarantee similar outcomes.

Contact Information:Bragar Eagel & Squire, P.C.Brandon Walker, Esq.Melissa Fortunato, Esq.Marion Passmore, Esq.(212) 355-4648investigations@bespc.comwww.bespc.com

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MESOBLAST ALERT: Bragar Eagel & Squire, PC Announces That a Class Action Lawsuit Has Been Filed Against Mesoblast Limited and Encourages Investors...

DetailsCategory: DNA RNA and CellsPublished on Thursday, 08 October 2020 15:15Hits: 536

NEW YORK, NY, USA and PARIS, France I October 08, 2020 I Cytovia Therapeutics ("Cytovia"), an emerging biopharmaceutical company, announces today that it has entered a research and licensing agreement with Inserm to develop NK engager bi-specific antibodies and iPSC CAR NK cell therapy targeting CD38, a key marker of multiple myeloma. The licensing agreement has been negotiated and signed by Inserm Transfert, the private subsidiary of Inserm, on behalf of Inserm (the French National Institute of Health and Medical Research) and its academic partners. Cytovia is licensing Inserm's CD38 antibody and Chimeric Antigen Receptor (CAR) patent and applying its proprietary NK engager bispecific antibody and iPSC CAR NK technology platforms. The research agreement will include evaluation of the therapeutic candidates at Hpital Saint-Louis Research Institute (Inserm Unit 976) under the leadership of Professors Armand Bensussan and Jean-Christophe Bories.

Dr Daniel Teper, Cytovia's Chairman and CEO commented: "We are delighted to partner with one of the top centers of excellence in the world for research and treatment in hematology. CD38 is a validated target and Natural Killer cells have significant cytotoxicity to Myeloma cells. We are looking forward to bringing promising new options to address the unmet needs of patients with Multiple Myeloma and aim for a cure."

Professor Armand Bensussan, Director of The Immuno-Oncology Research Institute at Hpital Saint-Louis added: "We have demonstrated the selectivity of our novel CD38 antibody in killing myeloma cells but not normal cells such as NK, T, and B cells. The activation of NK cells through NKp46 may enhance the efficacy of the bispecific antibody in patients not responsive to CD38 monoclonal antibody therapy. CD38 CAR NK is a promising approach forrelapsed/refractory patients and an alternative to CAR T therapies."

About Multiple MyelomaMultiple Myeloma is a currently incurable cancer, affecting a type of white blood cell known as plasma cells. It leads to an accumulation of tumor cells in the bone marrow, rapidly outnumbering healthy blood cells. Instead of producing beneficial antibodies, cancerous cells release abnormal proteins causing several complications. While symptoms are not always present, the majority of patients are diagnosed due to symptoms such as bone pain or fracture, low red blood cell counts, fatigue, high calcium levels, kidney problems, and infections. According to the World Cancer Research Fund, Multiple Myeloma is the second most common blood cancer, with nearly 160,000 new annual cases worldwide, including close to 50,000 in Europe. 32,000 in the US, and 30,000 in Eastern Asia. Over 95% of cases are diagnosed late, with a 5-year survival rate of 51%. Initial treatment comprises of a combination of different therapies, including biological and targeted therapies, corticosteroids, and chemotherapy, with the option for bone marrow transplants for eligible patients. Immunotherapy and cell therapy are the most promising new treatment option for Multiple Myeloma, with the potential for long term cancer remission.

About CAR NK cellsChimeric Antigen Receptors (CAR) are fusion proteins that combine an extracellular antigen recognition domain with an intracellular co-stimulatory signaling domain. Natural Killer (NK) cells are modified genetically to allow insertion of a CAR. CAR-NK cell therapy has demonstrated initial clinical relevance without the limitations of CAR-T, such as Cytokine Release Syndrome, neurotoxicity or Graft vs Host Disease (GVHD). Induced Pluripotent Stem Cells (iPSC) - derived CAR-NKs are naturally allogeneic, available off-the-shelf and may be able to be administered on an outpatient basis. Recent innovative developments with the iPSC, an innovative technology, allow large quantities of homogeneous genetically modified CAR NK cells to be produced from a master cell bank, and thus hold promise to expand access to cell therapy for many patients.

About CytoviaCytovia Therapeutics Inc is an emerging biotechnology company that aims to accelerate patient access to transformational immunotherapies, addressing several of the most challenging unmet medical needs in cancer and severe acute infectious diseases. Cytovia focuses on Natural Killer (NK) cell biology and is leveraging multiple advanced patented technologies, including an induced pluripotent stem cell (iPSC) platform for CAR (Chimeric Antigen Receptors) NK cell therapy, next-generation precision gene-editing to enhance targeting of NK cells, and NK engager multi-functional antibodies. Our initial product portfolio focuses on both hematological malignancies such as multiple myeloma and solid tumors including hepatocellular carcinoma and glioblastoma. The company partners with the University of California San Francisco (UCSF), the New York Stem Cell Foundation (NYSCF), the Hebrew University of Jerusalem, and CytoImmune Therapeutics. Learn more at http://www.cytoviatx.com

About InsermFounded in 1964, the French National Institute of Health and Medical Research (Inserm) is a public science and technology institute, jointly supervised by the French Ministry of National Education, Higher Education and Research, and the Ministry of Social Affairs, Health and Womens Rights. Inserm is the only French public research institute to focus entirely on human health and position itself on the pathway from the research laboratory to the patients bedside. The mission of its scientists is to study all diseases, from the most common to the rarest. With an initial 2020 budget of 927.28 million, Inserm supports nearly 350 laboratories throughout France, with a team of nearly 14,000 researchers, engineers, technicians, and post-doctoral students. http://www.inserm.fr

SOURCE: Cytovia Therapeutics

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Cytovia Therapeutics partners with Inserm to develop selective CD38 NK therapeutics and offer new treatment options for Multiple Myeloma patients |...

There are only a few specialised childhood cancer centres in Southern Africa.

Leukaemia and lymphoma are two of the most prevalent cancers in children in South Africa with between 800 and 1000 children diagnosed annually. Tragically, it is estimated that half of the children with cancer in this country are never diagnosed.

Dr Marion Morkel, Chief Medical Officer at Sanlam, believes that we all need to educate ourselves so we can recognise the symptoms of cancer.

Below, Dr Morkel explains what can be done in the fight against leukaemia and lymphoma.

Knowledge is key

You must be aware of the symptoms related to leukaemia and lymphoma so that you can notify your health professional should you see these symptoms in your child.

Leukaemia

Leukaemia is the most common childhood cancer accounting for 25% of all cases in South Africa.

Symptoms include:

Lymphoma

Lymphoma primarily originates from the lymph nodes and can often appear like any other illness that triggers an inflammatory response.

Symptoms to look out for include:

While other childhood illnesses can present in the same manner as leukaemia and lymphoma, health professionals have been trained to look out for symptoms that persist after routine treatment and will conduct tests to rule out the possibility of these childhood blood-related cancers.

Parents are encouraged to consult their doctor if there are any concerns about their childs health.

ALSO READ|Should I be worried if my child has pain in his tummy?

Register to become a blood stem cell (bone marrow) donor

The Sunflower Fund is a non-profit organisation that fights blood diseases through a blood stem cell transplant which replaces a persons defective stem cells with healthy ones and can be a potentially life-saving treatment for more than 70 different diseases.

Kim Webster, Head of Communications at The Sunflower Fund advises that finding a matching donor for a stem cell transplant is not as easy as finding a blood type match.

There is only a 1:100 000 chance of a patient finding their life-saving match with siblings only having a 25% chance of a match.

You can register to become a donor online via http://www.sunflowerfund.org.

Submitted to Parent24 by Atmosphere

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Knowledge is key: What you need to know about the most common childhood cancer in SA - News24

ENGLEWOOD, CO / ACCESSWIRE / October 6, 2020 / Aytu BioScience, Inc. (NASDAQ:AYTU), a specialty pharmaceutical company (the "Company") focused on commercializing novel products that address significant patient needs today reported financial results for its fiscal fourth quarter 2020, for the three month period ending June 30, 2020.

Fourth Quarter Fiscal 2020 Financial Highlights

Commenting on the fourth quarter of fiscal 2020, Josh Disbrow, Chief Executive Officer of Aytu BioScience, stated "Revenue increased exponentially in Q4 2020, to $14.9 million, compared to $1.7 million for Q4 2019. It is important to note that this was the first full quarter of revenue from the combined Aytu and Innovus businesses, along with the Cerecor assets. Turning to the bottom line, adjusted EBITDA loss was reduced to just $1.7 million for Q4 2020, compared to a $3.7 million adjusted EBITDA loss for Q4 2019. On the balance sheet, with approximately $48.3 million in cash, cash equivalents and restricted cash after paying $15 million to fully extinguish the Deerfield balloon payment previously due January 2021, we have less than $1 million of debt, and at current spending levels, we believe we have sufficient runway to reach profitability."

Mr. Disbrow continued, "Taking a closer look at the top line, both of our revenue streams, from the Consumer Health and Rx segments, performed well. On the Consumer Health side, we generated $6.9 million in revenue, an increase compared to Q3. Contributing to those results was organic growth within our core Consumer Health product lines of diabetes care, sexual wellness and bladder health. Additionally, we strengthened our e-commerce business for Consumer Health. Furthermore, our newly launched Consumer Health product, Regoxidine, an over-the-counter foam formulation of minoxidil for hair regrowth, is on track to contribute revenue in excess of seven figures in its first twelve months from launch."

Mr. Disbrow added, "On the Rx side, revenue was $7.9 million, a significant increase compared to Q3. Contributing to Rx revenue was solid contribution from the pediatric franchise. Additional value was created with Natesto gaining preferred status on Express Scripts' national formulary and the Natesto spermatogenesis study results published in the Journal of Urology, both of which we expect to drive prescription growth in the coming quarters. Organic Rx growth was fueled by a relatively balanced contribution across our key products and improved sales execution. Despite the impact COVID has had on physician office access, Q4 represented a record revenue quarter for our Rx business and significant growth over the previous quarters. This is a strong statement about our field execution and clinical value of our products, and I'm pleased to see our call levels now picking back up to near normal in the current quarter to further drive prescription growth."

Mr. Disbrow concluded, "At $14.9 million in record quarterly revenue, with a narrowed Adjusted EBITDA loss, $48.3 million of cash, cash equivalents and restricted cash on the balance sheet, the addition of the Healight opportunity for COVID-19 and future potential non-COVID-19 applications, and our addition to the Russell 2000, we have strong momentum to grow shareholder value in fiscal 2021 and onward."

Conference Call Information

The company will host a live conference call at 4:30 p.m. ET today. The conference call can be accessed by dialing either:

877-407-9124 (toll-free)

201-689-8584 (international)

The webcast will be accessible live at https://www.webcaster4.com/Webcast/Page/2142/37506 and archived on Aytu BioScience's website, within the Investors section under Events & Presentations, at aytubio.com, for 90 days.

A replay of the call will be available for fourteen days. Access the replay by calling 1-877-481-4010 (toll-free) or 919-882-2331 (international) and using the replay access code 37506.

About Aytu BioScience, Inc.

Aytu BioScience is a commercial-stage specialty pharmaceutical company focused on commercializing novel products that address significant patient needs. The company currently markets a portfolio of prescription products addressing large primary care and pediatric markets. The primary care portfolio includes (i) Natesto, the only FDA-approved nasal formulation of testosterone for men with hypogonadism (low testosterone, or "Low T"), (ii) ZolpiMist, the only FDA-approved oral spray prescription sleep aid, and (iii) Tuzistra XR, the only FDA-approved 12-hour codeine-based antitussive syrup. The recently acquired Pediatric Portfolio includes (i) Cefaclor, a second-generation cephalosporin antibiotic suspension; (ii) Karbinal ER, an extended-release carbinoxamine (antihistamine) suspension indicated to treat numerous allergic conditions; and (iii) Poly-Vi-Flor and Tri-Vi-Flor, two complementary prescription fluoride-based supplement product lines containing combinations of fluoride and vitamins in various for infants and children with fluoride deficiency. Aytu also distributes a COVID-19 IgG/IgM rapid test. This antibody test is a solid phase immunochromatographic assay used in the rapid, qualitative and differential detection of IgG and IgM antibodies to the 2019 Novel Coronavirus in human whole blood, serum or plasma. Aytu has also licensed the Healight Platform Technology. Healight is a pre-clinical investigational device being studied as a potential treatment for COVID-19 in severely ill, intubated patients and potentially other respiratory illnesses.

Aytu also operates a consumer health subsidiary, Innovus Pharmaceuticals, Inc. ("Innovus"), a specialty pharmaceutical company licensing, developing, and commercializing safe and effective consumer healthcare products designed to improve health and vitality. Innovus commercializes over twenty consumer health products competing in large healthcare categories including diabetes, men's health, sexual wellness and respiratory health. The Innovus product portfolio is commercialized through direct-to-consumer marketing channels utilizing the company's proprietary Beyond Human marketing and sales platform.

Aytu's strategy is to continue building its portfolio of revenue-generating Rx and consumer health products, leveraging its focused commercial team and expertise to build leading brands within large therapeutic markets. For more information visit aytubio.com and visit innovuspharma.com to learn about the company's consumer healthcare products.

Forward-Looking Statement

This press release includes forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, or the Exchange Act. All statements other than statements of historical facts contained in this presentation, are forward-looking statements. Forward-looking statements are generally written in the future tense and/or are preceded by words such as ''may,'' ''will,'' ''should,'' ''forecast,'' ''could,'' ''expect,'' ''suggest,'' ''believe,'' ''estimate,'' ''continue,'' ''anticipate,'' ''intend,'' ''plan,'' or similar words, or the negatives of such terms or other variations on such terms or comparable terminology. These statements are just predictions and are subject to risks and uncertainties that could cause the actual events or results to differ materially. These risks and uncertainties include, among others: market and other conditions, our ability to successfully commercialize Healight Platform Technology, our ability to obtain FDA approval for the Healight Platform Technology, the effectiveness of the Healight Platform Technology in treating patients with COVID-19 or other illnesses, our ability to adequately protect the intellectual property associated with the Healight Platform Technology, regulatory delays, the reliability of the Healight Platform Technology in killing viruses and bacteria, market acceptance of UV based medical devices, the regulatory and commercial risks associated with introducing the COVID-19 rapid tests, any delays in shipment that may impact our ability to distribute the COVID-19 rapid tests, any reputational harm we may incur if there are delays in receiving the shipment of the COVID-19 rapid tests, our ability to enforce the exclusivity provisions of the distribution agreements, the reliability of serological testing in detecting COVID-19, shipping delays and their impact on our ability to introduce the COVID-19 rapid tests, the ability of the COVID-19 rapid tests to accurately and reliably test for COVID-19, the manufacturers of the COVID-19 rapid tests' ability to manufacture such testing kits on a high volume scale, manufacturing problems or delays related to the COVID-19 rapid tests, our ability to satisfy any labelling conditions or other FDA or other regulatory conditions to sell the COVID-19 rapid test kits, the demand or lack thereof for the COVID-19 rapid test kits, our ability to obtain additional COVID-19 rapid tests to meet demand, our ability to secure additional tests if the manufacturers of the COVID-19 rapid tests are unable to meet demand, the effects of the business combination of Aytu and the Pediatric Portfolio and the recently completed merger ("Merger") with Innovus Pharmaceuticals, including the combined company's future financial condition, results of operations, strategy and plans, the ability of the combined company to realize anticipated synergies in the timeframe expected or at all, changes in capital markets and the ability of the combined company to finance operations in the manner expected, the diversion of management time on Merger-related issues and integration of the Pediatric Portfolio, the ultimate timing, outcome and results of integrating the operations the Pediatric Portfolio and Innovus with Aytu's existing operations, risks relating to gaining market acceptance of our products, obtaining or maintaining reimbursement by third-party payors for our prescription products, the potential future commercialization.

Contact for Media and Investors:

James CarbonaraHayden IR(646) 755-7412james@haydenir.com

Non-GAAP Financial Information

This press release contains a financial measure that does not comply with U.S. generally accepted accounting principles (GAAP), Non-GAAP Adjusted EBITDA. Non-GAAP Adjusted EBITDA excludes (i) amortization, (ii) depreciation, (iii) stock-based compensation, (iv) other expenses comprising net interest expense, (v) non-cash gains and/or losses recognized in the quarter or year due to changes in the fair value of certain of Aytu's financial liabilities, such as contingent consideration, derivative warrant liability, or certain exchanges of debt, (vi) bad debt expense, (vii) impairment of certain long-lived assets; (viii) one-time transaction costs and (ix) costs associated with the Company's Healight technology. Management believes these measures are useful to supplement its GAAP financial statements with this non-GAAP information because management uses such information internally for its operating, budgeting and financial planning purposes. In addition, Aytu believes these non-GAAP financial measures are useful to investors because they allow for greater transparency into the indicators used by management as a basis for its financial and operational decision making. Non-GAAP information is not prepared under a comprehensive set of accounting rules and therefore, should only be read in conjunction with financial information reported under U.S. GAAP when understanding Aytu's operating performance. A reconciliation between GAAP and non-GAAP financial information is provided in the financial statement tables below.

AYTU BIOSCIENCE, INC. AND SUBSIDIARIESConsolidated Statements of Operations

(Unaudited)

Three Months Ended June 30,

Revenues

Product revenue, net

License revenue, net

Total product revenue

Operating expenses

Cost of sales

Research and development

Selling, general and administrative

Selling, general and administrative - related party

Impairment of intangible assets

Amortization of intangible assets

Total operating expenses

Loss from operations

Other (expense) income

Other (expense), net

(Loss) / gain from change in fair value of contingent consideration

(Loss) on extinguishment of debt

Gain from warrant derivative liability

Total other (expense) income

Net loss

Weighted average number of shares outstanding ofcommon shares outstanding

Basic and diluted net loss per common share

AYTU BIOSCIENCE, INC. AND SUBSIDIARIESConsolidated Balance Sheets

Assets

Current assets

Cash and cash equivalents

Restricted cash

Accounts receivable, net

Inventory, net

Prepaid expenses and other

Other current assets

Total current assets

Fixed assets, net

Right-of-use asset

Licensed assets, net

Patents and tradenames, net

Product technology rights, net

Deposits

Goodwill

Total long-term assets

Total assets

AYTU BIOSCIENCE, INC. AND SUBSIDIARIESConsolidated Balance Sheets, Cont'd

Liabilities

Current liabilities

Accounts payable and other

Accrued liabilities

Accrued compensation

Debt

Contract liability

Current lease liability

Current portion of fixed payment arrangements

Current portion of CVR liabilities

Current portion of contingent consideration

Total current liabilities

Long-term contingent consideration, net of current portion

Long-term lease liability, net of current portion

Long-term fixed payment arrangements, net of current portion

Long-term CVR liabilities, net of current portion

Warrant derivative liability

Total liabilities

Read the rest here:
Aytu BioScience Announces Fiscal Q4 2020 Net Revenue of $14.9 Million, an Increase of 82% Sequentially, and 766% Year-Over-Year - BioSpace

Live Conference Call and Webcast at 4:30 PM ET

ENGLEWOOD, CO / ACCESSWIRE / October 5, 2020 / Aytu BioScience, Inc. (NASDAQ:AYTU) (the "Company"), a specialty pharmaceutical company focused on commercializing novel products that address significant patient needs, announced today that the Company will present its operational results for the fiscal fourth quarter and year ended June 30, 2020 on October 6, 2020, at 4:30 p.m. ET. The Company will review accomplishments from the quarter and fiscal year and provide an overview of its business and growth strategy.

The Company will file Form 10-K after the markets close on October 6, 2020.

Conference Call Information

1-877-407-9124 (toll-free)1-201-689-8584 (international)

The webcast will be accessible live and archived at the following link, https://www.webcaster4.com/Webcast/Page/2142/37506 and on Aytu BioScience's website, within the Investors section under Events & Presentations, at aytubio.com, for 90 days.

A replay of the call will be available for fourteen days. Access the replay by calling 1-877-481-4010 (toll-free) or 919-882-2331 (international) and using the replay access code 37506.

About Aytu BioScience, Inc.

Aytu BioScience is a commercial-stage specialty pharmaceutical company focused on commercializing novel products that address significant patient needs. The company currently markets a portfolio of prescription products addressing large primary care and pediatric markets. The primary care portfolio includes (i) Natesto, the only FDA-approved nasal formulation of testosterone for men with hypogonadism (low testosterone, or "Low T"), (ii) ZolpiMist, the only FDA-approved oral spray prescription sleep aid, and (iii) Tuzistra XR, the only FDA-approved 12-hour codeine-based antitussive syrup. The pediatric portfolio includes (i) AcipHex Sprinkle, a granule formulation of rabeprazole sodium, a commonly prescribed proton pump inhibitor; (ii) Cefaclor, a second-generation cephalosporin antibiotic suspension; (iii) Karbinal ER, an extended-release carbinoxamine (antihistamine) suspension indicated to treat numerous allergic conditions; and (iv) Poly-Vi-Flor and Tri-Vi-Flor, two complementary prescription fluoride-based supplement product lines containing combinations of fluoride and vitamins in various for infants and children with fluoride deficiency. Aytu also distributes a COVID-19 IgG/IgM rapid antibody test and rapid antigen tests. These assays are used in the rapid, qualitative diagnostic assessment of the 2019 Novel Coronavirus. Additionally, Aytu recently licensed worldwide rights to develop the Healight technology platform. Healight is an investigational medical device being studied as a prospective treatment for COVID-19 and other respiratory infections.

Story continues

Aytu also operates a consumer health subsidiary, Innovus Pharmaceuticals, Inc. ("Innovus"), a specialty pharmaceutical company commercializing, licensing and developing safe and effective consumer healthcare products designed to improve men's and women's health and vitality. Innovus commercializes over thirty-five consumer health products competing in large healthcare categories including diabetes, men's health, sexual wellness and respiratory health. The Innovus product portfolio is commercialized through direct-to-consumer marketing channels utilizing the company's proprietary Beyond Human marketing and sales platform.

Aytu's strategy is to continue building its portfolio of revenue-generating Rx and consumer health products, leveraging its focused commercial team and expertise to build leading brands within large therapeutic markets. For more information visit aytubio.com and visit innovuspharma.com to learn about the company's consumer healthcare products.

Forward-Looking Statement

This press release includes forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, or the Exchange Act. All statements other than statements of historical facts contained in this presentation, are forward-looking statements. Forward-looking statements are generally written in the future tense and/or are preceded by words such as ''may,'' ''will,'' ''should,'' ''forecast,'' ''could,'' ''expect,'' ''suggest,'' ''believe,'' ''estimate,'' ''continue,'' ''anticipate,'' ''intend,'' ''plan,'' or similar words, or the negatives of such terms or other variations on such terms or comparable terminology. These statements are just predictions and are subject to risks and uncertainties that could cause the actual events or results to differ materially. These risks and uncertainties include, among others: the regulatory and commercial risks associated with introducing the COVID-19 rapid tests, the accuracy of the COVID-19 rapid tests as compared to other COVID-19 tests, market acceptance of the tests, the ability to obtain FDA approval or authorization for the tests, our ability to obtain sufficient tests to meet consumer demand, if any, the manufacturers' ability to scale up manufacturing to meet customer demand, if any, reputation risks if the tests are not as effective as anticipated, and that the current regulatory environment continues to permit the sale of the tests. We also refer you to the risks described in ''Risk Factors'' in Part I, Item 1A of the company's Annual Report on Form 10-K and in the other reports and documents we file with the Securities and Exchange Commission from time to time.

Contact for Media and Investors:

James CarbonaraHayden IR(646) 755-7412james@haydenir.com

SOURCE: Aytu BioScience, Inc.

View source version on accesswire.com: https://www.accesswire.com/608913/Aytu-BioScience-to-Report-Fourth-Quarter-and-Full-Year-Fiscal-2020-Results-and-Provide-Business-Update-on-Tuesday-October-6-2020

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Aytu BioScience to Report Fourth Quarter and Full Year Fiscal 2020 Results and Provide Business Update on Tuesday, October 6, 2020 - Yahoo Finance

Once upon a time there was afour-year-old girlnamed Emilywhohad an English accent andliked playing with toy cars.Do you like her cars?She was just a stick figure with pigtails and a yellow triangle for a torso, buther extraordinary liferippled through the cosmosin aseeminglylimitlessnumber of strange directionsforcenturies after it was over. And possibly also before it began.

Of course,certain wrinkles in the fabric of space-timemake it hardtosay for sure when either of those things really happened. All we know is that Emilywas visited by a third-generation adult clone of herself at thebeginning of DonHertzfeldtsbeloved 2015 short World of Tomorrow,and spirited away on a whirlwind tour of the hilariously fucked up digital future that awaited her and all of the various back-up Emilysinto which she would dump her consciousness after her body stopped working.

It was a future shaped by the grotesque horrors that had resulted from humanitys various attempts at life extension: Consumer-grade time travel that glitched people into space, mentally deteriorated clones who fell in love with inanimate objects, solar-powered moon robots who were cursed to keep chasing after the sunlight forever and coped with their pain by sending depressive poetry back to the Earthlings who programmed them. By the time Emily Prime (Hertzfeldts surreptitiously recorded niece) and her maybe homicidal adult clone (animator Julia Pott) arrived back where they began just 16 minutes later, their circular odyssey along the fringes of whats to come had somehow resolved into a profound meditation on the infinite possibility of the present and how much of our lives we forfeit to what could be or what might have been. Now is the envy of all of the dead.

Its anotionthatHertzfeldtdeepened and expanded uponwith2017sbrilliantWorld of Tomorrow Episode II: The Burden of Other Peoples Thoughts, which found Emily Prime and an incompleteback-upclone plonking aroundthewasteland of thelattershalf-formed self-consciousnesswith the samemorbid wonder that the first installment zinged through outer space. Ittoldan implosivestory of identity and confabulation andmemory tourists a story about holding on tosome preciousessence ofourselves even whenit feels like the universe is trying to dissolve us together, or finding one when it feels like youre a clone in search of someone to be. Or, you know, when thats literally what you are.Episode II played like a distorted mirror image of World of Tomorrow in a way that made the twoshortfilms seem like a perfect, self-containedcouplet.

WORLD OF TOMORROW EPISODE THREE: THE ABSENT DESTINATIONS OF DAVID PRIME from don hertzfeldt on Vimeo.

Hertzfeldt could have left it there, secure in the knowledge that hed created one of the defining sci-fi series of this young century. But there was no way he was just going to pack up his toys and call it a day after mashing The Jetsons and Brazil into the kind of digital sandbox that someone could play in until the Earth blew up without ever growing bored of the existential crises it allowed them to imagineer along the way.

The Emilys are inexhaustibly entertaining characters, and though Episode II was another closed loop of atale, its non-linearnarrativeleft people reeling with ideasabout what might happen to this little girl and her ever-expandingarmyofbrain-damagedadult clones in afuture where even the most ordinary peoplecouldecho through eternity.If Carl Sagan was right to saywere all made of star-stuff, how beautiful andderangedmightthat actually look like on a long enough timeline one knotted by time travel, andlittered with people whoseorigins are ascloseand irrationalas the square root ofa prime number?

And so we arrive at World of Tomorrow Episode Three: The Absent Destinations of David Prime, aminiature34-minute epic thatstandson its owneven as itretrofitsthe previous installmentswith new layers that make them seem even morepoignantin hindsight. That title alone is probably enough to give Hertzfeldt fans some indication as to where this chapter might take us, but Episode Three opens with a flurry of sight gags so lucid and funny that series neophytes arent at any risk of getting lost in space; the laughter should be enough to localize most people, and everyone else can rest easy in the knowledge that the second half of the movie comes with its own flow charts.

A stick figure named Davidfloats through the traffic of deep space on a cramped ship thats barely any larger than his body; surrounded by the infinite wonder and mystery of the cosmos, he busies himself with a little online shoppingon his neural display(Why not?? reads the tagline for a pair of human gills).Suddenlyamessage appearsa memory that was buried deep in his subconscious as a child and time-lockeduntil the invention of interstellar travel. Its anEmily, and she needs David to travel to a remote alien planet in order to retrievea beacon that contains some very important information.Compelledby the dj vuofmaking contact with a stranger he recognizes as if she were his own shadow, Davidwordlesslyheeds Emilys request.

Theres only one problem: The relatively primitive computer that runs his brain doesnt have enough memory to handle a giant message from the future, and so David has to continually delete basic motor functions as he makes his way to whatever it is Emily left behind for him to find. Hilarity ensues. The first half of Episode Three might be the single funniest stretch of Hertzfeldts immaculate filmography, as Davids gradual debilitation marries the mortal anxiety of Its Such a Beautiful Day with the cartoon hyper-violence of Rejected in an ever-darkening crescendo of delectable chefs kiss moments. Its no surprise that Hertzfeldt distills the tragicomic absurdity of being alive in 2020 better than any other filmmaker has thus far (after all, hes been doing it for the last two decades).

But its what happens after David is able to download the rest of Emilys message that makes Episode Three such a vital and unexpected addition to this tantalizingly open-ended saga. The trail of where and when David goes from there quickly knot into Hertzfeldts most intricate narrative, as Emilys usual exposition gives way to the World of Tomorrow series first stretch of action-driven storytelling (but not before Pott delivers another of the peerlessly droll voice performances that give these movies their malformed heart, the Summer Camp Island creator twirling from sanguine to sociopath and back again as she prattles off dystopic jargon like a psychic college professor with brain worms).

Hertzfeldtjunkies will delight at how David Primes absent destinationsweave through the series previous chapters and answer LaJete-like questions about its lore that you may never have thought to ask; other cinematic universes could learn a thing or two fromhow seamlessly this movie is tailored to fititsbroader mythology. Everyonenewcomers includedcan Marvel at the elaborate time crisis thatHertzfeldtis able to execute. Its farcically complicatedstuff thatwends its way throughthe space between time,touches uponthe grandfather paradox,and builds toashootoutthat puts Tenet to shame withjust a handful of stick figures, but thehumanlogic ofthe heart-stopping final beatis clear enoughthat youwontneed a subreddit to explain the goosebumps on your skin(the films rich soundscape helps seal the deal, while Taylor Barrons eye-popping composite work allows thisto becomeHertzfeldtsmost tactile work so far).

And the World of Tomorrow series emotional undertow remains as powerful as ever. Hertzfeldt has always used Vonnegut-esque gallows humor to lower our defenses and make us laugh at things that might otherwise be too dark to even think about, but Episode Three in its own beautiful, demented way clarifies how that confrontationally mordant streak allows the Emilys to show us an ugly kind of hope worth keeping. The (almost) six years since the original World of Tomorrow premiered at Sundance have done so much to challenge the idea that now is the envy of all of the dead, and yet Hertzfeldts clones invariably twist the coldness of the universe and the constant threat of oblivion that comes with it into something perversely life-affirming.

At a time when technocratic futurism is pulling us forward while authoritarian regimes are holding us back, theres never been so much nauseating currency to the axiom that we should all strive to live in the moment. But Hertzfeldt knows thats easier said than done. For all of the bittersweet koans that litter his films, theres nothing prescriptive about his work. The original World of Tomorrow even ends with the Emily clone instructing Emily Prime on how to live her best life, but as any time-traveler should know she might have already lived it.

Time is a prison of living things, David tells us, and like any prison, we arealways looking for a way out. Theimpulse to escape will never change, it will only grow weirder.And yet, time is also a conduit for the abstract consequences that living thingsleave behind like messages in a bottle: Moments and memories thatfloat through the universe on butterfly wings, andare beautiful not for how they remain intact, but rather for how theyresublimated intothe star-stuff of a world that wouldnt be the same without them.Hertzfeldtsopen-ended fable(dont you dare call it a trilogy)is able to have so muchfun with the fact that were all going to die horrible deaths one daybecause its rooted inthebeliefthat weve alwaysbeen immortal.

That Emily Prime doesnt appear in Episode Three only makes it all the more obvious how shes hiding in the margins of every frame how even the least assuming of people (much like the profound short films that might be made about them) can pinball through space-time in ways that no one can imagine. Well, almost no one. Death is not a destination, Hertzfeldt offers, it is the absence of one. Ive never been more excited to see what detours he takes us on next.

World of Tomorrow Episode Three: The Absent Destinations of David Prime is now available to rent on Vimeo.

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World of Tomorrow Episode Three Review: The Best Sci-Fi Series of the 21st Century Goes Epic - IndieWire

Arms Control:

U.S. President Donald Trump: The Trump administration has withdrawn the U.S. from the 2015 Iran nuclear deal and the 1987 Intermediate-Range Nuclear Forces Treaty, and (almost) the 1992 Open Skies Treaty. It has loosened the Missile Technology Control Regimes restrictions on selling armed drones to foreign governments amid concerns about Chinas defense relationships in the Middle East. As of press time, administration officials have been unwilling to extend the 2010 New START nuclear pact with Russia, which expires in February, insisting that a new version include Russias growing arsenal of tactical nuclear weapons and China, whose smaller arsenal is rapidly expanding and which appears unwilling to sign such an agreement.

Former U.S. Vice President Joe Biden: Favored by arms control advocates, Biden has promised to renew New START and would likely accept Russias offer to extend it five years without preconditions. He also said he would rejoin the Iran nuclear deal if it returned to full compliance described in the agreement. While Trump has loosened restrictions on the use of landmines by the U.S. military in conflict areas, Biden has said the move unnecessarily puts civilians at risk and that he would reverse it.

Nuclear weapons:

Trump: Its expected the current president would stay on his path of modernizing all three legs of the nuclear arsenal something that has bipartisan support in Congress despite growing budget pressure. Trump deployed the W76-2 submarine-launched, low-yield nuclear warhead to counter a similar Russian weapon, and he has plans for a submarine-launched cruise missile, or SLCM. Trump approved a $44.5 billion nuclear weapons budget request in fiscal 2021 an increase of about 19 percent meant for the W76-2, several ongoing nuclear warhead life extension programs, a future W93 submarine-launched ballistic missile warhead, and the expansion of the production of plutonium pits for nuclear warheads to at least 80 per year.

Biden: Biden signaled he would scale back Trumps buildup. The Democratic nominee for president is opposed to the W76-2 and an SLCM. Biden would face pressure from the left to drop plans to build a new nuclear intercontinental ballistic missile force, replacing the Minuteman III fleet fielded in 1970, though he has not announced a position on it. Biden said he would review a policy reserving the option of using nuclear weapons first.

Defense budget:

Trump: The Pentagons five-year defense plan indicates it will request flat defense spending after 2021, and under pressure from coronavirus-related expenses the budget is widely expected to stay flat regardless of who is president. Trump championed record national defense top lines of $700 billion in 2018, $716 billion in 2019 and $733 billion for 2020, and he created the new Space Force. He has also diverted billions of defense dollars to fund a southern border wall, and in 2018 he backed off a proposal for a $750 billion defense budget, calling it crazy.

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Biden: Biden said Trump abandoned all fiscal discipline when it comes to defense spending, and while he doesnt foresee major U.S. defense cuts if elected, he would face pressure from the left to make them. To affordably deter Russia and China, Biden said he would shift investments from legacy systems that wont be relevant to smart investments in technologies and innovations including in cyber, space, unmanned systems and artificial intelligence. He also wants to boost neglected nonmilitary investments, such as diplomacy, economic power, education, and science and technology.

Afghanistan, Iraq and Iran:

Trump: Both candidates have railed against endless wars, and both have vowed to bring U.S. troops home from Afghanistan. After engaging in peace talks with the Taliban, the U.S. cut its troop presence to 8,600 in June, with plans to go to 4,500 by November and no troops by the spring. For Iraq, Trump plans to go from 5,200 troops to 3,000 by November. On Iran, Trump withdrew the U.S. from the nuclear deal and reimposed crippling trade sanctions as part of a maximum-pressure campaign. The administration recently warned allies it may target leaders of Iran-backed militias that have targeted U.S. forces and diplomatic posts in Iraq.

Biden: Biden has vowed to bring U.S. combat troops home from Iraq and Afghanistan, likely leaving residual counterterrorism forces. His camp favors small-scale operations (maybe led by special forces) rather than large, open-ended troop deployments, which he agrees would require the informed consent of the American people. Biden, who voted for the Iraq War when he was a senator, said during his current campaign that he played a key role in the Obama administrations drawdown of 150,000 U.S. forces from Iraq. On Iran, he said he would commit to preventing the country from acquiring a nuclear weapon, offer a diplomatic path while maintaining targeted sanctions, and work closely with Israel to ensure the American ally can defend itself against Iran and its proxies.

Arms sales:

Trump: Increasing U.S. arms sales has been a central focus of Trump and his administrations foreign policy. Hes moved to speed up the review process for major arms sales, made it easier to export firearms, eased the criteria for selling armed drones under the Missile Technology Control Regime and directed U.S. diplomats to advocate for American weapons purchases. He advanced several sales suspended under the Obama administration which played into a clash with Congress over sales to Saudi Arabia and other parties to the war in Yemen. Though Trump has touted the economic benefits of U.S. arms sales abroad, the idea is also to provide partners with American alternatives to Russian and Chinese weapons in order to maintain American influence.

Biden: While Biden hasnt made his views clear about arms sales overall, he said he would end U.S. military and other support for the Saudi-led war in Yemen. As he reassesses the U.S.-Saudi relationship, he would end weapon sales to Riyadh (which has historically been the top partner for U.S. military sales). We will make clear that America will never again check its principles at the door just to buy oil or sell weapons, Biden said. On firearm exports, his campaign said he may reverse a Trump administration rule that moved jurisdiction from the State Department to the Commerce Department.

NATO and Europe:

Trump: Among Trumps earliest foreign policy stances was a pledge to get allies to pay their fair share, particularly by getting NATO members to spend at least 2 percent of their gross domestic product on defense by 2024. That percentage of GDP is a NATO-backed goal. Trump often mischaracterizes that pledge as allies being delinquent in paying the U.S. funds. Trump has also pushed for tough trade rules with European nations, which has led to tensions with European capitals.

Biden: Biden and his advisers have drawn a contrast with Trump, pledging to rehabilitate frayed alliances. Biden has hit Trump for straining relations between the U.S. and Europe. He said the next president must salvage our reputation, rebuild confidence in our leadership, and mobilize our country and our allies to rapidly meet new challenges, pledging that he would take immediate steps to renew U.S. democracy and alliances, protect the United States' economic future, and once more have America lead the world. Biden plans to review troop movements out of Germany if he takes office, according to a top foreign policy aide.

Great power competition:

Trump: The Trump administrations National Defense Strategy announced a new era of great power competition. But while that includes Russia on paper, the administrations economic and military focus has squarely focused on China; the rhetoric from Trump has only increased following the COVID-19 outbreak, which the Republican president has called the China virus. Militarily, the Pentagon is attempting to shift focus and investments toward Pacific priorities, while also withdrawing forces from Europe.

Biden: While in the Senate, Biden pushed for better relations with China through increased commercial ties. But he now views China as the greatest strategic challenge to the United States and our allies in Asia and in Europe, one of the few areas in which he and Trump agree. Biden has called Chinese President Xi Jinping a thug and pledged swift economic sanctions against China if it tries to influence American companies or citizens. While Trump has bragged about having a good relationship with Russian President Vladimir Putin, expect a different tone from Biden should he occupy the White House. The former vice president has described Trump as subservient to Putin," and has talked about telling Putin directly: I dont think you have a soul.

Information about the candidates was compiled from a series of sources including: Defense News; Military Times; Al-Monitor; Arms Control Association; Center for International Policy; CNBC; CNN; Council for a Livable World; Defense One; Foreign Affairs; Forum on the Arms Trade; Los Angeles Times; Military Officers Association of America; New York Times; New Yorker Magazine; Reuters; Stars and Stripes; The Associated Press; Vox; Washington Examiner; and Washington Post.

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Find out where Trump and Biden stand on defense and security issues - DefenseNews.com

Our weekly column "White Whale Vinyl" spotlights the most sought-after rare vinyl in the heavy-music universe. Shop for vinyl, including a selection of limited-editionRevolver-exclusive variants, viaour store.

In 1984, Metallica released their hotly anticipated second album, Ride the Lightning. Taking its title from Stephen King's The Stand, the record boasted certified bangers like "Fight Fire With Fire," "Creeping Death" and "For Whom the Bell Tolls." Those soon-to-be-classics along with cryonics nightmare "Trapped Under Ice" and the Lovecraft-inspired instrumental "The Call of Ktulu" kept the denim n' leather faithful frothing at the mouth. But the band got some grief from seasoned heshers who balked at the power ballad "Fade to Black" and radio-friendly melodies of "Escape." Of course, millions more disagreed: Ride the Lightning has since been certified six times platinum. And that's just in the U.S.

Of the roughly gazillion copies sold worldwide, a few hundred don't share the album's iconic deep blue sleeve. Sure, the electric chair and lighting are still front and center, but the sleeve itself is an alien emerald green. These rare editions were the result of a misprint by Bernett Records, the label that released Ride the Lightning in France. But there seems to be some disagreement about how many of these misprints exist: Some sources claim 400, while others say it's as many as 1,000.

The higher number seems more likely, as this green monster comes up for sale fairly often. At least 10 have sold on Discogs so far in 2020, with the most recent copy going for $179 in VG+ condition. As of this writing, there are five copies available on the site all from overseas sellers ranging in price from 100 euros (G+ condition) to 350 euros (NM condition). The original misprint was pressed on black vinyl, and there are apparently two versions of the sleeve: one with the legend "Printed in France" and one without.

Bernett also produced a cassette version of Ride the Lightning with green artwork. It seems to be even rarer than the LP it hasn't appeared for sale on Discogs in over a year. Oddly enough, Metallica's U.S. record label at the time, Elektra, sent a promo single of "Fade to Black" to radio stations in early 1985. The record was pressed on phosphorescent green vinyl.

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White Whale Vinyl: Metallica Go Green With 'Ride the Lightning' - Revolver Magazine

A 24-year-old patient diagnosed with Pompe disease, a genetic fatal disorder, delivered a healthy baby at the Amrita Hospital here.

Patients with this rare condition have muscle weakness and a spectrum of severe complications, and often require long term, specialised treatments and management through Enzyme Replacement Therapy (ERT).

Sheela Nampoothiri, head of paediatric genetics, Amrita Hospital, said the patient had undergone the entire cycle of pregnancy to deliver a healthy baby as she had been put on the life-saving ERT under an access programme around six years ago after she was diagnosed with juvenile onset of Pompe disease.

Dr. Sheela said that this case was a testimony that patients diagnosed with rare diseases such as Pompe could lead a near-normal life if they were put on life-saving treatment early. The new-born female child, which weighed 2.8 kg at birth, did not have the defective gene and was free of Pompe disease, she said. Radhamani K., head of obstetrics and gynaecology, said that the patient was on ERT throughout her 37- week pregnancy and would continue to be on treatment in the post-natal phase too.

Continue reading here:
Woman with rare disease delivers healthy baby - The Hindu

Its this time of the year when those of us in northern temperate zones are spectators of a fascinating natural phenomenon the appearance of autumn leaf colors.

The leaves start to change colors as they age, or senesce. During this period a cluster of enzymes in the leaves start chewing up their green pigment, called chlorophyll. As the leaves become less green, their red, yellow, and orange pigments (known as anthocyanins and carotenes) begin to shine. However, exactly how chlorophyll breakdown works is still only partially understood.

While autumn leaves are a great example of chlorophyll breakdown, evergreen plants (those that remain green all year long), vegetables, and fruits also experience chlorophyll decay. However, this happens only under special conditions such when fruit ripen or when evergreen plants are deprived of nutrients and water.

Banana skin is one of the few fruits where chlorophyll degradation can be mapped under ultraviolet (UV) light. As bananas ripen, their skins lose their green color a sign of chlorophyll breakdown and form new pigments that fluoresce blue under the UV light. Scientists know that this new pigment, known as hypermodified fluorescent chlorophyll catabolite (hmFCC), is produced very briefly in most plants. Banana skins and grapevine leaves are known to produce hmFCCs for a longer period.

Recently scientists at Instituto de la Grasa, Spain analyzed devils ivy, an evergreen plant, in their quest to find signs of this fluorescent compound. They activated the aging process by starving the plant, and voila! Exposure to UV light produced the blue, fluorescent pigment hmFCC. The team also observed two other newly identified compounds that will provide more insights into the evergreen chlorophyll breakdown puzzle.

Although the actual benefit of producing this blue, fluorescent compound is still a mystery, scientists think that it could provide protection against radiation or function in communication between animals and plants.

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Working-class ants take the reins when the Indian jumping ant queen dies - Massive Science

publication date: Oct. 9, 2020

In a new clinical trial, City of Hope is investigating a treatment for cancer patients with COVID-19 by repurposing leflunomide, an anti-inflammatory drug for rheumatoid arthritis, which is inexpensive and has few serious side effects.

Patients treated for cancer in the past two years may also be eligible.

FDA has recently approved the start of a phase I trial. At a later date, a phase II randomized clinical trial may take place if the first trial finds leflunomide to be safe and tolerable for these patients. City of Hope plans to work with other local medical centers who are treating cancer patients for SARS-CoV-2, the virus that causes COVID-19, to enroll them in the trial.

There are currently few effective drugs against COVID-19, and our clinical trial targets a critical high-risk group cancer patients whose immune systems are already weak, Steven T. Rosen, City of Hope provost and chief scientific officer, and the Irell & Manella Cancer Center Directors Distinguished Chair and Morgan & Helen Chu Directors Chair of the Beckman Research Institute, said in a statement. Our hope is that leflunomide will eradicate COVID-19 in cancer patients, providing the medical community with an effective therapy against this devastating virus.

Sanjeet Dadwal, City of Hope chief of the Division of Infectious Diseases, is the principal investigator on the trial.

For the phase I trial, all patients will receive leflunomide and may also be able to simultaneously receive other standard of care treatments for COVID-19. They may receive remdesivir, an antiviral therapy. Patients with acute respiratory distress syndrome may receive the steroid, dexamethasone, and patients with complications of COVID-19 such as cytokine release syndrome, which can lead to multiple organ failure, can receive the antibody tocilizumab.

If the phase I trial is found to be a safe and tolerable treatment, then a phase II randomized, double-blind trial will open at a later date. About half the patients will receive leflunomide with standard of care therapies to treat COVID-19, and the other half will receive a placebo and standard of care drugs as well.

Leflunomide is an oral and generic anti-inflammatory drug approved by FDA to safely treat autoimmune diseases such as rheumatoid arthritis. The therapy has also been used in cancer patients with cytomegalovirus with tolerable side effects.

Laboratory experiments performed at City of Hope and Wuhan, China, indicate that leflunomide has high potential to shut down viral replication by preventing the synthesis of viral RNA, the genetic material. It also downregulates the expression of ACE 2, a receptor for COVID-19 cell entry. A small clinical trial using leflunomide in China also demonstrated the therapy has potential antiviral drug against COVID-19.

In a phase I clinical study, City of Hope treated patients with advanced multiple myeloma with leflunomide. The therapy stabilized their disease with tolerable side effects.

NCI has funded the trial with a P30 grant supplement for COVID-19 research projects. City of Hope is one of a few cancer centers that has received such funding during the pandemic.

City of Hope also received funding from private donors, including The Elias, Genevieve and Georgianna Atol Charitable Trust and The Norman and Sadie Lee Foundation.

Novel CAR T-cell lymphoma therapy developed at MCW advances to phase II study

A novel cancer therapy studied and developed at the Medical College of Wisconsin with promising clinical outcomes is leading to a larger phase II trial to improve on the current standard of care.

Results of phase I of the first-in-the-world double targeted CAR T-cell therapy clinical trial were published in Nature Medicine.

This is a novel, cell-based treatment against cancer targeting two proteins (antigens CD19 and CD20) on the surface of cancer cells. This CAR T-cell therapy trial began in October 2017 and resulted in safe and promising outcomes for patients with relapsed and refractory B cell non-Hodgkin lymphomas which are cancers of the immune system.

MCW researchers collected patient T cells and then used a specially engineered virus to augment their ability to identify and kill cancerous cells and effectively destroy the lymphoma. While phase I focused on safety and feasibility of the treatment, a multi-institutional phase II is being developed to determine the true efficacy and understand how the nuances of the treatment process can result in excellent outcomes for a larger subset of patients.

All patients in the clinical trial had failed prior treatments and their cancer had relapsed. Within 28 days of the CAR-T cell therapy, 82 percent responded positively. Six months later, more than half of the patients cancer remained in remission. A higher dose of the treatment correlated with a prolonged remission, a trend the researchers plan to study further in the trials second phase.

The new treatment genetically alters a persons own immune cells to target cancer cells in a unique and personalized fashion, a significant departure from more routine chemotherapy.

The cell product used for treatment was manufactured using the CliniMACS Prodigy device, which is part of an automated CAR T cell manufacturing platform developed by Miltenyi Biotec.

Housed at the Froedtert & MCW Clinical Cancer Center, the CliniMACS Prodigy device enabled the research team to conduct the CAR T-cell immunotherapy through a self-contained, desktop system, producing new cells ready to be infused back into a patients bloodstream within 14 days. With the device, the entire process was performed locally at Froedtert Hospital.

This research was made possible through philanthropic dollars raised by the Childrens Wisconsin Foundation and the MACC Fund and their support of the Cell Therapy Lab at MCW.

MD Anderson researchers identify characteristics of infused CAR T cells associated with efficacy and toxicity in large B-cell lymphoma

Researchers at MD Anderson Cancer Center have identified molecular and cellular characteristics of anti-CD19 CAR T cell infusion products associated with how patients with large B-cell lymphoma respond to treatment and develop side effects.

The research team also found that early changes in circulating tumor DNA one week after CAR T cell therapy may be predictive of treatment response in a particular patient. The paper was published online in Nature Medicine.

CAR T cell therapy is highly effective against LBCL, corresponding author Michael Green, associate professor of lymphoma and myeloma, said in a statement. However, we experience two main clinical challenges: achieving long-term remission and managing treatment-associated adverse events.

This study suggests that, within the first week of therapy, clinicians may be able to identify a subset of patients who may experience more poor outcomes or adverse treatment reactions, said Green. This would allow the care team to adjust therapy to improve efficacy or to act to mitigate toxicity.

For this study, researchers performed single-cell analysis on CAR T cells to study gene expression profiles in the infused cells. CAR T cells were collected from those remaining in infusion bags following treatment of 24 patients with LBCL. These genetic profiles were compared to treatment responses, determined at three months post-infusion by PET/CT scan.

When we look at the characteristics of the infused CAR T cells, we found that samples from patients who were less responsive to treatment had exhausted T cells, whereas those who experienced complete responses had T cells expressing memory signatures, co-corresponding author Sattva Neelapu, professor of lymphoma and myeloma, said in a statement. Additionally, one cellular signature of T cell exhaustion was more commonly found in patients who exhibited a poor molecular response, and poor molecular response is generally associated with less-positive, long-term outcomes.

Further, the researchers analyzed early molecular responses in the patients by monitoring changes in circulating tumor DNA from treatment to one week post-infusion. The magnitude of change in tumor-associated DNA corresponded with response, suggesting that patients who displayed an early molecular response were more likely to experience a clinical response to treatment.

When we examined the infusion product, we found that a cell population with characteristics similar to myeloid cells, with a monocyte-like transcriptional signature, was associated with development of high-grade neurotoxicity, Green said. Detecting these cells may subsequently lead us to identify patients who would be at higher risk of developing neurotoxicity, allowing us to provide prophylactic treatment with agents that target the specific cellular features.

Further examination may lead to insights into the types and attributes of the cells present within the CAR T infusion product.

This study also tells us that some rare and unexpected cells identified by single-cell analysis could be biologically important, said co-corresponding author Linghua Wang, assistant professor of Genomic Medicine. Going forward, we plan to functionally characterize these monocyte-like cells to better understand their specific biological mechanisms driving these clinical results.

These findings will help researchers develop clinical interventions that can block or target these cells. They also plan to validate the capacity of circulating tumor DNA to accurately predict patients long-term outcomes.

This research was supported in part by the B-cell Lymphoma Moon Shot, part of MD Andersons Moon Shots Program. With support from the Moon Shot and the Cancer Prevention & Research Institute of Texas, the research team plans to utilize PDX models of disease that relapsed following anti-CD19 CAR T cell therapy to preclinically test interventions that could lead to better treatment responses or to prevention of adverse side effects.

Other research support came from the Schweitzer Family Fund, NCI (P30 CA016672) and start-up research funds from MD Anderson. A full list of co-authors and their disclosures can be found here.

MD Anderson researchers: Cancer mutations accumulate in distinct regions based on structure of genome and mutational causes

A study from researchers at MD Anderson Cancer Center indicates that mutations found in cancers do not accumulate randomly, but are found in distinct patterns that vary based on the three-dimensional organization of the genome in the cell as well as the underlying factors causing the mutations.

Mutations caused by external factors, such as ultraviolet light or tobacco smoke, led to mutations in different regions than internal factors, such as defects in DNA damage repair or proofreading machinery. The findings, published in Nature Genetics, are important for understanding what factors may be driving mutations in a given cancer and may point to new therapeutic targets.

DNA is not randomly organized within the nucleus, and we found that this structure is strongly correlated with how cancer cells accumulate mutations, lead author Kadir Akdemir, instructor of genomic medicine, said in a statement. We know there are certain processes causing mutations in cancer cells, but we dont always understand the underlying causes. These findings should give us a clue as to how cancer accumulates mutations, and perhaps we can target and kill cancer cells by leveraging the mutations they accumulate.

Within the nucleus of the cell, DNA is packaged with proteins into chromatin, a highly organized and compacted structure that makes up our chromosomes. Within this structure, genes that are frequently used in the cells are organized together in active domains, which are more readily accessible. Those genes used less often are similarly organized together in inactive domains.

The researchers analyzed whether mutations are distributed more frequently in these active or inactive domains in cancer by studying publicly available whole-genome sequencing data of 3,000 paired samples of normal tissue and tumor tissue across 42 cancer types.

Across every cancer type studied, the inactive domains carried significantly more mutations than the active domains, suggesting that the accumulation of mutations is strongly correlated with the three-dimensional organization of the genome.

As a validation of these findings, the researchers looked specifically at the X chromosome in male and female patients. In females, one of their two X chromosomes is inactivated, so it is essentially itself an inactive domain. When comparing the X chromosome between sexes, females had more mutations than males with a marked distribution difference, largely driven by an abundance of mutations on the inactive chromosome.

Knowing that mutations can be caused by a variety of distinct processes, the researchers also investigated whether external environmental factors resulted in different mutation patterns compared to those caused by internal factors in the cell.

Interestingly, we found that different causes of mutations resulted in distinct accumulation patterns within the cell, senior author Andy Futreal, chair of genomic medicine, said in a statement. Extrinsic factors were associated with an enrichment of mutations in inactive domains, whereas intrinsic factors were correlated with enriched mutations in active domains. This provides us an important foundation going forward to understand the root of cancer mutations when we dont otherwise know the cause.

Knowing the causes and distributions of cancer-related mutations may open up potential therapeutic options, explained Akdemir, such as targeted therapies against a specific signaling pathway or combinations with immunotherapy.

For example, immunotherapy may be able to better recognize a cancer cell if more mutations are present. However, if mutations occur primarily in inactive domains, they would rarely be seen by the immune system. Therapeutic agents that restore activity to these domains, used in combination with immune checkpoint inhibitors, could stimulate a stronger anti-tumor immune response.

This research was supported by the Cancer Prevention & Research Institute of Texas (R1205), The Robert A. Welch Distinguished University Chair in Chemistry, and NIH (P50CA127001, DP5OD023071, Z1AES103266). A full list of authors and their disclosures can be found with the full paper here.

UCSD study: Personalized cancer therapy improves outcomes in advanced disease

Researchers at the University of California San Diego School of Medicine found that patients receiving care for advanced cancer at Moores Cancer Center at UC San Diego Health were more likely to survive or experience a longer period without their disease progressing if they received personalized cancer therapy.

The study was published in Nature Communications.

Led by Razelle Kurzrock, director of the Center for Personalized Cancer Therapy at Moores Cancer Center and senior author of the study, a multidisciplinary molecular tumor board was established to advise treating physicians on course of care using an individual patients molecular tumor makeup to design precision medicine strategies.

Patients who underwent a molecular tumor board-recommended therapy were better matched to genomic alterations in their cancer and had improved outcomes, Kurzrock said in a statement. The three-year survival for patients with the highest degree of matching and who received a personalized cancer therapy was approximately 55% compared to 25% in patients who received therapy that was unmatched or had low degrees of matching.

Of 429 patients evaluated by the molecular tumor board, 62% were matched to at least one drug. Twenty percent of patients matched to all recommended drugs, including combination therapies.

The tumor board acted in an advisory role and treating physicians chose not to use the boards recommended strategy in 38% of cases, opting instead for a standard therapy approach that might have been unmatched to the patients genetic alterations or had a low degree of matching. These patients experienced a lower progression-free survival and overall survival rates.

The use of next-generation sequencing allows for the identification of novel potential targets for patients with cancer to improve outcomes, but there are challenges to using this approach widely, said Shumei Kato, associate professor of medicine at UC San Diego School of Medicine and first author.

One of the hurdles is that every cancer patient appears to be carrying different molecular and genomic patterns despite having the same cancer type, Kato, a Moores Cancer Center medical oncologist specializing in rare and gastrointestinal cancers, said in a statement. This can be challenging since we are customizing therapy based on the unique genomic pattern patients have, and thus it is difficult to predict the response. In addition, this approach requires multidisciplinary expertise as well as access to drugs or clinical trials not always available in smaller practices.

At Moores Cancer Center, the molecular tumor board is composed of experts in basic, transitional and clinical research as well as bioinformatics, genetics, radiology, pathology and physicians in multiple specialties such as medical, surgical and radiation oncology.

This research was funded, in part, by NIH (P30 CA023100) and the Joan and Irwin Jacobs Fund.

Phase III CheckMate-816 trial: Opdivo + chemotherapy demonstrates improvement in pathologic CR in resectable NSCLC

The phase III CheckMate-816 trial met a primary endpoint of pathologic complete response in resectable non-small cell lung cancer.

In the trial, significantly more patients treated with Opdivo (nivolumab) plus chemotherapy before surgery showed no evidence of cancer cells in their resected tissue compared to those treated with chemotherapy alone. CheckMate-816 is the first and only phase III trial to demonstrate a benefit with an immune checkpoint inhibitor in combination with chemotherapy as a neoadjuvant treatment in non-metastatic NSCLC.

Opdivo is sponsored by Bristol Myers Squibb.

Patients in the experimental arm of the trial received up to three doses of Opdivo plus chemotherapy prior to surgery, a standard number of cycles of therapy in the neoadjuvant setting. The safety profile of Opdivo plus chemotherapy was consistent with previously reported studies in NSCLC.

Nivolumab has shown benefit as an adjuvant, or post-surgical, treatment option in other cancer types, and the positive results from CheckMate -816 speak to its potential in the neoadjuvant setting of resectable non-small cell lung cancer, Mark Awad, clinical director of Lowe Center for Thoracic Oncology at Dana-Farber Cancer Institute, said in a statement.

The CheckMate-816 trial is ongoing to assess the other primary endpoint of event-free survival, to which the company remains blinded, as well as key secondary endpoints.

In non-metastatic NSCLC, Bristol Myers Squibb and collaborators are exploring the use of immunotherapy in the neoadjuvant, adjuvant and peri-operative settings, as well as in association with chemoradiation. To date, Opdivo has shown improved efficacy in the neoadjuvant or adjuvant treatment of four tumor types: lung cancer, bladder cancer, esophageal/gastroesophageal junction cancer and melanoma.

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City of Hope leads novel clinical trial to treat cancer patients with COVID-19 - The Cancer Letter

Breeding the best in any type of livestock whether it be pedigree or commercial, sheep or cattle, requires a huge amount of determination, dedication and drive key features that come naturally to Laurencekirk-based Limousin breeder, Andrew Gammie and his wife Kathryn.

Passionate about the commercial, near dual purpose attributes of this beefy bovine, Andrew believes the Limousin is the breed for the future, when it can be finished in quicker period of time and to the desired weights demanded by the supermarkets with some of the highest killing out percentages.

Add to that the growing demand for young Limousin bull beef and he said producers are onto a winner when finishing such cattle not only bolsters end margins but also reduces greenhouse gas emissions.

Limousins are a great long-term option for the future because the females are so easy to keep and they produce fast growing calves that can either be sold for breeding or finishing, Andrew said.

An increasing number of butchers are now also looking for young bull beef too which is great for the breed as it adds another outlet. I can sell 13-14-month-old young bulls for 1400 at Carlisle and theyre all going for beef.

Andrew and Kathryn Gammie and young Finlay from Drumforber, Laurencekirk

It was Andrews grand-father George and father Jim Gammie, who established the Westpit pedigree Limousin herd at Drumforber in the early 1970s. At that time, the 480-acre unit was mostly home to 200 commercial cows, with an additional 1000 head of finishing cattle bought in every year for finishing off home-grown feeds.

It wasnt until Andrew returned home to farm in 2000 that he looked take the Limousin herd further.

Limousins have always appealed to me because we were brought up with them and because of their ease of management it doesnt cost anymore to keep a pedigree Limousin than a commercial cow, and breed the right ones, and the progeny can be worth so much more, he said.

Its a philosophy which is working a treat for team Gammie too as since Jim and Andrew bought 16 maiden heifers privately from Ian Nattress Greenwell herd in 2009, the Westpit herd has gone from strength to strength.

Most of these purchases were daughters of the French sires, Tanin and Vagabond, with one of the first bulls born, Westpit Fendt, selling for a colossal 15,500gns at Carlisle. He was bred from Greenwell Delight, which was served to Vagabond as a luckpenny before heading north to Drumforber.

It has nevertheless been the purchase of the 5800gns Brockhurst Holy, a Wilodge Vantastic daughter bought at Newark in 2015, that has bred the best to date for the herd.

Typical big stretchy cows and calves - just the type Andrew looks to breed

A daughter of the Grahams Samson show cow, Brockhurst Bolshoi, Holy has bred well in excess of 100,000 worth of bull sales. These include the 18,000gns Westpit Lowry sold at Carlisle to the Maraiscote herd; Westpit Nando, which was purchased privately by the Ronick herd for an undisclosed five-figure price and Westpit Omaha sold to Haltcliffe herd at last year's Royal Highland Show, again for an undisclosed sum.

Other notably bull sales from this top show winning female line include the two full brothers, Westpit Nevada and Westpit Nashville Dinmore Immense sons that sold at Carlisle in February 2019, for 14,000gns and 13,000gns. This years event also saw, Westpit Orlando, by Goldies Jackpot, sell for 12,000gns.

Ive always looked to breed big powerful easy fleshed square females, said Andrew who travelled down to Newark with his father specifically to buy Holy when she was bred from the show winning Brockhurst Bolshoi

I do like muscle but Im not a fan of double muscled females. I prefer to breed good big cows and then find a bull to suit them.

While foundation females from the Greenwell, Dinmore and Brockhurst herds have undoubtedly made their mark, the home-bred females now coming through, are also making their presence felt with Westpit Landlord, the first son of Jalex Itsallgood, a bull bought privately at the Highland Show, out of Westpit Finella, making 17,000gns in 2016.

Two years later, Westpit Macgregor, an AI son of Ampertaine Gigolo, bred from Westpit Florence realised 15,000gns and, at Carlisle in February, this year, Westpit Oklahoma, another by Itsallgood, out of Westpit Julie, made 13,000gns.

Westpit Julie one of the best breeding cows in the herd

Other top breeding bulls include Netherhall Double O Seven, purchased for 20,000gns which in turn has bred sons and daughters to 13,000gns and 10,000gns respectively.

Not afraid of modern technology either, Andrew has also exploited the herds genetic potential by introducing In-Vitro embryo Production (IVP), a cost effective and welfare friendly service from AB Europe.

This IVP process produces embryos from collected oocytes (unfertilised eggs) which are fertilised within a petri dish by selected semen, and subsequently cultured for seven days until fully developed embryos can be transferred or frozen.

A relatively new technique within the UK for producing embryos, it outcompetes MOET for its flexibility and multiple benefits to breeders and their donor animals, according to AB Europes vet Gavin Tait.

AB Europe currently offers two distinct IVP donor programmes dependent on the individual animal requirement and/or farmers preference, said Gavin.

The first programme is our non-stimulated system, where IVP donors are not subjected to any hormonal drugs or synchronisation prior to the collection of oocytes, which accordingly makes it the simpler, cheaper and less labour-intensive option.

The second is our stimulated system, which requires four injections prior to collection. Stimulation leads to a boost in oocyte quality on a given week sometimes it can improve number of oocytes too, however collection can only be done every fortnight and requires additional handling of the donor animal.

Jim and Andrew have seen huge success with the breeding system too.

Westpit Lioness, strength, depth, size, frame and femininity typical characteristics found in all the cattle

I could have continued to naturally expand the herd, however I became aware of In-Vitro embryo Production (IVP) as an alternative to MOET which has in fact put Westpit on the map, said Andrew.

IVP was preferred to MOET because no stimulation is required and the AB Europe team arrive on the farm to collect, whereas MOET requires multiple injections along with accompanying time, effort and cost.

Brockhurst Holy was the first female to undergo IVP, primarily as an insurance policy. We achieved 20 calves, including 18 bulls of which 16 sold to pedigree herds. Theyve also collected the silverware at both society shows and sales.

One of Holys IVP collections gave one heifer and four bulls which sold to average 12,000gns and they have secured both champion and reserve championships at 2019 Stars of the Future.

Last year AB Europe introduced IVP coasting featuring a programme with minimal stimulation. We achieved a better response in terms of embryos per collection, and it was much less invasive than MOET.

Andrew added: IVP and IVP coasting are enabling me to buy the best genetics I can. I select semen, anything from 50 to 1000 per straw to improve the herds genetic base selected for certain EBVs, according to accuracy, proven damline, breeding and showring success. One straw of semen can now cover up to five donors too.

AB Europe lines up an annual IVP programme with up to 10 cows; 2020 features five cows. Following collection, embryos are stored and implanted in commercial recipient cows and scheduled spring and autumn calving.

This years programme also features three, 12-month-old heifers. As long as they are cycling the process makes for a quicker turn around, speeding up genetic progress as well as spreading semen costs.

This year, we collected from one of Holys 12-month-old daughters, again as an insurance policy and a Sarkley heifer purchased from the Red Ladies sale of a similar age.

New to the herd from the Sarkley and Dinmore herds

Earlier this year we collected from 11 cows over two on-farm collections which resulted in 47 embryos. These fresh embryos went on to hold at around 70%, Andrew said, adding: If I have just one or two cows for collection, then Im finding its more cost effective to introduce them to AB Europes livery run by the companys vet, Gavin Tait on his farm in the Borders. It offers a safe and convenient environment. Communications are key for us farmers, and the team keeps us informed as to whats going on.

Its just as well too as with young Finlay fast approaching four years of age and Kathryn about to give birth to twins, Andrew is going to have his hands fuller than normal pretty soon. Add to that being elected on to the British Limousin Cattle Society Council as Scottish representative, and he's going to be busier than ever.

He does nevertheless have every confidence in the Limousin and the breeds potential to increase market share.

We have a fantastic product in the Limousin. What we need now is to get back to basics and create a level playing field for all members with increased communication to all members.

"With more promotion and support for all members, I am convinced the Limousin is the breed of the future, concluded Andrew.

Big, uniform, breedie cattle that are undoubtedly paying their way at Drumforber

Factfile

Farm business: Jim and Kate Gammie, son Andrew and his wife Kathryn

Livestock: 35 cow pedigree Westpit herd and 65 commercial breeding cows

Breeding policy: In-Vitro embryo Production (IVP) which has increased the genetic gain of the herd while also maximising potential sale returns.

Herd goal: Increase pedigree cow numbers at expense of commercial females with the introduction of Fleckviehs and Simmentals as recipient heifers.

Acreage: 100 acres grass and 380 acres spring barley

ONTHE spot

Biggest achievement? Establishing the herd, building it up to where it is today and selling bulls in to pedigree herds

Best investment? Brockhurst Holy a once in a lifetime cow

Where do you want to be in 2030? Hopefully building a successful business for the future generation and out of lockdown!

Best advice? Never stop learning and dont be afraid to ask questions

Biggest gripe? Kathryn says spending money!

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Andrew Gammie's Westpit Limousin herd makes its mark - The Scottish Farmer