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Westmead advanced manufacturing to transform lives – News – The University of Sydney

December 17th, 2019 8:42 am

A vector is a microscopic carrier of pieces of DNA. It is used to deliver healthy copies of genes to tissues and organs within patients or deliver the ability to correct the genetic errors. While the technology is moving rapidly, production of vectors is not.

NSW, and in particular the Westmead Precinct, is already at the forefront of international gene therapy research. The aim of this project is to speed up research and translate it into cures for serious genetic diseases affecting children.

The facility will produce vectors to treat illnesses impacting everything from those with life-threatening liver disease to children going blind. Currently the vectors need to imported and its extremely costly to get them to Australia.

Professor Ian Alexander, Head of the Gene Therapy Research Unit at Childrens Medical Research Institute, senior clinician at The Childrens Hospital at Westmead and Professor of Paediatric and Molecular Medicine at the University of Sydney, said the manufacturing facility would be a boost to translation of academic research in NSW.

We see it as the beginning of something much greater, Professor Alexander said.

It is about moving technology into the clinic, which, in future, will benefit many more patients by offering new and better treatment opportunities. This technology could translate into saving the lives of infants with life-threatening conditions.

Dr Leszek Lisowski heads the Translational Vectorology Group at CMRI and is Conjoint Senior Lecturer at the University of Sydney. His team will play a key role in the new facility, through training of staff and developing the manufacturing processes that will underpin operations. In addition, his team specialises in the development of novel vectors optimised for clinical applications targeting liver, eye and many other clinically important organs and tissues.

Dr Lisowski said that this new facility will allow Australian investigators to get around the "bottleneck" of getting vectors from overseas.

The biggest bottleneck that slows down translation of gene therapy tools to the patient is a global lack of vector manufacturing capacity, which significantly extends the timeline and increases the cost of translational studies," he said.

This facility will give Australian researchers prioritised and cost-effective access to clinical gene therapy reagents and will facilitate translation of a large number of exciting preclinical programs from bench to bedside.

The team is excited by this vital investment and looks forward to partnering with government and other funders to enable the facility to achieve its full potential.

The Westmead Precinct is one of the largest health, education, research and training precincts in Australia and a key provider of jobs for the greater Parramatta and western Sydney region. Spanning 75 hectares, the Precinct includes four hospitals, four world-leading medical research institutes, two multidisciplinary university campuses and the largest research-intensive pathology service in NSW.

The University of Sydney has long been a proud partner of the Precinct and is in negotiations about developing a second major campus in the area. By 2050, that campus will include 25,000 students; 1000 staff and researchers; generate $21.7 billion for the NSW economy and support up to 20,000 jobs.

University of Sydney Vice-Chancellor and Principal Dr Michael Spence said that as part of our collaborative work in building a western Sydney global centre of excellence, Precinct partners are growing Australias advanced manufacturing capability.

These developments will strengthen crucial collaborations in the Precinct from R&D and design to distribution in areas such as prevention and wellbeing, biomedical engineering, AI and personalised medicine, Dr Spence said.

Faculty of Medicine and Health Executive Dean Professor Robyn Ward said: This technology will scale up gene therapy using viral vectors from single-condition, life changing successes, for example in spinal muscle atrophy, to a national service.

We are so proud of this leadership at the Westmead Precinct and with our health partners. It is a whole-of-lifespan, true bench-to-clinic approach."

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5 things a Nobel Prize winner wants you to know about science – Futurity: Research News

December 17th, 2019 8:42 am

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Here are five things you ought to understand about science, according to professor of genetic medicine Gregg Semenza.

This week, Semenzaalong with William Kaelin Jr. and Peter Ratcliffewill accept the 2019 Nobel Prize in Physiology or Medicine in Stockholm, Sweden, for discovering the gene that controls how cells respond to low oxygen levels.

In the two months since the award was announced, Semenza, director of the vascular program at the Institute for Cell Engineering at Johns Hopkins University, has spoken with audiences around the world about the implications of this work in understanding and eventually treating blood disorders, blinding eye diseases, cancer, diabetes, and other conditions. But hes also spoken about the value of basic science.

Here are five things Semenza says he wishes more people knew about science:

The Nobel Prizes usually go to older scientists for discoveries they made when younger, and because of this, Semenza says people may think that good science is solely the domain of older people.

We often make these findings early in our careers, but it is only much later that the significance of those discoveries becomes apparent, he says.

A lot of science is about taking small steps forward. Big leaps are often the result of collaboration, Semenza says.

For example, when he and his lab identified the HIF-1 gene, which controls cells under low oxygen conditions, they initially ran into problems trying to clone the genes DNApart of the process of learning more about a genes function and other characteristics. He got help from fellow Johns Hopkins scientist Thomas Kelly, who had expertise in a workaround approach: purifying the protein made by HIF-1, which is another way to learn more about the gene and its function in the cell.

There are places with very smart people, and there are places where everybody is friendly, Semenza says. But there are few places with smart people who are almost always willing to help you.

When we wrote the manuscript reporting the discovery of HIF-1, we submitted it to top-tier journals, and they did not find it to be of sufficient interest to warrant publication.

But that didnt stop him: Semenza got help from scientist Victor McKusick, and the Proceedings of the National Academy of Sciences published the paper. It has been cited in more than 6,000 scientific publications.

In high school, I had a biology teacher who inspired me and others to pursue careers in scientific research by teaching us about the scientists and the scientific process that led to discoveries, Semenza says.

She would often preface her description of a scientific discovery by saying, When you win your Nobel Prize, I dont want you to forget that you learned that here. We need to give more emphasis to teachers and reward them for the work that they do, which makes such a difference in the lives of so many.

The inventions and discoveries that come out of basic research are critical for the economy, public health, and treating disease earlier, Semenza says.

It is better, both for patients and for the economy, to treat diseases early rather than later, and we need more research to learn how to more effectively treat many cancers.

Source: Johns Hopkins University

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Mother Nature provides new gene therapy strategy to reverse disease – Health Europa

December 17th, 2019 8:42 am

Though the research was intended as a proof of concept, the experimental gene therapy slowed tumour growth and prolonged survival in mice with gliomas, which constitute about 80% of malignant brain tumours in humans.

The technique takes advantage of exosomes, fluid-filled sacs that cells release as a way to communicate with other cells.

The research was carried out by scientists at the Ohio State University and published in the journal Nature Biomedical Engineering.

While exosomes are gaining ground as biologically friendly carriers of therapeutic materials because there are a lot of them and they dont prompt an immune response the trick with gene therapy is finding a way to fit those comparatively large genetic instructions inside their tiny bodies on a scale that will have a therapeutic effect.

This new method relies on patented technology that prompts donated human cells such as adult stem cells to spit out millions of exosomes that, after being collected and purified, function as nanocarriers containing a drug.

When they are injected into the bloodstream, they know exactly where in the body to find their target even if its in the brain.

Senior study author L. James Lee, professor emeritus of chemical and biomolecular engineering at Ohio State University, said: Think of them like Christmas gifts: the gift is inside a wrapped container that is postage paid and ready to go. This is a Mother Nature-induced therapeutic nanoparticle.

In 2017, Lee and colleagues made waves with news of a regenerative medicine discovery called tissue nanotransfection (TNT). The technique uses a nanotechnology-based chip to deliver biological cargo directly into skin, an action that converts adult cells into any cell type of interest for treatment within a patients own body.

By looking further into the mechanism behind TNTs success, scientists in Lees lab discovered that exosomes were the secret to delivering regenerative goods to tissue far below the skins surface.

The scientists placed about one million donated cells on a nano-engineered silicon wafer and used an electrical stimulus to inject synthetic DNA into the donor cells. As a result of this DNA force-feeding, as Lee described it, the cells need to eject unwanted material as part of DNA transcribed messenger RNA and repair holes that have been poked in their membranes.

The electrical stimulation had a bonus effect of a thousand-fold increase of therapeutic genes in a large number of exosomes released by the cells, a sign that the technology is scalable to produce enough nanoparticles for use in humans.

Essential to any gene therapy is knowing what genes need to be delivered to fix a medical problem. For this work, the researchers chose to test the results on glioma brain tumours by delivering a gene called PTEN, a cancer-suppressor gene. Mutations of PTEN that turn off that suppression role can allow cancer cells to grow unchecked.

For Lee, founder of Ohio States Center for Affordable Nanoengineering of Polymeric Biomedical Devices, producing the gene is the easy part. The synthetic DNA force-fed to donor cells is copied into a new molecule consisting of messenger RNA, which contains the instructions needed to produce a specific protein. Each exosome bubble containing messenger RNA is transformed into a nanoparticle ready for transport, with no blood-brain barrier to worry about.

The testing in mice showed the labelled exosomes were far more likely to travel to the brain tumours and slow their growth compared to substances used as controls.

Because of exosomes safe access to the brain, Lee said, this drug-delivery system has promise for future applications in neurological diseases such as Alzheimers and Parkinsons disease.

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Alnylam Reports Positive Topline Results from ILLUMINATE-A Phase 3 Study of Lumasiran for the Treatment of Primary Hyperoxaluria Type 1 – Business…

December 17th, 2019 8:42 am

CAMBRIDGE, Mass.--(BUSINESS WIRE)--Alnylam Pharmaceuticals, Inc. (Nasdaq: ALNY), the leading RNAi therapeutics company, announced today that the ILLUMINATE-A Phase 3 study of lumasiran, an investigational RNAi therapeutic targeting glycolate oxidase (GO) in development for the treatment of primary hyperoxaluria type 1 (PH1), met its primary efficacy endpoint and all tested secondary endpoints. Specifically, lumasiran met the primary efficacy endpoint of percent change from baseline, relative to placebo, in 24-hour urinary oxalate excretion averaged across months 3 to 6 (p less than 0.0001). The study also achieved statistically significant results for all six tested secondary endpoints (p less than or equal to 0.001). Lumasiran also demonstrated an encouraging safety and tolerability profile. Based on these results, the Company plans to submit a New Drug Application (NDA) and file a Marketing Authorisation Application (MAA) for lumasiran in early 2020.

We are very pleased to report positive topline Phase 3 results for lumasiran, our third wholly owned investigational RNAi therapeutic. Patients living with PH1 and their families are faced with the burden of recurrent and painful stone events and a progressive and unpredictable decline in kidney function that ultimately results in end-stage renal disease and the need for intensive dialysis as a bridge to dual liver/kidney transplantation. The results from ILLUMINATE-A demonstrate that lumasiran can significantly reduce the hepatic production of oxalate, which we believe can thereby address the underlying pathophysiology of PH1, said Akshay Vaishnaw, M.D., Ph.D., President of R&D at Alnylam. Further, we are encouraged by the safety and tolerability profile of lumasiran and believe this investigational medicine has the potential to have a meaningful clinical impact on patients living with PH1. We look forward to submitting regulatory filings in early 2020 and advancing this highly needed medicine one step closer to patients. Finally, we extend our deepest gratitude to the patients, caregivers, investigators, and study staff who participated in ILLUMINATE-A and contributed to what we believe is an important medical advance for the treatment of PH1.

The ILLUMINATE-A results represent a significant landmark for the PH1 patient community. These patients live with the angst of not knowing when that next kidney stone will come or for how long their kidneys will keep working, and they grapple with the possibility of needing new organs. We have lived with the hope that someday patients living with PH1 and their families would finally have a treatment with the potential to have a positive impact on their health and alleviate some of that angst, said Kim Hollander, Executive Director of the Oxalosis and Hyperoxaluria Foundation. Today we are hopeful that we are much closer to that day than we have ever been.

Lumasiran results in ILLUMINATE-A mark our third positive Phase 3 study readout in 2019, positioning Alnylam with the potential for four marketed products by the end of 2020, assuming positive regulatory reviews. We believe this achievement also provides further support of our relatively high product development success rate linked to selection of genetically validated targets and a modular and reproducible platform, said John Maraganore, Ph.D., Chief Executive Officer of Alnylam. With these results in hand, we believe that were on track to exceed our Alnylam 2020 guidance, building by the end of 2020 a global, multi-product, commercial-stage company with a robust portfolio of clinical-stage programs for future growth and an organic product engine for sustainable innovation and patient impact.

ILLUMINATE-A Topline Study ResultsILLUMINATE-A (NCT03681184), a randomized, double-blind, placebo-controlled trial, designed to enroll approximately 30 patients with PH1 ages six and above, at 16 study sites, in eight countries around the world, is the largest interventional study conducted specifically in PH1. Patients were randomized 2:1 to lumasiran or placebo, with lumasiran administered at 3 mg/kg monthly for three months followed by quarterly maintenance doses. The primary endpoint for the study was the percent change from baseline in 24-hour urinary oxalate excretion averaged across months 3 to 6 in patients treated with lumasiran as compared to placebo. At six months, lumasiran met the primary endpoint in patients with PH1 (p less than 0.0001) and achieved statistically significant results for all six hierarchically-tested secondary endpoints (p less than or equal to 0.001), including the proportion of lumasiran patients that achieved near-normalization or normalization of urinary oxalate levels, relative to placebo.

There were no serious or severe adverse events in the study, and results showed that lumasiran was generally well tolerated with an overall profile generally consistent with that observed in Phase 1/2 and open-label extension studies of lumasiran. Lumasiran has received U.S. and EU Orphan Drug Designations, Breakthrough Therapy Designation from the U.S. Food and Drug Administration (FDA), and a Priority Medicines (PRIME) designation from the European Medicines Agency (EMA). Full ILLUMINATE-A study results will be presented in an oral plenary session on Tuesday, March 31, 2020 at OxalEurope International Congress in Amsterdam, Netherlands.

The Company is also conducting ILLUMINATE-B a global Phase 3 study of lumasiran in PH1 patients less than six years of age, with results expected in mid-2020, and ILLUMINATE-C a global Phase 3 study of lumasiran in PH1 patients of all ages with advanced renal disease, with results expected in 2021.

Conference Call InformationAlnylam Management will discuss the ILLUMINATE-A results via conference call on Tuesday, December 17, 2019 at 8:00 am ET. A webcast presentation will also be available on the Investors page of the Companys website, http://www.alnylam.com. To access the call, please dial 800-239-9838 (domestic) or +1-323-794-2551 (international) five minutes prior to the start time and refer to conference ID 6976021. A replay of the call will be available beginning at 11:00 am ET on the day of the call. To access the replay, please dial 888-203-1112 (domestic) or +1-719-457-0820 (international) and refer to conference ID 6976021.

About LumasiranLumasiran is an investigational, subcutaneously administered RNAi therapeutic targeting hydroxyacid oxidase 1 (HAO1) in development for the treatment of primary hyperoxaluria type 1 (PH1). HAO1 encodes glycolate oxidase (GO). Thus, by silencing HAO1 and depleting the GO enzyme, lumasiran inhibits production of oxalate the metabolite that directly contributes to the pathophysiology of PH1. Lumasiran utilizes Alnylam's Enhanced Stabilization Chemistry (ESC)-GalNAc-conjugate technology, which enables subcutaneous dosing with increased potency and durability and a wide therapeutic index. Lumasiran has received both U.S. and EU Orphan Drug Designations, a Breakthrough Therapy Designation from the U.S. Food and Drug Administration (FDA), and a Priority Medicines (PRIME) designation from the European Medicines Agency (EMA). The safety and efficacy of lumasiran have not been evaluated by the FDA, EMA or any other health authority.

About Primary Hyperoxaluria Type 1 (PH1)PH1 is an ultra-rare disease in which excessive oxalate production results in the deposition of calcium oxalate crystals in the kidneys and urinary tract and can lead to the formation of painful and recurrent kidney stones and nephrocalcinosis. Renal damage is caused by a combination of tubular toxicity from oxalate, calcium oxalate deposition in the kidneys, and urinary obstruction by calcium oxalate stones. Compromised kidney function exacerbates the disease as the excess oxalate can no longer be effectively excreted, resulting in subsequent accumulation and crystallization in bones, eyes, skin, and heart, leading to severe illness and death. Current treatment options are very limited and include frequent renal dialysis or combined organ transplantation of liver and kidney, a procedure with high morbidity that is limited due to organ availability. Although a small minority of patients respond to Vitamin B6 therapy, there are no approved pharmaceutical therapies for PH1.

About RNAiRNAi (RNA interference) is a natural cellular process of gene silencing that represents one of the most promising and rapidly advancing frontiers in biology and drug development today. Its discovery has been heralded as a major scientific breakthrough that happens once every decade or so, and was recognized with the award of the 2006 Nobel Prize for Physiology or Medicine. By harnessing the natural biological process of RNAi occurring in our cells, a new class of medicines, known as RNAi therapeutics, is now a reality. Small interfering RNA (siRNA), the molecules that mediate RNAi and comprise Alnylam's RNAi therapeutic platform, function upstream of todays medicines by potently silencing messenger RNA (mRNA) the genetic precursors that encode for disease-causing proteins, thus preventing them from being made. This is a revolutionary approach with the potential to transform the care of patients with genetic and other diseases.

About Alnylam PharmaceuticalsAlnylam (Nasdaq: ALNY) is leading the translation of RNA interference (RNAi) into a whole new class of innovative medicines with the potential to transform the lives of people afflicted with rare genetic, cardio-metabolic, hepatic infectious, and central nervous system (CNS)/ocular diseases. Based on Nobel Prize-winning science, RNAi therapeutics represent a powerful, clinically validated approach for the treatment of a wide range of severe and debilitating diseases. Founded in 2002, Alnylam is delivering on a bold vision to turn scientific possibility into reality, with a robust discovery platform. Alnylams commercial RNAi therapeutic products are ONPATTRO (patisiran), approved in the U.S., EU, Canada, Japan, and Switzerland, and GIVLAARI (givosiran), approved in the U.S. Alnylam has a deep pipeline of investigational medicines, including five product candidates that are in late-stage development. Looking forward, Alnylam will continue to execute on its Alnylam 2020 strategy of building a multi-product, commercial-stage biopharmaceutical company with a sustainable pipeline of RNAi-based medicines to address the needs of patients who have limited or inadequate treatment options. Alnylam employs over 1,200 people worldwide and is headquartered in Cambridge, MA. For more information about our people, science and pipeline, please visit http://www.alnylam.com and engage with us on Twitter at @Alnylam or on LinkedIn.

Alnylam Forward Looking StatementsVarious statements in this release concerning Alnylam's future expectations, plans and prospects, including, without limitation, Alnylam's views with respect to the implications of the positive topline results from the ILLUMINATE-A study and the potential for lumasiran to have a meaningful clinical impact on patients living with PH1, its plans and expected timing for filing applications for regulatory approval of lumasiran, its plans for reporting the full results from the ILLUMINATE-A study, expectations regarding the timing for reporting results from the ILLUMINATE-B and ILLUMINATE-C clinical studies, and expectations regarding the potential to exceed its Alnylam 2020 guidance for the advancement and commercialization of RNAi therapeutics, constitute forward-looking statements for the purposes of the safe harbor provisions under The Private Securities Litigation Reform Act of 1995. Actual results and future plans may differ materially from those indicated by these forward-looking statements as a result of various important risks, uncertainties and other factors, including, without limitation, Alnylam's ability to discover and develop novel drug candidates and delivery approaches, successfully demonstrate the efficacy and safety of its product candidates, including lumasiran, the pre-clinical and clinical results for its product candidates, which may not be replicated or continue to occur in other subjects or in additional studies or otherwise support further development of product candidates for a specified indication or at all, actions or advice of regulatory agencies, which may affect the design, initiation, timing, continuation and/or progress of clinical trials or result in the need for additional pre-clinical and/or clinical testing, delays, interruptions or failures in the manufacture and supply of its product candidates, including lumasiran, obtaining, maintaining and protecting intellectual property, Alnylam's ability to enforce its intellectual property rights against third parties and defend its patent portfolio against challenges from third parties, obtaining and maintaining regulatory approval, pricing and reimbursement for products, including lumasiran, progress in establishing a commercial and ex-United States infrastructure, successfully launching, marketing and selling its approved products globally, Alnylams ability to successfully expand the indication for ONPATTRO in the future, competition from others using technology similar to Alnylam's and others developing products for similar uses, Alnylam's ability to manage its growth and operating expenses, obtain additional funding to support its business activities, and establish and maintain strategic business alliances and new business initiatives, Alnylam's dependence on third parties for development, manufacture and distribution of products, the outcome of litigation, the risk of government investigations, and unexpected expenditures, as well as those risks more fully discussed in the Risk Factors filed with Alnylam's most recent Quarterly Report on Form 10-Q filed with the Securities and Exchange Commission (SEC) and in other filings that Alnylam makes with the SEC. In addition, any forward-looking statements represent Alnylam's views only as of today and should not be relied upon as representing its views as of any subsequent date. Alnylam explicitly disclaims any obligation, except to the extent required by law, to update any forward-looking statements.

Lumasiran has not been approved by the FDA, EMA, or any other regulatory authority and no conclusions can or should be drawn regarding the safety or effectiveness of this investigational therapeutic.

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Interpace Biosciences Announces New Draft LCD and Reimbursement for Its Proprietary Thyroid Assay, ThyGeNEXT – GlobeNewswire

December 17th, 2019 8:42 am

Parsippany, NJ, Dec. 17, 2019 (GLOBE NEWSWIRE) -- Interpace Biosciences, Inc. (Nasdaq:IDXG) today announced that its Medicare Administrative Contractor (MAC) has issued a new draft local coverage determination (LCD) for the Companys ThyGeNEXT test, representing an increase of approximately $2,400 per assay over previous reimbursement coverage. This increase in reimbursement rates reflects the expansion of the ThyGeNEXT panel to aid in identifying the appropriate patients for surgery. In 2018, Interpace processed approximately 12,500 ThyGeNEXT tests.

Prior to the new LCD code (81455) becoming effective, it was subject to a public comment period, which ended December 15, 2019, and is now subject to an analysis and review period by MACs Medical Directors. Final approval is expected during the first quarter of 2020. ThyGeNEXT has been covered by an existing LCD since it was launched in mid-2018 and its predecessor, ThyGenX, has been covered since 2014.

Jack Stover, President & CEO of Interpace, said, I am very pleased with the draft local coverage announcement and look forward to the final determination, which when approved will demonstrate the quality of our expanded assay, and most importantly supports continued reimbursement for patients and their families potentially affected by Thyroid cancer.

About ThyGeNEXT and ThyraMIR

ThyGeNEXT utilizes state-of-the-art next-generation sequencing (NGS) to identify more than 100 genetic alterations associated with papillary and follicular thyroid carcinomas, the two most common forms of thyroid cancer, as well as Medullary Thyroid Carcinoma. ThyraMIR is the first microRNA gene expression classifier. MicroRNAs are small, non-coding RNAs that bind to messenger RNA and regulate expression of genes involved in human cancers, including every subtype of thyroid cancer. ThyraMIR measures the expression of 10 microRNAs. Both ThyGeNEXT and ThyraMIR are covered by Medicare and Commercial insurers, with more than 280 million members covered.

According to the American Thyroid Association, approximately 20% of the 525,000 thyroid fine needle aspirations (FNAs) performed on an annual basis in the U.S. are indeterminate for malignancy based on standard cytological evaluation, and thus are candidates for ThyGeNEXT and ThyraMIR.

ThyGeNEXT and ThyraMIR reflex testing yields high predictive value in determining the presence and absence of cancer in thyroid nodules. The combination of both tests can improve risk stratification and surgical decision-making when standard cytopathology does not provide a clear diagnosis.

About Interpace Biosciences

Interpace Biosciences is a leader in enabling personalized medicine, offering specialized services along the therapeutic value chain from early diagnosis and prognostic planning to targeted therapeutic applications.

Interpace Diagnostics is a fully integrated commercial and bioinformatics business unit that provides clinically useful molecular diagnostic tests, bioinformatics and pathology services for evaluating risk of cancer by leveraging the latest technology in personalized medicine for improved patient diagnosis and management. Interpace has four commercialized molecular tests and one test in a clinical evaluation process (CEP): PancraGEN for the diagnosis and prognosis of pancreatic cancer from pancreatic cysts; ThyGeNEXT for the diagnosis of thyroid cancer from thyroid nodules utilizing a next generation sequencing assay; ThyraMIR for the diagnosis of thyroid cancer from thyroid nodules utilizing a proprietary gene expression assay; and RespriDX that differentiates lung cancer of primary vs. metastatic origin. In addition, BarreGEN for Barretts Esophagus, is currently in a clinical evaluation program whereby we gather information from physicians using BarreGEN to assist us in positioning the product for full launch, partnering and potentially supporting reimbursement with payers.

Interpace Biopharma provides pharmacogenomics testing, genotyping, biorepository and other customized services to the pharmaceutical and biotech industries. The Biopharma business also advances personalized medicine by partnering with pharmaceutical, academic, and technology leaders to effectively integrate pharmacogenomics into their drug development and clinical trial programs with the goals of delivering safer, more effective drugs to market more quickly, and improving patient care.

For more information, please visit Interpace Biosciences website at http://www.interpace.com.

Forward-looking Statements

This press release contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, Section 21E of the Securities Exchange Act of 1934 and the Private Securities Litigation Reform Act of 1995, relating to the Company's future financial and operating performance. The Company has attempted to identify forward looking statements by terminology including "believes," "estimates," "anticipates," "expects," "plans," "projects," "intends," "potential," "may," "could," "might," "will," "should," "approximately" or other words that convey uncertainty of future events or outcomes to identify these forward-looking statements. These statements are based on current expectations, assumptions and uncertainties involving judgments about, among other things, future economic, competitive and market conditions and future business decisions, all of which are difficult or impossible to predict accurately and many of which are beyond the Company's control. These statements also involve known and unknown risks, uncertainties and other factors that may cause the Company's actual results to be materially different from those expressed or implied by any forward-looking statement. Additionally, all forward-looking statements are subject to the Risk Factors detailed from time to time in the Company's most recent Annual Report on Form 10-K and Quarterly Reports on Form 10Q. Because of these and other risks, uncertainties and assumptions, undue reliance should not be placed on these forward-looking statements. In addition, these statements speak only as of the date of this press release and, except as may be required by law, the Company undertakes no obligation to revise or update publicly any forward-looking statements for any reason.

CONTACTS:Investor Relations - Edison GroupJoseph Green(646) 653-7030jgreen@edisongroup.com

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Forum: Should doctors have legal duty to warn a patient’s relatives of genetic risks? – The Straits Times

December 17th, 2019 8:42 am

Dr Wong Chiang Yin's exposition (The way forward for informed consent in medicine, Dec 14) mentioned the proposals of the workgroup appointed by the Ministry of Health (MOH) to review the taking of informed consent and the Singapore Medical Council disciplinary process. MOH accepted 29 proposals early this month.

I participated in the feedback sessions, during which I submitted my medical and legal viewpoints.

In the field of informed consent, Dr Wong mentioned patient autonomy and patient's interest as cardinal points in the practice of medicine. In informed consent, the patient's right to information and confidentiality may be compromised in only two situations - when the patient is mentally incapacitated, or when the patient has a communicable disease and there is the larger national interest to inform the regulatory authorities.

A third aspect to the right of informed consent has just arisen. This involves the issue of whether doctors have a legal duty to warn patients' relatives of their genetic risks.

Just last month, a legal case was heard in the Royal Courts of Justice in London. The case concerns a man who was diagnosed with an inheritable disease (Huntington's disease). He told his doctors not to reveal this to his daughter, who was then pregnant, fearing that she would terminate her pregnancy. Subsequently, when the disease was manifested in the daughter, she sued the man's doctors on the basis that, if she had known, she would not have continued with her pregnancy.

This case centres on whether doctors should have a legal duty to warn patients' relatives about disease risks from an inherited condition - essentially the balancing act between a duty to protect patient confidentiality versus a duty to warn, and thus prevent harm to relatives.

The case has now gone on appeal to the European Court of Justice and the outcome should be out by the middle of next year. However, empirical data in the UK suggests that there is public support for a legal duty to warn relatives of their genetic risk of disease.

Lim Ee Koon (Dr)

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Oz & Roizen: Measles wipes out parts of the immune system – Bluffton Today

December 17th, 2019 8:41 am

I'm hesitant to give my child the measles vaccine, because I'm worried about long-lasting side effects. Is it dangerous? Sally G., Jacksonville, Florida

As we've said before, it's smart to get your child the vaccine as early as your pediatrician recommends. The risk of getting vaccinated is greatly outweighed by the benefit of avoiding the measles. For vaccinations overall, the ratio of risk to benefit is one to 40,000. Worldwide, the measles kills over 100,000 children annually. In the U.S., since Jan. 1, there have been 880 cases of the disease, which was declared eradicated here in 2000! The real news, however, is that the re-emergence of measles poses a greater risk than we knew.

Harvard researchers have found that measles causes immune amnesia. It wipes out 20% to 50% of your body's antibodies, which are protecting you from a slew of diseases caused by other viruses and bacteria. That may be why bacterial ear infections and pneumonia are common complications after getting the measles. Long-term effects may be even more serious. And that's another good reason to get your child vaccinated as early as recommended.

So why are so many American parents hesitant? Researchers at Brigham Young University thought it may be because folks don't have firsthand experience with the devastating effects of those illnesses. To test the theory, they sent 250 students out to interview locals who had come down with vaccine-preventable diseases, such as polio, shingles and tuberculosis. Some of those students referred to themselves as "vaccine hesitant," but around 70% became pro-vaccine after learning how life-damaging the diseases were.

Bottom line: Don't make yourself go through firsthand tragedy before you realize how smart it is to get vaccinated! Kids should get the MMR (measles, mumps, rubella) vaccine at 1 year old and again between 28 days later and 6 years old. You can also opt for two doses of the MMRV (measles, mumps, rubella, and varicella/chickenpox) vaccine; it's approved for children 12 months through 12 years old.

Last week I thought I heard someone at the door, but when I checked there was no one there. Am I losing my mind, or should I get my hearing checked? Sam B., Portland, Oregon

If you have ringing in your ears, doorbells or otherwise, you might want to get checked out by an audiologist. It could be a sign of hearing loss. But if it's just a one-time event, it's probably nothing.

Sensory hallucinations what that was are pretty common, and there are many forms. You can hear, see, smell, taste or feel something that isn't there. While they can be associated with serious mental disorders such as schizophrenia, they are also related to certain medications, drug abuse, medical conditions like Parkinson's and perhaps sleep deprivation, stress and anxiety.

They can also result from what Georgetown University neuroscientists say is a bottleneck of feed-forward and feedback signals. It's what can occur when the brain is asked to process more information than it can handle. These days, there is more information out there at your fingertips (coming in and going out) than at any time in human history.

In addition, researchers at Stanford University recently discovered how easy it is to provoke hallucinations. In the lab, they altered the neural activity of mice (those rodents have millions of neurons in their brains; humans have billions) by disrupting about 20 individual neurons using light and sound. When they did so, the mice showed signs of believing something was there when it wasn't. This prompted one researcher to ponder, "Why are we not hallucinating all the time, due to spurious random activity?"

Now, that's not to diminish the seriousness of recurrent hallucinatory episodes that interfere with your everyday quality of life. If that's the case, you should keep a journal of when and where they happen and discuss the incidents with your doctor so he/she can pinpoint the cause.

Mehmet Oz, M.D. is host of "The Dr. Oz Show," and Mike Roizen, M.D. is Chief Wellness Officer and Chair of Wellness Institute at Cleveland Clinic. Email your health and wellness questions to Dr. Oz and Dr. Roizen at youdocsdaily@sharecare.com.

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Tough nuts: why peanuts trigger such powerful allergic reactions – The Conversation AU

December 17th, 2019 8:41 am

Food allergens are the scourge of the modern school lunchbox. Many foods contain proteins that can set off an oversized immune reaction and one of the fiercest is the humble peanut.

Around 3% of children in Australia have a peanut allergy, and only 1 in 5 of them can expect to outgrow it. For these unlucky people, even trace amounts of peanut can trigger a fatal allergic reaction.

But what sets the peanut apart from other nuts? Why is it so good at being an allergen?

To answer this, we have to explore the pathway from allergen to allergy, and just what it is about an allergen that triggers a response from the immune system.

Read more: What are allergies and why are we getting more of them?

Before coming into contact with the immune system, an allergen in food needs to overcome a series of obstacles. First it needs to pass through the food manufacturing process, and then survive the chemicals and enzymes of the human gut, as well as cross the physical barrier of the intestinal lining.

After achieving all of this, the allergen must still have the identifying features that trigger the immune system to respond.

Many food allergens successfully achieve this, some better than others. This helps us to understand why some food allergies are worse than others.

The most potent allergens like peanuts have many characteristics that successfully allow them to overcome these challenges, while other nuts display these traits to a lesser extent.

The first characteristic many allergenic foods have, especially peanuts, is strength in numbers. Both tree nuts and peanuts contain multiple different allergens. At last count, cashews contain three allergens, almonds have five, walnuts and hazelnuts have 11 each and peanuts are loaded with no less than 17.

Each allergen has a unique shape, so the immune system recognises each one differently. The more allergens contained in a single food, the higher the potency.Additionally, many of these allergens also have numerous binding sites for both antibodies and specialised immune cells, further increasing their potency.

The first hurdle for a food allergen is the food manufacturing process. Many nuts are roasted prior to consumption. For most foods, heating changes the structure of proteins in a way that destroys the parts that trigger an immune response. This makes them far less potent as allergens.

This is not the case for many tree nuts: allergens in almonds, cashews and hazelnuts survived roasting with no loss of potency.

And for the major peanut allergens, its even worse. Roasting actually makes them more potent.

Read more: Can I prevent food allergies in my kids?

From here, the allergen will have to survive destruction by both stomach acid and digestive enzymes within the human gut. Many nut allergens have the ability to evade digestion to some degree.

Some simply have a robust structure, but peanut allergens actively inhibit some of the digestive enzymes of the gut. This helps them safely reach the small intestine, where the allergens then need to cross the gut lining to have contact with the immune system.

This is where peanut allergens really stand apart from most other allergens. They have the ability to cross the intestinal cells that make up the gut lining. Given their relative sizes, this is like a bus squeezing itself through a cat flap.

Peanut allergens accomplish this remarkable feat by altering the bonds that hold the gut cells together. They can also cross the lining by hijacking the guts own ability to move substances. Once across, the allergens will gain access to the immune system, and from there an allergic response is triggered.

The combination of multiple allergens, numerous immune binding sites, heat stability, digestion stability, enzyme blocking, and the effect on the gut lining makes peanut a truly nasty nut.

This leaves us with a nagging question: if peanuts are so potent, why doesnt everyone develop a peanut allergy? We still dont know.

Recently, a potential vaccine developed by researchers from the University of South Australia has shown promise in reprogramming the immune system of mice and blood taken from people with peanut allergy. Will this translate to a potential treatment for peanut allergy? We will have to wait and see.

For now, the more we learn about the action of allergens, and the more we understand their effects on our body, the more we can develop new ways to stop them. And eventually, we might outsmart these clever nuts for good.

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Heat Biologics Announces First Patient Dosed in the First Phase 1 Trial of HS-130 | Vaccines | News Channels – PipelineReview.com

December 17th, 2019 8:41 am

DetailsCategory: VaccinesPublished on Monday, 16 December 2019 19:29Hits: 279

First allogeneic, off-the-shelf cell therapy approach that enhances T-cell activation through localized OX40-mediated co-stimulation of dormant immune signals

DURHAM, NC, USA I December 16, 2019 IHeat Biologics, Inc. (NASDAQ:HTBX), a clinical-stage biopharmaceutical company specialized in the development of therapeutics designed to activate patients' immune systems against cancer, today announced that the Company has dosed the first patient in the first Phase 1 clinical trial of HS-130, in combination with HS-110, for patients with advanced solid tumors refractory to standard of care.

HS-130 is Heat's allogeneic cell line engineered to locally secrete the extracellular domain of OX40 ligand fusion protein (OX40L-Fc), a key costimulator of T cells, designed to augment antigen-specific CD8+ T cell response. HS-130 was manufactured by utilizing the Company's proprietary process to reprogram a live, genetically modified cancer cell line. In multiple preclinical models, these responses have demonstrated improved efficacy and safety using OX40L-Fc via cell-based delivery compared to systemic delivery of an OX40 agonist antibody in combination with HS-110.

The first-in-human study is expected to enroll up to 30 patients under the supervision of lead investigator Dr. Rachel Sanborn, Director of the Phase 1 Clinical Trials Program at the Earle A. Chiles Research Institute, a division of Providence Cancer Institute in Portland, Oregon. In this study, patients will receive escalating doses of HS-130 in combination with HS-110. The objectives of the study are to evaluate patient safety and to determine the optimal dose for a subsequent Phase 2 trial.

Jeff Wolf, Heat's CEO, commented, "We are pleased to announce the initiation of this combination study, which marks a key milestone for Heat as we advance our latest asset into clinical development. We look forward to sharing clinical proof of concept data to enable the development of a new generation of allogeneic therapy drug candidates in 2020."

About HS-110

HS-110 is designed by engineering gp96-Fc to deliver more than 70 cancer testis antigens to stimulate the patients' immune system and activate a robust cytotoxic T cell response. HS-110 has completed enrollment in a Phase 2 clinical trial for advanced non-small cell lung cancer, in combination with Bristol-Myers Squibb's nivolumab (Opdivo) or with Merck's pembrolizumab (Keytruda) (NCT 02439450).

About HS-130

HS-130 is designed with the same parent cell line as HS-110 but is engineered to secrete OX40L-Fc fusion protein, a potent inducer of antigen-specific CD8+ T cell proliferation. The first-in-human study aims to evaluate the safety and dose-response of HS-130 in combination with HS-110 in patients with advanced solid tumors (NCT04116710).

About Heat Biologics, Inc.

Heat Biologics is a clinical-stage biopharmaceutical company developing novel therapeutics designed to activate a patient's immune system against cancer using CD8+ "Killer" T-cells. Pelican Therapeutics, Inc., a subsidiary of Heat, is focused on the development of co-stimulatory monoclonal antibody and fusion protein-based therapies designed to activate the immune system. For more information, please visit http://www.heatbio.com.

Reference

Fromm G, de Silva S, Giffin L, Xu X, Rose J, Schreiber TH. Gp96-Ig/Costimulator (OX40L, ICOSL, or 4-1BBL) Combination Vaccine Improves T-cell Priming and Enhances Immunity, Memory, and Tumor Elimination. Cancer Immunol Res. 2016 Sep 2;4(9):766-78.

SOURCE: Heat Biologics

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The Effect of Size, Dose, and Administration Route on Zein Nanoparticl | IJN – Dove Medical Press

December 17th, 2019 8:41 am

Feng Li,1 Yan Chen,1,2 Shubo Liu,1 Xue Pan,1 Yulan Liu,1 Huiting Zhao,1 Xiujing Yin,1 Chunlin Yu,1 Wei Kong,1,2 Yong Zhang1,2

1National Engineering Laboratory for AIDS Vaccine, School of Life Sciences, Jilin University, Changchun 130012, Peoples Republic of China; 2Key Laboratory for Molecular Enzymology and Engineering, The Ministry of Education, School of Life Sciences, Jilin University, Changchun 130012, Peoples Republic of China

Correspondence: Yong ZhangSchool of Life Sciences, Jilin University, Qianjin Street No. 2699, Changchun 130012, Peoples Republic of ChinaTel +86431 85167751Fax +86431 85167674Email zhangyongking1@gmail.com

Background: Zein-based carriers are a promising delivery system for biomedical applications. However, few studies involve systematic investigation on their in vivo biocompatibility and immunogenicity.Purpose: The objective of this study was to identify the immunogenicity, type of immune response, biocompatibility and systemic recall immune response of zein nanoparticles administrated via different routes in mice.Animals and methods: Female Balb/c mice were selected as the animal model in this paper. The effect of particle size, dose and inoculation routes on immunogenicity were systematically explored. The mice were challenged at week 50 via intramuscular and subcutaneous routes to investigate the systemic recall immune responses of zein nanoparticles. Hematoxylin and eosin staining was performed to investigate the biocompatibility of zein nanoparticles at injection sites.Results: The administration of zein particles by parenteral routes led to a long-term systemic immune response. Particle size did not affect zein-specific IgG antibody titers. IgG antibody titers and inflammatory cell infiltration at the injection sites resulting from intramuscular zein particle injection were significantly higher than those from subcutaneous injection of the same dose. For intramuscular inoculation, dose-dependent IgG antibody titers were observed after the third inoculation, while no significant difference was found via the subcutaneous route. For both routes, IgG titer showed a time-dependent decrease at all dose levels from week 5 onward, and finally plateaued at week 28. The IgG subtype assay showed a predominant Th2-type immune response for both administration routes. Challenge with zein nanoparticles at week 50 led to a significant increase in specific IgG titer at all dose levels, indicating systemic recall immune responses. Interestingly, IgG antibody levels in the subcutaneous groups showed a delayed decrease compared to those of the intramuscular injection groups at all dose levels.Conclusion: This study indicated that immunogenicity may be one of the key challenges of using zein nanoparticles as carriers via parenteral administration. Further investigation is needed to illustrate zein immunogenicity in other forms, and the possible effect of systemic recall immune response on in vivo pharmacokinetic characteristics.

Keywords: zein, protein carrier, drug delivery, immune response, intramuscular injection, subcutaneous injection, parenteral administration

This work is published and licensed by Dove Medical Press Limited. The full terms of this license are available at https://www.dovepress.com/terms.php and incorporate the Creative Commons Attribution - Non Commercial (unported, v3.0) License.By accessing the work you hereby accept the Terms. Non-commercial uses of the work are permitted without any further permission from Dove Medical Press Limited, provided the work is properly attributed. For permission for commercial use of this work, please see paragraphs 4.2 and 5 of our Terms.

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NantKwest and ImmunityBio Present Results of Landmark Trial of First-in-Human Natural Killer Cell Combination Immunotherapy With Durable, Complete…

December 17th, 2019 8:41 am

DetailsCategory: DNA RNA and CellsPublished on Monday, 16 December 2019 19:43Hits: 277

CULVER CITY, CA, USA I December 16, 2019 I NantKwest Inc. (Nasdaq: NK), a clinical-stage natural killer cell-based therapeutics company, and ImmunityBio, a privately held immunotherapy company, today announced results from their Phase 1b trial investigating a novel, first-in-human immunotherapy protocol consisting of NantKwests off-the-shelf, antibody-targeted NK cells (haNK) combined with ImmunityBios IL-15 superagonist (N-803), low-dose metronomic chemoradiation therapy, adenoviral and yeast tumor-associated antigen vaccines (MUC1, brachyury, CEA) and a PD-L1 checkpoint inhibitor in patients with metastatic triple negative breast cancer (TNBC) who had relapsed after prior therapy.

The results were presented at the 2019 San Antonio Breast Cancer Symposium (SABCS) on December 13, 2019, in San Antonio, Texas, in a poster titled Safety and efficacy from first-in-human immunotherapy combining NK and T-cell activation with off-the-shelf, antibody-targeted CD16 NK cell line (haNK) in patients with 2nd-line or greater metastatic triple-negative breast cancer (TNBC).

This landmark study is the worlds first trial to combine cellular therapy with checkpoint inhibitors and IL-15 cytokine stimulation, as well as with adenoviral vectors, all acting in concert to induce immune simulation of both NK cells and T cells.

We are extremely pleased that the FDA granted us IND authorization to initiate this novel immunotherapy trial enabling the safety and efficacy study of multiple novel biological agents administered as a single protocol in the outpatient setting, said Dr. Patrick Soon-Shiong, Chairman and CEO of NantKwest. This important trial forms the basis of our approach to induce immunogenic cell death and long-term memory, and avoid the ravages of high dose chemotherapy.

Achieving durable, complete responses in metastatic TNBC patients that have failed all current standards of care is a promising finding and further validates our approach to orchestrate both the innate and adaptive immune system, continued Soon-Shiong. TNBC is a highly aggressive cancer, with limited treatment options and poor prognosis. These results are important proof-of-concept supporting our hypothesis that comprehensively activating the immune responses of the NK, T and Dendritic cells would induce immunogenic cell death leading to durable responses, even among this challenging patient population. We are thrilled with the safety and efficacy data from this first-in-human clinical trial of combination NK cell therapy, cytokine fusion protein, chemoradiation and checkpoint inhibitor, and look forward to advancing this exciting off-the-shelf cell therapy approach to randomized clinical trials in this setting.

Data Highlights Include:

The approximately 10-20% of breast cancer patients who are triple negative are faced with a grim prognosis with limited treatment options. These results are clinically significant, with overall response rates and complete response rates in this highly refractory, advanced metastatic patient population, said Dr. Chaitali Nangia, a Hematologist/Oncologist with the Chan Soon-Shiong Immuno-Oncology Network and study co-author. Importantly, these responses to treatment are also durable, with median progression free survival exceeding 13 months compared to historical controls of approximately 3 months in this heavily pretreated population. We also observed a positive safety and tolerability profile, with no cytokine release syndrome. Taken together, these efficacy and safety results point to the emergence of a new treatment paradigm for TNBC.

About NantKwest

NantKwest (NASDAQ: NK) is an innovative, clinical-stage immunotherapy company focused on harnessing the power of the innate immune system to treat cancer and virally induced infectious diseases. We are the leading producer of clinical dose forms of off-the-shelf Natural Killer (NK) cell therapies. Our activated NK cell platform is designed to destroy cancer and virally infected cells from the body. The safety of our optimized, activated NK cells, as well as their activity against a broad range of cancers, have been tested in phase I clinical trials in Canada and Europe, as well as in multiple phase I and II clinical trials in the United States. By leveraging an integrated and extensive genomics and transcriptomics discovery and development engine, together with a pipeline of multiple, clinical-stage, immuno-oncology programs, NantKwests goal is to transform medicine by delivering living drugs in a bag and bringing novel NK cell-based therapies to routine clinical care. NantKwest is a member of the NantWorks ecosystem of companies. For more information, please visit https://nantkwest.com.

haNK is a registered trademark of NantKwest, Inc.

About ImmunityBio

ImmunityBio is a privately held immunotherapy company with a broad portfolio of biological molecules, including an albumin-linked chemotherapeutic, peptides, fusion proteins, cytokines, monoclonal antibodies, adenovirus, and yeast vaccine therapies.

ImmunityBios oncological goals are two-fold: To employ the companys broad portfolio of biological molecules to activate endogenous NK and CD8+ T cells, and to develop a T cell memory cancer vaccine to combat multiple tumor types without the use of high-dose chemotherapy.

The companys platform of technologies has enabled it to achieve one of the most comprehensive, late-stage clinical pipelines, addressing both the innate (activated macrophage and natural killer cell) and the adaptive immune system (dendritic, CD4 and CD8 killer T cells). In 2020, ImmunityBio is planning to enroll patients in late-stage trials with molecules across multiple indications including triple negative breast cancer, lung cancer, head and neck cancer, Merkel cell carcinoma and glioblastoma.

In the field of infectious disease, ImmunityBios goal is to develop vaccine therapies for the prevention and treatment of Influenza, Zika, Ebola, and HIV. For more information, please visit our website at https://www.immunitybio.com/.

SOURCE: NantKwest

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Toxic makeup: What to avoid, risks, and alternatives – Medical News Today

December 17th, 2019 8:41 am

The following sections look at makeup ingredients that may have toxic effects. People may wish to avoid products that contain these chemicals.

In 2019, the FDA advised consumers to avoid using certain cosmetic items due to them testing positive for asbestos. These items contained talc, which itself is safe.

People can find talc in various makeup products, including blushes, eye shadows, and bronzers. It works in makeup to absorb moisture, give an opaque finish, and stop makeup from "caking."

However, talc may pose a health risk due to possible contamination with asbestos; both talc and asbestos are natural minerals in the earth that often occur close together. Asbestos is a known cancer-forming chemical and can contaminate untested talc that manufacturers use in certain cosmetics.

Triclosan may be present in some over-the-counter cosmetics. Some manufacturers add it to reduce the risk of contamination with bacteria. Products that might contain triclosan include toothpastes, antibacterial soaps, and body washes.

According to the FDA, high levels of triclosan may affect thyroid hormones and contribute to antibiotic resistance. Research is also currently looking into the long-term effects of triclosan on the development of skin cancer.

Scientists need further evidence to determine the exact effect of triclosan on human health.

It is currently banned from body care products sold at Whole Foods and is scheduled for a ban from CVS, Rite Aid, and Walgreens.

Cosmetic eye products that contain kohl may contain high levels of lead, which is a harmful heavy metal for the body.

Any eye product containing any of the following could potentially contain lead:

Any product containing these ingredients is illegal in the U.S., as they come under the FDA's list of illegal color additives.

Skin lighteners may contain mercury. Mercury is a heavy metal that is harmful to the body. It may affect the nervous system, cause kidney damage, and harm a developing fetus.

Thimerosal is a preservative that can appear in cosmetics and contains mercury.

Phthalates are present in some nail polishes and hair sprays, as well as the fragrances of many cleaning and cosmetic products.

Phthalates can unbalance hormones, particularly those that work alongside estrogen, such as testosterone. According to a breast cancer charity, phthalates may have a link with breast cancer. This is because certain changes in estrogen levels can cause breast cancer to develop.

Manufacturers use parabens as preservatives in many cosmetics. Parabens may appear on cosmetic labels as the following:

Parabens may be present in makeup, moisturizers, hair products, and shaving creams. Parabens can enter the body through the skin and mimic estrogen.

Although parabens will only act as a weak form of estrogen, it could still be enough to cause breast cancer cells to grow. This is because an imbalance of estrogen can sometimes trigger a certain type of breast cancer called hormone receptor-positive breast cancer.

Breast tissue and breast cancers can contain paraben, though this is not proof that they are linked with cancer. It could simply indicate their wide usage. Further research will help determine whether or not there is a definite link.

Formaldehyde, and chemicals that release formaldehyde over a certain period of time, are present in cosmetics, lotions, shampoos, shower gels, nail polishes, and hair straightening products.

Formaldehyde can cause allergic reactions, as well as irritation to the eyes and respiratory system. Some studies in laboratory animals have also linked the chemical with cancer.

According to the American Cancer Society, these cosmetics "may raise the concentration of formaldehyde in the air inside the room for a short time, but the levels reached are far below what is considered to be hazardous."

They also suggest that professional hair smoothing treatments that use keratin can raise the indoor concentration of formaldehyde to potentially hazardous levels.

Toluene is present in some nail treatments and nail polishes. It is a solvent that may be toxic to the brain, nervous system, and a developing fetus.

Like triclosan, toluene is also currently banned from body care products sold at Whole Foods and is scheduled for a ban from CVS, Rite Aid, and Walgreens.

Carbon black is present in mascaras, eye liners, and lipsticks, as it gives these products their coloring. The Environmental Working Group (EWG) link this chemical with cancer, and research has reported that carbon black is "possibly carcinogenic to humans."

Scientists usually base these studies on industrial-level exposure in factories or laboratory animals. More research is needed to determine the safety of small amounts of carbon black in cosmetics.

Per- and polyfluoroalkyl substances (PFAS) may be present in foundations, concealers, and eyeliners, as well as other cosmetic products.

According to the EWG, there are more than 4,000 chemicals classed as PFAS that may pose the following risks:

Some makeup products may contain ultraviolet (UV) filters. Benzophenone is a type of UV filter that may disrupt hormones and have links with endometriosis.

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Immune Checkpoint Inhibitors on Track for Better Personalization – Cancer Therapy Advisor

December 17th, 2019 8:41 am

Todays cancer therapies are often hailed for their ability to deliver a more personalized approach one that considers the mutations lurking in a patients tumor or proteins expressed on the surface of a patients T cells and while current therapies are largely considered improvements from some past therapies, they still stand to benefit from even more personalization.

In particular, therapies can become more personalized if they address how a persons own genomics influence response to treatment, also known as pharmacogenomics, and this type of evidence is emerging for immune checkpoint inhibitors.

Specifically, a better understanding of T-cell behavior during immune checkpoint blockade is starting to form.

Its the T cells that actually do the work, Timothy Chan, MD, PhD, Memorial Sloan Kettering Cancer Center, New York City, told Cancer Therapy Advisor. He explained that because of this, its even more important that everybodys own individual genetic make-up is examined.

In a study recently published in Nature Medicine, Dr Chan and colleagues looked at the diversity of human leukocyte antigen class I (HLA-I) genes, which help the immune system fight off viruses, and juxtaposed it with the efficacy of antiCTLA-4 or antiPD-1/PD-L1 inhibitor therapy in patients with metastatic melanoma or non-small cell lung cancer. The study revealed that greater evolutionary HLA-1 diversity was linked to higher T-cell infiltration into the tumor and better response to immune checkpoint blockade.1

If youre very diverse, youre likely to benefit, Dr Chan explained. It is probably the most powerful pharmacogenomics signal that I have personally seen.

HLA diversity can vary depending on where a person lives in the world, with more isolated populations being more genetically homogenous and having lower HLA diversity, and the greater the diversity, the more efficient the immune system is at fighting off infections. However, while HLA diversity is a factor thats controlled for in vaccine clinical trials, it is not routinely examined or measured in cancer clinical trials.

I actually think that that is one of the missing pieces in understanding why some trials are positive [and] some trials are negative, Dr Chan said. Its because nobody is controlling for this one aspect that is critical for the success of immune checkpoint therapy.

In fact, the lack of consideration of HLA diversity in clinical trials may even explain the mixed success tumor mutation burden has seen as a biomarker for response to immune checkpoint inhibitors to date.2 According to Dr Chan, tumor mutation burden is only half the story and that trial investigators really need to look at the other half HLA diversity.

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Viraday and Tenvir Best HIV Infection and AIDS Treatment – The African Exponent

December 17th, 2019 8:41 am

What is HIV/AIDS?

HIV is a virus that infects humans. It attacks your immune system causing it to malfunction and makes you very ill. HIV stands for human immunodeficiency virus, the virus that causes AIDS.

AIDS is a serious medical condition comprising of a variety of diseases that occur because HIV interferes with your bodys ability to fight off other infections. AIDS stands for acquired immunodeficiency syndrome. Get tha more details about HIV only at genhealthtips.com

How HIV affects your body ?

A virus is a small infectious organism that can only replicate inside living cells of other organisms; in HIVs case, human immune cells. In order to understand how HIV and AIDS are connected, we need to take a closer look at how the immune system works. Your immune system is a complex network of organs, tissues, and cells, called white blood cells. The white blood cells are made in the bone marrow, migrate to other parts of the immune system such as the lymph nodes, spleen, and thymus and float around in the bloodstream. The components of your immune system work together to prevent germs from entering, growing, and multiplying inside your body.

How do you get HIV?

The most common way to get HIV is by having sex with an HIV infected person.

HIV spreads from one person to another when certain body fluids (blood, semen, vaginal secretions, rectal fluids, and breast milk) from an HIV infected person come into contact with a mucous membrane in the nose, mouth, rectum, vagina, or penis of an uninfected person. Vaginal, anal, and oral sex all set the scene for HIV to spread from one person to another.

The 2nd most common way to get HIV is by injecting HIV directly into your body.

This most commonly happens when HIV contaminated needles or syringes, or other drug injecting equipment is shared by injection drug users.

How to avoid getting infected with HIV

To avoid getting HIV, you must prevent any contaminated body fluids from entering your body through your nose or mouth, vagina, anus, penis, or breaks in your skin. This can be done by practicing safe sex and safe drug use, which means:

Always use a condom

Get tested regularly - this is a must if you are having sex with someone you know has HIV, or if you are worried you might have been exposed to HIV, and

Never share intravenous needles, syringes, cookers, cotton, cocaine spoons, or eye droppers if you use drugs.

There are other ways you can catch HIV, although it very rarely happens. It is possible to become infected through a needle stick injury or blood transfusion, or by getting bitten by an HIV infected person. HIV can also be passed on from an infected mother to a baby during pregnancy, labor, and birth or via breast milk, but with proper medical treatment during pregnancy, this is also rare.

How do you treat HIV/AIDS?

Antiretroviral therapy or ART is the medicine used to treat HIV infection. It is a combination of three different medicines that are often taken as a single tablet and must be taken every day to be of maximum benefit. ART is recommended for everyone infected with HIV. Although it is not a cure, if you have HIV, it lets you live a longer, healthier life, and reduces the chances you will spread the virus to someone else.

HIV medicines work by preventing HIV from multiplying, which lowers the amount of virus in your bloodstream (viral load). Although the medicine does not get rid of HIV entirely, it gives your CD4 cells a chance to recover so that they can fight off opportunistic infections and cancers. If you dont take ART, you are likely to die within 12 years from the time you first got infected. On the other hand, if you do take ART, you can have a life expectancy equal to or even higher than the general population.

HIV is managed with prescription viral suppression medications called Highly Active Antiretroviral Therapy (HAART). Taking Viraday has become much easier over the past few years. New treatments include two or three medicines combined in one pill. Many people living with HIV are treated with just one or two pills a day.

If you test positive for HIV infection, your doctor will take a medical history, conduct a physical exam, and order some more tests to find out how HIV is affecting your immune system. There are more than 20 HIV medicines available like Tenvir EM, Tenvir L Tablet, Tenvir and several different ART combinations that may be suitable, depending on your individual needs. Three important tests that help your doctor decide which medicines will work best for you are:

CD4 tests that measure your CD4 cell count.

Viral load tests that measure the number of viruses in your bloodstream, and Drug resistance tests that find out whether or not the HIV you are infected with is resistant to any of the anti-HIV medicines that are available.

As HIV medicines are known to interact badly with some other medicines, the choice of therapy will also depend on what else you are taking. Later, your HIV medicine may need to be changed if you have unpleasant side effects, or if your HIV becomes resistant to the medicine. Prep pill is not for everyone. Doctors guide PrEP for some sufferers who have a very high risk of getting in touch with HIV by not using a condom when they have sex with a personality who has HIV infection.

Consider the following:

You might be one of the millions of people who use a lubricant during sex. If you are using latex condoms, you can have safer sex if you use a water-based lubricant rather than an oil-based lubricant. Why would that be? Oil-based lubricants like Vaseline can weaken latex, making it more likely to break. So, only choose an oil-based lubricant if you are using polyurethane condoms. Get best treatment for hiv aids at http://www.genericforce.com

You might think that forgetting to take your HIV medicine now and then is not a big deal, but it is! Why would that be? HIV can multiply very quickly, and sometimes it mutates, meaning it evolves into a new form. Forgetting to take your HIV medicine increases the chances that your HIV will multiply and mutate into a drug-resistant form. If this happens, your HIV medicine will no longer work very well, and HIV will do more damage to your immune system.

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19-year-old man arrested in connection with Houston mercury spills – NBC News

December 17th, 2019 8:41 am

A teenager was arrested Monday in connection with mercury spills at three Houston businesses that led to one hospitalization, according to authorities.

Christopher Lee Melder, 19, faces charges of burglary, unlawful disposal of hazardous material and an outstanding felony drug possession warrant, according to the FBI's Houston office. Earlier, the office said a man was being questioned in connection with the spills.

A person called police at about 11:15 a.m. Sunday to report a white liquid on the ground, Houston Fire Chief Sam Pena said at a news conference Sunday night.

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Less than a pint of mercury had been spilled outside a Walmart, a Sonic Drive-In and a Shell gas station, officials said.

Investigators were looking into reports that someone checked into a Houston-area hospital claiming to have been exposed to mercury Friday, as well as reports of a possible recent warehouse break-in.

Between 30 and 60 people at the locations were hosed down, and a pregnant woman was taken to the hospital as a precaution.

Pena said dangers from exposure to the spills were "low risk" because the mercury was spilled on the ground, would evaporate and is only dangerous if ingested or inhaled.

The threat to the public is very low because the spill occurred outdoors and the amount of chemical spilled is small, Dr. David Persse, local health authority for the Houston Health Department, said in a statement. The amount of chemical detected on those exposed is below the level thats dangerous to the average individual.

Mercury is liquid at room temperature, according to the Centers for Disease Control and Prevention.

High levels of mercury exposure can harm the brain, heart, kidneys, lungs and immune system, and could affect the development of fetuses and young children, according to the Environmental Protection Agency. Symptoms of mercury exposure are headache, stuffy nose and nausea.

A private company was conducting cleanup at the three businesses.

Elisha Fieldstadt is a breaking news reporter for NBC News.

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Blindness should have spared Hall and more letters to the editors – Chattanooga Times Free Press

December 15th, 2019 9:54 pm

Time behind bars can change a man, especially 30 years. All that time, alone in your thoughts, and replaying that horrible day you did the unthinkable. I don't think the now-executed Lee Hall should have been freed but rewarded for his good behavior for these past 30 years.

The fact they sent a man his death who served 30 years with not even a misdemeanor on his prison record is absurd. The time he did and with the condition he was in, Lee should have been given a chance for a retrial with the chance of a life sentence without death row or probation. But the controversial killing of a blind man could have been prevented if not for the Department of Correction.

The Department of Correction knew Lee Hall had glaucoma since 2010 and failed to listen to the medical recommendations. Everyone should have the right medicine and to not be in pain, no matter how much pain they have given to the world.

Killing a blind person who is no longer any harm to this world is wrong and not what this amazing country represents.

Noah Allen, McDonald, Tennessee

***

Drain Trump Swamp in November 2020

We've got a problem. We have a dishonest administration that seems to be out of control. The government appears to be guided by a person who is mentally ill. This person, Donald J. Trump, is supported by platoons of stooges, "yes men" who do his bidding. Hunting has started for a stooge scapegoat for the current mess. Stooges are expendable.

My feelings are that it is better to let Trump get his comeuppance at the hands of the voters. This loss of the election would bring a message to the base and the evangelicals about clay feet. It would be a traumatic learning experience.

Also, nobody would need to deal with conspiracy theories and books by nutball minor players in the impeachment. If the evangelicals want to evangelize, they could start with the Trump Swamp at the top. Don't fiddle with the underlings.

The big question is how many generations will it take to fix this inside attack on America? Judges have a lifetime appointment.

Bill Reed

***

Recycle restaurant packaging waste

Restaurants create a lot of material waste. I have worked in a lot of restaurants in the past few years, and I have seen many, many recyclables go into the trash cans. Glass, plastic and paper waste is a major problem in the industry due to the packaging in food and alcohol deliveries.

Those materials waste precious resources such as water and energy. Of course, this is an integral part of the restaurant industry. However, we are able to make more responsible choices by choosing to recycle correctly and sourcing food locally.

The food will be fresher, in season, and will help boost local economies. If we are willing to take it a step further, we can consider composting the food waste we are able to.

Eden Skelton

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Retinitis pigmentosa cure breakthrough? Next generation of artificial lenses being developed with flexible silicon-like chips to combat genetic…

December 15th, 2019 9:54 pm

The good news is that this particular form of blindness leaves an opening for technology. Two types of artificial retinas have already been approved for human use. And new [research] suggests a way for those retinas to one day get much better.

The key point is that retinitis pigmentosa targets the rod and cone cells almost exclusively. The disease does minimal damage to the retinas many other neurons, which process signals from the rods and cones and convey the results to the optic nerve. So in principle, fixing vision is just a matter of going in through the very back of the eye, where the ravaged rods and cones originally formed a layer just 100 micrometers thick, and replacing them with a device that will generate electrical pulses in response to light. Pulses from various points on the device can then communicate with the retinas surviving neurons in a natural way.

Existing retinal prostheses require silicon or metal implants that are comparatively thick and completely rigid, a combination that the sensitive retinal tissue does not like at all, says physicist Guglielmo Lanzani of the Italian Institute of Technology (IIT) in Milan. Over time, he says, inflammation is followed by fibrosis scarring, which can reduce the artificial retinas already limited effectiveness.

So instead, as Lanzani and his IIT colleagues explain in the recentAnnual Review of Physical Chemistry, their group is investigating a different kind of retinal prosthesis made from semiconductive polymers, a class of carbon-based plastics that can conduct electricity in much the same way that silicon microchips do.

These polymers are best known for their use in some types of organic light-emitting diode (OLED) displays, the richly colored screens found in millions of smartphones. But the materials also show promise for a new generation of cheap, flexible, lightweight solar cells. And they show even more promise as soft, flexible bioelectronic interfaces to living tissue one of the emerging and very exciting applications of organic semiconductors, says Carlos Silva, a physicist at Georgia Tech in Atlanta. These applications include drug delivery and biosensors.

Because semiconductive polymers bend and flex like natural tissues, Lanzani says, they are biocompatible. In tests in the lab and in animals, the polymer retina seems to coexist with them quite happily, with no adverse reactions at all.

Just as important, adds IIT neuroscientist Fabio Benfenati, semiconducting polymers can get the physiology right. When light hits the polymer sheet, he says, it triggers a localized pulse of electrical activity about 80 to 100 micrometers across. Because this is roughly comparable to the spacing of rod and cone cells outside the densely packed fovea, where the eyes visual acuity is the highest, the polymer prosthesis would allow a resolution akin to a persons natural peripheral vision.

And because the sheet can be engineered to deliver its electrical pulses as a flow of ions, it can pass signals to the surviving retinal neurons in a way that they recognize: Ion flows are neurons native language. Even though the mechanism is probably different from what is occurring in nature, Benfenati says, what we do is very biomimetic.

Carbon-based polymers such as rubber, nylon and polyester are usually thought of as insulators, preventing electricity from flowing out of wires or other metal parts. But in the 1970s, chemists established that certain polymers could conduct electricity quite well and better still, could function as semiconductors like silicon. By 2000, when work in this area won the Nobel Prize in chemistry, the field was flourishing.

Today, there are a number of semiconducting polymers that might be suitable for an artificial retina, but the IIT group has focused on P3HT, short for poly(3-hexylthiophene-2,5-diyl), a material widely used in photovoltaic cells. In 2007, recalls Lanzani, as part of an effort to develop a more accurate device for measuring colors, he and his physicist colleagues showed thatP3HT could be engineered to respond to lightin much the same way as green-sensitive human cone cells. And shortly thereafter, he says, I heard about people building an artificial eye for robotics, including a retina-like detector, and I thought, The best place for a retina is in the eye the real eye!

This artificial retina idea became concrete when he met Benfenati at the coffee machine during an institute meeting. Fabio was excited, says Lanzani and as a neuroscientist, he knew how to work with living neurons.

Joining forces, their teams showed in 2011 thatneurons cultivated on a film of P3HT would indeed make connections with the polymer. Whats more, the neurons responded to electrical impulses from the polymer in the same way they would to nerve impulses from a rod or cone cell. Then in 2013 they showed thatretinas taken from a strain of rat with dysfunctional rod and cone cells would connect to the polymerin the same way, and would have a similar response to impulses. That was a confidence-booster, says Benfenati. Its one thing to have a cell growing onto a surface and getting a very tight contact, he says, and another thing just to put preformed tissue in contact.

Independently, as it happens, K.S. Narayan and his team at the Jawaharlal Nehru Centre for Advanced Scientific Research in Bangalore, India, were gettingsimilar resultsusing a polymer blended with P3HT. But since then, the two teams paths have diverged somewhat. Narayans group has been carrying out laboratory studies with photoreceptor-free retinas obtained from chick embryos to get a very precise understanding of how the polymer and the retinal neurons interact. We are interested in biophysics, he says how neurons get excited when we introduce these artificial polymers to replace the receptors.

Lanzani and Benfenati, in the meantime, have moved on to testing their polymer prosthesis in the retinas of living animals. A crucial factor in this work has been their partnership with Grazia Pertile, says Benfenati. Not only is she head of the ophthalmology department at the Sacrocuore Hospital in Verona, Italy, he says, and one of the most skilled retinal surgeons in Europe, she is very interested in basic research, as well.

In 2017,Pertile and colleagues succeeded in implanting a full prosthesis in the eyes of living rats from a strain that has a genetic defect analogous to retinitis pigmentosa. After a months healing time, the pupils of these once-blind rats were contracting in response to light exactly like those of healthy rats, and their once-dormant visual cortex was abuzz with renewed activity. Its impossible to know what the rats were actually experiencing, but they showed every sign of being able to see again.

The team has now embarked on the multiyear road toward human experimentation. To prepare the way, Pertile has been developing techniques to implant the polymer retinal prosthesis in pigs, whose eyes are similar to peoples in both size and visual acuity, while others on the team have been refining the prosthesis itself.

Were taking the time, says Lanzani, in order to have the best architecture before going to humans.

M. Mitchell Waldrop is a freelance writer based in Washington, DC. Follow him on Twitter @MitchWaldrop

A version of this article was originally published on Knowables website as Polymers promise a more flexible artificial retina and has been republished here with permission.

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9 High-Impact Charities Where Your Holiday Donation Will Actually Make a Difference – Robb Report

December 15th, 2019 9:54 pm

Some nonprofits are household names, but small organizations can also be extremely effective. Here are nine high-impact charities that might not be on your radar but are worthy of your consideration this holiday seasonand throughout the year.

In 2015, the number of migrants arriving in Europe hit 1 million, a four-fold rise from the previous year, due to the Syrian civil war. Many remain in makeshift camps. Help Refugees, which started as a social-media campaign in response to the crisis, has grown to become the largest grassroots distributor of aid in Europe, providing food, shelter, interpreters and nurses. Nearly 90 percent of its budget goes directly to supporting refugees.

Courtesy of Innocence Project

The Innocence Project was founded by civil-rights attorneys in 1992 and uses DNA testing to free wrongfully convicted prisoners. Since 1989, the technology has exonerated 367 people in the US, 21 of whom had been sentenced to death. The group provides legal representation to prisoners, lobbies for criminal-justice reforms and helps freed prisoners, many of whom have spent decades in jail, transition back into society.

Frustrated with the failure of conventional aid programs to stop infant deaths in developing countries, Timothy Prestero set up Design That Matters, which produces cheap, innovative devices that treat neonatal pneumonia, hypothermia and jaundicethree leading causes of infant death. According to Prestero, a third of medical equipment donated to developing countries is wasted because its too complicated and difficult to maintain. Design That Matters, which has won multiple design awards, creates devices specifically for low-income rural hospitals.

Courtesy of Nurse-Family Partnership

In many countries, new mothers are supported at home by government-funded midwives. In the US, Nurse-Family Partnership is seeking to replicate that care for young, low-income mothers. The groups nurses make regular visits, starting early in a womans pregnancy and continuing until the child is two. The average client is 20 and unmarried with an annual income of $9,000. The nurses take a holistic approach, tackling everything from cigarette smoking to job searches, with the goal of reducing child abuse, behavioral and intellectual problems and juvenile arrests.

Since 1982, the Orbis Flying Eye Hospitala state-of-the-art teaching facility on a planehas treated people in 18 low-income countries, preventing blindness from cataracts and glaucoma. There are 36 million blind people globally, though more than 75 percent of cases are avoidable, according to the International Agency for the Prevention of Blindness. In each country Orbis visits, volunteer surgeons and nurses treat patients, train local doctors and advocate with governments to improve eye care. Orbis International spends 93 percent of donations on sight-saving work.

In every country around the globe, girls are held back educationally because of a lack of access to feminine-hygiene products. More than half of Ethiopian girls miss school when they have their period. But even in rich nations, girls stay home due to poverty and shame. Celeste Mergens founded Days for Girls in 2008, when she discovered that girls in a Kenyan orphanage where she was volunteering spent several days every month sitting on cardboard in their bedrooms. Mergens and her team designed an affordable, washable sanitary kit that lasts for years. More than a million females in 125 countries, including low-income women in the US, have received the kits. The nonprofit also trains women in developing countries to produce and sell the kits themselves.

Courtesy of Bail Project

Though most countries have ended the cash-bail system, the Bail Project estimates that 2.5 million people in the US are held in jail each year because they cannot afford bail. A high proportion of those in pretrial detention have young children, with women and people of color disproportionately affected. Their bail is often less than $1,000. Faced with loss of jobs, housing and custody of their children, many plead guilty in exchange for release but end up with a permanent criminal record. The Bail Project estimates that taxpayers pay around $14 billion a year for pretrial detention alone, not including the social costs of unemployment and family breakdown. The Bail Project lends bail money to those awaiting trial.

More than 40 percent of American children are from low-income families, and half of those are below the poverty line. For families who have to choose between food and rent, childrens shoes are a particular burden, because they are expensive and quickly outgrown. Shoes That Fit provides new athletic shoes to elementary-school children from those families, who often suffer from stigma and bullying. The nonprofit, which spends more than 94 percent of its budget on footwear, helped more than 124,000 children in the last school year.

Courtesy of World Bicycle Relief

In developing countries, the majority of travel is done on foot. In rural communities, every doctors visit and school commute can take hours, if not days. Founded in 2005 with a donation of 24,400 bicycles to displaced survivors of the tsunami in Sri Lanka, World Bicycle Relief has now provided more than 469,000 bikes to isolated communities. The result, according to the organization, has been strong improvements in access to education, health care and work. The group also trains local mechanics to assemble and sell bikes. Stores, distribution facilities and supply chains provide employment, spare parts and repair services. Profits are reinvested in philanthropic work, creating a self-sustaining virtuous cycle.

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Blindness In India Reduced By 47 Per Cent Since 2007: Report – Sunriseread

December 15th, 2019 9:54 pm

The estimates have been primarily based on Nationwide Blindness and Visually Impaired Survey (2019).

New Delhi:

The prevalence of blindness in India has come down by round 47 per cent since 2007, in accordance with a authorities survey launched on Thursday, indicating that the nation is near reaching the WHOs objective of decreasing it to 0.Three per cent of the whole inhabitants by 2020.

In absolute numbers, folks affected by blindness have diminished from 12 million in 2006-07 to 4.eight million in 2019. Additionally, cataract nonetheless stays to be most typical explanation for blindness (66.2 per cent) adopted by corneal blindness (7.Four laptop). In addition to this, the proportion of blindness attributable to problems of cataract surgical procedure (7.2 laptop) has additionally elevated, the survey revealed.

In accordance with the Nationwide Blindness and Visually Impaired Survey (2019) launched by Union Well being Minister Harsh Vardhan, the estimated prevalence of blindness within the nation has come right down to 0.36 per cent from 1.00 per cent in 2006-2007.

The present survey was carried out over a interval between 2015 and 2018 by Dr Rajendra Prasad Centre for Ophthalmic Sciences of the AIIMS in collaboration with the Union Well being ministry in these aged = 50 years inhabitants (93,000) utilizing Speedy Evaluation of Avoidable Blindness (RAAB) methodology in 31 districts of 24 states and Union Territories.

Dr Promila Gupta, Principal Guide within the Nationwide Programme for Management of Blindness within the Ministry of Well being stated this house-to-house survey was designed to generate consultant knowledge for the sampled districts in addition to for India. An extra survey was carried out between 0-49 years age group in January-February 2019 and lined 18,00Zero folks in 6 districts throughout varied areas of India.

The outcomes of each surveys, in 0-49 age group and in = 50 years inhabitants, have been used to estimate the prevalence of blindness and visible impairment in India throughout all age group, Dr Gupta stated.The prevalence of blindness in India has come down by round 47 per cent for the reason that final survey carried out in 2006-2007 and the findings of the present survey are for blindness as outlined to be imaginative and prescient of lower than 3/60 within the higher eye, Dr Vardhan stated including the nation is near reaching the WHOs objective of decreasing it to 0.Three per cent by 2020. India modified its over four-decade-old definition of blindness in 2017, bringing it consistent with the WHO standards.

In accordance with the brand new definition, an individual whos unable to depend fingers from a distance of three metres can be thought-about blind as in opposition to the sooner stipulation of six metres, which was adopted in 1976. The purpose of revising the definition can be to have the ability to generate knowledge which could be in contrast with international estimates and obtain the WHO objective of decreasing the blindness prevalence in India to 0.Three per cent of the whole inhabitants by 2020, Dr Gupta stated.

The survey additionally discovered that the visible impairment has come down by 51.9 per cent to 2.55 per cent as a in comparison with 2010 ranges. The WHO had set the objective of reducing the prevalence of visible impairment by 25 per cent by 2019 as in comparison with 2010 ranges. In 2010, the prevalence of visible impairment was 5.30 per cent within the Indian inhabitants. We now have achieved this objective by a a lot better margin, Dr Gupta stated.

(Aside from the headline, this story has not been edited by NDTV employees and is printed from a syndicated feed.)

Get Breaking information, stay protection, and Newest Information from India and all over the world on NDTV.com. Catch all of the Reside TV motion on NDTV 247 and NDTV India. Like us on Fb or observe us on Twitter and Instagram for contemporary information and stay information updates.

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How the entertainment industry can catch up with Apple TV+’s ‘See’ – Mashable

December 15th, 2019 9:54 pm

When casting See, Apple and showrunners Steven Knight, Dan Shotz, Jon Steinberg, and Francis Lawrence aimed to involve individuals who are blind and low vision as much as possible. Accordingly, the first two actors cast on the series, a sci-fi epic set in a world in which all of humanity is blind, were Marilee Talkington and Bree Klauser both of whom are blind and have ample credits to their names.

However, besides Klauser and Talkington, there arent many other blind or low vision actors who have adequate experience on large-scale projects like See. So, to further cast the series as authentically as possible, its casting process took on an unprecedented form.

First, creators of the series utilized community outreach to recruit background and stunt actors who were blind or low vision. Once auditions began, Sees casting team coached and provided feedback to less-experienced actors who are blind and low vision to help them land a role on the series or on another program in the future.

Such inclusive behavior isnt a big surprise coming from Apple, which has a longstanding reputation for leading the charge in digital accessibility for individuals with disabilities, and specifically users who are blind and low vision.

In fact, Sarah Herrlinger, Apples director of Global Accessibility & Policy Initiatives, sits on the board of the American Foundation for the Blind. In a 2016 interview with Mashable, Herrlinger discussed Apples never-ending approach to make sure that its products are universally accessible to everyone.

When engineering specialized accessible features and content, Apples efforts have centered on consulting and working with individuals with disabilities. For instance, executive director Eric Bridges of the American Council of the Blind (ACB) told Mashable in a recent call that Apple worked with the organization to create the blind person holding a cane and guide dog emoji.

In June 2019, Apple released iOS 13, a software update that features Voice Control and VoiceOver comprehensive accessibility features that revolutionized the ways in which individuals with disabilities can use their iPhones and other Apple products.

Journalist Steve Aquino, who uses assistive technology to access their Apple devices, praised the update in TechCrunch, writing, Apple continues to lead the industry at making accessibility a first-class citizen. More recently, Sina Barham, who is blind and serves as the president of an accessibility consulting firm, affirmed that Apples efforts on iOS far exceed Androids progress on accessibility, according to Slate.

Apple is also unmatched with regard to the audio descriptions included on Apple TV+ content and original programming: Viewers can watch shows with audio descriptions in multiple languages regardless of their location.

Similarly, when launching See, Knight, Shotz, and Lawrence made sure to heavily consult with individuals who are blind and low vision throughout the entire production process to ensure respectful portrayals of blindness and disability.

Every actor we brought on who was blind or low vision provided comments on aspects of the world [of See], Joe Strechay, the series official blindness consultant, told Mashable over the phone. Strechays gig on See has been a topic of conversation in the entertainment press, and the consultant also worked with Charlie Cox on Netflixs Daredevil.

Hera Hilmar, who plays Maghra on 'See,' with Strechay on set.

Image: Photo Courtesy Apple

Strechay also shared that Knight and Lawrence began getting input from folks who are blind and low vision on Sees concept and initial scripts in March 2018. Between those first consultations and the start of filming in September of that year, Strechay, who is blind, reviewed scripts and provided countless suggestions on the series portrayal of blindness. Apple set a standard around respect, he said.

Tasked to train Sees sighted cast members playing characters who are blind, Strechay began the blindness training on set with lessons on education and awareness to address misconceptions about blindness. In particular, Strechay stressed that there are a lot of comical portrayals of blindness onscreen. See, he reaffirmed, is not one of them.

The casting of sighted actors to play blind characters is a discriminatory trend that the blind and low vision community is all too familiar with.

Despite the current discourse surrounding authentic and inclusive casting, portrayals of blindness in which the punchline is that a blind person cannot see have persisted. In 2016, Adam Scott played a blind lead alongside Nick Kroll and Jenny Slate in the comedy My Blind Brother, wherein the love triangle between Kroll, Slate, and Scotts character relies on the fact that Kroll and Slates characters can have sex without Scotts character ever catching them in the act. Similarly, in Deadpool (2016) and Deadpool 2 (2018), Leslie Uggams played Blind Al alongside Ryan Reynolds. Neither Scott nor Uggams are blind or low vision.

The casting of sighted actors to play blind characters is a discriminatory trend that the blind and low vision community is all too familiar with. An ambivalent review of Sees pilot from Chris Danielsen, public relations director of the National Federation of the Blind (NFB), contextualizes See as coming at a time when blind people are always wary of how [they] are portrayed in the mass media, based on decades of past bad experiences.

Danielsen explained to Mashable that there has been little or no effort in the entertainment industry to cultivate blind talent. A guild for blind and low vision actors still doesnt exist, and such performers struggle to land roles as extras on screen, or don't make it past the initial audition, said Bridges in a separate conversation.

See isnt perfect: The series stars Jason Momoa, Alfre Woodard, Hera Hilmar, and Sylvia Hoeks, none of whom are blind or low vision. Its casting practices (with regard to lead actors) dont appear to be any different than that of My Blind Brother and Deadpool.

Moreover, in its blog post, the NFB raised specific questions about the inclusion of sighted characters in the series whom some of the blind characters seem to view with reverence. In a phone call with Mashable, Danielsen elaborated that the NFB wondered why sighted characters were used as a source of salvation: Why are we not just seeing a society run by blind people and seeing how that plays out?

Chiefly, Danielsen stated that the NFBs concern is that they are not seeing authentic representation to the extent that [they] would like because its not apparent... that any of the blind cast have a role that is significant in more than a few episodes.

Talkington and Klauser both play members of the Alkenny tribe alongside Momoa and Woodard. Talkingtons Souter Bax is a multidimensional but minor character who opposes the Alkenny tribe leadership. Klauser plays a recurring character named Matal, a female warrior whose abilities to sense energies are shown to be valuable to the survival of the Alkenny. In addition, Jessica Harper, an actor who is low vision, plays Cora, a slave of one of the tribes in the world of See. Cora appears in the final three episodes of the first season.

Jessica Harper as Cora alongside Sylvia Hoeks, who plays Queen Kane.

In an interview with Horror Fuel, Klauser applauded Sees creators for being open-minded when she suggested that the set up of a particular scene didnt ring true to her lived experience as an individual who is legally blind, and shared that she was glad to have had the opportunity to accurately represent [her] community. Similarly, Talkington tweeted that she was proud to make history by authentically representing on the series.

Notably, however, neither Talkington or Klauser are top-billed cast members. After being heavily featured on Sees first four episodes, Talkingtons presence on the series has waned significantly. Because Talkington is the most prominent cast member who is blind, her apparent absence from the rest of the series seems disappointing with regard to the burgeoning representation of the blind and low vision communities on See. Strechay told Mashable that Talkingtons brief timeline on the series first season was just how it was written, and merely a result of Sees storyline.

Still, Apple and See showrunners are using the series as a catalyst for change. Despite and as a result of Sees efforts, Bridges said the series is a starting point.

Its taking Apple stepping in as a new force within entertainment to really have the first go at this problem... theyre putting their best foot forward, he said.

Similarly, Strechay clarified that authentic representation of individuals who are blind and low vision on screen is a continuing process. Were nowhere near perfect, he said, and reassured Mashable that the series will continue adding cast members who are blind and low vision for its second season.

Strechay explained that although A-list names like Momoa and Woodard dont currently exist in the blind and low vision community, See is working to identify and support the blind and low vision actors on set so they can be fantastic actors down the line. Sees background cast also included individuals who are deaf or hard of hearing, individuals of short stature, individuals who utilize prosthetic limbs, and an actor with cerebral palsy.

Marilee Talkington at the premiere of Apple TV+'s 'See.'

Image: jean baptiste for WireImage/getty images

Bree Klauser at the premiere of Apple TV+'s 'See.'

Image: frazer herrison/Getty Images

Speaking with Mashable, Tatiana Lee, a Hollywood inclusionist at Respectability, echoed Strechays sentiment and praised See for casting blind and low vision actors and actors with disabilities so they can eventually land a lead role in something else. Bridges hoped that the series will find more qualified blind actors and that there will be ever increasing levels of disability on the show in future seasons.

As See attempts to remedy a complex issue after a decades of discrimination in Hollywood, reservations coexist with optimism for the future. See has already cast more blind actors than any other film or TV show that we know of. So, progress, while perhaps incremental, has been made, wrote Danielsen. The series has been renewed for a second season, which grants showrunners a vital opportunity to cast individuals who are blind and low vision in upcoming lead roles while continuing to cast individuals with disabilities in future episodes.

In any event, the progress made by Sees second season will undoubtedly be compared to the strides made by its first. Hopefully, the expectation of such an assessment is motivation enough for showrunners to continue making change in Hollywood.

See is available for streaming on Apple TV+.

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