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Asthma/COPD Device Maker Lands $14.5M in Venture Funds

Illustration of lungs (Mikael Häggström/Wikimedia Commons)

(Mikael Häggström/Wikimedia Commons)

5 September 2014. Propeller Health in Madison, Wisconsin, developer of a system to track respiratory disorder medications in real time, secured $14.5 million in its second round of venture financing. The funding round was led by venture investment company Safeguard Scientifics, with participation by the Social+Capital Partnership, Propeller Health’s previous funding source.

The Propeller Health system is designed to help people with asthma and chronic obstructive pulmonary disease or COPD track their maintenance therapy. Asthma is chronic condition, where the airways become inflamed and narrow, causing people with asthma to experience wheezing, shortness of breath, tightness in the chest, and coughing for periods of time. Centers for Disease Control and Prevention estimates that in 2010 asthma 18.7 million adults had asthma, along with 7 million children.

COPD has symptoms resembling asthma, including wheezing, shortness of breath, and chest tightness, but COPD is more of a progressive disease where the airways and air sacs in the lungs lose their flexibility, become inflamed, or make more mucus than usual, preventing blood vessels in the lungs to bring in oxygen and remove carbon dioxide. There are two major forms of COPD, emphysema and chronic bronchitis, together affecting at least 15 million people in the U.S., mainly over the age of 65, according to CDC.

People with asthma or COPD are asked to keep close track of their symptoms and events that trigger attacks or exacerbations that cause flare-ups of the symptoms, as well as record use of medications, such as rescue inhalers, to relieve those symptoms. With COPD in particular, exacerbations can make the disease progress faster and result in hospitalization. Keeping a diary, however, is an unreliable record and not easy for many people to maintain.

The Propeller Health system combines a medication sensor that fits over the the inhaler and measures the amount of medication administered with each use. Those data are captured in software on a smartphone app — iOS and Android versions are available — via a Bluetooth connection that adds the location with date and time, to provide an ongoing record of medication use. The software also allows patients to record symptoms. The data are then transmitted to parents and physicians, who can make any adjustments in the medications if warranted by these reports..

The company plans to apply the funding round’s proceeds to product development, new alliances, and marketing. In May 2014, FDA cleared a new version of the system with a smaller sensor to conserve battery life and more sophisticated analytics. In July, Arizona Care Network, an accountable care organization, began offering the Propeller Health system to its members with COPD. Accountable care organizations are groups of health care providers that voluntarily coordinate their services, particularly for patients with chronic diseases.

Safeguard Scientifics, in Wayne, Pennsylvania, is a venture investment company that specializes in growth-stage enterprises working in health or medical technologies developing innovative solutions, with intellectual property protection and a rapid path to commercialization. The company generally makes initial investments of $5 to $15 million.

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Hat tip: Fortune/Term Sheet

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Coffee Genome Sequenced, Caffeine Enzymes Analyzed

Coffee beans

(Harald Hoyer, Wikimedia Commons)

5 September 2014. An international team of researchers sequenced the genome of a major type of coffee that revealed the evolutionary pathway of this popular drink, and more details about caffeine, a main attraction of coffee. The team was led by Institute of Research for Development and National Sequencing Center, both in France, and University at Buffalo in New York. The findings appear in this week’s issue of the journal Science (paid subscription required).

According to International Coffee Organization, coffee is grown in 70 countries, mainly in tropical and sub-tropical regions, producing some 8.7 million metric tons (9.6 million short tons) in 2013. For many of the countries, coffee is an important cash crop and income generator. International Coffee Organization estimates in 2010 coffee production generated $15.4 billion in revenue and employed some 26 million people worldwide.

The research team — from institutions in Europe, Asia, and North and South America — used a whole genome shotgun sequencing strategy that reveals the order of all DNA molecules in an organism. This analysis makes it possible to pinpoint the evolution of the organism and identify similarities or differences in other species. The results offer a better understanding of strengths and weaknesses of the species, which makes possible tweaks in the genome to make coffee, in this case, resist pests or adapt to changing climatic conditions.

The researchers analyzed the genome of Robusta coffee (Coffea canephora) that accounts for about 30 percent of worldwide coffee production, grown in West and Central Africa, as well as Southeast Asia and Brazil. The team compared the sequencing data from Robusta coffee with a similar analysis of tomatoes, grapes, and Arabidopsis, a well-documented reference plant.

The findings show the coffee genome has similarities in evolutionary development to grapes and tomatoes, but coffee evolved separately, creating unique and more stable families of genes, including those that give coffee its recognizable aroma and flavor. These unique gene families also help make Robusta more resistant to disease than Arabica coffee, grown in more regions of the world.

“By looking at which families of genes expanded in the plant,” says Buffalo biologist and senior co-author Victor Albert in a university statement, “and the relationship between the genome structure of coffee and other species, we were able to learn about coffee’s independent pathway in evolution, including — excitingly — the story of caffeine.”

Caffeine not only produces the mild stimulants that attract drinkers, it is also believed to give the plants protection against pests and disease. The analysis revealed that the genes producing enzymes known as N-methyltransferases or NMTs in turn produce the caffeine in coffee. While this process is similar in tea and cacao, which also produce caffeine, the analysis shows the NMT-producing genes in coffee developed separately from tea and cacao.

Albert tells more about the study in the following video.

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PBS to Air Documentary on Vaccine Attitudes and Disease

Paul Offit and Sonya Pemberton

Paul Offit, left, and Sonya Pemberton (A. Kotok)

4 September 2014. Public Broadcasting Service (PBS) will air a documentary next week on the changing public attitudes toward vaccines and their effects on the growing occurrence of communicable diseases in the U.S. The show, Vaccines — Calling the Shots premieres on PBS as part of the NOVA series of science documentaries on Wednesday 10 September.

At a briefing today for media in Washington, D.C., the show’s producer-director and some of the experts appearing in the film described the degree of public resistance to vaccinations for children, which appears to be bringing back more cases of diseases once thought eradicated. Centers for Disease Control and Prevention reports as of the end of August 2014 nearly 600 cases of measles in the U.S., for example, the largest number in 20 years. Also as of August, the state of California declared a pertussis or whooping cough epidemic, with more than 7,500 cases reported so far in the state this year. Refused or delayed vaccinations are considered a prime cause of both outbreaks.

Paul Offit, director of vaccine education at Children’s Hospital in Philadelphia, outlined the idea of community or herd immunity, a situation where nearly all people in a community are vaccinated against a disease, which sharply reduces chances for that disease to spread, and the keeps the disease contained. However, once the rate of vaccination drops below 95 percent, said Offit, herd immunity begins to break down for diseases like measles.

One of the reasons for growing resistance to vaccinations, Offit noted, is the lack of awareness of the suffering these diseases can cause. Before development of the measles vaccine in 1963, measles was familiar and feared, causing 38,000 hospitalizations and 500 deaths a year. Offit told about dealing personally with a measles outbreak in Philadelphia in 1991, causing 1,400 cases and 9 deaths. “The city was in a panic,” he added.

Sonya Pemberton — a film maker, science journalist, and the show’s producer, director, and lead writer — noted the small numbers of people who are adamantly opposed to vaccinating their children, about 1 percent, but still have an influence on many more who have questions about vaccine safety. Pemberton estimates those opposed or questioning vaccinations comprise about 10 percent of the population, a relatively small percentage, but enough to break herd immunity.

Pemberton recommended speaking to parents with questions or concerns about vaccines “respectfully and acknowledging people are not necessarily outright refusing, but are concerned.” People with concerns about vaccines will get all kinds of information over the Internet, and you need to deal with those fears with sensible and impartial information based on science. “It is okay to talk concerns and fear,” said Pemberton, noting that “acknowledging fear helps people deal with fear.”

Brian Zikmund-Fisher, a psychologist and professor of public health at University of Michigan, studies perceptions of risk associated with vaccines. He noted that vaccines are among the safest of medicines made, yet on a personal level, it is often difficult to sell parents — the vast majority of whom never experienced the diseases — of the benefits of a vaccine, as long as there are fears about safety. Zikmund-Fisher said discussing statistical probabilities, no matter how small, does not work, adding “parents care about possibility not probability.”

Joe Lawlor, a health reporter for the Portland Press Herald in Maine, wrote a series about vaccines in Maine that suffered a pertussis outbreak in 2012.He said the series got some 600 comments, about 10 times the usual number.

Maine, like most states, allows parents to opt out of vaccines for religious or philosophical reasons, and nearly 4 percent of parents exempt their children from vaccinations. Some of the resistance is political, Lawlor said, where some people object to government telling parents what to do. Nonetheless, Washington State tightened their exemption requirements, which resulted in fewer disease outbreaks in that state.

In response to a question from Science and Enterprise, Offit said pediatricians do a better job at explaining the rationale behind vaccines for children than family practitioners convincing adults to get vaccinated for the flu or shingles. While family practitioners are doing better, he still called vaccination rates among adults “woeful.”

Zikmund-Fisher added people tend to be more protective of children than themselves. “Children are people that are looked upon as needing special protection,” said Zikmund-Fisher, “and that makes the conversation more difficult when the tradeoff between benefits and risks comes to the surface.”

Vaccines -- Calling the Shots logo

(PBS.org)

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Calico, AbbVie Partner on Aging Disorder Therapies

Hands with arthritis (NIH)

(National Institutes of Health)

3 September 2014. California Life Sciences LLC, better known as Calico, and the pharmaceutical company AbbVie Inc. are collaborating on discovery and commercialization of drugs for age-related diseases such as cancer and neurodegenerative disorders. The partnership, which includes building a new research center, could result in a joint investment as high as $1.5 billion.

Calico, started a year ago by Google, aims to address diseases associated with the aging process and that degrade the quality of life as people age. Google last year recruited Arthur Levinson as the company’s CEO. Levinson was chairman and CEO of the biotechnology company Genentech, now a subsidiary of Roche, and is currently chairman of Apple. Levinson also served on Google’s board from 2004 to 2009.

Under the deal, Calico and AbbVie will each contribute $250 million to fund the partnership, including the building of a research and development center in the San Francisco Bay region. Calico will concentrate on drug discovery and early drug development, through initial intermediate-stage clinical trials.

AbbVie plans focus on later-stage clinical trials and commercialization that advance new drugs to the marketplace. Both companies are expected to share costs and profits. The companies also agreed that further financial contributions could reach as high as $500 million from each party.

AbbVie currently has in its pipeline drugs and biologics for various disorders associated with aging, such as osteoarthritis, Parkinson’s disease, and both blood-related and solid tumor cancers.

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Multi-Purpose Drug Boosts Adherence After Heart Attack

Human heart and arteries (Yale School of Medicine/Wikimedia Commons)

(Yale School of Medicine/Wikimedia Commons)

3 September 2014. Researchers at Mount Sinai Hospital in New York and National Centre for Cardiovascular Research in Madrid, Spain found a pill combining three cardiovascular drugs usually prescribed separately helps heart attack patients stick to their medications better than the three drugs taken separately. The team led by Valentin Fuster, accredited to both institutions, presented its findings yesterday at the European Society of Cardiology meeting in Barcelona.

Physicians treating people who suffer heart attacks often report problems getting their patients to stick to their prescribed medications, with non-adherence rates at 60 percent or more, which impedes the patients’ recoveries. The authors cite data estimating half of the reduction in cardiovascular deaths in Western countries in the past 20 years can be attributed to heart attack patients taking their medications as prescribed, thus improving medication adherence can lead to fewer subsequent heart attacks.

Fuster and colleagues first surveyed the medication adherence behavior of 2,118 people in Spain, Italy, Argentina, Brazil, and Paraguay who suffered a heart attack to establish baselines and uncover reasons for not taking prescribed medications. Their analysis revealed less than half (46%) of heart attack patients in these countries took their medications, with reasons for non-adherence occurring more among younger patients and those with depression, as well as patients citing problems following a complex regimen, poor health insurance, and a low level of social support.

The team then designed a clinical trial to test a drug containing three medications usually prescribed separately, against the usual practice of prescribing the individual drugs. The trial tested the drug Trinomia, made by Ferrer Laboratories, a Spanish pharmaceutical company, containing:

– 100 milligrams (mg) of aspirin that acts as a blood thinner

– 40 mg of simvastatin, a statin drug to control cholesterol levels

– 10 mg of ramipril, an angiotensin-converting enzyme (ACE) inhibitor to treat high blood pressure

The trial recruited 695 patients from four of the countries in the original analysis — Italy, Argentina, Brazil, and Paraguay — who suffered heart attacks, randomly assigned the patients to receive Trinomia or the three separate drugs, and followed their progress for 9 months. The researchers measured adherence through a standard drug-adherence questionnaire and an audit of the drugs maintained by the patients.

The trial results showed more patients taking the single pill stay with medication schedule (63%) than patients taking three separate medications (52%), with the findings consistent for both the questionnaire and the pill counts. The follow-up also revealed, however, no statistically reliable differences between the single or multiple-drug groups in average blood pressure, cholesterol levels, serious adverse effects, or deaths.

A longer-term trial is in development, says Fuster in a Mount Sinai statement, to test if improved drug adherence with the multi-purpose drug leads to reductions in subsequent heart attacks.

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Breakthrough Status Given Parkinson’s Psychosis Drug

Brain networks illustration

(DARPA.mil)

2 September 2014. Acadia Pharmaceuticals says the U.S. Food and Drug Administration designated its drug candidate pimavanserin as a breakthrough therapy for the treatment of psychosis associated with Parkinson’s disease. Acadia is a biopharmaceutical company in San Diego specializing in neurological and central nervous system disorders.

Pimavanserin is Acadia’s lead therapy candidate, to be offered under the trade name Nuplazid, and designed for patients with Parkinson’s disease experiencing periods of psychosis. Parkinson’s disease is probably best known for its physical symptoms like tremors and balance problems, but the disorder can also lead to psychiatric symptoms including hallucinations and delusions.

The company cites data indicating up to 40 percent of Parkinson’s disease patients have occurrences of psychosis, with no treatment yet approved for the condition in the U.S. Patients with psychosis as well as the physical symptoms experience a sharply reduced quality of life and impose a significant burden on caregivers.

Pimavanserin is a small molecule drug that binds to receptor proteins in the brain associated with psychosis, and exert a controlling or moderating influence on those receptors. The drug is administered orally once a day. In October 2013, Acadia reported results of a late-stage clinical trial in the journal The Lancet showing Parkinson’s disease patients taking pimavanserin have fewer experiences of psychosis, such as hallucinations and delusions, while maintaining motor control, compared to a placebo.

FDA designates therapy candidates as breakthroughs when they address a serious condition and demonstrate through clinical evidence that the treatment is a substantial improvement over current methods. Once designated as a breakthrough therapy, a drug or biologic can receive early and frequent communications with FDA staff, quick resolution of questions, intensive guidance on drug development, and an organizational commitment from top managers at FDA.

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U.S. Diet Quality Improves, But Still Not Healthy

Complex carbohydrates (Agricultural Research Service/USDA)

(Agricultural Research Service/USDA)

2 September 2014. A study by researchers at Harvard University shows some improvement in the health benefits of food eaten by Americans over the last decade, but the overall quality of the American diet remains poor. The study led by nutrition and epidemiology professor Walter Willett appears online in the journal JAMA Internal Medicine (paid subscription required).

Willett and colleagues — from Harvard’s School of Public Health, Brigham and Women’s Hospital, and University of California in San Francisco — looked for any changes in the quality of food eaten in the U.S. over the period 1999 to 2010, given the link between diet and various chronic diseases. That period experienced significant changes in the economy and several policy changes related to nutrition. The researchers also examined differences in diet among various ethnic and socioeconomic groups.

The team took a sample of more than 29,000 adult responses from the National Health and Nutrition Examination Surveys conducted from 1999 to 2010, which include items on diet and nutrition. The researchers then rated the responses on two dietary quality indexes: Health Eating Index 2010 and Alternate Healthy Eating Index 2010, which correlates with incidences of major chronic diseases.

The research team found the Alternate Healthy Eating Index score, which ranges from 0 to 110, increased overall from 39.9 in 1999-2000 to 46.8 in 2009-2010. More than half of the quality gain is from lower intake of food with trans fat, unsaturated fat artificially laden with hydrogen to remain solid, but that also adds LDL (bad) cholesterol and reduces HDL (good) cholesterol, increasing the risk of heart disease. The authors attribute the reduction in trans fat in diets to changes in food choices, including fewer processed foods.

The researchers also found Americans eating more whole fruit, whole grains, nuts, and polyunsaturated fats, and drinking fewer sugary drinks. At the same time, Americans were still eating about the same amount of red and processed meat, with no increase in the consumption of fresh vegetables. In addition, the team found an increase in the amount of salt consumed in diets.

People in higher socioeconomic groups had higher quality diets than people at the lower end of the socioeconomic scale throughout the study period, with the gap increasing during the decade. The authors attribute the gap to higher prices for fresh food and more access to sources of fresh food in high-income neighborhoods. The researchers also found education to play a role, with lower-quality diets and less improvement in diet quality among people with 12 years of schooling or less.

“The overall improvement in diet quality is encouraging,” says Willett in a university statement, “but the widening gap related to income and education presents a serious challenge to our society as a whole.” Many of the improvements, note the authors, were helped by policy changes, such as new laws in some jurisdictions banning trans fat, which influenced individual food choices.

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Labor Day 2014

1 September 2014. Today is Labor Day in the U.S. and Labour Day in Canada, thus Science & Enterprise will be taking a break. Regular posting resumes tomorrow.

Way before rap, there was talking blues. Here’s a recording of the late Pete Seeger with a talking blues song for Labor Day, Talking Union.

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Humanoid Robots Help Children with Autism Learn Interaction

Maja Mataric´ and robot

Maja Mataric´(University of Southern California)

29 August 2014. Engineers and computer scientists at University of Southern California in Los Angeles show how commercial humanoid robots can help children with autism spectrum disorder learn basic social behavior. The team from the lab of Maja Mataric´, director of USC’s Robotics and Autonomous Systems Center, presented its findings earlier this week at the IEEE International Symposium on Robot and Human Interactive Communication in Edinburgh, Scotland.

Autism spectrum disorder is a collection of neurodevelopmental conditions, marked by communication difficulties and impaired social interaction, as well as repetitive and stereotyped patterns of behavior. At age 8, some 1 in 88 children have autism spectrum disorder, according to Centers for Disease Control and Prevention. Classic autism is considered the most severe form of the syndrome.

The study devised by Mataric´ and colleagues aimed to find out how children with autism spectrum disorder react to humanoid robots that provide graded cueing, a process shaping behavior that uses increasing specific prompts to improve everyday skills of people in recuperative therapy. Graded cueing is employed for conditions such as brain injury, or to learn new or lost skills, as in the case of children with autism spectrum disorder.

For this pilot study, the USC researchers enrolled 12 children with autism spectrum disorder, who played an imitation game, a form of copycat, with a humanoid robot, the Nao model made by Aldebaran Robotics. The game asked the children to imitate 25 different arm poses.

Children performing the pose correctly received positive feedback from the robot in the form of flashing green eyes, or a nod and the spoken words “good job” in response. Half of the group received graded cueing feedback from the robot partner when the child did not accurately perform the pose. The prompts first began as verbal cues, followed first by more detailed instructions and then demonstrations. For the children in the other (control) group, the robots only repeated the command.

The results show children receiving the graded cueing feedback until the correct pose was performed improve or maintain their performance, while those receiving only a repetition of the command show no improvement or regress. The findings suggest receiving the varied feedback from a socially assistive robot can help children with autism spectrum disorder learn simple interactive skills.

The pilot study is one of a number of projects underway in USC’s Interaction Lab developing adaptive or personalized socially assistive robots to help people with special needs. “There is a vast health care need,” says Mataric´in a university statement, “that can be aided by intelligent machines capable of helping people of all ages to be less lonely, to do rehabilitative exercises, and to learn social behaviors.”

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Ebola Vaccine Safety Trials Scheduled in U.S., U.K., Africa

Ebola health care workers

Ebola health care workers in Guinea (European Commission-ECHO/USAID)

28 August 2014. Early-stage clinical trials testing the safety of new vaccines to protect against the Ebola virus are scheduled to begin as early as next week at sites in the U.S., United Kingdom, Mali, and The Gambia in West Africa. The vaccines are being developed by National Institute of Allergy and Infectious Diseases (NIAID), part of National Institutes of Health in the U.S., and the pharmaceutical company GlaxoSmithKline in the U.K.

This year’s Ebola virus disease outbreak is one of the largest ever recorded and affects four countries in Africa: Guinea, Liberia, Sierra Leone, and Nigeria. The disease is caused by a virus spread through direct contact, often through broken skin or mucous membranes, with a sick person’s blood or bodily fluids, contaminated objects such as needles, and infected animals. Family and friends of people with Ebola and health care workers are among those most at risk, because of the higher probability of coming into contact with bodily fluids from a person with the disease.

Early symptoms of Ebola virus disease are fever, severe headache, muscle and abdominal pain, weakness, diarrhea, vomiting, and unexplained bruising or bleeding that quickly become more severe and often lead to death. The incubation period is 2 to 21 days. According to Centers for Disease Control and Prevention, more than 3,000 cases of Ebola are confirmed or suspected, resulting in 1,552 deaths. World Health Organization says the 47 percent survival rate of the current outbreak is higher than in previous Ebola outbreaks.

Two Ebola vaccines are being developed. One vaccine aims to protect against the Zaire strain of the virus, causing the current West Africa outbreak. The other vaccine is designed to protect against both the Zaire strain and a separate Sudan strain of Ebola.

The first clinical trials will test the vaccines with healthy adults, to reveal unforeseen side effects and to measure the immune response generated by the vaccine. The trial in the U.S. will test the vaccine developed by NIAID and GlaxoSmithKline developed for both Ebola strains. The parallel trial in the U.K., Mali, and the Gambia will test the vaccine covering only the Zaire strain. Later trials will test for the vaccine’s efficacy, in this case its ability to prevent the disease in a healthy individual.

The vaccine is made of tiny amount of Ebola genetic material designed to generate a single Ebola protein, which in turn provokes an immune response in the recipient, but not cause the recipient to contract the disease. NIAID and GlaxoSmithKline say preclinical studies conducted last year show the vaccine was able to protect against the Ebola virus in primates, while not causing adverse effects.

The trial in the U.S. will be conducted at National Institutes of Health. The U.K. study will be conducted by the Jenner Institute at University of Oxford, which will be followed by a trial in the Gambia. A parallel study in Mali will be conducted by University of Maryland and the Malian health ministry in Bamako, the capital city.

GlaxoSmithKline says funding for the trials will enable the company to manufacture some 10,000 additional doses of its vaccine while the trials are underway, should results show the vaccine is successful. The additional doses will be provided to World Health Organization for distribution in high-risk communities.

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