Gates Foundation to Invest Up to $140 Million in HIV Prevention Device.


Intarcia Therapeutics is developing implantable pump which holds six or 12 months’ supply of medicine

An Intarcia factory in Hayward, Calif., last year.
An Intarcia factory in Hayward, Calif., last year.

The Bill & Melinda Gates Foundation is investing as much as $140 million to support development of a tiny implantable drug pump it believes could help prevent people in sub-Saharan Africa and elsewhere from becoming infected with HIV, the virus that causes AIDS.

The matchstick-size pump is being developed by Intarcia Therapeutics Inc., a closely held Boston biotechnology company. It can hold six or 12 months’ supply of medicine and is designed to deliver microdoses continuously to patients, ensuring they stay on the treatment.

The new investment, which Intarcia announced Thursday, comes amid a flurry of fresh efforts to develop HIV prevention strategies.

 Last week, the National Institute of Allergy and Infectious Diseases announced a global 4,500-patient clinical trial to test whether injections every eight weeks of an experimental HIV drug, cabotegravir, from U.K.-based ViiV Healthcare is effective in preventing HIV infection. Last month, the first efficacy study of an HIV vaccine in seven years was begun in South Africa.

This is “one of the most exciting years ever in HIV prevention,” said Mitchell Warren, executive director of AVAC, a global HIV advocacy organization supported by the Gates Foundation.

Progress is needed. Despite major gains against HIV and AIDS in the past two decades, 1.9 million people become infected with the virus each year, the Joint United Nations Programme on HIV/AIDS estimates. The majority are in resource-poor regions such as sub-Saharan Africa, where the epidemic’s toll has been severe.

Experts worry that without effective prevention efforts, an emerging generation of young people are at risk of becoming infected.

“If we don’t find a way to prevent infection, we’re going to wind up with more people infected in that part of the world than we have now,” said Emilio Emini, director of the HIV program at the Gates Foundation.

Using the pump in this manner would fit a prevention strategy called pre-exposure prophylaxis, or PrEP.

Gilead Sciences Inc.’s daily pill Truvada, the only drug regulators have approved for PrEP, has been shown in clinical trials to reduce risk of HIV infection by more than 90%. It is becoming available in generic versions in some African countries.

Bill and Melinda Gates in February. Mr. Gates visited Intarcia’s Boston headquarters in June.
Bill and Melinda Gates in February. Mr. Gates visited Intarcia’s Boston headquarters in June.

But “its real-world effectiveness is much lower than that because you have to take a pill” every day and getting healthy people to do so is difficult, Dr. Emini said. That is what makes Intarcia’s pump so attractive, he said. “You put it in and you forget it,” he said, likening it to long-acting forms of contraception. “You can immediately imagine how it could be applicable.”

Under terms of the agreement, the foundation will take a $50 million equity stake in the company and provide as much as $90 million more in grants, pegged to certain research milestones toward development of the device.

The money comes from a $1.5 billion fund the foundation has set aside apart from its larger grant-funding operation to make investments in technologies being developed in the private sector. The goal of the fund isn’t to generate a financial return but to back ideas with equity, loans and other financing that advance the foundation’s charitable mission, Andrew Farnum, the foundation’s director of program-related investments, said in an interview.

The Intarcia deal is one of about 50 such investments the foundation has made since 2009. The pump would likely find a market in the U.S. and other wealthy countries, but “the ultimate goal is developing an HIV prophylaxis device that will save lives in the developing world,” Mr. Farnum said.

 Intarcia has already developed a version of the pump loaded with the diabetes drug exenatide as a treatment for patients with Type 2 diabetes. The company filed an application with the U.S. Food and Drug Administration last month to market the device, called the ITCA650. If all goes well, it could be on the market by the end of 2017.

It took a decade to develop. The challenge the company faced was to come up with a formulation of exenatide that would remain stable at body temperature for at least a year and that was potent enough to be effective at the micro doses delivered by the pump. The company mounted several phase 3 clinical trials, which demonstrated its efficacy in controlling blood sugar.

“We’re going to basically take that same approach” with an HIV drug, said Kurt Graves, Intarcia’s chairman, president and chief executive officer.

The $50 million in equity is part of a larger round of new financing for Intarcia totaling $206 million, Mr. Graves said.

The foundation, which considers prevention a critical component of its efforts to combat HIV, first heard about the Intarcia pump about a year ago while searching for technologies with the potential to provide long-term protection against the virus.

As part of the due diligence, Bill Gates visited Intarcia’s Boston headquarters in June, where he and Mr. Graves discussed the technology for nearly two hours.

The company and the foundation haven’t decided which HIV drug to put in the pump, but Mr. Graves said initial tests indicate “we have a very good probability of success” in coming up with an effective formulation.  It will likely take several years before the pump reaches the market.

If they are successful, the agreement is intended to make sure the pump available and affordable to poor populations in the developing world.

Controversial vaccine studies: Why is Bill & Melinda Gates Foundation under fire from critics in India? t


http://economictimes.indiatimes.com/industry/healthcare/biotech/healthcare/controversial-vaccine-studies-why-is-bill-melinda-gates-foundation-under-fire-from-critics-in-india/articleshow/41280050.cms?intenttarget=no&from=mdr

Gates’ Human experimentation with GM bananas in Africa condemned by scientists


‘At least 124 food and outreach organizations, as well as 26 individual scientists, have signed onto a letter sent to the Bill & Melinda Gates Foundation protesting ongoing human trials of genetically modified (GM), beta-carotene-enriched bananas intended for Africa.

The GM bananas, which never underwent animal trials, are currently being administered to 12 students attending Iowa State University (ISU), presumably without full disclosure as to the many unknown risks involved.

According to the letter, the trials are taking place under the guidance of Dr. Wendy White, an associate professor of food science and human nutrition. Funding for the trials came from a grant issued by the Bill & Melinda Gates Foundation.’

 

Scans show premature-baby brain arrested development.


Premature birth may interrupt vital brain development processes, medical scans reveal.

Researchers at King’s College London scanned 55 premature infants and 10 babies born at full term, using a novel type of MRI scan.

Premature baby in hospital

The brain scans showed arrested development in the premature babies at a key stage of maturation.

Experts say the work, in PNAS, could further understanding, but that parents should not be alarmed by the findings.

In recent decades there have been big advances in caring for premature babies, which mean most can go on to live a healthy life.

“Start Quote

Most premature babies are unaffected by their early arrival and families of these babies should not be unduly concerned”

Andy Cole Bliss

The researchers say the new type of imaging – which tracks the movement of water in the brain – will enable them to explore how the disruption of key processes might cause conditions such as autism.

It could also be used to monitor possible treatments to prevent brain damage.

Interrupted development

The scans showed cortical development was reduced in the preterm babies compared with those born at full term, with the greatest effect in the most premature infants – those born at about 27 weeks.

The brain regions affected govern social and emotional processing, as well as memory.

The same children were assessed at two years of age and those who had been born prematurely performed less well on neurodevelopmental tests, which the researchers say suggests the weeks a baby loses in the womb may matter.

Lead investigator Prof David Edwards said: “The number of babies born prematurely is increasing, so it has never been more important to improve our understanding of how preterm birth affects brain development and causes brain damage.

“We know that prematurity is extremely stressful for an infant, but by using a new technique we are able to track brain maturation in babies to pinpoint the exact processes that might be affected by premature birth.”

Andy Cole, chief executive of the premature baby charity Bliss, said: “It is very exciting that this ground-breaking research is being driven forward here in the UK.

“A better understanding of the way that preterm babies’ brains develop is an important step for doctors to help identify improvements in care that will benefit the 60,000 preterm children born every year.

“It is important to mention that most premature babies are unaffected by their early arrival and families of these babies should not be unduly concerned.”

WHO prequalifies JE vaccine, clears way to reach children in poor countries.


The World Health Organization (WHO) today granted its seal of approval to a vaccine that protects children from a deadly brain infection. The live, attenuated Japanese encephalitis (JE) vaccine, known as SA 14-14-2 and manufactured in China through a unique partnership with PATH, has the potential to protect millions of children in Asia against the devastating infection.

“With WHO prequalification, we can accelerate the availability of a safe, affordable vaccine to children who need it most,” said Dr. Kathleen Neuzil, director of PATH’s Vaccine Access and Delivery program. “It’s a landmark moment that signals the power of collaboration in tackling this devastating disease and bringing lifesaving solutions to vulnerable communities.”

 

A historic moment

From negotiating an affordable public-sector price for the vaccine to constructing a new manufacturing facility, PATH and the Chengdu Institute of Biological Products (CDIBP) have worked toward this tremendous milestone for more than ten years with support from the Bill & Melinda Gates Foundation.

WHO’s prequalification clears the way for international financing to help bring greater access to the vaccine in low-resource, JE-endemic countries where 4 billion people live in areas at risk for the disease.

JE kills as many as 15,000 people, mostly children, each year and causes lifelong disabilities for tens of thousands more. The disease, transmitted by mosquitoes, is untreatable, which makes prevention even more critical.

 

Tapping into China’s capacity to improve health

The vaccine is the first-ever Chinese vaccine to receive WHO prequalification, marking China’s debut as a manufacturer of high-quality vaccines for the global health marketplace. The model has the potential to have a long-term effect on the availability and affordability of more vaccines for the people who need them most.

PATH harnessed our technical expertise and forged effective partnerships to help distribute the vaccine beyond China, where it has been used successfully for more than two decades, to reach millions more people in poor countries with affordable and sustainable protection. Outside of China, more than 200 million people in India, Cambodia, Nepal, and eight other countries have already received SA 14-14-2—the first JE vaccine prequalified for use in children—with stellar results.

Source:PATH

 

 

GMOs Become Obsolete, Bazilian Scientists Make Breakthrough.


Agriculture scientists in Brazil have spent the past decade developing so-called “superfoods” that will soon become a natural alternative to genetically modified frankenfoods grown in many countries including the United States and will alleviate malnutrition for nearly one-third of the world’s population.
These eight biofortified foods are expected to be widely available to consumers throughout Brazil in less than a decade; already there is a pilot program underway in 15 municipalities around the country, Britain’s Guardian newspaper reported.

Continuing, the paper said:

Biofortification uses conventional plant-breeding methods to enhance the concentration of micronutrients in food crops through a combination of laboratory and agricultural techniques.

The goal is to combat micronutrient deficiencies, which can cause severe health problems such as anemia, blindness, impaired immune response and development delays. According to the UN Food and Agriculture Organization, micronutrient malnutrition affects 2 billion people globally.

Taking on ‘hidden hunger’

Efforts to develop biofortified superfoods began a decade ago, when Embrapa, the government’s agricultural research agency, began the project as part of a group of nations seeking to develop varieties of crops that have higher concentrations of necessary micronutrients. The department chose eight foods that are staples in the Brazilian diet: beans, cowpeas (black-eyed peas), rice, sweet potatoes, corn, wheat, cassava and squash.

“We are working on increasing the iron, zinc and provitamin A content. These are the nutrients most lacking not only in Brazil, but in the rest of Latin America and the world as well, the cause of what we call hidden hunger,” food engineer and a biofort co-ordinator, Marilia Nutti, told Tierramerica.

Nutti said iron was especially important, because half of Brazil’s children suffer from some level of iron deficiency.

In addition to the current biofortification project, Brazilian scientists are also working to breed plants of the same species, choosing seeds that appear to exhibit the best traits regarding micronutrient content.

“This is not transgenics. We want a varied diet. Biofortification attacks the root of the problem and is aimed at the poorest sectors of the population. It is scientifically viable and economically viable as well,” Nutti said.

And it’s not genetic modification, either – and that’s key.

The development project is being supported by HarvestPlus and AgroSalud, a pair of research programs that operate in Latin America, Africa and Asia with funding from the Bill and Melinda Gates Foundation, the World Bank and other developmental agencies.

Booming nutritional content

So far, it looks as though the project is, um, fruitful. The iron content of the beans, for instance, has been elevated from 50 to 90 milligrams of iron per kilogram; cassava, which normally has almost no beta-carotene, now has nine milligrams of the essential vitamin A source per gram.

Meanwhile, the beta-carotene level in sweet potatoes has grown from 10 micrograms per gram to an astounding 115 per gram. Zinc content of rice has grown from 12 to 18 milligrams per kilogram.

Not bad – and without turning the foods into “Frankenfoods.”

Already pre-school children are benefiting from the bio-nutritionally enhanced foods. “In Itaguai, an industrial municipality 44 miles south of Rio de Janeiro, about 8,000 pre-school children are benefiting from these extra-nutritious foods,” the Guardian reported.

Eventually all of the municipality’s family farmers will be included in the project – at least, that’s the goal. Further, within a couple years, the plan is to offer biofortified foods in all schools within the municipality, as well as in stores and public markets.

Curiosity of children is one factor that is “selling” the new biofortified superfoods. “When we tell them that these foods have more vitamins, and they see the deeper colors [of the biofortified crops], they are eager to try them out,” municipal secretary of environment, agriculture and fisheries, Ivana Neves Couto told Tierramerica.

“Brazil is the only country working with eight biofortified crops. Bangladesh, Colombia, India, Mozambique, Nicaragua, Pakistan, Peru, the Democratic Republic of the Congo and Uganda are conducting research on one crop each,” Guardian reported.

Source: Raw For Beauty

Urine-powered mobile phone charger lets you spend a penny to make a call.


New microbial fuel cells contain bacteria that produce electricity from urine as part of their natural life cycle

A group of researchers from the University of the West of England have invented a method of charging mobile phones using urine.

Key to the breakthrough is the creation of a new microbial fuel cell (MFC) that turns organic matter – in the case, urine – into electricity.

v2-Ioannis

The MFCs are full of specially-grown bacteria that break down the chemicals in urine as part of their normal metabolic process. The bacteria produce electrons as they consume the matter and it this natural process that creates a small electrical charge to be stored in the MFC.

“No one has harnessed power from urine to do this so it’s an exciting discovery,” said Dr Ioannis Ieropoulos, an engineer at the Bristol Robotics Laboratory where the fuel cells were developed.

“The beauty of this fuel source is that we are not relying on the erratic nature of the wind or the sun; we are actually reusing waste to create energy. One product that we can be sure of an unending supply is our own urine.”

After the urine has been processed by the MFCs the electrical charge is stored in a capacitor. In the first test of the new invention, researchers simply plugged in a commercial Samsung phone charger and were able to charge up the handset.

Although the amount of electricity produced by the fuel cell is relatively small – only enough for a single call on the mobile – researcher believe it might be installed in bathrooms in the future, helping to power electric razors, toothbrushes and lights.

The device is about the size of a car battery, but engineers believe that future versions will be smaller and more portable. With each fuel cell only costing around £1 to produce such devices could provide a new, cheaper way of generating power.

The research was sponsored by public money from the Engineering and Physical Sciences Research Council and the Gates Foundation (the charity run by Microsoft-founder Bill Gates), with the scientists hopeful that the technology could be beneficial in developing countries.

“One [use] would be to put these into domestic situations or it could be used in remote regions of the developing world,” said Dr Ieropoulos.

“The fuel cells we have used to charge a mobile phone with hold around 50ml of urine but the smallest we have had working in the laboratory hold 1ml, so we can make them a lot smaller. Our aim is to have something that can be carried around easily.”

“The concept has been tested and it works – it’s now for us to develop and refine the process so that we can develop MFCs to fully charge a battery.”

Source: http://www.independent.co.uk

 

2018 must be the final target for polio eradication.


Since the eradication of smallpox in the late 1970s, no other diseases have followed suit; the goal that has come closest so far is eradication of polio. The development of vaccines in the 1950s led to cases of polio plummeting: whereas hundreds of thousands were affected annually in the middle of last century, in 2012 around 250 people were paralysed by the disease. But the final stages of eradication are proving more difficult than the early phases. The disease remains entrenched in three countries—Afghanistan, Nigeria, and Pakistan—where social, political, and logistical factors prevent effective vaccination campaigns and lead to export of virus to countries that have previously been free of the disease.

As Haris Riaz and Anis Rehman reported in the journal last month, the global polio eradication programme suffered a grave setback in December last year when seven vaccination workers were shot dead by terrorists as they took part in a 3 day campaign to deliver vaccine in Karachi and Peshawar. At the end of January, two more vaccine workers were killed in a landmine explosion in the Kurrum tribal region. These two latest casualties are not thought to have been directly targeted, but unwitting victims of sectarian violence.

Such events are not only tragic losses—people dedicating their time to a global health effort senselessly killed—but also they leave children who would have received vaccine unprotected and allow the virus to continue to circulate. The consequences of which can be extremely far reaching: in January, poliovirus related to strains circulating in Pakistan was detected in sewage samples in Cairo, Egypt, more than 3000 km away (the last case of polio in Egypt was recorded in 2004). No new cases of polio have been recorded in Cairo, but health authorities are surveying the impoverished districts of Al Salam and Al Haggana where the virus was found for recent cases of paralysis, and vaccination campaigns have been initiated.

In the middle of the 20th century, children in developed countries of Europe and North America would return to school at the end of the summer break and look around to see empty chairs of classmates who had not returned because they had been crippled or killed by polio. When the global polio eradication initiative (GPEI) was launched in 1988, the disease was endemic in 125 countries and caused paralysis in around 350 000 people every year. Recent events highlight how a threat that for many is thankfully a distant memory—or for younger generations in some developed countries unknown—remains a real and present danger.

The Bill & Melinda Gates Foundation is one of the major contributors of financial aid to the polio eradication effort, and speaking recently in London at the Richard Dimbleby lecture, Bill Gates reiterated his commitment to wiping out the diseases, highlighting the new eradication target of 2018. On January 23, the GPEI published a draft Polio Eradication and Endgame Strategic Plan (2013—18). The plan has four main objectives and four milestones for eradication. The four objectives are, detection and interruption of wild poliovirus, strengthening of routine immunisation and withdrawal of the oral polio vaccine, containment and certification (enabling some facilities to store poliovirus and outlining the processes for certification of eradication), and legacy planning to ensure that resources put aside for polio eradication are repurposed when the goal is achieved. The milestones for the new strategic plan are for the last case of wild polio by 2014, withdrawal of type 2 oral polio vaccine by 2015—16, worldwide certification of polio eradication by the end of 2018, and cessation of bivalent oral polio vaccination during 2019.

This is not the first deadline for polio eradication. When the GPEI was set up, the planned date for eradication was 2000. As the cases become fewer, the problems become knottier, and hindrances to final eradication become ever more dependent on localised factors and characteristics of the virus’s remaining toeholds. As the saying goes, the devil is in the detail.

The new plan encouragingly contains intricate analyses of recent outbreaks in the three remaining countries, reasons for programmatic declines, and reflection on the lessons learned from success in India, which has not recorded a case in more than 2 years. It is an excellent example of how data, local knowledge, and experience can be synthesised to provide clear goals and realistic targets. 2018 seems soon, but for some children it will not be soon enough. And for the vaccination workers who have lost their lives, eradication of polio within 5 years would be a tribute to their efforts.

Source: lancet