Tag Archives: Research

Zika vaccine race spurred by crisis and profit potential

Research scientist Dan Galperin works in the research laboratory at Protein Sciences Inc. where they are working on developing a vaccine for the Zika virus i

By Bill Berkrot

NEW YORK (Reuters) – The race to find protection against the Zika virus is fueled by something often missing from tropical disease research: the potential for big profit.

The prospect of a blockbuster vaccine against a mosquito-borne virus has accelerated the pace of development and attracted the interest of big drugmakers, including Sanofi, GlaxoSmithKline Plc and Takeda Pharmaceuticals.

Although Zika infections are mild or asymptomatic in most people, demand for a vaccine is expected to be strong because it can cause devastating birth defects, pharmaceutical executives and disease experts said.

The most lucrative market is seen in travelers seeking inoculation against the virus that has moved rapidly across the Americas and is the only mosquito-borne disease also spread through sex.

“It scares people,” said Scott Weaver, a virologist with the University of Texas and chairman of the Zika task force for the Global Virus Network. “Europeans and Americans can pay a pretty high price for these kinds of vaccines.”

A vaccine could come to market in as little as two years. Even if the current outbreaks in Latin America and the Caribbean burn out by that time, people living in those regions are expected to want protection against a return of Zika.

Tens of millions of travelers from United States and other wealthy nations, including people on business trips with corporate-sponsored health coverage, are expected to get vaccines before visiting areas where Zika is circulating.

“If you consider just a portion of the U.S. traveler population, we can conservatively envision a Zika market opportunity exceeding $1 billion” a year, said Joseph Kim, chief executive of Inovio Pharmaceuticals, a Pennsylvania company that is farthest along in the development path with human testing of a vaccine candidate underway in hard hit Puerto Rico.

Drugmakers and disease experts also envision the vaccine becoming standard care for girls before puberty to guard against birth defects in future pregnancies. Boys also could be candidates to protect eventual sexual partners.

“Hopefully a vaccine can be developed that’s sold for a low cost in endemic areas,” Weaver said.

ZIKA’S DIFFERENCE

Blockbuster sales for vaccines against mosquito-borne viruses are unheard of. Sanofi’s dengue vaccine, approved in nine countries, is generating near-blockbuster expectations, the biggest in the market by far. Analysts forecast annual sales for Dengvaxia reaching about $900 million by 2020, according to Thomson Reuters data.

Efforts to find a malaria vaccine are purely philanthropic. The Bill and Melinda Gates Foundation has contributed significantly to GSK’s decades-long effort to produce a vaccine for children in Africa. Development is ongoing, and GSK expects no profit.

The U.S. National Institutes of Health (NIH) developed a potential vaccine for West Nile virus, but it failed to find a commercial partner because the virus did not inspire enough public alarm to generate big sales. West Nile leads to serious complications in less than 1 percent of people infected.

In February, the World Health Organization declared a global public health emergency because of Zika’s apparent link to microcephaly, a birth defect marked by small heads and serious developmental problems. That, and evidence of other severe fetal brain abnormalities linked to Zika, have galvanized efforts to speed vaccine development.

The NIH is negotiating with companies to produce Zika vaccines but has its own pilot plant that can make enough for early clinical testing, which began with its first candidate in August.

“We’re not dependent on a company until you prove it works and then you need somebody to manufacture millions of doses,” said Dr. Anthony Fauci, director of the NIH’s National Institute of Allergy and Infectious Diseases (NIAID).

The first NIH candidate is a DNA vaccine containing no actual virus, in which genetically engineered cells produce an antigen that triggers an immune response, similar to the West Nile vaccine. By early 2017, the agency expects to be able to decide whether to begin enrolling thousands of patients in an efficacy study, or move on to the next candidate.

The size of the Zika outbreak may help development efforts. If it remains widespread, it will be easier to tell if a vaccine is effective.

“If the infections die down, then it’s going to take much longer to find out if it works,” Fauci said.

A second NIH candidate contains inactivated viral material, while a third utilizes attenuated, or weakened, live virus.

DNA-based candidates are most likely to prove safe, but they typically require multiple doses to work. Vaccines that contain live virus are considered most effective with one dose, but have a far higher safety hurdle, particularly if they are intended for pregnant women, and so they take longer to get to market.

INDUSTRY PILES IN

Inovio’s DNA vaccine is injected along with a brief low voltage electronic pulse that induces cell membranes to open, making them more receptive, in theory, to accepting the vaccine’s genetic material.

Privately-held Protein Sciences Corp built its Zika vaccine using technology similar to its already approved Flublok flu vaccine. The drugmaker has partnerships with companies in Argentina, Brazil, Japan and Mexico and plans to seek funding from Brazil and the NIH. It expects to start human trials by January.

Chief Executive Manon Cox estimated the cost of developing and securing approval for a vaccine could be as high as $1 billion. Without government funding, “that product has got to have a market of a few billion dollars,” she said.

With the help of $43 million in initial funding from the U.S. government, France’s Sanofi is developing a candidate using live attenuated virus. The company is not as far along as some other efforts, but it aims to start human trials next year and is confident it can catch up.

“We’ve got technologies, infrastructure, experience dealing with regulators in this field. All of that gives us a jumpstart,” said Nick Jackson, head of research for Sanofi’s vaccine unit.

Another French vaccine maker, Valneva SE, generated an inactivated Zika vaccine candidate using the same process as its already approved Japanese encephalitis vaccine.

GSK is working with NIAID on a new type of vaccine technology. Japan’s Takeda also secured U.S. government funding to help develop a vaccine using killed Zika virus and plans to begin human testing in the second half of 2017.

“If there is a huge need,” said Dr. Rajeev Venkayya, president of Takeda’s global vaccine unit, “there will be a business model that works.”

(Reporting by Bill Berkrot; Editing by Michele Gershberg and Lisa Girion)

U.S. fights Zika mosquitoes with limited arsenal

Zika virus kit

By Julie Steenhuysen

(Reuters) – Over Wynwood, the Miami neighborhood where Zika gained a foothold in the continental United States, low flying planes have been spraying naled, a tightly controlled pesticide often used as a last resort. It appears to be working, killing at least 90 percent of the target mosquitoes.

Across the Biscayne Bay in Miami Beach, wind and high-rise buildings make aerial spraying challenging. So, the effort in the popular tourist destination has focused on ground-sprayed pyrethroids – pesticides that are safer but don’t always work.

The arrival in Florida of Zika, a virus that can cause a crippling birth defect known as microcephaly, has drawn into focus the limitations of the U.S. mosquito control arsenal.

Larvicides reduce future populations relatively safely. But for use against the mature mosquitoes that spread disease, only two classes of pesticides are approved. Each has drawbacks.

Organophosphates, such as naled, are effective. But there are strict controls to limit risk. Pyrethroids are safer but have been used so much that mosquitoes, in many places, are immune.

“That’s really the weak link in much of the United States,” said Michael Doyle, director of the Florida Keys Mosquito Control District. “We’re kind of caught off guard.”

DENGUE PREVIEW

Doyle led a 2009 effort against a dengue outbreak in South Florida, the first in the United States in nearly a century. Authorities threw everything they had at the Aedes aegypti, the same mosquito that carries Zika: backpack fogging, door-to-door yard inspections looking for watery breeding sites and larvicide spraying.

Still, 88 people were infected before the virus was brought under control more than two years later, and there continue to be sporadic cases in Florida.

The outbreak highlighted gaps in the mosquito control arsenal that remain, according to pesticide makers, abatement officials and entomologists. Few companies make pesticides for use in public health outbreaks, a niche market that is expensive to get into, has a limited upside and varies season to season.

Safety testing a new pesticide can cost up to $250 million and take 10 years, said Karen Larson, vice president of regulatory affairs at privately held Clarke Mosquito.

As long as a product remains on the market, companies must continue testing for unforeseen side effects, an expense that some makers have blamed for decisions to abandon products.

“There’s not a lot of profit,” Larson said.

Sales of the Dibrome brand of naled have been estimated at $12 million a year. By comparison, total crop pesticide sales for some companies can exceed $500 million in a single quarter.

Bayer, Dow Chemical, BASF and other agricultural pesticide makers “are not interested in going after a $20 million or $30 million a year market,” said William A. Kuser, investor relations director at Dibrome maker American Vanguard Corp.

The U.S. Environmental Protection Agency has approved several new pesticides in recent years. But it has received few requests for using them against mosquitoes, said Jim Jones, Assistant Administrator for the agency’s Office of Chemical Safety and Pollution Prevention.

“Although it’s of critical importance, the amount one can sell is small and it’s variable, which makes it difficult for business planning,” Jones said. “You can go many years without having much of a market at all, then suddenly, whether it’s because of a nuisance outbreak of mosquitoes or something like West Nile or Zika, the market grows significantly.”

Abatement authorities have pressed for help with the cost of developing mosquito control pesticides. The 1996 U.S. Food Quality Protection Act includes a provision for subsidies to defray the expense of safety testing, but Congress has never funded it.

RISK AND RESISTANCE

At least 49 cases of locally transmitted Zika infections have been reported in Florida, most in Wynwood and Miami Beach. Most people have no symptoms or mild illness.

Because of the microcephaly link, efforts are focused on preventing infection among pregnant women.

In Wynwood, the campaign began with pyrethroids, synthetic versions of a chemical derived from chrysanthemums. Amid signs of resistance, authorities switched to naled.

Developed as nerve agents, organophosphates, at high doses, can cause nausea, convulsions and death. They can be toxic to wildlife, including bees. The EPA considers naled safe at permitted ultra-low concentrations, and it is sprayed annually over 16 million acres in the United States.

But it is banned in Europe, where the risk is seen as unacceptable. In the U.S. territory of Puerto Rico, where Zika is widespread, the governor prohibited naled amid protests over safety concerns.

Although naled killed more than 90 percent of mosquitoes in traps set in Wynwood, the Aedes aegypti’s resilience remains a concern.

“This is truly the cockroach of mosquitoes,” said Tom Frieden, director of the U.S. Centers for Disease Control and Prevention.

DROPPING PESTICIDES

CDC entomologist Janet McAllister said pyrethroid resistance typically is limited by the mosquito’s small range. When resistance to one pyrethroid develops, another often works.

Still, she said, “we would love to see additional classes of insecticides available because, even in places that may have an effective tool today, that doesn’t mean it is going to last down the road.”

The EPA can fast-track its evaluation of new pesticides and expand the use of old ones. In response to Zika, it expedited new uses for pesticide-treated bed nets and mosquito traps.

Still, development of pesticides is painstaking. Even if the EPA speeds up its evaluation, required safety data can take years to collect. And the expense of ongoing safety testing has prompted companies to drop products.

Bayer CropScience, for example, told distributors it dropped the pyrethroid resmethrin in 2012, rather than do additional testing. Clarke Mosquito gave up temephos, a larvicide, six years ago, because of costs, Larson said.

That decision led to stockpiling in southwest Florida, said Wayne Gale, director of the Lee County Mosquito Control District.

“We purchased just about every bit,” he said.

(Reporting by Julie Steenhuysen; Editing by Michele Gershberg and Lisa Girion)

U.S. researcher contracts Zika during experiement

Aedes aegypti mosquitoes are seen at the Laboratory of Entomology and Ecology of the Dengue Branch of the U.S. Centers for Disease Control and Prevention in San Juan

(Reuters) – A United States laboratory researcher was back at work after contracting the Zika virus by pricking herself with a needle during an experiment last month, broadcaster ABC News said on Thursday.

There is no vaccine or treatment for Zika, which is a close cousin of diseases such as dengue and chikungunya, and causes mild fever, rash and red eyes. An estimated 80 percent of those infected have no symptoms.

The unidentified researcher at the University of Pittsburgh pricked herself on May 23 and showed symptoms on June 1, returning to work five days later when she no longer had a fever, ABC News said, citing a statement from the school.

School officials were not immediately available for comment.

The incident was the fourth confirmed case of the Zika virus in Allegheny County, its health department said, without giving details of the accident.

“Despite this rare incident, there is still no current risk of contracting Zika from mosquitos in Allegheny County,” department director Karen Hacker said in a statement.

U.S. health officials have concluded that Zika infections in pregnant women can cause microcephaly, a birth defect marked by small head size that can lead to severe developmental problems in babies.

The World Health Organization has said there is strong scientific consensus that Zika can also cause Guillain-Barre, a rare neurological syndrome that causes temporary paralysis in adults.

The connection between Zika and microcephaly first came to light last fall in Brazil, which has now confirmed more than 1,400 cases of microcephaly that it considers to be related to Zika infections in the mothers.

To reduce the chance of virus transmission, the Pittsburgh researcher is using insect repellent to avoid mosquito bites, besides wearing garments with long sleeves and trousers, ABC News added.

(Reporting by Brendan O’Brien in Milwaukee; Editing by Clarence Fernandez)

U.S. targets spying threat on campus with proposed research clampdown

A man walks through Killian Court at MIT in Cambridge

By Julia Edwards

WASHINGTON (Reuters) – Leading U.S. universities are pushing back against a proposed State Department rule that would bar foreign students from more research projects and classes involving information seen as vital to national security.

The proposal by the administration of President Barack Obama reflects growing worries in Washington over a rise in intellectual property theft from foreign adversaries such as China.

Research related to defense technology such as munitions, nuclear engineering and satellite technology would be particularly affected by the rule, which is still in the proposal process and has not been widely reported.

Defense contractors such as Northrop Grumman, Boeing and Lockheed Martin regularly sponsor university research, but did not respond to requests for comment.

The new rule, which largely applies to company-sponsored research, threatens to shrink the pool of research opportunities available for U.S. colleges, which have grown strongly in popularity among high-paying foreign students in recent years.

Some top U.S. schools do not accept any research grants that restrict participation by foreign citizens because it runs counter to their policies of academic freedom and non-discrimination.

In a letter to the State Department, Stanford University said it joined The Association of American Universities (AAU), Massachusetts Institute of Technology (MIT) and the University of Pennsylvania in criticizing the rule, citing “disastrous consequences.” The AAU represents 62 leading research institutions, including Harvard, Duke University, and the University of Chicago.

The universities say the rule would tip the balance too far in favor of national security against academic freedom.

“We wouldn’t be able to perform the same basic foundational research that we do,” said Stanford’s director of export compliance Steve Eisner. “Stanford has a policy of conducting research openly regardless of citizenship. We’re not going to tell our Chinese students that they can’t participate.”

No current cases of industrial espionage involve university research, though government officials told Reuters they suspect university faculty are violating loosely defined research rules.

A 2011 FBI report said “foreign adversaries and competitors take advantage” of the openness of information on college campuses and a small percentage of students, researchers and foreign professors are “working at the behest of another government.”

There were just under 1 million foreign students at U.S. colleges in the 2014-2015 school year, 31 percent of whom were Chinese, according to the Institute of International Education. That has grown from fewer than 100,000 in the 1960s when the United States began regulating their access to research.

In 2015, the number of intellectual property cases investigated by the FBI rose 53 percent from the previous year.

The FBI says China is the main culprit. It has accused Chinese nationals of attempting to export technology from the United States, including genetically modified corn seed and sensitive military information stored on Boeing computers.

The Department of Justice said in a statement that “we know that some foreign spies and criminals target students and faculty alike to steal valuable technology and intellectual property.” It added it was working with universities and laboratories to raise awareness of the threat.

A spokesman for China’s Ministry of Foreign Affairs, Hong Lei, said the United States should be improving cooperation with China instead of adding restrictions on foreign students.

“China’s scientific and technological developments have been achieved through the hard struggle of the Chinese people,” Lei said at a ministry briefing on Thursday.

SHRINKING RESEARCH CHOICES The proposed rule comes as universities face shrinking federal funding for research, forcing many to rely more on industry-sponsored projects.

State Department officials told Reuters they are aware of universities’ opposition to the rule, but have received no complaints or advice from companies that sponsor university research.

Experts in counterterrorism and counter nuclear proliferation told the State Department tighter restrictions on research access are necessary because universities are “a soft target,” said Tony Dearth, director of defense trade controls licensing at the State Department.

In the first case of its kind, University of Tennessee electrical engineering professor John Reese Roth was convicted in 2008 of exporting “defense articles” without a license, and of wire fraud and conspiracy and sentenced to four years.

Roth used foreign students in research on plasma-based flight-control devices for drone aircraft under a U.S. Air Force contract. He let two foreign students illegally gain access to sensitive information and export it to China, said the FBI.

The proposed rule would expand the definition of research classified as “technical” to any project that undergoes a pre-publication review by a private sponsor.

Unlike less-sensitive “fundamental” research, technical research is regulated in a variety of ways including a requirement that foreign students must apply for a license. Students from China, Iran and North Korea are usually denied licenses, said university officials.

The State Department argues that if a company wants to take a second look at research because it may be sensitive to its economic interests, foreign student involvement should be regulated.

Stanford told the State Department in a public letter that the new rule would affect a broad portion of industry-backed research because universities “routinely” allow sponsors to review results for up to 90 days.

Colleges that object to the government’s foreign-student restrictions have long avoided technical research and focused solely on projects classed as fundamental. The new rule would force them to either loosen their policies or give up defense-related research.

Schools with fundamental research-only policies are already in the minority. A Reuters survey of the top 35 research universities, ranked by R&D expenditures, found only 11 were still adhering to such a position.

Federal funding for research still dwarfs business funding, but the two are trending in opposite directions.

Over 2011-2014, federal funds for university research fell to $37.9 billion from $40.8 billion, according to the National Science Foundation. Over the same period, industry-sponsored university research grew to $5.9 billion from $4.9 billion.

“As federal funds have become scarcer and the competition has increased, I think we see a lot of universities expanding their partnerships with industry,” said Bob Hardy, director of intellectual property management at the Council on Government Relations, an association of research universities.

(Reporting by Julia Edwards; Editing by Kevin Drawbaugh and Stuart Grudgings)

Evidence of Water Found on Mars Announced by NASA

The strongest evidence yet of water on mars was announced by NASA Monday afternoon.

“Our quest on Mars has been to ‘follow the water’ in our search for life in the universe, and now we have convincing science that validates what we’ve long suspected,” said John Grunsfeld, associate administrator at NASA’s Science Mission Directorate in Washington, D.C. “This is a significant development, as it appears to confirm that water — albeit briny — is flowing today on the surface of Mars.”

Although scientists are not sure where the water comes from, liquid water runs down the crater walls over the summer months and leave dark stains on the Martian terrain that have been measured hundreds of meters downhill before they dry up in the autumn when temperatures drop.  

Researchers say the discovery raises the chances of this being home to some form of life.  

Widow Sells Late Husband’s Prized Car for Mental Health Research

A woman who lost her husband to suicide brought on by mental illness has parted with her biggest link to her late husband to try and help others.

Susan Futterman cried as her late husband’s 1967 Lamborghini 400 GT 2+2 sat in their garage for one of the last times.  The car, one of only 250 ever made, was a passion of her husband’s until he was stricken with mental illness at age 58.   Frederic Paroutaud lost his battle with mental illness just two months later when he committed suicide at the couple’s home.

“We really didn’t know there was an issue until April 2012, until he had what appeared to be a psychotic break,” Futterman said. “Things deteriorated pretty rapidly, and at some point he was diagnosed as bipolar.”

The car was auctioned over the weekend for $522,500.

Futterman gave every dollar from the sale to La Cheim Behavioral Health Services, a non-profit group seeking to help boost mental health care in Alameda and Contra Costa counties in California.

“I think the staff is a very dedicated group of people really trying to serve an underserved community, and they’ve been operating on a shoestring,” Futterman said. “I’d like to contribute to something where I can see a difference being made.”

“I think it’s tremendously generous and redemptive. She’s turning a tragedy into something that provides healing for people,” Frances Raeside, La Cheim’s program director, told the Contra Costa Times. “She’s creating a legacy for a really creative and beautiful person. … It’s a great act of courage on Susan’s part, letting go of the car that’s sitting in her garage and was a constant reminder of her husband.”

Eleven Christians Killed Every Hour, Says Catholic Bishop

The chair of the council for Justice & Peace of the Irish Catholic Bishop’s conference is speaking out about Christian persecution around the world, saying that 11 Christians are killed every hour for their faith in Christ.

Bishop John McAreavey cited a Pew Research survey showing Christianity is the most prosecuted religion around the world with persecution against them reported in 110 countries.

“Many of these countries have significant trade links with Ireland. Persecution is increasing in China. In North Korea a quarter of the country’s Christians live in forced labour camps. Saudi Arabia, Yemen, and the Maldives all feature in the 10 worst places to be Christian,” McAreavey said.  “According to the International Society for Human Rights, a non-religious organization, 80 percent of all acts of religious discrimination in the world today are directed against Christians.”

McAreavey said that the persecution of Christians in the Middle East is “a threat to our common humanity” and that the stability of the entire planet is at risk because of the violence in the region.  He also condemned Western leaders who are not taking steps to help persecuted Christians.

“Perhaps because of a fear of being seen as less than aggressively secular in their own country,” he said, many governments of majority Christian countries in the West seem reluctant to give direct aid to churches and religious minorities.”

McAreavey defined the loss of religious freedom and persecution as something that “can run from subtle cultural exclusion of the religious voice from the public square and refusal to accommodate reasonable differences of conscience to active discrimination, forced displacement, exploitation and loss of life.”

Scientists Find Protein To “Turbo-Charge” Immune System

Scientists at Imperial College London have found what they call a “game-changer” for cancer treatment: a protein that will “turbo-charge” the immune system to fighting cancers and viruses.

“This is exciting because we have found a completely different way to use the immune system to fight cancer,” said Professor Philip Ashton-Rickardt, from the Section of Immunobiology in the Department of Medicine at Imperial, who led the study.

“It could be a game-changer for treating a number of different cancers and viruses. This is a completely unknown protein. Nobody had ever seen it before or was even aware that it existed. It looks and acts like no other protein.”

When the body detects cancer, it will immediately flood the immune system with T-cells which fight the cancer.  However, the body quickly reduces that output after the initial wave.  The new protein creates T-cells in large enough numbers that cancer cannot fight them off.

The protein also creates “memory cells” in the immune system to recognize previously fought cancers and viruses to lessen the chances of their return.

“The discovery of a protein that could boost the immune response to not only cancer, but also to viruses, is a fascinating one,” Dr. Mike Turner of the Wellcome Trust, told the Daily Telegraph.  “Further investigation in animal models is needed before human trials can commence, but there is potential for a new type of treatment that capitalizes on the immune system’s innate ability to detect and kill abnormal cells.”

The study has been published in the journal Science.

Muslims Could Outnumber Christians Worldwide By 2070

A new study shows that Islam is the fastest growing religion in the world and will surpass Christianity by the middle of the century.

The study from the Pew Research Center says that the only religion that won’t see increases in numbers by 2050 is Buddhism.  Islam will be the only religion that increases faster than the world’s population on the whole.

Christianity and Islam will obtain equal status by 2050 according to the study.

The study showed bad news for Christianity in North America.  The number of Christians in the United States will decline from 78 percent of the population to around 66 percent by 2050.

Muslims, “other religions” and those who are not affiliated with any religion will see the largest increases.  The study predicts there will be more Muslims than Jews in the U.S. by 2050.

The study attributes the increase to Muslim women having the highest fertility rate with 3.1 children per woman.  Christians are second with 2.7 per woman.  The highest percentage of youth are Muslim at 34 percent compared to 27 percent for Christians.

Cow Bile & Garlic Potion Kills Superbug

A medieval remedy for eye infections has accidentally been discovered as a killer of the drug-resistant superbug MRSA.

Dr. Christina Lee of Nottingham University, England, recreated the 10th century potion to see if it really worked as an anti-bacterial remedy for stys and other eye infections.

The salve comes from two species of Allium (garlic, onions or leeks), wine and oxgall (the bile from a cow’s stomach.)  The substances are place din a brass vessel to brew, strained for purity and then left for nine days before used on the subjects.

The researchers were shocked to see the “medication” cured stys.

The researchers then decided to see if other diseases could be impacted by the salve and tested it on mice that had MRSA in wounds.  The study showed 999 of 1000 MRSA cells were killed by the remedy.

Dr. Kendra Rumbaugh of Texas Tech University said the salve worked “as good, if not better than” drugs that are currently on the market.

The researchers are now seeking approvals to test the concoction on humans.