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Inexpensive Pumps Devised for Portable Labs-on-Chips

Hydraulic battery

‘Hydraulic battery’ shown here pumping fluid through a simple microchannel, with images taken 12 minutes apart. (Glenn Walker, North Carolina State University)

9 March 2017. An engineering lab developed an inexpensive pump without electric power for lab-on-a-chip devices, making these systems more portable for diagnostics. Researchers from a joint biomedical engineering lab at North Carolina State University and University of North Carolina describe the pumps in an article published in late February 2017 in the journal World Scientific Technology (free registration required).

The pumps are the work of the lab in Raleigh led by biomedical engineering professor Glenn Walker that studies microfluidic, or lab-on-a-chip devices for testing and patient monitoring. Among the devices in development by Walker and colleagues are chips to replicate the microenvironment or support system for cancerous tumors, and monitor parathyroid hormone levels among people with overactive thyroid glands. Microfluidic devices, however, require fluids to be pumped through the fine microchannels in their chips, which today also require power sources and control functions.

When microfluidic devices are used in a hospital or clinic, external power is not a problem. When taken into the field to the point of care, however, the pumping devices need a power source, such as batteries, that add weight, cost, and complexity to the systems. “Portability is important, because it makes new applications possible, such as diagnostic tools that can be used in the field,” says Walker in a North Carolina State statement. “Electric pumps, and tubing to connect them, are fine for a laboratory environment, but those aren’t easy to take with you.”

Providing power is only part of the problem. Pumping systems on microfluidic devices also need to start, stop, and adjust their flow rates on demand. The Carolina team calls its solution for these functions an hydraulic battery, another name for the capillary action of water through paper, where fluids such as blood are drawn into minute empty pores by their surface tension. In the team’s microfluidic pumps, the pores are 125 microns across, where 1 micron equals 1 millionth of a meter.

Control functions are designed or programmed into the paper. Two-dimensional pores make it possible to turn pumps off and on by attaching or detaching the paper to the chip. But more complex functions can be programmed with three-dimensional designs, where individual paper pumps are stacked and integrated. In their paper, the team demonstrates various control functions of flow rates, including step changes, as well as ramping and oscillating flows.

The researchers designed the paper pump as an attachment to microfluidic chips, with its low cost as a highly desirable feature. The pump is made from commercial chromatography paper used to separate chemical components in the lab, with the sheets laminated to prevent evaporation. The team estimates those materials cost about $0.07 per pump. The low cost means it’s disposable, but its detachable nature also makes it possible to save the fluid sample in the paper for analysis later on.

The lab filed a patent application for the technology and is seeking industry partners to take the technology to market. “Our hydraulic battery is small, lightweight, very inexpensive, easy to connect to a device and disposable,” adds Walker. “We’re optimistic that it could make a difference in both public health and advancing fundamental research.”

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Trial Shows Bioactive Glass Stops Bone Infections

Implanting bioactive glass granules

Implanting bioactive glass granules (BonAlive Biomaterials Ltd.)

8 March 2017. Grafts of glass-based substitute material were shown in a clinical trial to stop bacterial bone infections from osteomyelitis, in most cases without additional antibiotics. Results of the study were reported in January 2017 as part of the Advances in Experimental Medicine and Biology series published by Springer.

The study, led by Nina Lindfors, a professor of surgery at University of Helsinki, tested the bioactive glass product code-named BAG-S53P4 by BonAlive Biomaterials Ltd. in Turku, Finland among patients with chronic osteomyelitis. The condition often results from trauma, where infections spread from nearby tissue or through the blood stream, to longer bones in the arms or legs. Infections can also affect bones in the feet as a result of diabetic foot ulcers.

BonAlive designs BAG-S53P4 as granules for surgical implants for grafts to fill voids in infected bones. The product, says BonAlive, is made with materials found in the body including silicon, sodium, calcium, and phosphorous. When bioactive glass comes in contact with fluids in the body, sodium is released from the granules’ surfaces causing an increase in pH, which discourages bacterial growth. The release of silicon, calcium, and phosphorous ions, along with sodium, also increases osmotic pressure in the bone, further inhibiting growth of bacteria.

At the same time, says the company, bioactive glass forms a silica gel layer on the surface of granules to receive calcium phosphate precipitation, which crystallizes into bone-like material. This crystallized calcium phosphate bonds with surrounding bone in the patient to fill voids caused by the infections.

For the study, Linford and colleagues recruited 116 individuals in 6 countries in Europe and central Asia with chronic osteomyelitis, age 15 to 87 (median: 48), with infections in their tibia or femur bones in the leg, or heel bones. Many patients already received previous surgeries, in some cases for as long as a decade. Most (85%) participants received only the BAG-S53P4 granules, with the remainder first being treated with antibiotics. The results show nearly all (90%) participants reported total clearance of their infections, followed by a full recovery.

“The use of bioglass is a new approach without local antibiotics, thus the risk of creating resistant bacteria is reduced and the bone has a good template to grow,” says Arnold Suda, an orthopedic surgeon at Mannheim University Medical Center in Germany, and a co-author of the study. “With the amount of refugees with rare and very aggressive bacteria from the near east, Africa or Afghanistan, antibiotic treatment encounters its limits and bioglass seems to be an effective opportunity in these cases.”

BonAlive bioactive glass granules are used in smaller sizes for facial bone reconstruction. The product is used in neuro, trauma, orthopedic, and ear surgery for both adults and children. The company says some 10,000 surgeries used bioactive glass last year.

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Nanotech Gel Designed to Treat Snake Bites

Western diamondback rattlesnake

Western diamondback rattlesnake (H. Krisp, Wikimedia Commons)

8 March 2017. A team from University of California in Irvine developed a snake bite treatment that in lab tests stops venom more effectively and at lower cost than current antidotes. Researchers in the lab of chemistry professor Ken Shea published their findings in December 2016 in Journal of the American Chemical Society (paid subscription required).

Shea’s lab studies synthetic chemicals, in this case as polymers formulated into nanoscale particles that can neutralize the toxins in snake venom. The UC-Irvine team cites data showing some 4.5 million people worldwide are bitten by snakes each year, with more than half suffering serious injuries, leading to an estimated 100,000 deaths. Many of the snake bite victims are farm workers in low-resource regions of India and Africa.

Current treatments require intravenous infusions at hospitals or clinics that can cost up to $100,000. In addition, many treatments target specific types of venom or species. The UC-Irvine researchers, led by doctoral student and first author Jeffrey O’Brien are seeking a more readily available and less expensive alternative that can treat a wide range of toxic bites.

In their solution, O’Brien and colleagues address a group of phospholipase A2 or PLA2 proteins found in a number of venomous snakes including cobras and kraits in Asia and Africa, and pit vipers in North America. These enzymes break down the outer membranes of cells enabling the rapid spread of toxins in the body. The team applied techniques developed earlier to treat bee stings, which mix synthetic antidote chemicals formulated into nanoparticles for a gel material that can be easily transported and spread on affected areas.

The researchers in this case synthesized antibodies usually generated from venom injected in horses and extracted from their blood, a process that can take weeks and is illegal in the U.S. The team formulated the antibodies into nanoparticles and mixed the particles in hydrogels, networks of material that contain primarily water, but maintain enough substance to form into 3-D gelatinous structures.

Tests in lab dishes with human blood serum show the hydrogel binds to the PLA2 proteins, preventing them from breaking down red blood cell membranes. The tests show the toxins are absorbed into the nanoparticles, and sequestered from blood cells, preventing the toxins from causing harm.

“Current anti-venom is very specific to certain snake types,” says O’Brien in a university statement. “Ours seems to show broad-spectrum ability to stop cell destruction across species on many continents, and that is quite a big deal.”

The researchers say they learned since publication of the study their process could also be applied to scorpion and some spider bites. The university filed for patents on the technology, and the lab is seeking funds for clinical trials and product development. The U.S. military that financed early stages of the lab’s research is seen as a major potential market, particularly since snake bite kits can be made at a fraction of the cost of current antidotes.

“The military has platoons in the tropics and sub-Saharan Africa, and there are a variety of toxic snakes where they’re traipsing around,” notes Shea. “If soldiers are bitten, they don’t have a hospital nearby; they’ve got a medic with a backpack. They need something they can use in the field to at least delay the spread of the venom.”

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Precision Medicine, “My Hope for the Future”

Emily Kramer-Golinkoff

Emily Kramer-Golinkoff (A. Kotok)

7 March 2017. A meeting on Capitol Hill in Washington, D.C. today heard about one person’s struggle with cystic fibrosis and her hope for precision medicine to provide a cure. Emily Kramer-Golinkoff, co-founder of the patient advocacy group Emily’s Entourage, described her experience with cystic fibrosis and the work of her organization at a briefing on a new report on precision medicine released today by the Personalized Medicine Coalition.

Kramer-Golinkoff’s story was meant to highlight the need for precision medicine to tackle inherited diseases like cystic fibrosis featured in the report. Precision medicine takes advantage of recent advances in technology making it faster and less expensive to genetically analyze and reveal particular biomarkers or molecular indicators responsible for disease, then finding treatments addressing those indicators. In cancer, for example,  genetic analysis of tumors can reveal mutations underlying the tumor that can be addressed with drugs sometimes used to treat cancer found in other parts of the body.

For Kramer-Golinkoff, however, precision medicine has yet to find a cure for her cystic fibrosis, a genetic disease of the glands that make mucus, a substance keeping the lungs and airways moist, as well as helping prevent infection. The disease results from mutated genes passed from each parent to their children. With cystic fibrosis, the mucus becomes thick and sticky, and builds up in the lungs and airways, where the accumulation of mucus makes it easier for bacteria to grow, leading to repeated lung infections. The build-up of mucus in the other organs like the pancreas can likewise block ducts interrupting the flow of enzymes for digestion.

Emily’s Entourage, the organization in Philadelphia started by Kramer-Golinkoff offers a patient registry and raises money for research in cystic fibrosis. The group awards grants for high-impact breakthroughs designed to accelerate progress in nonsense mutations, where a mutated sequence results in an incomplete and shorter than usual protein. The group also provided seed funding for Talee Bio, a start-up company commercializing research leading to gene therapies for cystic fibrosis.

Precision medicine contributed to development of two drugs so far to treat cystic fibrosis, Kalydeco in 2012 and Orkambi in 2015, both made by Vertex that address specific mutations in the cystic fibrosis gene. Unfortunately Kramer-Golinkoff has none of the mutations addressed by the drugs. Nonetheless, she told the meeting, “Personalized medicine is my hope for the future.”

The document, “Personalized Medicine Report: Opportunity, Challenges, and the Future,” released by Personalized Medicine Coalition at the meeting and provided to Science & Enterprise tells of a 62 percent increase since 2012 in the number of precision medicines on the market. The report lists 132 drugs and their corresponding biomarkers approved as of September 2016. Most of the drugs in the inventory are for cancer, cardiac conditions, psychiatric disorders, and infectious diseases. The report also indicates that a recent review finds some 65,000 different genetic tests are also on the market, making genetic data much more widely available than before.

In addition, the report highlights changes in regulations and reimbursement practices that could clear away obstacles to adoption of precision medicine. In the discussion of the report, Michael Sherman, chief medical officer of Harvard Pilgrim Health Care, a not-for-profit health plan serving New England, noted regulations should provide incentives for rewarding value, which would support more use of diagnostics combined with treatments that make up precision medicine.

Instead, says Sherman, you often find unintended consequences of regulations like Medicaid’s “best price” rules that require Medicaid to pay the lowest price charged for comparable goods or services. When companion diagnostics are included in the price of a drug, the cost of those tests to Medicaid is $0.00, providing no incentive for increased diagnostics required in precision medicine. Jay Wohlgemuth, chief medical officer of Quest Diagnostics and another panel member, confirmed that reimbursement practices focusing on individual services particularly discourage diagnostics, and he urged more reimbursement practices for overall treatment strategies.

Sen. Edward Markey

Sen. Edward Markey (A. Kotok)

Keynote speaker, Senator Edward Markey, Democrat from Massachusetts, pointed out more serious headwinds threatening precision medicine and U.S. health care in general. Markey said the Trump Administration’s proposed $54 billion increase in defense spending, coupled with $20 billion for a border wall with Mexico, will require compensating cuts in non-defense discretionary programs, such as medical research.

In addition, the threatened repeal of the Affordable Care Act, often called ObamaCare, will degrade the quality of U.S. health care. Markey noted the experience of Massachusetts that began a similar statewide program before passage of the Affordable Care Act, which now gives the state the highest rate of insurance coverage and most favorable health outcomes in the country, while still enjoying only a 3 percent unemployment rate.

He also underscored that Massachusetts may be known as the Bay State, but it is also the “brain state” which benefits from health research spending. Massachusetts, said Markey, has 2 percent of the U.S. population, but manages to attract 11 percent of NIH’s research grants.

Update, 7 March 2017: The report is now online.

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Process Converts Food Waste to Auto Tire Materials

Katrina Crnish and Cindy Barrea

Katrina Cornish, left, and Cindy Barrera examine ground tomato skins and egg shells. (Kenneth Chamberlain, Ohio State University)

7 March 2017. Agricultural scientists in Ohio are developing a process for converting common food waste into materials used in car tires, and filed a patent for these techniques. The lab of biomaterials professor Katrina Cornish at Ohio State University also started a spin-off enterprise to commercialize their discoveries for producing rubber products from alternative sources.

Cornish and colleagues study the production of bio-based materials that can substitute for imported rubber, a vital material for a wide range of consumer and industrial goods. Natural rubber, however, is derived largely from one plant species, Hevea brasiliensis, native to South America and grown commercially as well in southeast Asia and west Africa. Cornish’s lab cites data showing that the U.S. could face a shortfall of 1.5 metric tons of imported rubber by 2020, due largely from increasing global demand, creating a need for domestic raw material sources.

Researchers in the lab are already investigating methods for converting common plants and even those considered weeds growing in North America into raw materials for rubber. Among those materials are guayule, a flowering plant in the southwestern U.S. and Mexico,. Cornish and colleagues are developing guayule into an alternative for latex rubber used in stretchable products like gloves and condoms. In addition, attempts to make rubber from dandelions go back as far as the early 20th century, but Cornish’s lab is studying a variation of a dandelion native to Kazakhstan in central Asia that they call Buckeye Gold, which has roots that can produce rubber nearly identical to Hevea plants.

As part of these studies, the researchers are also looking into replacements for additives used in making rubber products, such as car tires. About 30 percent of the content of car tires is carbon black, a derivative of carbon made from heavy oil or natural gas into particles that mix with rubber to improve its durability and give tires their black color.  And just as the need for natural rubber is growing with the expanding world economy, the need for carbon black is growing as well, thus the need for domestic alternatives.

Cornish’s lab discovered alternatives to carbon black that provide durability for tires in common waste items from food, such as egg shells and tomato skins. Research by Cindy Barrera, a postdoctoral fellow in the lab, shows egg shells have a porous microstructure that offer a larger surface area to bind with rubber molecules, while tomato skins are stable at high temperatures, a key property for tires. Both egg shells and tomato skins are available in large quantities as waste items from food products manufacturers.

“Fillers generally make rubber stronger, but they also make it less flexible,” says Barrea in a university statement. “We found that replacing different portions of carbon black with ground egg shells and tomato peels caused synergistic effects — for instance, enabling strong rubber to retain flexibility.” Colleagues in the lab are studying other additives to keep tires black in color, rather than the reddish-brown hue from egg shells and tomato skins.

Ohio States technology transfer office filed for a patent on processes to replace carbon black and other additives with natural products, such as food wastes. Cornish and Barrea are among the inventors listed on the document. Cornish is also the founder of the company EnergyEne in Wooster, Ohio licensing the rights to this patent from Ohio State for commercial development. EnergyEne is already developing commercial techniques for deriving latex rubber from guayule plants, and received a small business technology transfer grant from National Science Foundation to support its work.

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Air Sampling Device Finds Unreported Allergens

Pollen

Pollen (Wikimedia Commons)

6 March 2017. A system designed to sample the air in homes of people with allergies found a number of airborne allergens in residences that previously went undetected by other devices. The founders of Inspirotec LLC, based in Chicago, reported on test results of the company’s exhale system in a session on Sunday, 5 March at the annual meeting in Atlanta of the American Academy of Allergy, Asthma, & Immunology.

The presentation, by Inspirotec founders Prasanthi Ghandi and Julian Gordon, and Paul Detjen, a Chicago allergist, describes a test of the company’s system with individuals having asthma and hay fever. Asthma is a chronic condition where the airways become inflamed and narrow, causing people 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 some 18.7 million adults had asthma, along with 7 million children.

Hay fever, also called seasonal allergic rhinitis, causes symptoms similar to the common cold:  runny nose, itchy eyes, congestion, sneezing and sinus pressure. While the common cold is usually caused by a virus, hay fever is an allergic reaction to pollen, dust mites, pet dander, and other allergens found indoors and outdoors.

Inspirotec’s exhale system samples air in homes for allergens that the company says is superior to current methods that analyze dust from the environment as a surrogate for the air actually breathed by people with allergies. The device plugs into a standard wall outlet and runs for 5 days. It uses electrostatic particle technology to sample the air at a rate the company says is 8 times faster than normal breathing. Electric currents capture biological matter, including mites, hair, pollen, fungi, bacteria, and viruses.

Users of the system then send the device back to Inspirotec, and answer a questionnaire about personal health and their environment. Inspirotec uses laser-based analytical techniques to quantify allergens in homes where the device was run, which the company reports to the user in a personal profile, as well as compared to similar individuals with allergies or to previous samples.

At the Atlanta meeting, the Inspirotec team reported on results from 92 individuals served by 5 allergists in or near Chicago. The 92 participants ran the exhale devices in their bedrooms for 5 days, which provided samples that the company analyzed for 12 common household allergens such as from dust mites, dogs, cats, mice, mold, cockroaches, and pollen. Participants also completed health and environment surveys.

The results show expected correlations between Inspirotec device readings and number of pets, as well as humidity and presence of dust mites, and use of high-efficiency particulate air or HEPA filters to clean the air with fewer allergens. But the results also show in some cases the presence of cat or dog allergens in homes without those pets, as well as dust mite and cockroach allergens that were not previously found in those homes. The company says the results will be used to provide baseline measures to use in future data gathering, and to compare with other regions.

As reported by Science & Enterprise, Inspirotec was among the first group of companies in 2012 supported by Breakout Labs, a revolving investment fund in San Francisco that aims to support early-stage enterprises developing new technologies. Breakout Labs is backed by the Thiel Foundation, established by entrepreneur Peter Thiel, a founder of online payments service PayPal and an early investor in Facebook.

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Trial Underway to Test Cancer Immunotherapy Aid

Cancer in headline

(PDPics/Pixabay)

6 March 2017. A clinical trial began recruiting participants with advanced tumors to test a compound that helps treatments for cancer harnessing the immune system. The study, conducted by biotechnology company Deciphera Pharmaceuticals LLC in Waltham, Massachusetts, is testing its experimental drug code-named DCC-3014.

Deciphera Pharmaceuticals develops small molecule, or low molecular weight, drugs that act against enzymes encouraging the growth and spread of cancers. The company maintains a library of compounds designed to deactivate these enzymes and keep them switched off, and develops drugs from those compounds to address resistance to cancer therapies or inhibitors preventing the immune system from acting against cancer.

DCC-3014 is in the latter category, designed to target macrophages, white blood cells in the immune system that normally attack and absorb invading pathogens. In this case, cancer hijacks macrophages and uses them to keep the immune system from attacking the cancer. DCC-3014 acts against these hijacked macrophages by blocking a key protein known as colony stimulating factor 1, or CSF-1, receptor. These CSF-1 receptor proteins are found on the surface of many cell types, but with cancer the proteins cause macrophages to prevent rather than activate the immune system from fighting the cancer.

Deciphera designed DCC-3014 to stop macrophages acting as checkpoints that prevent the immune system from fighting tumors. The company says preclinical studies show DCC-3014 stops solid tumor growth working on its own or added to other checkpoint inhibitors in mice induced with colorectal or prostate cancer. The findings also show DCC-3014 works only on CSF-1 receptor proteins, and spares other related enzymes.

“Preclinical data from a number of cancer models have demonstrated that DCC-3014 has potent macrophage checkpoint inhibitory activity,” says Michael Taylor, Deciphera’s president in a company statement. “We believe DCC-3014 has great potential as a novel immunomodulatory agent and an important new therapy for cancer patients.”

The early-stage clinical trial is recruiting 55 individuals, age 16 and over, with advanced solid tumor cancers,  at Sarah Cannon Research Institute in Nashville. The trial may also enroll some patients with blood-related cancers, such as leukemia. The study will evaluate DCC-3014’s safety at various dosage levels, looking for signs of adverse effects and seeking out the maximum tolerated dose. The trial is also tracking chemical activity of DCC-3014 in the body, as well as levels of white blood cells like macrophages dependent on CSF-1 receptor proteins.

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Messenger RNA Engineered to Produce Antibodies

RNA molecule illustration

RNA molecule illustration (Nicolle Rager Fuller, National Science Foundation)

3 March 2017. Academic and industry researchers demonstrated production of therapeutic antibodies inside cells of lab mice, offering a simpler and lower-cost alternative to monoclonal antibodies. The team led by University of Pennsylvania immunologist Drew Weissman describes its technology in the 2 March issue of the journal Nature Communications.

Monoclonal antibodies, synthetic proteins designed to treat disease by neutralizing proteins responsible for the condition, are a fast-growing segment of the pharmaceutical industry for treating diseases including cancer and autoimmune disorders. These synthetic antibodies, however, are costly to develop and often expensive for patients. An emerging option to synthetic antibodies is gene therapy that uses adeno-associated viruses to deliver antibody-producing genes to counter disease-causing proteins. While adeno-associated viruses are considered benign, they still present safety risks for some patients, including unwanted immune responses.

In their paper, Weissman and colleagues demonstrated another alternative, engineered messenger ribonucleic acid or mRNA, a nucleic acid related to DNA with the instructions used by cells to produce the amino acids in proteins for carrying out functions in the body. The researchers — with team members from UPenn’s medical school and biotechnology companies BioNTech AG in Mainz, Gemany and Acuitas Therapeutics in Vancouver, British Columbia — evaluated harnessing mRNA to deliver the instructions for producing therapeutic antibodies inside cells, rather than delivering antibodies created outside the body.

In its natural state, however, mRNA would present the same problems some patients encounter with adeno-associated viruses, namely immune reactions such as inflammation. To overcome this obstacle, the researchers encased mRNA in nanoscale lipid capsules, a technique devised by post-doctoral researcher Norbert Pardi and doctoral candidate Michael Hogan, co-authors of this paper and tested earlier with an mRNA vaccine candidate for the Zika virus. Acuitas Therapeutics is commercializing this technology and prepared the lipid nanoparticles for this project.

In the study, the team demonstrated delivery of mRNA to produce an antibody protecting against the HIV virus that causes AIDS. The antibody, known as VRC01, addresses a common target found across multiple strains of HIV, and is being tested both as a treatment and protective vaccine for HIV. Cost to patients is a key issue with HIV medications, and a synthetic VRC01 antibody would likely be too expensive for many patients and public health agencies.

The researchers tested mRNA encoding VRC01 antibodies in lab mice induced with compromised immune systems and thus highly susceptible to HIV infections. Within 24 hours following a single injection of the lipid nanoparticles with mRNA, the mice showed higher concentrations VRC01 antibodies in their blood. And with weekly injections, the mice could maintain a basic threshold level of VRC01.

The team also tested the ability of the mRNA in lipid nanoparticles encoding VRC01 to protect against HIV viruses. The researchers found small vaccine-style quantities of these nanoparticles could protect against two different HIV strains. For comparison, doses 40 times larger were needed to provide the same protection against HIV infections, when directly injecting VRC01 antibodies.

Weissman believes encoding mRNA to produce antibodies in cells may be safer for patients than some biotechnology manufacturing practices. “Biotech manufacturing,” says Weissman in a university statement, “requires a cell line and extensive purification that can aggregate or misfold the protein, resulting in an unwanted immune response against the protein or other adverse events.”

Nonetheless, biotech companies are exploring this technology. Katalin Kariko, an adjunct professor at UPenn and  co-author of the paper, is vice-president of BioNTech, a company developing therapies from synthetic forms of mRNA. As reported in Science & Enterprise, the Genentech division of the Roche Group, is licensing BioNTech’s mRNA technology for cancer treatments.

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Biotech Companies to Discover Ebola, Zika Vaccines

Ebola clinic

Woman being evaluated at an Ebola clinic in Sierra Leone (Rebecca Rollins, Partners In Health)

2 March 2017. Two biotechnology companies are collaborating to discover new vaccines protecting against Ebola and Zika viruses that present global threats to public health. This project is the second partnership between Integral Molecular in Philadelphia and Integrated BioTherapeutics in Rockville, Maryland dealing with urgently needed vaccines.

The Ebola outbreak in 2014-15 caused a serious public health emergency in West Africa, with nearly 29,000 cases reported in Liberia, Sierra Leone, and Guinea, leading to more than 11,000 deaths. 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. No treatments or vaccines for Ebola are yet approved, although World Health Organization says 2 vaccine candidates are being evaluated.

The Zika outbreak is a current public health challenge, with an outbreak in Brazil spreading to the Caribbean and the Americas, including the U.S. mainland. The Zika virus is transmitted primarily by aedes aegypti mosquitoes, the same species carrying chikungunya, dengue, and yellow fever pathogens. The virus may also be spread through sexual contacts. Most people contracting the Zika virus report symptoms such as mild fever, conjunctivitis or pink eye, and muscle and joint pain.

The current Zika outbreak, however, is resulting in increasing numbers of cases of birth defects, notably microcephaly and Guillain-Barré syndrome. Centers for Disease Control and Prevention counts more than 5,000 Zika cases in the 50 U.S. states and District of Columbia, and almost 37,500 cases in U.S. territories. As with Ebola, no treatments or vaccines are yet available.

Both Integral Molecular and Integrated BioTherapeutics develop vaccines for infectious diseases. Integral Molecular’s technology addresses proteins generated by viruses with outer lipid membranes or envelopes that attach and transmit viral proteins to the host cells. In this project, Integral Molecular plans to screen its panel of viral envelope protein variants to find optimal targets for Ebola and Zika vaccines.

Integrated BioTherapeutics discovers and develops vaccines for infectious diseases, with a technology focusing on carbohydrate-based proteins and virus-like particles. The company has a separate infectious disease testing service with established models for Zika and other pathogens. In this collaboration, Integrated BioTherapeutics will conduct preclinical tests of vaccine candidates.

The two companies previously worked together with Mapp Biopharmaceutical in San Diego and researchers from several universities and research institutes to create a synthetic antibody to protect against the two main strains of the Ebola virus. That antibody, code-named FVM04, extends the ZMapp antibodies to address the Sudan Ebola variation, while still covering ZMapp’s original Zaire strain.

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Mobile App-Controlled Patch Reduces Migraine Pain

Nerve cells illustration

(commonfund.nih.gov)

2 March 2017. A patch worn on the arm providing stimulation to nerve cells was shown in a clinical trial to reduce the amount of pain experienced by people with migraines. Results of the trial appear in the 1 March issue of the journal Neurology (paid subscription required), published by American Academy of Neurology.

The trial tested a system made by Theranica Bio-Electronics, a company in Netanya, Israel developing devices to control pain, beginning with migraine, using neuromodulation, or electronic stimulation of circuits in the nervous system. Migraine is a neurological syndrome causing severe headaches along with nausea, vomiting, and extreme sensitivity to light and sound. In some cases, migraines are preceded by warning episodes called aura including flashes of light, blind spots, or tingling in arms and legs. The web site Migraine.com estimates 37 million people in the U.S. suffer from migraines, and cites World Health Organization data indicating migraines affect 18 percent of American women and 7 percent of men.

Theranica’s system consists of a patch worn on the upper arm with a miniature battery, chip, and electrodes emitting painless, weak electronic impulses designed to block pain signals from reaching the brain. The device is controlled wirelessly with a smartphone app. People with the device are asked to apply the patch and start the device when they begin experiencing a migraine and wear it for 20 minutes. The company says the chip also processes feedback from motor neurons, and has safety features to detect, for example, improper placement of the patch.

The clinical trial was led by David Yarnitsky, a professor of neurology at Technion-Israel Institute of Technology in Haifa, and a medical advisor to Theranica. The study enrolled 71 individuals who experienced between 2 and 8 migraine episodes a month. Participants were asked to use the Theranica device for 20 episodes, as well as refrain from using pain medication for 2 hours after using the device.

The system used in the trial was programmed to randomly emit impulses at 3 levels of stimulation, as well as a non-stimulating sham signal for comparison. For this study, the 71 systems captured data on 299 migraine episodes, where participants rated their migraine pain levels on the smartphone app. Data from the devices were transmitted without personal identification to a remote database for analysis.

The results show nearly two-thirds (64%) of participants receiving stimulation at the 3 active levels experienced reductions in pain by 50 percent or more in the 2 hours following treatment, compared to about a quarter (26%) receiving a non-stimulating signal. More than half (58%) of individuals experiencing severe to moderate pain in their migraine episodes found their pain reduced to mild levels or no pain when receiving the highest stimulation level. Again, only about a quarter (24%) of those receiving non-stimulating signals experienced similar pain reductions.

More participants starting the stimulation within 20 minutes of an episode (47%) experienced reductions in pain, compared to those who started the device after 20 minutes (25%). However, many participants turned off the device during the non-stimulating signals, when they discovered the signals were not reducing their pain.

“People with migraine are looking for non-drug treatments,” says Yarnitsky in an American Academy of Neurology statement, “and this new device is easy to use, has no side effects, and can be conveniently used in work or social settings.”

Theranica says migraine is the first target of its non-drug pain technology. The company plans to expand its use to other types of acute and chronic pain, including muscle soreness.

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