StemCell Therapy

Up to 40 patients are planned to be enrolled in this Phase 1b/2, multicenter, randomized, controlled, open-label study to evaluate the clinical response, safety and tolerability, as well as multiple pharmacodynamic parameters, of BL-8040 in combination with atezolizumab. Initially, patients will receive BL-8040 injections as priming monotherapy for five consecutive days, after which, from day 8, they will receive both BL-8040 and atezolizumab, and continue with multiple treatment cycles for up to two years or until disease progression, clinical deterioration or unacceptable toxicity.

The clinical study collaboration between BioLineRx and Genentech, a member of the Roche Group, is part of MORPHEUS, Roche's Novel Cancer Immunotherapy Development Platform. MORPHEUS is a phase 1b/2 adaptive platform to assess the efficacy and safety of combination cancer immunotherapies.

Philip Serlin, Chief Executive Officer of BioLineRx, stated, "We are very pleased with the launch of the first clinical study under our cancer immunotherapy collaboration with Genentech. Pancreatic cancer is a very difficult cancer to treat, and both conventional chemotherapy and immunotherapy have failed to demonstrate a significant benefit for these patients. BL-8040 has been shown to have robust mobilization of immune cells, improve the infiltration of T cells into solid tumors, and affect the immunosuppressive tumor micro-environment. We are therefore hopeful that combining atezolizumab with BL-8040 can lead to a significant advancement in the treatment of pancreatic cancer, and of other solid tumors that are difficult to treat. We look forward to the initiation of additional combination studies under this collaboration, all planned for the second half of this year."

BioLineRx is carrying out a larger cancer immunotherapy collaboration with Genentech to conduct several Phase 1b/2 studies investigating BL-8040 in combination with atezolizumab in multiple cancer indications, announced in September 2016.

BL-8040, BioLineRx's lead oncology platform, is a CXCR4 antagonist that has been shown in clinical trials to be a robust mobilizer of immune cells and to be effective in inducing direct tumor cell death. Additional findings suggest that BL-8040 may be effective in inducing the migration of anti-tumor T cells into the tumor micro-environment, as well as improving the infiltration of T cells into solid tumors. Atezolizumab is a humanized monoclonal antibody designed to bind to PD-L1 in tumor cells and tumor infiltrating immune cells and blocks interactions with the PD-1 and B7.1 receptors. Through this interaction, atezolizumab may enable the activation of T cells, whose migration into the tumor may be enhanced by BL-8040.

About BL-8040

BL-8040 is a short peptide for the treatment of acute myeloid leukemia, solid tumors, and stem cell mobilization. It functions as a high-affinity antagonist for CXCR4, a chemokine receptor that is directly involved in tumor progression, angiogenesis, metastasis and cell survival. CXCR4 is over-expressed in more than 70% of human cancers and its expression often correlates with disease severity. In a number of clinical and pre-clinical studies, BL-8040 has shown robust mobilization of cancer cells from the bone marrow, thereby sensitizing these cells to chemo- and bio-based anti-cancer therapy, as well as a direct anti-cancer effect by inducing cell death (apoptosis). In addition, BL-8040 has also demonstrated robust stem-cell mobilization, including the mobilization of colony-forming cells, T, B and NK cells. BL-8040 was licensed by BioLineRx from Biokine Therapeutics and was previously developed under the name BKT-140.

About BioLineRx

BioLineRx is a clinical-stage biopharmaceutical company focused on oncology and immunology. The Company in-licenses novel compounds, develops them through pre-clinical and/or clinical stages, and then partners with pharmaceutical companies for advanced clinical development and/or commercialization.

BioLineRx's leading therapeutic candidates are: BL-8040, a cancer therapy platform, which has successfully completed a Phase 2a study for relapsed/refractory acute myeloid leukemia (AML), is in the midst of a Phase 2b study as an AML consolidation treatment, and is expected to initiate a Phase 3 study in stem cell mobilization for autologous transplantation; and AGI-134, an immunotherapy treatment in development for multiple solid tumors, which is expected to initiate a first-in-man study in the first half of 2018. In addition, BioLineRx has a strategic collaboration with Novartis Pharma AG for the co-development of selected Israeli-sourced novel drug candidates; a collaboration agreement with MSD (known as Merck in the US and Canada), on the basis of which the Company has initiated a Phase 2a study in pancreatic cancer using the combination of BL-8040 and Merck's KEYTRUDA; and a collaboration agreement with Genentech Inc., a member of the Roche Group, to investigate the combination of BL-8040 and Genentech's TECENTRIQ in several Phase 1b/2 studies for multiple solid tumor indications and AML.

For additional information on BioLineRx, please visit the Company's website athttp://www.biolinerx.com, where you can review the Company's SEC filings, press releases, announcements and events. BioLineRx industry updates are also regularly updated onFacebook,Twitter, andLinkedIn.

TECENTRIQ (atezolizumab) is a registered trademark of Genentech, a member of the Roche Group.

Various statements in this release concerning BioLineRx's future expectations constitute "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995. These statements include words such as "may," "expects," "anticipates," "believes," and "intends," and describe opinions about future events. These forward-looking statements involve known and unknown risks and uncertainties that may cause the actual results, performance or achievements of BioLineRx to be materially different from any future results, performance or achievements expressed or implied by such forward-looking statements. Some of these risks are: changes in relationships with collaborators; the impact of competitive products and technological changes; risks relating to the development of new products; and the ability to implement technological improvements. These and other factors are more fully discussed in the "Risk Factors" section of BioLineRx's most recent annual report on Form 20-F filed with the Securities and Exchange Commission on March 23, 2017. In addition, any forward-looking statements represent BioLineRx's views only as of the date of this release and should not be relied upon as representing its views as of any subsequent date. BioLineRx does not assume any obligation to update any forward-looking statements unless required by law.

Contacts: PCG Advisory Vivian Cervantes Investor Relations +1-212-554-5482 vivian@pcgadvisory.com

or

Tsipi Haitovsky Public Relations +972-52-989892 tsipihai5@gmail.com

SOURCE BioLineRx Ltd.

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BioLineRx Announces Initiation of Phase 1b/2 Trial of BL-8040 in Pancreatic Cancer Under Immunotherapy ... - PR Newswire (press release)

Australian researchers have successfully turned stem cells from Friedreichs ataxia (FA) patients into heart cells to study molecular anomalies that maycontribute to this disease.

Theseheart cells in a dish provide valuable information for the design of novel treatments.

Their study, Friedreichs ataxia induced pluripotent stem cell-derived cardiomyocytes display electrophysiological abnormalities and calcium handling deficiency. appearedin the journal Aging.

FAis caused by low levels of the frataxin protein due to anomalies in the gene sequence encoding this protein repeats of DNA portions within the gene. The higher the number of repeats, the sooner the onset of FAand its associated complications.

Frataxin plays an important role in the mitochondria, the cells powerhouse, so the mutated protein accounts for several symptoms that reflect deficiencies in energy production. The heart is one of the organs affected by this lack of energy.

Cardiomyopathy is detected in two-thirds of individuals with FRDA[Friedreichs ataxia], researchers wrote. Individuals with FRDA generally present with progressive cardiomyopathy of the left ventricle, which is the leading cause of death in FRDA due to arrhythmias and/or heart failure.

Previous studies have shown that death of heart cells, or cardiomyocytes, and fibrosis may contribute to heart complications in FA, but little is known about the diseases impact on the heart.

Researchers generated stem cell cultures using cells from three FA patients with heart complications. They then stimulated the development of these stem cells into cardiomyocytes basically, heart cells in a dish.

The new cardiomyocytes had low levels of frataxin, as expected, but alsoabnormal ionic currents, which are crucial for the normal functioning of these cells. They also had morevariation in their beating rates, which was linked todeficient calcium control, ultimately affecting howthe cardiomyocytes work.

Together, these results pave the way for understanding how FA patients develop abnormal heart activity as well as theuse of induced stem cells to studycardiomyopathy within the context of this disease.

Importantly, our data clearly indicates that FRDA iPSC [stem cells]- derivedcardiomyocytes can be used for screening of compounds able to alter or reverse phenotypes, in human cells, hence providing a novel and unique tool for FRDAresearch, researchers concluded.

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Researchers Create 'Heart Cells in a Dish' to Study FA Heart Disease - Friedreich's Ataxia News

Advertising forstem cell therapies not supported by clinical researchoftenmadedirectly to patients and sometimes promoted as a cure for diseases like multiple sclerosis or Parkinsons is a growing problem that needs to be addressed and regulated, a team of leading experts say, calling suchstem cell tourism potentially unsafe.

Stem cell tourism is the unflattering name given to the practice of encouragingpatients totravel outside their home country to undergo suchtreatment, typicaly at a private clinic.

The article, titledMarketing of unproven stem cellbased interventions: A call to actionandrecently published inthe journal Science Translational Medicine, was co-authored by scientistswith universities and hospitals in the U.S., Canada, U.K., Belgium, Italy, Japan, and Australia. It focuses on the global problem of thecommercial promotion of stem cell therapies and ongoing resistance to regulatory efforts.

Its authors suggest that a coordinated approach, at national and international levels, be focused on engagement, harmonization, and enforcement in order to reduce risks associated with direct-to-consumer marketing of unproven stem cell treatments.

Treatments involving stem cell transplants are now being offered by hundreds of medical institutions worldwide, claiming efficacy in repairing tissue damaged by degenerative disorders like MS, even thoughthose claim often lack or are supported bylittle evidence .

They alsonoted that the continued availability of these treatments undermines the development of rigorously tested therapies, and potentially canendanger a patients life.

The researchers emphasizethat tighter regulations on stem cell therapy advertising are needed, especiallyregarding potential clinical benefits. They support the establishment ofinternational regulatory standards for the manufacture and testing of human cell and tissue-based therapies.

Many patients feel that potential cures are being held back by red tape and lengthy approval processes. Although this can be frustrating, these procedures are there to protect patients from undergoing needless treatments that could put their lives at risk, Sarah Chan, a University of Edinburgh Chancellors Fellow and report co-author, saidin anews release.

Chan and her colleagues are also calling for the World Health Organization to offer guidance on responsible clinical use of cells and tissues, as it does for medicines and medical devices.

Stem cell therapies hold a lot of promise, Chan said, but we need rigorous clinical trials and regulatory processes to determine whether a proposed treatment is safe, effective and better than existing treatments.

According to the release, the report and its recommendationsfollowed the death of two children at a German clinic in 2010. The clinichas since been shut down.

Certainstem cell therapies mostly involving blood and skin stem cells have undergone rigorous testing in clinical trials, the researchers noted. A number of theseresulted in aprovedtreatments for certain blood cancers, and to grow skin grafts for patients with severe burns.

Information about the current status of stem cell research andpotential uses of stem cell therapiesis availableon the websiteEuroStemCell.

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Experts Call for Tighter Regulation of Stem Cell Therapies in Use at Clinics Worldwide - Multiple Sclerosis News Today

Mindnosis, developed by graduate designer Sara Lopez Ibanez, consists of a set of exercises that help understand emotional distress and how to feel better about it.

The first tool, named Discover, is made of six colourful triangles, whereby each represents a different area affecting the user's wellbeing. The triangles can be pasted into the Record journal along with daily thoughts and reflections.

The third element of the toolkit, named TryOut, is a set of eight activity cards that combine mindfulness, cognitive behaviour therapy techniques (CBT) and tips from peers to help users when they feel unwell.

Learn, is the fourth tool which comprises six small coloured cards that correspond with the Discover triangles briefly explaining the different issues, while a Crisis Help sheet has information about services and help lines.

Researchers say that their 3-D-printed heart valve models (shown here) could improve the outcomes of heart valve replacements. Photo credit: Rob Felt

In TAVR surgeries, paravalvular leakages are common especially when the prosthetic valve fails to achieve a precise fit within the patient's damaged aortic valve.

Therefore the Cardiovascular Imaging Research at Piedmont Heart Institute in Atlanta US, has developed 3-D heart valve models that could better predict the fit of a prosthetic valve.

The models were created to simulate the physiological properties of heart valve tissue using a variety of different synthetic materials. Prosthetic valves were then implanted in the 3-D models and through medical imaging and computer software, the team monitored the valves in the 3-D models.

A "bulge index" was then created to predict the severity of paravalvular leakage after undergoing TAVR; the greater the bulge index score, the higher their severity of paravalvular leakage.

The researchers looked at allergies that produce respiratory and skin symptoms including dust mites, cats and grass. The team gathered data from nearly 9,000 mother-child pairs in the Avon Longitudinal Study of Parent and Children, an ongoing research project that tracks the health of families with children born between 1 April 1991 and 31 December 1992.

The amount of free sugars consumed by women during pregnancy was based on self-reported estimates in questionnaires. The team also looked at how the mothers' sugar consumption compared with allergies and asthma diagnosed in the children beginning age of seven.

Approximately 22% of the children had a common allergy, 16% had eczema, 12% had asthma, 11% had wheezing with whistling and 9% developed hay fever.

Comparing with children whose mothers consumed the least sugar during pregnancy less than 34g per day the children of women with highest sugar intake during pregnancy had a 38% higher risk of allergy diagnosis. There was also a 73% increased risk of being diagnosed with an allergy to two or more allergens and the allergic asthma risk increased by 101%.

This is a human colon organoid, with colors showing signals also found in the natural human colon. Photo credit: Cincinnati Children's Hospital Medical Centre

The cells expressed several colon genes and to prove that their newly made human colon organoids were stable, they transplanted them into mice. The organoids continued to grow and mature in the mouse model.

What is also different in the team's work is that the stem cells can come from a simple blood draw and the method used, creates multiple cell types, so they could study how different cells interact within the complex layers of the colon. This could prove to be important when understanding diseases like colon cancer.

The team is now beginning to use the organoids to model inflammatory diseases such as ulcerative colitis and Crohn's disease. MIMS

Read more: News Bites: Microneedle patch could replace flu vaccines, Tick saliva could pave way for a range of new drugs News Bites: Preeclampsia may be linked to babies' DNA, Vaccine can lower "bad" cholesterol and heart attacks News Bites: Implanting pig cells into brains to slow down Parkinson's Disease, Aspirin may lower breast cancer risk

Sources: http://www.telegraph.co.uk/science/2017/07/03/heartburn-drugs-taken-millions-may-increase-risk-early-death/ https://www.dezeen.com/2017/07/04/mindnosis-kit-helps-people-overcome-mental-health-issues-graduate-designers-2017/ http://www.medicalnewstoday.com/articles/318193.php http://edition.cnn.com/2017/07/05/health/sugar-pregnancy-child-allergy-asthma-study/index.html https://www.statnews.com/2017/06/30/gut-organoids-medicine/

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News Bites: PPIs found to increase risk of early death, Mini colons in-a-dish could allow personalised drug testing - MIMS General News (Hong Kong)...

Rudrapur, Uttrakhand, India (PRWEB) July 02, 2017

Revita Life Sciences, (http://revitalife.co.in) a biotechnology company focused on translational regenerative therapeutic applications, has announced that it is continuing to advance their novel, multi-modality clinical intervention in the state of brain death in humans.

We have proactively continued to advance our multi-modality protocol, as an extended treatment before extubation, in an attempt to reverse the state of brain death said Mr.Pranjal Agrawal, CEO Revita Life Sciences. This treatment approach has yielded some very encouraging initial outcome signs, ranging from minor observations on blood pressure changes with response to painful stimuli, to eye opening and finger movements, with corresponding transient to permanent reversal changes in EEG patterns.

This first exploratory study, entitled Non-randomized, Open-labelled, Interventional, Single Group, and Proof of Concept Study with Multi-modality Approach in Cases of Brain Death Due to Traumatic Brain Injury Having Diffuse Axonal Injury is ongoing at Anupam Hospital, Rudrapur, Uttrakhand. The intervention primarily involves intrathecal administration of minimal manipulated (processed at point of care) autologous stem cells derived from patients fat and bone marrow twice a week.

This study was inappropriately removed from the Indian Council of Medical Research (ICMR) database. ICMR has no regulatory oversight on such research in India.

The Central Drugs Standard Control Organization (CDSCO), Drug Controller General of India, had no objection to the program progressing. Regulatory approval as needed for new drugs, is currently not required when research is conducted on the recently deceased, although IRB and family consent is definitely required. CDSCO, the regulator of such studies, clearly states that no regulatory requirements are needed for any study with minimal manipulated autologous stem cells in brain death subjects.

Death is defined as the termination of all biological functions that sustain a living organism. Brain death, the complete and irreversible loss of brain function (including involuntary activity necessary to sustain life) as defined in the 1968 report of the Ad Hoc Committee of the Harvard Medical School, is the legal definition of human death in most countries around the world. Either directly through trauma, or indirectly through secondary disease indications, brain death is the final pathological state that over 60 million people globally transfer through each year.

We are in process of publishing our initial retrospective results, as well ongoing early results, in a peer reviewed journal. These initial findings will prove invaluable to the future evolution of the program, as well as in progressing the development multi-modality regenerative therapeutics for the full range of the severe disorders of consciousness, including coma, PVS, the minimally conscious state, and a range of other degenerative CNS conditions in humans, said Dr. Himanshu Bansal, Chief Scientific Officer, Revita Life Sciences and Director of Mother Cell.

With the maturation of the tools of medical science in the 21st century, especially cell therapies and regenerative medicines, tissues once considered irretrievable, may finally be able to be revived or rejuvenated. Hence many scientists believe that brain death, as presently defined, may one day be reversed. While the very long term goal is to find a solution for re-infusing life, the short term purpose of these types of studies is much less dramatic, which is to confirm if the current definition of brain irreversibility still holds true. There have been many anecdotal reports of brain death reversal across the world over the past decades in the scientific literature. Studies of this nature serve to verify and establish this very fact in a scientific and controlled manner. It will also one day give a fair chance to individuals, who are declared brain dead, especially after trauma.

About Revita Life Sciences

Revita Life Sciences is a biotechnology company focused on the development of stem cell therapies and regenerative medicine interventions that target areas of significant unmet medical need. Revita is led by Dr. Himanshu Bansal MD, who has spent over two decades developing novel MRI based classifications of spinal cord injuries as well as comprehensive treatment protocols with autologous tissues including bone marrow stem cells, Dural nerve grafts, nasal olfactory tissues, and omental transposition.

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MOSCOW, June 28. /TASS/ An international research team from Novosibirsk State University (NSU), the Institute of Cytology and Genetics of Siberian Branch of the Russian Academy of Sciences (ICG SB RAS), and the National University of Singapore have identified and analyzed the mechanism enabling plants to adapt to cold temperatures. This breakthrough was announced by NSUs Computational Transcriptomic and Evolutionary Bioinformatics Laboratory (LCTEB).

It turns out that plants sacrifice their newborn cells of the root tip in order to survive cold temperature conditions and retain their own stem cells. The study was published recently in the journal, Cell.

Plants possess stem cells just as animals do, which are the cells located at the tip of roots or sprouts from where any other plant tissues originate. Researchers from Singapore revealed that at a low temperature (+4 C) the DNA in a plants stem cells is damaged which can result in the death of the cells offspring. With that, the death of cells inside the root tip has been shown to help other tissues survive and toughen up the plant in such a way that it becomes more resistant to any other types of stress.

"Only a few stem cell offspring die (during cold spells), and thats despite the fact that the lifespan of these cells are very short even under normal conditions. By contrast, the other tissues remained unscathed," Victoria Mironova, PhD Biologist and Head of the NSUs Computational Transcriptomic and Evolutionary Bioinformatics Laboratory and Chief of the Sector for System Biology of Plant Morphogenesis at the RAS Institute of Cytology and Genetics of Siberian Branch, commented.

Russian scientists addressed the processes occurring at the roots tip using a mathematical approach. The mechanism which decides on what cells will be sacrificed in order to enable a plant to survive, is controlled by the genes responsible for transmitting auxin, the hormone required for the normal growth of roots.

"The modeling proved that under cold temperature conditions, the concentration of this hormone drops which puts the lifespan of a plant in jeopardy. If the cells at the root tip are destroyed, the concentration of auxin is restored providing for the stem cells maintenance, Maria Savina, the leading engineer at LCTEB at NSU and a junior research assistant at ICG SB RAS explained.

According to the scientists, continued research on this topic might be very beneficial for agriculture. Plants and crops could be treated with auxin prior to the onset of any cold spell. This way, it would be possible to avoid the death of cells and help plants overcome severe temperature stress without resorting to any sacrifices. The studys results could be also applied in analyzing mammals mechanisms for adapting to cold temperatures, since the structure of stem cell niches, their functions and sensitivity to stress have many similarities between animals and plants.

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Russian, Singaporean scientists reveal how plants weather cold temperatures - TASS

AsianScientist (Jun. 29, 2017) - Researchers from the National University of Singapore have found that some plants selectively kill parts of their roots to survive in cold conditions. These findings, published in Cell, could pave the way for the development of novel strategies to improve the growth and yield of crops that undergo such environmental stress.

Plants adopt different strategies to survive the changing temperatures of their natural environments. This is most evident in temperate regions where forest trees shed their leaves to conserve energy during the cold season. Studies have shown that temperature can induce damage in the DNA of plant cells and has a profound effect on plant development and growth. However, its effects on plant stem cell behaviour and activity are still not well understood.

In the present study, a team led by Assistant Professor Xu Jian from NUS studied the effect of low temperatures on a small flowering plant called thale cress, known scientifically as Arabidopsis. This plant is a member of the Brassicaceae family, and its relatives include mustard greens, cabbage and kale.

The study of plant roots has been largely neglected by agricultural researchers in crop improvement until recently. Examining roots is important as they serve as the major interface between a plant and its soil environment, and are responsible for water and nutrient uptake; both resources which are critical for a plants survival, said Xu, who is also from the Centre for BioImaging Sciences at NUS.

To investigate the effect of chilling temperature on root development and growth, the team used the Arabidopsis root stem cell niche as an experimental model to perform in-depth studies at high spatial and temporal resolutions. They found that a chilling temperature of four degree Celsius leads to DNA damage in the root stem cells of the Arabidopsis, as well as their early descendants.

However, this DNA damage only caused the newly generated daughter stem cells to die, allowing the plants to maintain a functional stem cell niche. Inhibiting the DNA damage response in these daughter cells prevents their death, but this in turn increased the likelihood that other stem cells in the root stem cell niche would die, ultimately leading to the plants death.

The sacrificial mechanism improves the roots ability to withstand other low temperature-related stresses. When optimal temperatures are restored, the plant stem cells can divide at a faster rate, which will in turn enhance recovery and survival of the plant, said study first author Dr. Hong Jing Han.

Our discovery of how the Arabidopsis plant slays its columella stem cell daughters shed light on the plants unique strategy to survive harsh weather conditions, and demonstrates that the potential of engineering cold tolerance in plants to help them withstand harsh environmental conditions, added Xu.

The ability to do so will certainly allow farmers to extend the growing season of crops and the land area in which to grow them, increasing both yield stability and production capacity.

Xu and his team next plan to uncover the gene regulatory network that has underpinned the successful adaptation of plants and their stem cells to cold environments.

The article can be found at: Hong et al. (2017) A Sacrifice-for-Survival Mechanism Protects Root Stem Cell Niche from Chilling Stress.

Source: National University of Singapore. Disclaimer: This article does not necessarily reflect the views of AsianScientist or its staff.

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June 28, 2017 A model of erythropoetin, a glycoprotein involved in red blood cell production. Glycans are indicated in purple. Credit: Mark Wormald, Oxford Glycobiology Institute

Over two weeks in 2004, Song Zhiwei witnessed the slow death of a colony of cells. Song, a bioengineer at the A*STAR Bioprocessing Technology Institute (BTI), had bathed a plate of Chinese hamster ovary cells (CHO) with lectin, a toxic protein derived from plants. He then observed the millions of cells shrink to a dozen survivors. They looked average, but Song knew they had superpowers. The secret was hidden in the sweetening.

Sugars are essential for life. Among the most important class of sugars are those that are chemically attached to proteins. These glycoproteins are involved in everything from recognizing immune system invaders to lubricating membranes and stimulating the thyroid. They also fuel a booming pharmaceutical industrymany household drugs contain glycoproteins, and biotech companies invest significant resources in optimizing the sugaring of these proteins to improve their bioactivity and therapeutic potency.

Lectin is known to bind to sugars dangling on the ends of glycoproteins. In Song's experiment, only mutant CHO cells that did not produce those binding sugars could survive the lectin treatment. This approach of 'seeing what sticks' is an established method of identifying mutants that can subsequently be mass-produced by the biotech industry.

Song spent the next two years conducting cell culture experiments, molecular biology studies and genetic tests to prove that the cells were actually mutants. Determining the exact structure of the mutant glycoproteins required help from his colleague Lee May May, who headed the analytics group at BTI. May used mass spectrometry tools to determine the exact biochemical structure of the proteins produced by Song's mutant cells, revealing that they lacked key sugars. Song had created the first sugar-mutant cell lines applicable to biotech manufacturing.

The collaboration has since expanded into a globally renowned partnership between bioengineers and bioanalysts at A*STAR, advancing understanding of the role of sugars in disease.

Sweet talk

Sugars are the smallest and simplest form of carbohydrate, made of single or connected molecular units of carbon, hydrogen and oxygen. Our blood contains hundreds of types of sugars: some floating freely, but many more attached to proteins like decorations on a Christmas tree. Almost 70 per cent of the proteins in our body are glycosylated, which means that they won't function without their sugary accoutrement. The specific arrangement of sugars, or glycans, on a glycoprotein determines how a protein folds and interacts with other molecules, alters its solubility and sometimes even the messages it transmits to cells. "The cell expends an enormous amount of energy to put sugars on proteins," says Pauline Rudd, a veteran in the field of glycobiology, who joined the BTI analytics team in 2015. "If you didn't have sugars, you wouldn't survive."

Researchers first discovered the critical role of glycoproteins in the early 1900s. An Austrian physician, Karl Landsteiner, noticed that human blood mixed with the blood of animals, or even other humans, forms clumps. These clumps can clog vessels or crack open to release toxic proteins into the body. However, Landsteiner noticed that some blends did not coagulate. This discovery led him to the blood-group classification still used todayA, B, AB and Oand won him the Nobel Prize in Physiology or Medicine in 1930. In the 1950s researchers determined that the sugars exposed on the surface of red blood cells determined which blood group they belonged to.

The blood work encouraged research into glycoproteins. By the 1990s, biologists were caught up in the genetics craze. The cure for everything, they posited, was hidden in our DNA. "Genes were claimed to be the cause of everything," says Rudd, who saw funding for glycobiology wane. Between 1998 and 2000, $3.5 billion was spent globally on genomics research, including the initiative to sequence the entire human genome. "There was a lot of information but it didn't give us a direct route to understanding disease," says Rudd. "People began to suggest that maybe genes don't do anything except code for proteins."

Scientists shifted their attention to the many other stages of biological activity until they arrived again at sugars.

"DNA is the first layer of information. This information is transcribed into RNA, which sends a message that is translated into a protein with a function," says Song. "Carbohydrates, or sugars, are the last layer of biological information."

Knowing the importance of sugars didn't make them any easier to study. DNA and proteins are essentially linear structures that "curl up into fancy shapes," says Rudd. Sugars branch out into multiple chains. "They are like big trees hanging off the sides of proteins." It would take several years before sugars could be analyzed with the precision and speed of genes and proteins.

Shake up

In 1989 an earthquake hit California. Rudd remembers it well. She was deep into a collaboration between the Oxford Glycobiology Institute (led by Director Raymond Dwek) and a research team in London, looking for changes in the way proteins are glycosylated in patients with autoimmune diseases. She was analyzing 600 samples of the immunoglobulin G (IgG) protein, using a special gel to filter the sugars. The factory that produced this gel was destroyed by the earthquake.

When the factory was rebuilt, its gel was not the same. "It was completely useless," remembers Rudd. "I was tearing my hair out trying to get these 600 samples analyzed."

Necessity breeds invention, so Rudd looked around and noticed the liquid chromatography (LC) columns she had been using to sort proteins. She stuck a syringe filled with a mixture of sugars released from her glycoprotein samples into the columns. The LC device filtered the sugars to a much higher resolution than the gel process. "We never went back," she says.

Since then, Rudd has collaborated with private and institutional partners to speed up, automate and improve the specificity of techniques for sorting and characterizing sugars from a sample. What used to take a year can now be done in a day.The workflow, bioinformatics and databases developed by Rudd's team at the National Institute for Bioprocessing Research and Training (Dublin, Ireland) have been incorporated into Waters Corporation's UNIFI analytical coupled liquid chromatography/mass spectrometry platform, which means that much of the complexity of glycoanalysis is now automated. Hence, glycoanalysis has entered a new era of glycomics, bringing it closer to the big-data universe of genetics, transcriptomics and proteomics.

"We can now look at large cohorts of samples to understand more about diseases and to support biologic development and production," says Terry Nguyen-Khuong, who heads the analytics group at BTI. Since teaming up with Rudd, A*STAR has expanded its analytics portfolio to zoom in on sugars and identify their exact location, basic building blocks and linking structures.

Pharming glycoproteins

Glycoproteins fuel a US$163 billion biopharma industry of drugs whose efficacy can be dictated by sugars. For example, when the hormone erythropoietin is adorned with sialic acid sugars, it is ten times more effective at stimulating red blood cell production in anemic patients than the hormone alone.

In the glycoprotein business, CHO cells comprise the entire workforce. They can produce any proteins the biotech industry demands, and can sugar-coat the proteins in the same way humans do.

Before Song created his first CHO-cell mutants, no-one had been able to control the glycosylation of proteins in mass-producible cell lines. Pamela Stanley's group in the United States had been tweaking the glycosylation of CHO cells for years using cell lines that lived and died on a flat petri dish, fed on protein-rich cow's blood. Song instead developed mutants using cells that he knew could replicate indefinitely while swirling in spherical 20,000-liter bioreactors used in biopharma factoriesfree of bovine additives.

He named the cell line CHO-glycosylation mutant 1 (GMT-1), and since then, more than twenty successors have followed in numerical order. When tools emerged that made editing genes as simple as cutting and pasting words on a computer screen, he used them to generate more mutants.

In GMT-3, he deleted a gene required to fix fucose sugars to proteins. GMT-9 glycoproteins lack the sugars fucose and galactose; and GMT-17 lacks fucose, galactose and sialic acid. The absence of these sugars can dictate the potency of drugs. Song's cells produce antibodies that are up to a hundred times better at killing cancer cells than their equivalent drugs in the market, such as rituximab (branded Rituxan) to treat leukemia. "The cell lines are comparable to industrial lines and are ready for commercialization," says Song, who has been managing a S$11 million glycomics grant called GlycoSing since 2014. Treatments with these improved antibodies would mean significantly reduced doses.

In 2008, Andre Choo, a researcher at BTI, developed the first antibodies that could specifically kill embryonic stem cells, alleviating concerns about the cells forming tumors in transplant patients. The antibodies have since been licensed to several companies.

Many diseases have a distinct sugar profile, a concept that Choo has begun to exploit for cancer therapeutics. He screens for antibodies that specifically target aberrant sugar molecules on the surface of cancer cells, working with Rudd and Nguyen-Khuong's team to analyze them.

Recently this year, his team generated an antibody that recognizes sugars expressed on ovarian cancer cells. "In the past we would generate an antibody without really knowing what it targeted, we are now focused on trying to get these anti-glycan antibodies."

At A*STAR, research has expanded into dengue, the Zika virus and heart disease. "All major areas in medicinecancer, infectious disease and inflammatory problemsare related to glycoproteins," says Song, whose mutants could potentially cure these diseases.

Explore further: Research on active substances in breast milk can begin

Hundreds of unique sugars comprise the difference between cow's milk and human breast milk. Some of these sugars are already known to contribute to the baby's immune system, but until recently, more detailed research into ...

A Purdue University biochemist has developed a novel method for detecting certain types of proteins that serve as indicators for cancer and other diseases.

(Phys.org)A Simon Fraser University chemist is the lead author on a new paper that advances scientific understanding of the structure and function of glycoproteins, in particular the number and positioning of sugars on ...

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The body relies on thousands of sugarprotein complexes to stay healthy - Phys.Org

Emma Hodson

Neurosurgeon Harry Bulstrode at the University of Cambridge, UK, is eager to research new treatments for glioblastoma, an aggressive yet common type of brain tumour. In May, he won a 200,000 (US$255,000) Cancer Research UK Pioneer Award to investigate whether the Zika virus, which has been linked to thousands of cases of microencephaly in newborns, offers a promising treatment pathway.

What attracted you to glioblastomas?

They are the most aggressive of primary brain tumours. Fewer than 5% of the 2,300 people diagnosed in England each year survive for 5 or more years. These tumours have rather unusual biology. They are mainly creatures of brain tissue; they don't usually spread throughout the body. All through my PhD programme, a recurring theme was the parallels between how glioma stem cells drive tumour development and how neural stem cells grow in fetuses. As a rule, adult brain cells don't display this rapid growth pattern. Glioblastoma tumours are the exception. My PhD work left one question unanswered how to specifically target these tumour-causing cells.

How did you get the idea to test Zika as a possible brain-tumour treatment?

As soon as published papers confirmed that Zika caused specific damage to the developing brain while generally sparing mature cells, a light bulb went on for me. If the cancer cells resemble those in the developing brain, maybe Zika could attack them, too? If Zika could cross the bloodbrain barrier and target glioma stem cells while passing by normal adult brain cells two formidable hurdles for existing treatments it could open up a way to use Zika to attack the tumour.

Did you seek advice from colleagues?

Yes. I dropped the idea into an e-mail to my PhD adviser, Steven Pollard. He said that it was an interesting idea, and reassured me that I wasn't crazy. Other mentors linked me up to a facility working with Zika and put me onto the Pioneer Award idea.

Are there concerns about your Zika research?

Pollard pointed out that any clinical trial could struggle to secure ethics approval to deliberately infect people with Zika. But I thought, why not explore the idea? Three million people have had this infection in the Americas. And adults who contracted it have almost universally made excellent recoveries or did not even notice the infection. I don't think it's a crazy idea to one day be able to offer the Zika virus or a modified version of it in a clinical trial to a person facing the prospect of death by brain tumour. But even before that step, this research offers interesting prospects for learning from Zika how to design potential therapies. A group at Cambridge recently published a study highlighting how Zika binds to a protein produced by neural stem cells, which simultaneously increases the viral turnover that leads to their destruction (P. L. Chavali et al. Science http://dx.doi.org/10.1126/science.aam9243; 2017).

How would you describe the risk level for this project?

The Pioneer Award is for high-risk projects. That said, I think this is quite a safe bet. The techniques are not revolutionary: cell cultures of tumour lines and neural stem cells are well established. The mouse models might be difficult to get right. Mice don't get Zika, so we'll need to work on how to give brain tumours and Zika to immune-compromised mice. If we can use Zika to show that tumours in the mice are smaller or ablated, that would be a huge result.

How might this project impact your career?

As an MD-PhD, my hope is to offer people with tumours the option of being involved in clinical trials. I think this project should help set me up well for that.

This interview has been edited for length and clarity.

Continued here:
Turning point: Tumour tactician - Nature.com

Richard Sennott - Star Tribune file During a family portrait in 2000, Molly Nash gives her 4-week-old brother Adam a kiss. Molly Nash received some umbilical blood from her brother, saving her from a fatal genetic disease.

Adam Nash was dubbed Little Frankenstein by the New York Post in 2000 because he was conceived via in vitro fertilization specifically so doctors at the University of Minnesota could collect stem cells from his umbilical cord blood to save his sister, Molly.

Today, back home in Colorado, Adam has a drivers license and helps disabled children ski. His sister once weeks from death due to a condition called Fanconi anemia is debating whether to focus on oceanography or graphic design in college. And IVF to produce an ideal child for a siblings stem cell transplant is common, albeit with lingering ethics concerns.

A squirrelly trio of teens is vindication for Adams mother, Lisa Nash, who felt the weight of the ethical questions when the Us Dr. John Wagner suggested IVF in 1995.

Follow this link:
'Little Frankenstein' is now a happy teenager - Minneapolis Star Tribune

June 23, 2017 Assistant Professor Xu Jian (right) and Dr Hong Jing Han (left), together with their research team at the National University of Singapore, found that the Arabidopsis (in photo) may selectively kill part of their roots to survive under cold weather conditions. Credit: National University of Singapore

Plants adopt different strategies to survive the changing temperatures of their natural environments. This is most evident in temperate regions where forest trees shed their leaves to conserve energy during the cold season. In a new study, a team of plant biologists from the National University of Singapore (NUS) found that some plants may selectively kill part of their roots to survive under cold weather conditions.

This approach allows the plants to withstand chilling stress and to recover faster when the weather turns better. The discovery and understanding of this survival approach could pave the way for the development of novel strategies to improve the growth and yield of crops that undergo such environmental stress.

The study, led by Assistant Professor Xu Jian from the Department of Biological Sciences at the NUS Faculty of Science, was carried out using a small flowering plant called thale cress, known scientifically as Arabidopsis. This plant is a member of the Brassicaceae family, and its relatives include mustard greens, cabbage and kale.

The research was carried out in collaboration with scientists from the Novosibirsk State University, and the findings were reported in the online edition of the journal Cell on 22 June 2017.

Sacrificial mechanism of plants

Studies have shown that temperature can induce damage in the deoxyribonucleic acid (DNA) of plant cells, and has a profound effect on plant development and growth. However, its effects on plant stem cell behaviour and activity are still not well understood.

"The study of plant roots has been largely neglected by agricultural researchers in crop improvement until recently. Examining roots is important as they serve as the major interface between a plant and its soil environment, and are responsible for water and nutrient uptake - both resources which are critical for a plant's survival," said Asst Prof Xu, who is also from the Centre for BioImaging Sciences at NUS.

The research team conducted experiments on the roots of Arabidopsis, a plant often used as a "model organism" in plant biology and had its genome fully sequenced in 2000. To investigate the effect of chilling temperature on root development and growth, the team used the Arabidopsis root stem cell niche as an experimental model to perform in-depth studies at high spatial and temporal resolutions. The use of such experimental models provides deep insights on the survival strategies that plants employ when the odds are against them.

The research team found that a chilling temperature of four degree Celsius leads to DNA damage in the root stem cells of the Arabidopsis, as well as their early descendants. However, only the columella stem cell daughters die preferentially, and the death of these daughter cells allows maintenance of a functional stem cell niche. On the other hand, inhibition of the DNA damage response in these daughter cells prevents their death. Yet, this increases the probability that the other stem cells in the root stem cell niche will die due to the cold, leading to the plant's death.

Dr Hong Jing Han, who is the first author of the study, elaborated, "The sacrificial mechanism improves the root's ability to withstand other low temperature-related stresses. When optimal temperatures are restored, the plant stem cells can divide at a faster rate, which will in turn enhance recovery and survival of the plant." Dr Hong carried out the research as part of her doctoral thesis under the supervision of Asst Prof Xu.

Engineering cold tolerance in plants

"Our discovery of how the Arabidopsis plant slays its columella stem cell daughters shed light on the plant's unique strategy to survive harsh weather conditions, and demonstrates that the potential of engineering cold tolerance in plants to help them withstand harsh environmental conditions. The ability to do so will certainly allow farmers to extend the growing season of crops and the land area in which to grow them, increasing both yield stability and production capacity," said Asst Prof Xu.

The next step for Asst Prof Xu and his team would be to uncover the gene regulatory network that has underpinned the successful adaptation of plants and their stem cells to cold environments.

Explore further: The origin of stem cells

More information: Jing Han Hong et al. A Sacrifice-for-Survival Mechanism Protects Root Stem Cell Niche from Chilling Stress, Cell (2017). DOI: 10.1016/j.cell.2017.06.002

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Excerpt from:
Plants sacrifice 'daughters' to survive chilly weather - Phys.Org

Like a plate of poisoned cookies from Grandma, cancer could be coming from an unlikely place. Increasingly, some research is pointing to stem cells, usually thought of as a promising disease cure-all.

The term "stem cells" covers any cells capable of perpetually growing more of themselves. Most often, people refer to pluripotent, or embryonic, stem cells, which have the ability to become any cell in the body. But there are also adult stem cells, which are more limited in the cells they can create.

Now, according to some researchers, there are also tumor stem cells.

"They aren't the same thing as regular stem cells," said Dr. Allan Mufson, chief of Cancer Immunology/Hematology Branch Division of Cancer Biology at the National Cancer Institute. "But there seems to be a small population of cells within tumors that are responsible for keeping the tumor going. They're the only cells that can give rise to new tumors."

According to the tumor stem cell theory, the problem with common cancer treatments (chemotherapy and radiation) is that they focus on the whole tumor, when it's only the rare tumor stem cells that really matter. Doctors tend to use large doses of potentially deadly medications that weaken patients and aren't specifically aimed at killing tumor stem cells, increasing the risk that they'll be missed and the cancer will grow back.

This new theory of cancer is being studied, but questions still remain. One of the big ones: Where do tumor stem cells come from? Dr. John Kersey, a researcher at the University of Minnesota's Masonic Cancer Center, thinks he's found an answer: Tumor stem cells may be damaged versions of normal, potentially life-saving adult stem cells.

Adult stem cells come in two flavors: The highly specialized progenitor stem cells and an immature variety that are more flexible. For instance, a progenitor cell might only be able to grow white blood cells, while the immature adult stem cell could grow several different cells in the circulatory system. Researchers are still debating which type becomes a tumor stem cell, but Kersey's findings, detailed in the May issue of the journal Cancer Cell, suggest it is the immature adult stem cells, at least for certain types of leukemia.

To figure that out, Kersey and his team grew mice whose adult stem cells, both progenitor and immature, contained a gene that causes leukemia. Both types were then separated out and injected into healthy mice. The mice who got progenitor cells didn't get leukemia. The ones who got the immature adult stem cells did.

While this doesn't completely prove stem cells are the culprit behind leukemia, it does go a long way towards showing that low doses of cancer genes can transform a stem cell from something that creates life to something that takes it, Mufson said. Cancer researchers say that figuring out where tumor stem cells come from is the first step in turning them back into useful tools for health. If damaged stem cells really are the building blocks behind tumors, doctors might be able to figure out a way to target those cells, or even just a part of them, leading to safer and more effective cancer treatments.

"This is exciting stuff," Kersey said. "Understanding this will be essential to developing specific treatments for specific cancers, based on the part of the cancer that's actually growing."

Read more:
Stem Cells Might Cause Cancer - livescience.com

For two years, Alyssa Hillpot didn't know the name of the man who saved her life.

His blood-forming cells work in her body, taking the place of the unhealthy cells that kept her in and out of the hospital during the prime of her life.

"We're bonded by that," she said.

She wrote him a letter through her doctor, but privacy rules prevented them from learning each others' name, email or phone number.

A year later, he wrote back. And last summer, the two agreed to share personal information and talked online through Skype.

She learned her stem cell donor, Stephan Mages, is a German medical student and aspiring neurologist who has traveled around the world. He learned she almost died from pneumonia and fought non-Hodgkin lymphoma, a blood cancer, multiple times.

Now, at 26, Hillpot, of Phillipsburg, N.J., has been cancer-free for about two years and wants to help other blood cancer patients find the person who can help them recover. The young cancer survivor will be leading the inaugural Leukemia & Lymphoma Society 5K Run/ Walk Saturday at Notre Dame High School in Bethlehem Township, an event organized by her doctor at St. Luke's Hospital-Warren Campus.

Leukemia, lymphoma and myeloma are expected to make up a tenth of the cancers diagnosed in the country this year, according to the Leukemia & Lymphoma Society. Money raised at Saturday's event will go to the organization, which funds research and treatment.

Dr. Eugene Decker, Hillpot's primary care doctor, said 148 people were signed up by Tuesday night. He expects that number to grow. Those attending the event also can join a bone marrow donors' registry by giving a sample of their DNA through a cheek swab.

Decker, a lifelong runner and an assistant cross-country coach at Notre Dame, got the idea from runners he met at a half-marathon at Walt Disney World in Florida. The race, benefiting the Leukemia & Lymphoma Society , draws tens of thousands of people. And when stormy weather prompted organizers to cancel the race earlier this year, he felt a stronger resolve to organize his own race, he said.

"We had to complete what we started," he said.

He's inspired by Hillpot, he said, because she beat back death multiple times.

"Never give up. Always be a fighter. That's a story I can tell over and over again," he said.

In his three-decade career in medicine, Decker has had to tell dozens of patients they have blood cancer. About a quarter of them died, he said. In the hopes of helping more people survive, Decker is using the run to raise awareness of bone marrow donation, a process that he said has become less invasive. He hopes the race will continue annually.

After graduating college, Hillpot found out she had cancer two months into her job teaching preschool. Instead of working her way up in education, she was stuck in cancer treatment and watched her friends build careers, fall in love, get married and have kids.

But now she feels she can start her life.

She's looking for a job in sales, human resources or customer service. She wants to teach, but her doctors warned her against working with young children, considering her fragile immune system.

After fighting cancer, a career change isn't a big deal to Hillpot. She's optimistic about her future.

Her birthday is Jan. 23. But she celebrates another date too: April 25, 2014, the day she got the transplant.

"That's my rebirth," she said.

Bhuang@mcall.com

Twitter @Bhuang2012

610-820-6745

What: Leukemia & Lymphoma Society 5K Run/Walk and one-mile children's walk

When: 9:30 a.m., Saturday.

Where: Notre Dame High School of Green Pond, 3417 Church Road, Bethlehem Township.

What else: Be The Match will be doing on-site testing to find donor matches.

Register online: pretzelcitysports.com, click on calendar

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Cancer survivor to lead inaugural Leukemia & Lymphoma Society 5K Run - Allentown Morning Call

Two Hong Kong beauty salon doctors and a technician involved in the death of a woman in 2012 used an unproven and wholly unnecessary cancer therapy learned in mainland China on healthy customers that hospitals in the city would not even deploy for the sick, prosecutors alleged at their trial on Tuesday.

The expensive treatment offered by DR Group which involves blood being taken, processed and reintroduced into a patients body resulted in the death of Chan Yuen-lam, 46, after her blood sample became infected by bacteria, the prosecutors told a jury at the High Court.

The procedure had been learned from a mainland Chinese hospital just months before it was administered to the women, the court heard.

Police raid Hong Kong salon offering bogus medical treatments

Another patient, Wong Ching-bor, was forced to have two legs and four fingers amputated following the treatment, while a third customer, Wong Fung-kwan, recovered but was permanently injured. All three received the treatment on the same day, prosecutor Raymond Leung Wai-man SC said.

Dr Stephen Chow Heung-wing, head of DR Group, Dr Mak Wan-ling, and Chan Kwun-chung each deny one count of manslaughter due to gross negligence.

Summarising the case for the nine jurors six men and three women Leung said unproven and wholly unnecessary medical treatment was provided, arranged and applied by one or more of the defendants, who were motivated by monetary and personal gain.

He said the incident began after the three women paid about HK$59,500 for each infusion and had blood drawn on September 12, 2012, at a DR Group clinic in Causeway Bay.

The samples were then processed by Asia-Pacific Stem Cell Science at Hong Kong Science and Technology Park for a treatment involving cytokine-induced killer cells. Chow owned the laboratory, while Chan Kwun-chung worked there as a technician.

The prosecutor alleged the trio went to Guangzhou Military Commands general hospital on the mainland, which boasted an exaggerated success rate in treating cancer patients. The two-day visit in February 2012, he added, was meant to learn about the procedure.

Leung alleged that a company circular showed that, within days of their return to Hong Kong, it was already announced internally that staff would begin offering the procedure.

Chan Kwun-chung, holder of a biomedical degree from the Chinese University of Hong Kong, as well as another staff member were each sent back to the hospital to learn about the procedure later that February. This happened, the prosecutor argued, despite the fact that such a procedure was typically performed by a haematologist and required three years of training.

Risky medical treatments in the private market face review

Leung said the two practiced on two staff members in March 2012 and claimed they gave favourable feedback. But he described the process as anecdotal, biased, and unscientific.

It would be naive for [Chow] to think that such testing was effective and a sufficient basis to launch such products, he added.

Leung explained the theory behind the procedure was that it could improve ones immune system. But he added the theory was unproven.

He questioned why the procedure would be marketed, promoted and applied to three healthy women when hospitals in the city had refrained from providing the treatment even to cancer patients.

In Hong Kong we do not provide CIK treatment because we have better alternatives, he said. It should only be done, if at all, in a supervised hospital setting where all the support is there and preparation of the blood cells is supervised by a haematologist.

Weeks later, the blood samples were sent to the clinic, where on October 3 they were reintroduced into the patients bloodstream by Mak.

As a result of the infusion, one died, one ended up having two limbs and four fingers amputated, and one recovered but with permanent injuries to her limbs, Leung said.

He said the three women experienced a range of symptoms including dizziness, shivering, chest discomfort, numb limbs, and septic shock within 24 hours of the infusion, and were admitted to Ruttonjee Hospital and United Christian Hospital.

Lines blurred between beauty services and medical procedures

Chan died on October 10, 2012, after multiple organ failure.

Leung cited blood poisoning as the cause. The blood they were infused with was contaminated with mycobacterium abscessus, he said.

He added that Chows sister, who had cancer, went through the same procedure and ended up suffering from the same kind of bacterial infection.

Infusing blood products is a medical procedure if it isnt done properly it carries legal consequences

Raymond Leung Wai-man SC, prosecutor

The prosecutor said Mak, who administered the infusion, had been acutely aware of the bacterial infection, having previously prescribed antibiotics to the two Wong women shortly after the infusions when each complained of discomfort.

What appeared to be a medical blunder normally warranting a civil claim had ended up in a criminal court because the defendants breach of their duty of care and disregard were so blatantly wrong that they amounted to a crime of the state, Leung told the court.

He urged the jury not to be fooled by phrases and labels that might be adopted during the trial by the defence, such as referring to the women as customers instead of patients.

That does not detract from the fact that infusing blood products is a medical procedure therefore if it isnt done properly it carries legal consequences, he said.

The trial continues before Mrs Justice Judianna Barnes Wai-ling on Wednesday.

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Healthy woman died due to 'unproven and wholly unnecessary' cancer treatment from private clinic, court hears - South China Morning Post

Controversial research and trials aim to reverse clinical brain death and bring people back from irreversible coma.

Philadelphia-based biotech company Bioquark is preparing to run trials in Latin America of a controversial new treatment to restore brain function in people with brain damage.

The procedure consists of several different parts. One of which uses a patients own stem cells to regrow dead brain tissue. The procedure also includes a peptide injection into the spine, laser therapy on the brain, and nerve stimulation.

The first thing we are really looking at is how do we make that new tissue, along the lines of how it is done in nature, Ira Pastor, CEO of Bioquark, told Healthline.

Doctors and staff measure the brain activity and physical signs of the patient to establish whether or not there has been an improvement.

While the research has often been labeled as an attempt to raise the dead, Pastor said that there are actually significant limitations to the scope of what they are trying to accomplish.

We are only focusing on what we refer to as the gray zone that exists between [a] deep coma and so-called irreversible coma, which is the definition of brain death, and transitioning the subject back through that area, said Pastor.

Measure of an individuals state of coma or unconsciousness typically utilizes the Glasgow Coma Scale, an indicator of the severity based on verbal and physiological responses.

Bioquarks aim is essentially to be able to take individuals from a state of irreversible coma to, potentially, one in which they are showing higher brain functioning and physiological response.

He said that the treatment is not intended for individuals with catastrophic injuries, or those with chronic diseases, such as metastatic cancer.

Brain death is a relatively new concept in medicine and law, and still varies largely from one country to the next. Unlike clinical death, as defined by the stopping of certain biological functions such as breathing and heart rate brain death is a state in which an individual may still be physically alive but with little or no cognitive ability.

The concept of brain death is attributed to a 1968 paper from Harvard University that sought to define irreversible coma as a new criterion for death. Since then, legislation such as the Uniform Determination of Death Act, has sought to create a unified framework for how death is diagnosed, including brain death.

The implications of Bioquarks research potentially altering or muddying an already complex definition of death are profound. This study deepens the ambiguity of the validity of the definition of death, Kerry Bowman, PhD, a bioethicist at the University of Toronto, told Healthline.

Read more: Using stem cells to heal broken bones

The procedure has also proved wildly controversial for ethical and medical reasons.

Firstly, the research falls under the classification of living cadaver research, which Pastor describes as, The ability to use a recently deceased individual who is still on life support for medical research purposes.

Pastor argued previously that living cadaver research has been carried out ethically for a variety of reasons in the Unites States. Nonetheless, it remains a sensitive subject.

There are those in the medical community who criticize Bioquark because there simply isnt any medical research to support its work. One meta study published in the journal Neurology in 2010, concluded that from 1995 onward, There are no published reports of recovery of neurologic function after a diagnosis of brain death.

Pastor contests this, citing sporadic cases challenging that conclusion.

Read more: Stem cell therapy offers hop for MS remission

Bowman said the two major concerns surrounding Bioquarks work are family grief and patient consent.

In the first case, he said, the procedure could create a situation where [the family] believes that their brain-dead or close to brain-dead loved one has a chance for survival, and that the medical establishments are blocking them from pursuing that chance.

I think that really could be very difficult in terms of complicating grief.

The second issue, consent, is even more contentious. Who signs off on the procedure if the patient doesnt have the capacity to say Yes or No?

Clearly this is a case where the subject cannot consent, said Pastor. The informed consent documents that we have put together are really family centric.

There is a line of reasons why a family might want to come down this path, but ultimately its their decision.

Others disagree that consent in this situation is as clear as Pastor makes it.

Bowman said that the potential risk of such a procedure is so high that the consent must come directly from the patient.

The ranges of outcomes I see physical impairment and neurological impairment as almost a certainty even if there is success that I just dont think you could have a substituted consent.

Some have suggested that consent could be coerced under the proposition of bringing back a loved one.

Pastor, however, is confident in Bioquarks proceedings.

Of the multitude of different types of bioethical arguments or questions we get, I think were comfortable with that family-centric, informed consent approach, he said.

Whether or not Bioquark ultimately succeeds, their upcoming trials will undoubtedly have a profound impact on the concept of death.

Bowman, while skeptical of Bioquarks research from a medical perspective, is open to challenging the established notion of brain death.

There are places in the world that are much more hesitant about accepting brain death as truly death, he said. We constructed this as a definition of death, but we can also deconstruct a definition that we created ourselves.

As to the claim that Pastor and Bioquark are offering false hope to those that are already vulnerable and suffering, he remains defiant.

Exploratory research programs of this nature are not false hope. They are a glimmer of hope.

Read more: Stem cell research advancing rapidly

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Are Stem Cells the Answer to Bringing People Back from the Dead? - Healthline

Breanna and Jason Deschaine are doing their best to keep smiling during a difficult time in their lives.

That's what their son Dawson would have wanted, they said.

Dawson died Saturday after two years of battling leukemia, a cancer that causes the body to produce too many immature white blood cells. He was eight years old.

"He always had a smile on his face," said his mom, Breanna. "It was the most infectious smile. So we're just smiling now, because that's all Dawson would want."

But he fought a hard battle for years. I was talking to his doctor today, and she told me she could always tell his tenacity and his drive to live every single day was just amazing.

Breanna Deschaine

Dawson became an honorary Nevada County firefighter last year during "Dawson's Day," a celebration of the bravery and courage he showed throughout his fight with leukemia.

Dawson rode around the county on a fire truck, and Grass Valley Fire Chief Mark Buttron honored him with a badge-pinning ceremony.

"We wanted to do something to show we appreciated how courageous he was," said Shawna Cresswell, Nevada County Consolidated Fire District's finance administrative assistant.

The Deschaine family helped Dawson experience a variety of exciting adventures in an effort to brighten his life. He'd spent countless hours in hospital beds since he was diagnosed with cancer at the age of five.

"He was always ready for whatever adventure we came up with," Breanna said. "He may have thought they were crazy afterward, but he was always super excited to go out and live his life to the fullest."

The Deschaines took Dawson white-water rafting, horseback riding, go-kart racing and mini golfing, among other adventures. It had been Dawson's dream to go to Hawaii, and the family is still planning to make that happen. Eventually, Breanna said, they will bring his ashes out with them on a family trip to the islands.

'Incredible' community support

Kelsey Anderson, a close friend of the Deschaine family, said she has been blown away by the amount of support the community has shown to Dawson, his parents and his 12-year-old sister Harlie.

"The support has been incredible," Anderson said. "Through the pain, the love shines through."

Anderson helped organize a variety of community events to raise money for the Deschaine family to pay for Dawson's many treatments.

During his fight with cancer, Dawson received chemotherapy treatments, radiation, and two stem cell transplants. He'd recently started a new drug trial that was said to be a possible cure for leukemia.

The family tried everything to help Dawson fight off his illness. But, according to Breanna, there isn't enough funding for childhood cancer treatments.

"Only 4 percent of cancer funding goes to childhood cancer," she said. "That's not enough for these kids that go through hell for years and years."

Support for those still fighting

The Deschaines have become close friends with other families who have children battling cancer. Breanna wants to help those kids who are still fighting. She said it's her mission to push for more research into childhood cancer treatments.

Breanna said she's not sure exactly what ended Dawson's battle with leukemia.

"His little heart and his little lungs just couldn't take it anymore," she said.

But as far as she's concerned, Dawson has won the fight. He's in a better place.

"We'd like to have him here. Trust me," she said. "But he fought a hard battle for years. I was talking to his doctor today, and she told me she could always tell his tenacity and his drive to live every single day was just amazing."

The Deschaine family will host a memorial service for Dawson at 4 p.m. July 2 at Western Gateway Park. Breanna said the ceremony will be open to anyone wishing to be a part of celebrating Dawson's life.

To contact Staff Writer Matthew Pera, email mpera@theunion.com or call 530-477-4231.

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'The most infectious smile': Nevada County mourns the death of 8-year-old Dawson Deschaine - The Union of Grass Valley

Texas Governor Greg Abbott just signed a law making it easier for unproven stem cell therapies to be given to patients in his state.

Marjorie Kamys Cotera/Bob Daemmrich Photography/Alamy Stock Photo

By Kelly ServickJun. 15, 2017 , 11:15 AM

Texas Governor Greg Abbott yesterday signed a bill allowing clinics and companies in the state to offer people unproven stem cell interventions without the testing and approval required under federal law. Like the right to try laws that have sprung up in more than 30 states, the measure is meant to give desperately ill patients access to experimental treatments without oversight from the U.S. Food and Drug Administration (FDA).

In a state where unproven stem cell therapies are already offered widely with little legal backlash, bioethicists and patient advocates wonder whether the states official blessing will maintain the status quo, tighten certain protections for patients, or simply embolden clinics already profiting from potentially risky therapies.

You could make the argument thatif [the new law] was vigorously enforcedits going to put some constraints in place, says Leigh Turner, a bioethicist at the University of Minnesota in Minneapolis, who last year co-authored a study documenting U.S. stem cell clinics marketing directly to consumers online, 71 of which were based in Texas. But it would really be surprising if anybody in Texas is going to wander around the state making sure that businesses are complying with these standards, he adds. Either way, Turner says theres powerful symbolic value in setting up this conflict between state law and federal law.

The law, effective 1 September, will allow people with severe chronic or terminal illness to be treated at a clinic that purports to isolate therapeutic stem cells from adult tissuesuch as a patients own fatif their doctor recommends it after considering all other options, and if its administered by a physician at a hospital or medical school with oversight from an institutional review board (IRB). It also requires that the same intervention already be tested on humans in a clinical trial. The law sanctions a much broader set of therapies than federal rules, which already exempt certain stem cell interventions from FDAs lengthy approval process, provided the cells are only minimally manipulated and perform the same function they normally have in body.

The Texas bills clinical trial and IRB requirements seem to weed out some dubious therapies, but the language is too nebulous to protect patients, says Beth Roxland, a bioethicist at New York Universitys Langone Medical Center in New York City. The bill doesnt specify that a trial be conducted in the United States or that the therapy get clearance from FDA for human testing. You could gain access to something [as long as its] being studied in a human somewhere on the planet, she says, which in the stem cell area makes it really very scary.

Awareness about the risks of unproven stem cell therapies is growing. A case report published in The New England Journal of Medicine earlier this year documented three women who lost their vision after receiving purported stem cell injections meant to treat age-related degeneration of the retina. Such risks are also the subject of a news conference today at the annual meeting of the International Society for Stem Cell Research in Boston.

Roxland is also unnerved by a provision in the Texas law that would prevent any state government entity from interfering with a patients access to treatment. Hypothetically, if a state officially gets wind of nefarious doings at a for-profit clinic the state officials are now restrained from doing anything. She notes that that language mirrors a proposal in a federal bill known as the Trickett Wendler Right to Try Act, introduced in the Senate in January, which would prevent the federal government from interfering with a terminally ill patients access to an experimental drug outside of a clinical trial, and would prevent FDA from considering those patients outcomes in its drug approval decisions. Vice President Mike Pence signaled his support for the law in February and met with the family of Trickett Wendler, who advocated for right to try laws before her death from amyotrophic lateral sclerosis in 2015.

Others also believe that the Texas laws approval might signal a coming thaw in federal regulation of stem cell clinics. The FDA obviously doesnt have the manpower to watch over these people, says David Bales, chairman of the advocacy group Texans for Cures in Austin, which pushed for more patient protections in the new bill. We really feel like theyre trying to open up the floodgates.

Read the original here:
Texas has sanctioned unapproved stem cell therapies. Will it change anything? - Science Magazine

El Grecos Resurrection

A rabbi has issued a warning after concluding that raising the dead is clearly possible.

Its not for man to do.

The comments come from Rabbi Moshe Avraham Halperin and were reported by Breaking Israel News.

If they are able to revive a person from total brain death, it will be considered techiyat hamaytim [resurrection], he told BIN. Torah laws puts limits on man, forbidding him from some areas which are strictly divine. Reviving the dead is one of them.

Further, another rabbi said such experiments never will succeed.

The Rambam states that we must believe that the resurrection of the dead will happen when it is Gods will for it to take place and at no other time, Rabbi Yosef Berger, of King Davids Tom on Mount Zion in Jerusalem, told the news agency.

Transhumanism: Recreating humanity reveals the secret ways scientists are using technologyto pursue immortality, omniscience and ultimate power. Now available in the WND Superstore.

He was citing the 13 Principles of Faith set down by Rabbi Moses ben Maimon, whose 12th century work established him as a Torah authority and gave him the acronym Rambam.

He stated, I believe by complete faith that there will be a resurrection of the dead at the time that will be pleasing before the Creator.

That, Berger suggested, means: Not only does this effort by scientists go against this principle of faith, but we know that true resurrection can only happen by Divine will. Resurrection of the dead is described in depth, and it is proof of Gods rule over the physical world. But it is also stated that before the Messiah, there is no return from the grave.

The comments come on the heels of plans by a biomedical company, Bioquark, a startup based in Pennsylvania, to experiment with stem cells in an attempt to revive brain-dead patients.

BIN reported the company said it would launch experiments before the end of the year on such patients.

The trial will involve a multi-pronged approach, involving injecting stem cells and peptides into the spinal cords, electrical nerve stimulation, and laser therapy. The researchers hope this will grow new neurons and spur them to connect to each other, bringing the brain back to life, BIN reported.

What do YOU think? Sound off on scientific efforts to revive dead people

The story pointed out that Bioquark reportedly tried such an experiment in India in 2016 but it was not with the approval of the nations drug regulators.

Amar Jesani, editor of the Indian Journal of Medical Ethics in Mumbai, cautioned that even partial success would traumatize families that had come to terms with a situation they believed irreversible. In point of fact, no families permitted their loved ones to be part of the experiment, BIN reported.

Halperin said, This is like using genetics to create a new form of life. There are realms that are strictly divine. Resurrection of the dead is clearly possible. It is definitely going to happen after the Messiah, but it restricted to God.

It was reported about a year ago that Bioquark and another company were embarking on the Reanima project, using a new drug formula involving stem cells.

Their plan was to use neurons, proteins, peptides and more that would create a microenvironment in which the stems cells can mature.

The report said, Inspired by organisms like salamanders that can regrow severed or damaged tails, Bioquark researchers have been developing regenerative treatments for a host of uses, from cancer to spinal cord injuries.

WND had reported when the company was given the green light on the visionary project.

The company said then it was capable of creating dynamics in mature tissues that are normally only seen during human fetal development, as well as during limb and organ regeneration in organisms like amphibians.

Christian author and filmmaker Tom Horn, at that time, said scientists are redefining what it means to be human, with the goal of transcending humanity.

Right here in North Carolina at your university, they have what is called a transgenic lab, which means they have mice that have human genetic material, for testing to see if the human parts in that animal are responding, he told TV host Sid Roth in a recent interview.

Using a gene-editing technique, one university lab cured cancer in a group of rats, but the unintended consequences were that the rats started aging very quickly and died at half-life, and nobody knows why that happened, Horn said. There is a danger in playing God because youre not God and you dont know.

Transhumanism: Recreating humanity reveals the secret ways scientists are using technologyto pursue immortality, omniscience and ultimate power. Now available in the WND Superstore.

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Rabbi has warning after concluding reviving dead 'clearly possible' - WND.com

Xconomy New York

Immunotherapy drugs known as checkpoint inhibitors have started to change how a variety of cancers are treated, but they have yet to break through in multiple myeloma, a progressive cancer of the bone marrow. There was a setback on that front today.

Merck (NYSE: MRK) Monday afternoon paused enrollment in two Phase 3 trials testing its immunotherapy drug, pembrolizumab (Keytruda), in combination with two established therapies, pomalidamide (Pomalyst) and dexamethasone, in patients with multiple myeloma. Merck stopped the trials, called Keynote-183 and Keynote-185, to collect more information and better understand more reports of death of the patients on its drug, according to a statement.

Merck didnt disclose additional details, other than to say additional pembrolizumab studies continue unchanged. The analyses need to be conducted, said spokesperson Pam Eisele. But the news offers a fresh reminder of the unknowns and potential safety perils of combining immunotherapy drugs with other treatments to expand their reach. As Xconomy reported last month, with the frenzy to test such combinations, many cancer experts worry that the field is moving too fast; that studies are not being designed with enough care; and that the glut of combination trials is bound to provoke a backlash. Unexpected safety problems have popped up during certain tests.

Merck shares slid 0.9 percent in post-market trading on Monday.

In multiple myeloma, the bone marrows plasma cellsa type of immune cell that normally churns out infection-fighting antibodiesgrow rapidly and abnormally and crowd out healthy red and white blood cells. According to the American Cancer Society, about 30,000 people in the U.S. will be diagnosed with multiple myeloma this year. Its the third most common blood cancer in the country after lymphoma and leukemia.

There are many treatment options available for myelomainjectable antibody drugs, chemotherapies, pills, stem cell transplants, and moreand theyve helped extend patients life expectancy dramatically from just a few decades ago. Yet there is no cure, and the disease progresses even if patients initially respond to treatment. So far, at least, there are no approved immunotherapy treatments for the disease, despite progress with such drugs in a variety of other cancers.

One form of immunotherapy, a cell therapy technique known as CAR-T, has shown early promise in treating handfuls of multiple myeloma patients who have failed several prior therapies. Those tests are early, however. Checkpoint inhibitors, like pembrolizumab and Bristol-Myers Squibbs (NYSE: BMY) nivolumab (Opdivo), are being tested too, and are further along. These drugs have been approved for lung, skin, bladder, and other cancers and have become the standard of care for some patients. While checkpoint inhibitors havent been effective on their own in multiple myeloma, they have shown positive signs when combined with existing treatment regimens. The latest results from Mercks prior multiple myeloma study, Keynote-023, for example, were presented at the American Society of Clinical Oncologys meeting earlier this month and showed that 44 percent of patients who could be evaluated responded to treatment with a combination of pembrolizumab, pomalidamide, and dexamethasone. Results from the Keynote-023 study have been published in the journal Blood.

That study didnt reveal any unexpected dangerous side effects. As ISI Evercore analyst Umer Raffat wrote in a research note, there was no clear hint in prior studies of a new safety problem when combining Mercks drug with pomalidomide and dexamethasone. Given Mercks news today, such problems are worth watching with other, similar combination trials currently underway: Bristol-Myers has a Phase 3 trial, Checkmate-602, that began in April 2016, while AstraZenecas Phase 2 study, FusionMM-003, started last July, according to a note from Raffat.

Ben Fidler is Xconomy's Deputy Biotechnology Editor. You can e-mail him at bfidler@xconomy.com

See the rest here:
In a Myeloma Setback, Merck Halts Studies Due to Patient Deaths - Xconomy

A Chinese informant for the Central Intelligence Agency was shot in front of colleagues in the courtyard of a government building, reports The New York Times. Chinas government, according to former American officials, executed at least a dozen supposed CIA sources from the end of 2010 through 2012.

Beijings Global Times, a semi-official tabloid, calls the reporting of the courtyard killing a purely fabricated story, most likely a piece of American-style imagination based on ideology, but the publication, controlled by the authoritative Peoples Daily, did not deny the New York papers report of the other executions.

The Peoples Republic of China has very little compunction about killing its citizens. There is no question about that. The range of victimsfrom supposedly hardened spies to infants barely out of the wombis stunning and should be taken into account by Washington whenever it deals with Beijing.

We start with babies born without permits issued by population control officials.

Mao Hengfeng heard the piercing cries of her baby after a forced abortion. Yet instead of being able to hold her newborn child, veteran journalist Verna Yu reports, she watched helplessly while her baby was drowned in a bucket.

The baby was alive, I could hear the baby cry, Mao said. They killed my baby. Mao was also forced by family planning officials to undergo a hysterectomy. She had been seven-and-a-half months pregnant at the time.

Her baby was killed a quarter century ago, but the practice continues today. In todays China, under the Communist rule, says blind activist Chen Guangcheng, the government can put their hand into your body, grab your baby out of your womb, and kill your baby in your face. Chen talks of a war zone created by family planning officials.

Forced abortions occur as late as the ninth month, according to Reggie Littlejohn, founder and president of Womens Rights Without Frontiers, in 2009 testimony before the Tom Lantos Human Rights Commission of the U.S. Congress (PDF). Chinese methods of infanticide include puncturing the skulls and injecting alcohol into the brains of full-term fetuses to kill them during labor, she testified.

Littlejohn appended a translation of a Chinese document labeled Best Practices, Infanticide, issued to handle the question, What if the infant is still alive after induced labor?

This is the hallmark of communistic governments: the peacetime mass killings of their own citizens, Littlejohn told The Daily Beast.

China, since the beginning of 2016, has generally permitted couples to have two children, a relaxation of the notorious One-Child Policy, in place since 1979. Yet the requirement that couples obtain birth permits and the other coercive rules remain in place.

And that, unfortunately, means gendercide. As Susan Yoshihara, senior vice president for research at the Center for Family and Human Rights, pointed out in comments to me, brutal Chinese family planning policy has led to the direct and indirect killing of tens of millions of innocent Chinese baby girls just because they are girls.

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Almost as grisly is organ harvesting. Dr. Jacob Lavee, president of the Israel Society of Transplantation, told PBS NewsHour that in 2005 one of his patients was promised a heart transplant in China two weeks ahead of time.

If a patient was promised to undergo a heart transplant on a specific date, Lavee said, this could only mean that thethose who promised that they knew ahead of time when his potential donor would be dead.

China said in 2014 that, beginning the following year, it would no longer take organs from executed prisoners. But forced donations are continuing according to Ethan Gutmann, author of The Slaughter.

Gutmann, along with David Kilgour and David Matas, is co-author of an exhaustive June 2016 report. They maintain there are somewhere between 60,000 and 100,000 organ transplants a year, a number far in excess of donations available from voluntary sources.

Prisoners corroborate conclusions of the report. Wang Chunying and Yin Liping, Falun Gong practitioners, told PBS they were forced to take tests needed for matching organs with recipients. Gutmann says he has heard similar accounts from other prisoners.

China is not the only country with organ-transplant abuse, David Matas, a Canadian human rights lawyer, told the Toronto-based Globe and Mail. Whats different about China is its institutionalized, its state-run, its party-directed. Its not a few criminals in back alleys trying to make a fast buck. Kilgour, a former Canadian MP and now a human rights activist, implored the Chinese government to stop what he labeled an industrial-scale crime against humanity.

In China, you can get livers, kidneys, hearts, spleens, hands, breasts, arms, corneas, intestines, pancreases, thyroids, stem cells, hair, and bone marrow, and it looks like they come from more than just common criminals. China has used Falun Gong practitioners, Uighurs, Tibetans, and Christians as forced donors, the three authors charge.

Beijing called the charges groundless accusations after the U.S. House of Representatives last year passed a resolution on the practice.

Despite noticeable improvement in Chinese donor practices, the Chinese state looks like it is searching for a new source of organs. Forced organ harvesting of political dissidents began in the 90s, in Xinjiang, Gutmann told The Daily Beast. With the recent revelation from Human Rights Watchthat the Chinese authorities are comprehensively mapping Uighur DNAit is difficult to suppress the thought that Beijing has entered a new stage: not simply the murder of individual political dissidents but a slow-motion version of racial genocide.

But, in fact, China is still murdering political dissidents, even if the killings often are out of sight. In 2009, police said a 24-year-old prisoner, Li Qiaoming, died while playing hide-and-seek. Li, however, had been beaten to death, and this term suddenly became a common euphemism for official brutality.

Last year, Lei Yang, 29 years old and an environmental activist, died an hour after being taken into custody in the Chinese capital. Police blamed a heart attack. An autopsy revealed Lei choked on his own vomit.

These days, activists also disappear. Take 2015s 709 crackdown, so named because it began on July 9. Some 300 rights lawyers, legal assistants, and dissidents were swept up. A few of themZhao Wei and Wang Quanzhangare still missing. The 709 campaign, primarily directed at the legal profession, has been called the war on law and is widely seen as a sign of a growing intolerance of dissent under President Xi Jinping.

In China, there are countless allegations of police torture, abuse, and suspicious deaths, widely followed freelance journalist Paul Mooney tells The Daily Beast. The police, he says, are killing citizens with impunity. And as he points out, police power is growing and we can expect the situation to get worse and worse.

Many people call the country China. But we would understand it better if we thought of it as the Peoples Republic of Death.

Excerpt from:
China: Inside the People's Republic of Death - Daily Beast