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Calling All Heart Docs – Your Diabetes Drugs Need You – Seeking Alpha

April 28th, 2017 3:44 pm

Astrazeneca (NYSE:AZN) followed Johnson & Johnson (NYSE:JNJ) and Eli Lilly (NYSE:LLY) this morning by delivering a disappointing performance from its SGLT-2 inhibitor Farxiga. The drug belongs to a class that is widely projected to become the fastest growing among diabetes medicines (see tables below).

As such, weak first-quarter sales from the main players is worrying, and the blame is being laid at the feet of US pricing pressures. Diabetes is an area where payers have successfully flexed their muscles. However, it seems that another factor is playing a role: the message that this class can reduce a patient's risks from heart disease is taking time to have an impact.

Astrazeneca said growing intra-class competition and the impact of affordability programmes and managed-care access subdued Farxiga growth in the US, where sales inched only 2% higher, to $96m, in the first quarter.

J&J painted an even worse picture with Invokana - lower prices caused US sales of the medicine to fall 13% on the same quarter of last year. The company also blamed increasing discounts for managed care and a higher composition of Medicaid sales, where prices are typically lower.

The Lilly result was probably the most surprising given that the company has been heavily marketing Jardiance's success in its cardiovascular outcome study since January. New patient starts have surged 75% since the company was allowed to begin marketing on evidence that the drug can reduce the risks of death and complications from heart disease, the company said this week. However revenues still came in lower than the sell-side was expecting.

Lilly and partner Boehringer Ingelheim are the only companies allowed to actively market a cardiac benefit for their SGLT2, although big studies are due to report on Invokana and Farxiga in the next couple of years. These are widely expected to confirm a class effect, helping to drive use of all of these medicines (ACC - Jardiance heart benefit looks like a class effect, March 20, 2017).

However, the finding represents a big philosophical shift for this area of medicine, which is more used to dealing with the discovery of safety signals.

"We have to remember we are talking about changing very well entrenched treatment practises and physicians do take some time to get comfortable with new drugs and new classes," said Mark Mallon, head of Astrazeneca's global product strategy and medical affairs, in a media call this morning. "They need to see the data and the data is absolutely coming. But it's going to take time to build that up."

Assuming the class effect is confirmed, having three companies actively promoting a cardiac benefit will surely help drive uptake. However another issue is bringing cardiologists on board - endocrinologists and primary care doctors are currently the main prescribers of these drugs - an issue that Lilly executives have said they are closely monitoring.

"Cardiologists, in the case of Jardiance, are a significant source of authority. And while we have seen an increase, the base of prescribing is extremely, extremely small," Enrique Conterno, head of Lilly's diabetes business, told analysts on a call last week.

Merging therapy areas

The discovery of cardioprotective benefits for the SGLT2s and to a lesser extent the GLP-1 agonists points to a merging of therapy areas that looks set to become only more apparent in the coming years.

Novo Nordisk (NYSE:NVO) has already won approval for Victoza as an obesity therapy. Astrazeneca this year started two outcome trials with Farxiga in heart failure and chronic kidney disease, which will recruit both diabetic and non-diabetic patients. And its blood thinner Brilinta is being trialed in diabetic patients in the huge Themis study, to see if it can reduce the risk of heart attack and stroke.

The UK pharma giant has even merged its cardiovascular and diabetes drugs into a single reporting unit, which chief executive Pascal Soriot put down to more and more overlap.

"We believe there are substantial synergies across those therapy areas - operationally in the field but also from a medical view point," he told journalists earlier today.

A cynic might also see the move as a convenient way to de-emphasise Brilinta, sales of which have long disappointed.

However it is readily apparent that the SGLT2s have the potential to steer the treatment of diabetics closer to the cardiovascular world than ever before. The extent to which these drugs will be embraced by cardiologists is hard to foresee until more trials report, but could have a huge impact on the commercial potential of the class.

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Diabetes app forecasts blood sugar levels: First-of-its-kind … – Science Daily

April 28th, 2017 3:44 pm

Healthline
Diabetes app forecasts blood sugar levels: First-of-its-kind ...
Science Daily
Glucoracle is a new app for people with type 2 diabetes that uses a personalized algorithm to predict the impact of particular foods on blood sugar levels.
Diabetes App Designed to Predict Blood Sugar Levels After Each MealHealthline

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Stem cell lines grown in lab dish may acquire mutations – Harvard Gazette

April 28th, 2017 3:42 pm

Photo by Hannah Robbins/HSCI

In a cross-school collaboration, Harvard researchers Steve McCarroll (left) and Kevin Eggan couple stem cell science with genetics and genomicsto advance the understanding of human brain illnesses. Their latest project identifiedmutations that stem cell lines acquire in culture.

Regenerative medicine using human pluripotent stem cells to grow transplantable tissue outside the body carries the promise to treat a range of intractable disorders, such as diabetes and Parkinsons disease.

However, a research team from the Harvard Stem Cell Institute (HSCI), Harvard Medical School (HMS), and the Stanley Center for Psychiatric Research at the Broad Institute of MIT and Harvard has found that as stem cell lines grow in a lab dish, they often acquire mutations in the TP53 (p53) gene, an important tumor suppressor responsible for controlling cell growth and division.

Their research suggests that genetic sequencing technologies should be used to screen for mutated cells in stem cell cultures, so that cultures with mutated cells can be excluded from scientific experiments and clinical therapies. If such methods are not employed it could lead to an elevated cancer risk in those receiving transplants.

The paper, published online today in the journal Nature, comes at just the right time, the researchers said, as experimental treatments using human pluripotent stem cells are ramping up across the country.

Our results underscore the need for the field of regenerative medicine to proceed with care, said the studys co-corresponding author Kevin Eggan, an HSCI principal faculty member and the director of stem cell biology for the Stanley Center. Eggans lab in Harvard Universitys Department of Stem Cell and Regenerative Biology uses human stem cells to study the mechanisms of brain disorders, including amyotrophic lateral sclerosis, intellectual disability, and schizophrenia.

The research, the team said, should not discourage the pursuit of experimental treatments but instead be heeded as a call to screen rigorously all cell lines for mutations at various stages of development as well as immediately before transplantation.

Our findings indicate that an additional series of quality control checks should be implemented during the production of stem cells and their downstream use in developing therapies, Eggan said. Fortunately, these genetic checks can be readily performed with precise, sensitive, and increasingly inexpensive sequencing methods.

With human stem cells, researchers can re-create human tissue in the lab. This enables them to study the mechanisms by which certain genes can predispose an individual to a particular disease. Eggan has been working with Steve McCarroll, associate professor of genetics at Harvard Medical School and director of genetics at the Stanley Center, to study how genes shape the biology of neurons, which can be derived from these stem cells.

McCarrolls lab recently discovered a common, precancerous condition in which a blood stem cell in the body acquires a pro-growth mutation and then outcompetes a persons normal stem cells, becoming the dominant generator of his or her blood cells. People in whom this condition has appeared are 12 times likelier to develop blood cancer later in life. The studys lead authors, Florian Merkle and Sulagna Ghosh, collaborated with Eggan and McCarroll to test whether laboratory-grown stem cells might be vulnerable to an analogous process.

Cells in the lab, like cells in the body, acquire mutations all the time, said McCarroll, co-corresponding author. Mutations in most genes have little impact on the larger tissue or cell line. But cells with a pro-growth mutation can outcompete other cells, become very numerous, and take over a tissue. We found that this process of clonal selection the basis of cancer formation in the body is also routinely happening in laboratories.

To find acquired mutations, the researchers performed genetic analyses on 140 stem cell lines 26 of which were developed for therapeutic purposes using Good Manufacturing Practices, a quality control standard set by regulatory agencies in multiple countries. The remaining 114 were listed on the National Institutes of Health registry of human pluripotent stem cells.

While we expected to find some mutations in stem cell lines, we were surprised to find that about 5 percent of the stem cell lines we analyzed had acquired mutations in a tumor-suppressing gene called p53, said Merkle.

Nicknamed the guardian of the genome, p53 controls cell growth and cell death. People who inherit p53 mutations develop a rare disorder called Li-Fraumeni Syndrome, which confers a near 100 percent risk of developing cancer in a wide range of tissue types.

The specific mutations that the researchers observed are dominant-negative mutations, meaning that when they are present on even one copy of p53, they are able to compromise the function of the normal protein, whose components are made from both gene copies. The exact same dominant-negative mutations are among the most commonly observed mutations in human cancers.

These precise mutations are very familiar to cancer scientists. They are among the worst p53 mutations to have, said Ghosh, a co-lead author of the study.

The researchers performed a sophisticated set of DNA analyses to rule out the possibility that these mutations had been inherited rather than acquired as the cells grew in the lab. In subsequent experiments, the Harvard scientists found that p53 mutant cells outperformed and outcompeted non-mutant cells in the lab dish. In other words, a culture with a million healthy cells and one p53 mutant cell, said Eggan, could quickly become a culture of only mutant cells.

The spectrum of tissues at risk for transformation when harboring a p53 mutation includes many of those that we would like to target for repair with regenerative medicine using human pluripotent stem cells, said Eggan. Those organs include the pancreas, brain, blood, bone, skin, liver, and lungs.

However, Eggan and McCarroll emphasized that now that this phenomenon has been found, inexpensive gene-sequencing tests will allow researchers to identify and remove from the production line cell cultures with worrisome mutations that might prove dangerous after transplantation.

The researchers point out in their paper that screening approaches to identify these p53 mutations and others that confer cancer risk already exist and are used in cancer diagnostics. In fact, in an ongoing clinical trial that is transplanting cells derived from induced pluripotent stem cells, gene sequencing is used to ensure the transplanted cell products are free of dangerous mutations.

This work was supported by the Harvard Stem Cell Institute, the Stanley Center for Psychiatric Research, the Rosetrees Trust, the Azrieli Foundation, Howard Hughes Medical Institute, the Wellcome Trust, the Medical Research Council, the Academy of Medical Sciences, and by grants from the NIH.

By Al Powell, Harvard Staff Writer | April 26, 2017

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Stem cell lines grown in lab dish may acquire mutations - Harvard Gazette

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Artificial intelligence shows potential to fight blindness – Science Daily

April 28th, 2017 3:42 pm
Artificial intelligence shows potential to fight blindness
Science Daily
Diabetic retinopathy (DR) is a condition that damages the blood vessels at the back of the eye, potentially causing blindness. "What we showed is that an artificial intelligence-based grading algorithm can be used to identify, with high reliability ...

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‘State of the Swamp’ Spotlights Trump Team’s Ethical Blindness – Common Dreams

April 28th, 2017 3:42 pm

Common Dreams
'State of the Swamp' Spotlights Trump Team's Ethical Blindness
Common Dreams
'This president's first hundred days have seen no progress in 'draining the swamp;' instead, they have been the most corrupt in our national history.' (Image: Common Cause). President Trump marks his 100th day in office on Saturday, a milestone he ...

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'State of the Swamp' Spotlights Trump Team's Ethical Blindness - Common Dreams

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New glaucoma test could save millions from blindness – NHS Choices

April 28th, 2017 3:42 pm

Thursday April 27 2017

Glaucoma develops slowly over many years

"It might be possible to treat the main cause of permanent blindness before people notice any loss of vision," BBC News report.

A proof of concept study of early testing for glaucoma the most common cause of sight loss had promising results.

In glaucoma, the light-sensitive cells of the retinal nerve die, usually because of increased pressure in the eye. The damage to the nerve, which is irreversible, causes progressive loss of vision. Because people with glaucoma often don't have symptoms in the early stages of the disease, a lot of damage may be done before it is picked up. Diagnosing glaucoma early would allow earlier treatment to relieve pressure in the eye, and may prevent sight loss.

The new technique involves injecting people with a fluorescent dye (thankfully into the bloodstream, not the eye), and taking images of the eye. Dying retinal nerve cells show up as white spots on the image.

Researchers compared images from eight people with early glaucoma and eight healthy people, and showed that white spots were more than twice as common in people with glaucoma. They also seemed more common in people whose glaucoma got worse quickly over time.

However, the technique needs to be tested in large-scale studies to confirm the result as well as find out more about any safety issues.

The study reinforces the importance of having regular eye tests as these can oftenpick up glaucomabefore it becomes a significant problem. You should have an eye test at least every two years.

The study was carried out by researchers from Western Eye Hospital, Imperial College and University College London and was funded by the Wellcome Trust. The study was published in thepeer-reviewed journal Brain on anopen-access basis so it is free to read online.

BBC News, ITV News and The Daily Telegraph all covered the story. Their reports were mostly accurate and balanced, although none made clear the amount of research that still needs to be done before the new test can be put into use.

This was an open label,phase one clinical trial designed to establish proof of concept. Trials of medicines and tests go through three phases to ensure they are safe and effective.

The study was the first done in humans, so researchers wanted to know if it worked, if it caused any adverse effects, and what effect different doses of the dye had. They will now need to dophase 2and phase 3 trialson much bigger groups of patients to confirm their initial results.

Researchers recruited eight healthy adults without eye disease and eight adults being treated for early glaucoma at the hospital, with no other eye disease. People had an injection of the fluorescent dye (one of four different doses) then had their eye scanned by an infrared laser ophthalmoscope. The researchers assessed the images and compared those from healthy people and people with glaucoma.

Everyone was given a full eye examination when they were recruited, on the day of the test, and 30 days later. They were monitored for adverse events from the injection for six hours, with a phone call 24 hours later.

Researchers also looked to see what happened to the people with glaucoma during their future clinical follow-up visits, for up to 16 months. They then looked to see if the test results predicted how their glaucoma progressed.

Participants with glaucoma had on average more than twice as many white spots showing dying nerve cells as people with healthy eyes (2.37-fold increase, 95%confidence interval 1.4 to 4.03).

People with glaucoma whose disease got worse over the following months also had more white spots than those whose disease stayed the same. Among people without eye disease, older people had more white spots.

Glaucoma is more common among people aged over 75.

No-one had major side effects linked to the injection (one person found it painful and one person had a bruise afterwards).

The researchers stress their results need to be confirmed by bigger trials, saying: "Like any new technology," it will "need robust testing if it is to be successfully validated."

However, they say, it might be possible to use the test "as a method of detection and monitoring of patients" with glaucoma. They say they have shown that the technique may be useful for identifying nerve degeneration.

They further theorise that it might one day be used for other diseases, including the eye disease macular degeneration, optic neuritis (inflammation of the optic nerve) and "Alzheimers-related disease."

Glaucoma is responsible for about 10 in 100 people registered blind in the UK. About 2 in 100 people over 40 in the UK have glaucoma, and around 10 in 100 of those aged over 75. Because there is no cure, but early treatment can often help slow or prevent damage, early diagnosis is important.

Regular eye tests may pick up glaucoma, but often there's no sign of the disease until people have already begun to lose vision. That's why this test is interesting. If it can be shown to work well and safely, it could be a quick and efficient way to diagnose glaucoma before people have started to lose their sight. However, there's more work to do before we get to that stage.

The initial trial results in 16 people need to be repeated among bigger groups, to be sure the results hold true. The researchers need to establish the best dose of the fluorescent dye. Importantly, they need to establish what number of white dots is normal, and what number suggests early glaucoma. This research only shows that people with glaucoma had more white dots, not what would be a good cut-off point for early diagnosis.

Everyone should have a routine eye test at least every two years. This may include a test for high pressure in the eye, as well as a sight test.

If a close relative has glaucoma, mention it to the optician to be sure they carry out appropriate checks. Some types of glaucoma can run in families, so if you do have a family history, more frequent tests may be recommended.

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New glaucoma test could save millions from blindness - NHS Choices

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A college’s willful blindness to a sexual assault scandal – The … – Washington Post

April 28th, 2017 3:42 pm

THEY JUST didnt listen. So said one gymnast allegedly molested by Larry Nassar, a former USA Gymnastics doctor at the center of a sexual abuse scandal. Dr. Nassar also worked at Michigan State University where multiple female athletes complained to officials about his so-called treatment, only to have the school shamelessly and shamefully ignore them.

USA Gymnastics has borne the brunt of the blame for Dr. Nassars alleged exploits. But, as reporting by The Posts Will Hobson and the Lansing State Journal reveals, Michigan State shares responsibility for letting an alleged abuser reportedly carry on a decades-long criminal career. When athletes there told coaches and administrators that Dr. Nassar had massaged their buttocks and inserted his fingers, without gloves, into their vaginas, the officials told them they were misinterpreting the work of a medical superstar. A university Title IX investigation in 2014 cleared Dr. Nassar of wrongdoing.

Dr. Nassar worked with aspiring Olympians across the country, and a nationwide network of coaches and officials apparently let their athletes down again and again. But that bigger story should not obscure the appalling series of events that played out on Michigan States campus, for which the school has no excuse. Authorities say Dr. Nassar was brazen in his abuse, to the point where, as FBI agents discovered during their investigation, he allegedly recorded video of himself groping underage girls in a pool.

Michigan State is undergoing internal reviews to figure out what went so terribly wrong on its watch. Thats important, but equally important are structural reforms at Michigan State and colleges across the country to hold abusers accountable and prevent abuse from occurring in the first place. Michigan States shortcomings underscore the importance of the Education Departments recent efforts to more carefully enforce Title IX, which governs how schools address sexual violence. Troublingly, Education Secretary Betsy DeVos would not commit to continuing those efforts in her confirmation hearing.

I have been told it is virtually impossible to stop a determined sexual predator and pedophile, that they will go to incomprehensible lengths to keep what they do in the shadows, Michigan State President Lou Anna Simon said at a meeting of trustees this month. But Dr. Nassar was not in the shadows. He and his behavior were on full display, for years, waiting for administrators to take action. They chose not to listen, and they chose not to see.

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Protecting eyes from ultraviolet rays can prevent blindness – Portsmouth Daily Times

April 28th, 2017 3:42 pm

Many people know about the damage that ultraviolet (UV) rays can have on the skin, from sunburns to skin cancers. But many may not know about the damage it may cause to the eyes. That is why the Ohio Affiliate of Prevent Blindness has declared May as UV (ultraviolet) Awareness Month. The goal is to help educate the public on the dangers of UV and steps to take to protect vision today and in the future.

UV damage to the eyes can be immediate, including a condition called ultraviolet keratitis. According to the Cleveland Clinic, this occurs from exposure to ultraviolet rays that can temporarily damage the cornea (the clear portion of the eye in front of the pupil) and the conjunctiva, a layer of cells covering the inside of the eyelid and the whites of the eye. Symptoms, such as eye pain, tears, blurred vision, light sensitivity and seeing halos, may last from 6 to 24 hours, but they usually disappear within 48 hours.

However, some UV damage may be cumulative, leading to cataract or macular degeneration later in life. People who work or play in the sun for long periods of time are at the greatest risk. Parents should make sure that children are wearing the proper sun protection at all times when outdoors.

When purchasing sunglasses, Prevent Blindness also recommends buying sunglasses that:

Sunglasses should be worn in conjunction with a brimmed hat. Wrap-around sunglasses are best as they protect not only the eyes but the delicate skin around the eyes as well.

The best way to protect your eyes, and your familys eyes from UV, is to talk with an eyecare professional. By discussing your unique needs, he or she can provide guidance on the best ways to protect your eyes today and help ensure healthy vision for years to come, said Sherry Williams, President &CEO of Prevent Blindness, Ohio Affiliate.

For more information on the dangers of UV exposure and how to choose the best UV protection, please visit the Prevent Blindness dedicated Web page at http://www.preventblindness.org/protect-your-eyes-sun or Prevent Blindness, Ohio Affiliate at call (800) 301-2020.

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Mexico Eliminates The Infectious Disease That Is The Leading … – Konbini

April 28th, 2017 3:42 pm

Trachoma is the leading infectious cause of blindness worldwide. The disease causes the inner surface of eyelids to become rough, potentially ending up in visual impairment. On average, trachoma affects 1.9 million people around the world. It mainly harms people living in poor areas.

On Monday, the Pan American Health Organization (PAHO) and the World Health Organization (WHO) announced that after more than ten years of effort, Mexico managed to eliminate trachoma.

This was achieved through the Trachoma Prevention and Control program promoted by the Ministryof Health inChiapas, Mexico, since 2004, as well as the "Trachoma Brigades" to promote hygiene and provide information and antibiotics to those affected in vulnerable areas of the state.

Thanks to these efforts, it was possible to reduce the number of cases from 1,794 in 2004 to0 in 2016.

(Source: GIPHY)

With this monumental achievement, Mexico becomes the first country in the Americas and the third in the world (after Oman and Morocco) to receive WHO validation for eliminating trachoma.

Read More ->The World's First Malaria Vaccine Is Here, And Africa Gets It First

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Bosan for establishing Islamic Biotechnology Centre – Pakistan Observer

April 28th, 2017 3:41 pm

Staff Reporter

Islamabad

Minister for National Food Security and Research Sikandar Hayat Khan Bosan called for establishing Islamic biotechnology center in order to develop the agriculture and related sectors for the socio-economic prosperity of Muslim countries. Addressing the 3rd International Conference on Agriculture, Food Security and Biotechnology on an other day, he said that government believes that practical collaboration among the Muslim countries in the cutting edge areas of modern biotechnology was the need of time. The event was organized by Pakistan Agricultural Research Council (PARC) in collaboration with COMSATS, Islamic Educational, Scientific and Cultural Organization (ISESCO) and CIMMYT. The aim of the conference was to share the international best practices of using the biotechnology for the development of agriculture sector and food security. The minister termed the exchange of eminent scientist for short term and graduating students among Islamic countries as another good form of cooperation. He called upon the scientists for encouraging and promoting smart agricultural practices to build the resilience in agri-sector. Pakistan was working on the development of infrastructure for using modern and innovative technologies including the biotechnology for uplift of agriculture, health and industrial sectors of the country, he added. Pakistan has improved its crop yield and productivity over the years and it was producing surplus of wheat, maize, potato and sugarcane, he added. He said that scientist and biotechnologist in Pakistan has achieved the diversification in seed development and moved to a higher value added seeds, particularly in the crops sector. The minister said that all the modern techniques should be replicated after tailor-made alterations keeping in view of local settings and environmental factors.

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Plandai Biotechnology Names Ezra Jones as Vice President of Sales and Marketing – Yahoo Finance

April 28th, 2017 3:41 pm

LONDON, UNITED KINGDOM--(Marketwired - Apr 28, 2017) - Planda Biotechnology, Inc. ( OTC PINK : PLPL ) ("Planda" or "the Company"), producer of the highly bioavailable Phytofare catechin complex, today announced that Ezra Jones has been appointed Vice President of Sales and Marketing, a role he assumes from Callum Cottrell-Duffield, who was recently named Chief Operating Officer of Planda.

Mr. Jones has been involved in sales of nutraceutical branded ingredients for the past 18 years. He was he was with NutraGenesis for 3.5 years, and has recently, before Planda, been working as an independent sales representative for numerous worldwide companies.Since 2016, Mr. Jones has overseen all North American sales efforts for Planda.As the new head of sales and marketing, his responsibilities will expand to overseeing all global sales efforts, working with the company's independent sales reps and distributors, building additional sales channels, and growing the Phytofare brand.

Callum Cottrell-Duffield, President of Planda, commented, "Having worked with Ezra for the past year, I have been impressed with his passion for the product and knowledge of the industry.He has been instrumental in opening our largest accounts and is a driven salesman.As we now expand into a global brand and introduce new products in the coming year, Ezra's experience in building and training a sales force will be invaluable."

About Planda Biotechnology, Inc.

Planda Biotechnology, Inc. and its subsidiaries develop highly phyto-available extracts. Planda Biotechnology controls every aspect of the process, from growing green tea on its farms in South Africa, to producing its proprietary Phytofare extracts in-house, allowing the Company to guarantee the continuity of supply as well as quality control throughout the entire process. Targeted industries for the Company's products include beverage, cosmeceutical, wellness, nutriceutical, anti-aging, and pharmaceutical. For more information, please visit http://www.plandaibiotech.com.

Safe Harbor Statement

This release contains forward-looking statements that are based upon current expectations or beliefs, as well as a number of assumptions about future events. Although we believe that the expectations reflected in the forward-looking statements and the assumptions upon which they are based are reasonable, we can give no assurance or guarantee that such expectations and assumptions will prove to have been correct. Forward-looking statements are generally identifiable by the use of words like "may," "will," "should," "could," "expect," "anticipate," "estimate," "believe," "intend," or "project" or the negative of these words or other variations on these words or comparable terminology. The reader is cautioned not to put undue reliance on these forward-looking statements, as these statements are subject to numerous factors and uncertainties, including but not limited to: adverse economic conditions, competition, adverse federal, state and local government regulation, international governmental regulation, inadequate capital, inability to carry out research, development and commercialization plans, loss or retirement of key executives and other specific risks. To the extent that statements in this press release are not strictly historical, including statements as to revenue projections, business strategy, outlook, objectives, future milestones, plans, intentions, goals, future financial conditions, events conditioned on stockholder or other approval, or otherwise as to future events, such statements are forward-looking, and are made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. The forward-looking statements contained in this release are subject to certain risks and uncertainties that could cause actual results to differ materially from the statements made. Readers are advised to review our filings with the Securities and Exchange Commission that can be accessed over the Internet at the SEC's website located at http://www.sec.gov.

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Plandai Biotechnology Names Ezra Jones as Vice President of Sales and Marketing - Yahoo Finance

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Improving Joint Health with Putative Therapeutics at Matis, Iceland’s … – SelectScience

April 28th, 2017 3:41 pm

Use of cell imaging technology enables cutting-edge research into the assessment of bioactive compounds in cell lines

Matis is a leading food and biotechnology research institute in Iceland. Matis vision is to increase the value of food processing and food production, and to ensure the safety and quality of food and food products. SelectScience spoke to Dr. Eva Kuttner, to learn more about the technology the company is using in its research.

SS: Could you briefly introduce yourself and your place of work?

EK: My name is Dr. Eva Kuttner, Im a Project Leader in the Analysis and Structure division at Matis (mat=food + is=Iceland). Matis is a government owned, non-profit, independent research company in Iceland. The main focus of Matis is research and development, aligned to the food and biotechnology industries, as well as providing Iceland's leading food analytical testing service for public and private authorities.

I personally am German, and I hold a Diploma (equal to an MSc) in Botany, from the Universitt Braunschweig in Germany. I received my PhD in Integrative Biology (2007-2012) from the University of Guelph (Ontario, Canada).

SS: Could you describe your job role and work at Matis?

EK: My job title is Regional Manager, which means I am responsible for the 2 locations of Matis in the North of Iceland, Saurkrkur and Akureyri. My main work is that of a project leader (bioactives) in the Analysis and Structure Division and I am specialized in screening for bioactive secondary metabolites using in vitro chemical and cell-based assays.

Our laboratory focus is on identifying and describing compounds regarding antioxidant activity for healthcare (anti-diabetes, anti-inflammatory) and skin care. We now have a fully equipped cell laboratory (currently working with two cell lines), and we routinely run chemical and cell-based assays to identify and describe the bioactivity properties of extracted and fractionated compounds.

Testing putative therapeutics

SS: Please tell us about your marine compounds project that you are working on, and the main challenges involved?

EK: We are currently looking into how marine compounds influence the mineralization in a murine chondrocyte cell line (ATDC5). The aim of the project is to test putative therapeutics, to improve joint health. Specifically, we are interested in seeing how they affect differentiation of these cells.

SS: Which methods do you use to investigate this project and how does the BioTek Cytation 5 play a part in this?

EK: We are exposing the cells to different concentrations of fractionated marine compounds in a 96-well microplate format. After 24 days of incubation we stain the cells both with calcein and Alizarin Red to quantify calcium deposition. This is when the Cytation 5 from BioTek comes in: we have a workflow set up that images (magnification 4x) each well in phase contrast and fluorescence (we are using a GFP filter cube for this assay), and also carries out a read of the fluorescence signal. We then perform the Alizarin Red staining, take more pictures and extract the bound color after several washing steps. A further reading step quantifies the Alizarin Red using an absorbance read.

The figure below shows an example read of the calcein stain: first picture, phase contrast, second picture, fluorescence channel (GFP filter cube) and the third picture, overlay of both:

Image courtesy of Dr. Eva Kuttner

SS: What are your main research findings so far?

EK: We have identified several possible inhibitors of mineralization, but we are still in the process of improving the assay protocol to make the quantification of the mineralization more reproducible. The Alizarin Red stain has proven to represent more accurate calcium deposition into the cells, when testing the assay protocol using standard inhibitors like levamisole, so we are using the calcein stain to visualize mineralization, and Alizarin Red to quantify.

SS: What is the future of your research?

EK: We are looking into setting up assays investigating blood pressure. Our project partner developed a product line based on fish protein hydrolysate using trimmings from cod (Gadus morhua). The proteins are extracted and broken down to smaller peptides that have been shown to inhibit a key enzyme involved in increasing blood pressure (ACE). For this research we will develop and perform cell-based assays.

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Improving Joint Health with Putative Therapeutics at Matis, Iceland's ... - SelectScience

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iShares NASDAQ Biotechnology Index (IBB) Upgraded to Buy at … – The Cerbat Gem

April 28th, 2017 3:41 pm

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iShares NASDAQ Biotechnology Index (IBB) Upgraded to Buy at ... - The Cerbat Gem

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Stem cells edited to fight arthritis: Goal is vaccine that targets … – Science Daily

April 28th, 2017 3:41 pm
Stem cells edited to fight arthritis: Goal is vaccine that targets ...
Science Daily
Using CRISPR technology, a team of researchers rewired stem cells' genetic circuits to produce an anti-inflammatory arthritis drug when the cells encounter ...

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CRISPR-SMART Cells Regenerate Cartilage, Secrete Anti-Arthritis Drug – Genetic Engineering & Biotechnology News

April 28th, 2017 3:41 pm

We have anti-arthritis drugs. What we lack is the ability to deploy them when and where they are needed in the body. The drugs would be far more effective, and occasion fewer side effects, if they were to appear only in response to inflammation, and only in the joints. If the drugs could be delivered so painstakinglyso smartlythey wouldnt have to be administered systemically.

Although conventional drug delivery systems may be unable to respond to arthritic flares with such adroitness, cells may have better luckif they are suitably modified. Stem cells, for example, have been rewired by means of gene-editing technology to fight arthritis. These stem cells, known as SMART cells (Stem cells Modified for Autonomous Regenerative Therapy), develop into cartilage cells that produce a biologic anti-inflammatory drug. Ideally, the new cartilage cells will replace arthritic cartilage, and the biologic will protect against chronic inflammation, preserving joints and other tissues.

SMART cells of this sort were prepared by scientists based at Washington University School of Medicine in St. Louis. The scientists initially worked with skin cells taken from the tails of mice and converted those cells into stem cells. Then, using the gene-editing tool CRISPR in cells grown in culture, they removed a key gene in the inflammatory process and replaced it with a gene that releases a biologic drug that combats inflammation.

Details of this work appeared April 27 in the journal Stem Cell Reports, in an article entitled Genome Engineering of Stem Cells for Autonomously Regulated, Closed-Loop Delivery of Biologic Drugs. The article describes how modified stem cells grew into cartilage and produced cartilage tissue. The engineered cartilage, the scientists reported, was protected from inflammation.

Using the CRISPR/Cas9 genome-engineering system, we created stem cells that antagonize IL-1- [interleukin-1] or TNF-- [tumor necrosis factor-] mediated inflammation in an autoregulated, feedback-controlled manner, wrote the authors of the Stem Cell Reports article. Our results show that genome engineering can be used successfully to rewire endogenous cell circuits to allow for prescribed input/output relationships between inflammatory mediators and their antagonists, providing a foundation for cell-based drug delivery or cell-based vaccines via a rapidly responsive, autoregulated system.

Many current drugs used to treat arthritisincluding Enbrel (etanercept), Humira (adalimumab), and Remicade (infliximab)attack TNF-, an inflammation-promoting molecule. But the problem with these drugs is that they are given systemically rather than targeted to joints. As a result, they interfere with the immune system throughout the body and can make patients susceptible to side effects such as infections.

"We want to use our gene-editing technology as a way to deliver targeted therapy in response to localized inflammation in a joint, as opposed to current drug therapies that can interfere with the inflammatory response through the entire body," said Farshid Guilak, Ph.D., the paper's senior author and a professor of orthopedic surgery at Washington University School of Medicine. "If this strategy proves to be successful, the engineered cells only would block inflammation when inflammatory signals are released, such as during an arthritic flare in that joint."

Dr. Guilak's team encoded the stem/cartilage cells with genes that made the cells light up when responding to inflammation, so the scientists easily could determine when the cells were responding. Recently, the team began testing the engineered stem cells in mouse models of rheumatoid arthritis and other inflammatory diseases.

If the work can be replicated in animals and then developed into a clinical therapy, the engineered cells or cartilage grown from stem cells would respond to inflammation by releasing a biologic drugthe TNF- inhibitorthat would protect the synthetic cartilage cells that Dr. Guilak's team created and the natural cartilage cells in specific joints.

"When these cells see TNF-, they rapidly activate a therapy that reduces inflammation," Dr. Guilak explained. "We believe this strategy also may work for other systems that depend on a feedback loop. In diabetes, for example, it's possible we could make stem cells that would sense glucose and turn on insulin in response. We are using pluripotent stem cells, so we can make them into any cell type, and with CRISPR, we can remove or insert genes that have the potential to treat many types of disorders."

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SMART cells open door to arthritis vaccine – New Atlas

April 28th, 2017 3:41 pm

An artist's impression of the reengineered cell that produces an anti-inflammatory drug when it encounters inflammation (Credit: Ella Marushchenko)

Combining two cellular-editing processes, researchers have developed cartilage that fights inflammation. The scientists hope that the breakthrough could eventually lead to localized injections that combat arthritis or perhaps a vaccine that would eliminate the condition altogether.

Like many of the biology breakthroughs happening today, the WU researchers started with stem cells. To be more accurate, they actually started with skin cells from the tails of mice and converted them into stem cells. They then used a gene-editing technique called CRISPR to remove a gene involved in inflammation and replace it with one that releases an anti-inflammatory drug. The resulting cells are known as SMART cells, which stands for Stem cells Modified for Autonomous Regenerative Therapy.

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"Our goal is to package the rewired stem cells as a vaccine for arthritis, which would deliver an anti-inflammatory drug to an arthritic joint but only when it is needed," said Farshid Guilak, the senior author of a paper about the work and a professor of orthopedic surgery at Washington University School of Medicine. "To do this, we needed to create a 'smart' cell."

As part of the current fight against arthritis, there are several drugs that work to eliminate an inflammatory molecule called tumor necrosis factor-alpha (TNF-alpha). The issue with such drugs, however, is that they work throughout the entire body, rather than only at the site of inflammation, and can have an impact on the body's overall immune system.

To change this dynamic, the researchers replaced the gene that expresses TNF-alpha with one that inhibits it by releasing a drug, basically converting the cells from those that create inflammation to those that fight it. "We hijacked an inflammatory pathway to create cells that produced a protective drug," said Jonathan Brunger, a postdoctoral fellow in cellular and molecular pharmacology at the University of California, San Francisco. They then coaxed these cells to grow into cartilage in the lab which, they found, was successful in combating inflammation.

The hope is that injecting the cells into areas afflicted by arthritis, the new anti-inflammatory cartilage could replace the old cartilage. This would effectively create a vaccine against the condition, as the newly engineered cells would only release the anti-inflammatory drug when inflammation is present such as during an arthritic flare-up and turn off the release of the drug when the flare subsides.

Additionally, the researchers also engineered the new cells to light up when they responded to inflammation so that they could track their response in the body. The cells are now being tested in mice with rheumatoid arthritis and other inflammatory disorders and the researchers think that the method of combining stem cells with CRISPR could help fight other diseases as well.

"We believe this strategy also may work for other systems that depend on a feedback loop," said Guilak. "In diabetes, for example, it's possible we could make stem cells that would sense glucose and turn on insulin in response. We are using pluripotent stem cells, so we can make them into any cell type, and with CRISPR, we can remove or insert genes that have the potential to treat many types of disorders."

The paper is published in the journal Stem Cell Reports.

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Helping juvenile idiopathic arthritis sufferers — ScienceDaily – Science Daily

April 28th, 2017 3:41 pm

Express.co.uk
Helping juvenile idiopathic arthritis sufferers -- ScienceDaily
Science Daily
A drug combination that could help thousands of children with arthritis has been discovered by a team of researchers. Children and adolescents with Juvenile ...
Arthritis news: Condition can cause BLINDNESS in sufferers | Health ...Express.co.uk

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All About Arthritis – mySteinbach.ca (blog)

April 28th, 2017 3:41 pm

The word arthritis literally means inflammation of the joints. Joints in the body occur where bones meet. Bone ends are covered by cartilage and are encased in a fluid-filled synovial membrane used to lubricate the joint. Common symptoms are generally pain, swelling, stiffness and reduced function/mobility. However, the root causes are not always the same. There are distinctive differences between Osteo Arthritis (OA: wear & tear/degenerative joint disease) and Rheumatoid Arthritis (RA: auto-immune/inflammatory disease). Lets explore.

Who

OA: Affects both men and women. Process can begin after the age of 40 and symptoms are often present by age of 65.

RA: More common in women and can affect anyone, at any age.

When & How

OA: Gradual onset & increase in severity. Characterized by deterioration of and decreased ability to turn over (replace) cartilage tissue. This can be due to altered enzyme activity, building block deficiency and repetitive use/damage. This results in painful friction of exposed joints rubbing together, leading to inflammation of joint lining. After much cartilage is worn away, bone spurs may develop in joint spaces.

RA: Rapid onset. Characterized by an auto-immune response that leads to a self-attack on synovial membrane, which in turn leads to its inflammation, thickening, cartilage destruction and scar tissue formation.

Number & Types of Joins Affected

OA: 1-2 joints, Asymmetrical (Not even on both sides usually one side acts up first). Affects the weight-bearing joints (i.e. knees & hips).

RA: Multiple joints, Symmetrical (Affects both sides of the body the same way). Affects the synovial joints (i.e. hands & feet) but can progress to larger joints.

Non-Joint Involvement

OA: Absent.

RA: Commonly affects other tissues throughout the body. Other symptoms include fever, depression, fatigue, etc.

Types & Causes

OA: 2 Types Primary & Secondary.

Primary Potential causes include age, obesity, high impact sports, excessive use/exercise, free radical damage, poor nutrition, dehydration.

Secondary Results from a pre-disposing factor/condition such as joint or ligament damage/abnormality, infection, previous inflammation, loss of blood supply.

RA: Single Type.

Auto-immune response (when your body breaks itself down/attacks its own tissues). Potential underlying causes include poor digestion/diet (nutrition deficiencies, imbalance of gut bacteria, leaky gut, and food sensitivities), stress, chronic inflammation, heredity/genetics, imbalanced immune system, smoking/toxins and infections or overgrowth (i.e. candida).

Did you know 56% of patients with inflammatory arthritis have an imbalance of gut bacteria?

Suggestions?

1. Symptom Relief:

2. Tissue Protection: Look for Antioxidants (Quercetin, Zinc, Pycnogenol, Selenium, Vitamin E, Grape Seed Extract)

3. Repair Nutrients:

4. Topical Ingredients: Capsaicin, MSM, Arnica, Celadrin, Menthol, Peppermint, Eucalyptus.

5. Diet Tips: Avoid nightshades (i.e. tomatoes, white potatoes, eggplant, peppers and paprika), citrus, red meat, dairy, sugar, tobacco and any potential food sensitivities as they may aggravate pain & inflammation. Drink plenty of water. Eat mineral-rich and green foods to detox & alkalize. Eat more sulfur-containing foods such as garlic, onions, asparagus, etc.

6. Lifestyle Suggestions: Attain a healthy weight, manage stress and blood sugars, do light, non-weight bearing exercises (i.e. swimming). Consider wearing Cirulating Clothing!

7. Improve Gut Health: Ensure daily Probiotics and consider supplemental L-Glutamine, Enzymes/HCL, Fibre & VITAMIN D3.

8. Modulate Immunity: Consider ingredients such as Plant Sterols, Medicinal Mushrooms or Saccharomyces Cerevisiae

9. Fight Infection (if necessary): Oregano, Silver, Garlic, Grapefruit Seed Extract

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Arthritis Foundation’s Coast Classic Bike Tour Changes Course – Aptos Times

April 28th, 2017 3:41 pm

Landslide, Bridge Closure in Big Sur Result in Modified Route

LOS ANGELES Following lengthy review, organizers of the Arthritis Foundation California Coast Classic (CCC) Bike Tour presented by Amgen have announced a route change. This years 8-day flagship fundraising ride from San Francisco to Los Angeles takes place Sept. 9-16 and registration is currently open.

The new routing is for days 3 and 4, and is a bypass around the Pfeiffer Canyon Bridge on Highway 1 in Big Sur, which became structurally unstable after heavy storms caused a landslide last winter. The California Transportation Department (CalTrans) tore down the bridge in March and is building a replacement slated for completion in Sept. 2017.

While wed prefer to keep our traditional route, said Shannon Marang Cox, ride director for the CCC Bike Tour, our main priorities are rider safety and preserving the essence of the CCC riding experience. Chances are very slim that the bridge will be ready by early September, so weve decided to plan on our alternate course through Carmel Valley. The route is incredible, offering views of rivers, pastures, vineyards and mountains. Next year, well return to our original course, so this is a once-in-a-lifetime year to ride CCC.

In true Arthritis Foundation spirit, we explored many options and are forging ahead with a plan, Marang Cox continued. Weve consulted with our route team, taken several scouting trips, and kept in regular contact with CalTrans to find out whether or not the bridge will be done in time. In order to plan properly, we have to make the call now.

Days 1 and 2 of the 2017 California Coast Classic remain unchanged, as riders depart from Pier 39 in San Francisco and travel along the Pacific coast to Santa Cruz, then Monterey. On Day 3, cyclists will ride the famed 17-Mile Drive, and

then head southeast to new territory, pedaling through the bucolic Carmel Valley, alongside the Salinas River and trees draped in Spanish moss. The ride will stop for an overnight in King City.

The Day 4 route traverses the rolling Santa Lucia Mountain foothills and takes riders on a spin between Lake San Antonio and Lake Nacimiento on the way to their overnight stop in Paso Robles, which is known for hot springs and world-class wineries. On Day 5, the riders rejoin the original CCC route into Oceano, continuing to Buellton, and Ventura, and arriving in Los Angeles on Saturday, Sept. 16.

In developing our alternate route, we selected roads that provide the exceptional rider experience that CCC is known for, said Eli Campbell, CEO of Sentio Cycling, which provides logistics assistance to CCC. The bypass adds about 45 miles and an additional 2,700 of elevation gain, pending final permitting. Our 2017 route will rival previous years and offer a top-notch and rewarding experience for all.

Registration for the California Coast Classic, named one of The 30 Best Road Biking Trips by Outside Magazine, is capped at 250 riders and expected to sell out again in 2017. The eight-day, full-service, fully supported ride from San Francisco to Los Angeles raises funds to support the research, advocacy, and programs of the Arthritis Foundation. It is open to beginner and experienced riders who commit to a fundraising goal. More information is available at arthritis.org/CaliforniaCoastClassic.

The Arthritis Foundation is the Champion of Yes. Leading the fight for the arthritis community, the Foundation helps conquer everyday battles through life-changing information and resources, access to optimal care, advancements in science, and community connections. The Arthritis Foundations goal is to chart a winning course, guiding families in developing personalized plans for living a full life and making each day another stride towards a cure.

The Arthritis Foundations California Coast Classic Bike Tour, The Ride of a Lifetime, is one of four Arthritis Bike Classic events staged on the West Coast. It began in 2001 and is the flagship fundraising bike tour of the Arthritis Foundation, raising over one million dollars annually. Beginner and experienced cyclists are welcome on the 8-day, fully supported 525-mile journey down the coast of California from San Francisco to Los Angeles. For more information, please visit arthritis.org/CaliforniaCoastClassic.

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Kelly Osbourne Campaigning to Make Stem Cell Therapy Affordable in America – Hollywood.com

April 28th, 2017 3:40 pm

Wenn

Singer-turned-TV personality Kelly Osbourne wants to help cure fellow Lyme disease sufferers by making stem cell therapy available for all in the U.S.

Ozzy and Sharon Osbournes daughter contracted the condition after she was bitten by a tick during a party for the rockers 56th birthday back in 2004, when her mother had a reindeer sanctuary installed at their Los Angeles home.

However, Kelly wasnt properly diagnosed until 2014, months after suffering a seizure while filming an episode of E!s Fashion Police show in 2013, when doctors claimed her collapse had been caused by epilepsy.

She did some research into her ailments and discovered she was actually struggling with Lyme disease, and promptly sought out alternative treatment to help her overcome the illness.

I started to actually do the one thing doctors tell you not to do and thats to go online and look it up, she explained on Good Morning America, and all roads pointed to Lyme disease so I found a doctor through my mum.

I went to Frankfurt, Germany, and I did stem cell (therapy) and I got cured, Kelly claimed.

The 32-year-old is lucky to have been in a position to afford the treatment, which involves the transplant of stem cells to heal those damaged by the disease, and now she is looking to get involved in making the therapy more widely available and affordable to others less fortunate.

It sickens me that thats not available to everyone and that you have to be considered lucky or privileged to get that sort of treatment, she said. I want to make sure and I will do anything that I can do to make sure that that treatment is available in this country.

Kelly details her experience with the bacterial infection in her new memoir There Is No F**king Secret: Letters from a Bada** B**ch. She isnt the only celebrity to open up about her struggles with Lyme disease pop star Avril Lavigne, and veteran model Yolanda Hadid and her runway star kids Bella and Anwar Hadid have also been battling the illness.

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