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Drug Delivery, Rewards Companies Partner on Med. Adherence

Pills and drug bottles (FDA.gov)

(FDA.gov)

6 October 2014. West Pharmaceutical Services, a company producing devices for administering drugs, and HealthPrize Technologies that offers an online system for rewarding patients when they follow medication instructions, are collaborating on a platform that connects their products into a service to boost medication adherence. Financial details of the venture were not disclosed.

The companies plan to offer their service to drug manufacturers as an integrated system to improve the number of patients taking their medications as prescribed. Getting patients to take prescribed drugs is a particular problem with chronic diseases. A 2003 report by World Health Organization estimates half of patients are not taking medications as prescribed, with reasons attributed to behavior, activities, and incentives of the patients, physicians, and health care systems.

Not only does the health of patients suffer when they don’t take their prescribed drugs, the pharmaceutical companies worldwide lose an estimated $564 billion in revenue, according to a study for HealthPrize by CapGemini. HealthPrize Technologies, in Norwalk, Connecticut offers online services to encourage patients with chronic diseases to take their medications as prescribed, using games and other incentives. Its program aims to provide short-term rewards for patients who may receive long-term benefits from taking their drugs, but who need incentives in the interim to keep up with their medications.

West Pharmaceutical Services in Exton, Pennsylvania produces drug packaging, diagnostics, and delivery systems for the pharmaceutical industry. Among its products are hand-held and wearable devices for self-injected drugs or biologics, such as insulin. Under the deal, West and HealthPrize will develop drug delivery systems connected electronically to track adherence, engage and educate patients on the value of following medication instructions, and provide rewards for taking their drugs as prescribed.

While the collaboration is expected to focus first on West’s self-medication systems, the companies say they’re aiming for a comprehensive solution that can be applied to more types of devices. They anticipate employing technologies such as QR codes, near-field communications, and so-called smart labels with built-in radio-frequency ID tags, that can be extended to drug delivery systems made by companies other than West.

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Tissue Engineers, Biotech Firm Partner on Cartilage Repair

Engineered replacement cartilage

NeoCart engineered replacement cartilage (Histogenics Corporation)

3 October 2014. Histogenics Corp. that develops replacement cartilage is licensing technology from Intrexon Corp., a biotechnology company producing engineered genetics for commercial applications, for a new process to repair cartilage injuries with a patient’s own cells. The deal has a potential value of at least $44.5 million to Intrexon, but could also result in a return investment of up to $15 million in Histogenics.

Cartilage is the elastic connective tissue between joints that also acts as a cushion between the bones in the joint, but unlike bones, does not repair itself. While highly resilient, cartilage can wear down with age or tear under stress from trauma. The wear and tear of age, often compounded by obesity, can lead to a loss of joint cartilage, a condition known as osteoarthritis causing inflammation and pain. Various therapies are available from drugs to relieve the pain and inflammation to surgery.

One type of surgery takes a patients own cartilage cells, called chondrocytes, and cultures the cells in a lab, to grow replacement cartilage tissue. Histogenics, in Waltham, Massachusetts, offers a form of this therapy, which takes a piece of a patient’s cartilage from non-weight bearing surfaces in the body and grows new cartilage tissue on a collagen scaffold that can be implanted in the patient. The company is testing its implant therapy, called NeoCart, in a late-stage clinical trial.

Intrexon’s technology, known as UltraVector, combines DNA with cellular and protein engineering, but also applies computational models for the design and production of synthetic biological functions. UltraVector, says the company, acts as the operating system for the technology, with applications for the regulation of gene expression and precise targeting of engineered genetics built to work with UltraVector.

The deal calls for Histogenics to adapt genetic engineering techniques from Intrexon, in Germantown, Maryland, to develop a new kind of cartilage repair that starts with a patient’s own cells. The collaboration aims to create an off-the-shelf line of genetically modified chondrocyte cells that can control for immune system compatibility, and still work with Histogenics’ cellular scaffolds and manufacturing processes.

Under the deal, Histogenics pays Intrexon a one-time “technology access fee” of $10 million as a convertible promissory note, and will reimburse Intrexon for research and development costs, in two installments over the course of the collaboration. In addition, Histogenics will provide commercial and regulatory milestone payments to Intrexon of $34.5 million, as well as royalties on gross profits of products from the partnership. Intrexon, for its part, will have an option of investing up to $15 million in Histogenics.

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Google Glass Captioning Developed for Hearing Impaired

James Foley wearing Google Glass

James Foley wearing Google Glass (Georgia Institute of Technology)

3 October 2014. Computer scientists at Georgia Institute of Technology in Atlanta designed a system that converts speech from conversation partners to text, displayed on Google Glass systems worn by people with hearing difficulties. Google Glass is a wearable miniature computer that displays data on eyeglasses worn by the user.

The software is a creation of Georgia Tech’s Contextual Computing Group led by computing professor Thad Starner. The Captioning on Glass system records speech vocalized by conversation partners in a smartphone near the Google Glass wearer. The software then converts the speech to text, transmits the text via Bluetooth, and displays the text on Google Glass.

Google Glass has its own built-in microphone, but that microphone is designed to capture spoken words from the wearer, not by other people in conversation. The separate smartphone, designed to capture speech in telephone calls and spoken commands, records the spoken words of the conversation partner, while minimizing ambient noise that might distort the conversation.

The software, written by graduate student Jay Zuerndorfer, adapts an Android application program interface — a standard set of instructions — for transcription to convert speech of the conversation partner to text. The speech-to-text transcription happens almost instantly, and can be edited by the conversation partner before sending to the Google Glass wearer.

James Foley, a fellow computer science faculty member at Georgia Tech who began losing his hearing, is an early adopter of the system. “This system allows wearers like me to focus on the speaker’s lips and facial gestures,” says Foley in a university statement. “If hard-of-hearing people understand the speech, the conversation can continue immediately without waiting for the caption. However, if I miss a word,” adds Foley, “I can glance at the transcription, get the word or two I need and get back into the conversation.”

Another project from Starner’s lab uses the same basic technology for real-time conversational foreign language translations. Translation on Glass, as the system is called, captures the spoken words of the conversation partner, then translates the words before transmission to Google Glass. The system, still in development, allows for a Google Glass wearer to respond, where the software translates the wearer’s words into the language of the conversation partner. Languages supported so far include English, Spanish, French, Russian, Korean, and Japanese.

Captioning on Glass is not recommended for all conversations, only those with known associates who can work with the smartphone. Google Glass wearers also face occasional resistance from people who find the presence of the devices threatening or intrusive. Starner told the New York Times in May 2013, much of that concern is overblown. “Asocial people will be able to find a way to do asocial things with this technology,” said Starner, “but on average people like to maintain the social contract.”

Foley and Zuerndorfer demonstrate Captioning on Glass in the following video.

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Drug-Error Analytics Service Raises $1M in Early Funding

Pills in a prescription bottle (Photos8.com)

(Photos8.com)

2 October 2014. MedAware, a company harnessing big-data analytics to prevent erroneous drug prescriptions, raised $1 million in its first round of venture financing. The Ra’anana, Israel enterprise completed the funding round led by OurCrowd, an Israeli crowdfunding investment service, with contributions from GE Ventures.

The company is the creation of CEO Gidi Stein, a practicing internist with a Ph.D. in computational biology from Tel Aviv University. Stein and others started MedAware in 2012 to fill a need for better tools to prevent prescription drug errors. Institute of Medicine in the U.S. estimated in 2006 that 1.5 million adverse drug events happen in the U.S. each year. The institute’s report cited data that each adverse drug event costs hospitals some $8,750 (2006 dollars) with the costs in human and financial terms largely preventable.

The U.S. Centers for Disease Control and Prevention points to factors making adverse drug events even more likely: continued development of new drugs and new uses found for current drugs, aging of the population, increase in medications to prevent disease, and increased insurance or Medicare coverage for prescriptions.

At the same time, the increasing use of electronic medical records is believed to offer a way to prevent these errors. Electronic medical records and electronic prescription systems, says MedAware, can address only parts of the problem, such as known drug interactions and allergic reactions. These systems can also be a source for new types of prescription errors, such as picking the wrong drug from a drop-down menu. And these systems often result in false-positives, leading to users questioning alerts that are issued.

MedAware says it has a better approach that detects a wider range of prescription errors and with greater accuracy. The company’s technology is based on algorithms that analyze large quantities of data in electronic medical records, combined with machine learning to build a mathematical model representing real-world treatments. These models are then built into the prescription ordering systems to provide more realistic error checking.

As with most current systems, new prescriptions are checked against a patient profile and issues an alert if the new order deviates from previous patterns. However, the MedAware technology also learns the physician’s prescription patterns and stops sending alerts when alerts are repeatedly overridden. In addition, the systems provide quality-assurance reports that compare prescriptions and outcome patterns for complex diseases with patients having similar disorders.

The MedAware technology was used in pilot studies in Israel that evaluated results of prescription ordering systems at 3 medical institutions over at least 5 years, covering both hospitalized patients and outpatient clients, for whom the systems approved prescriptions be written. MedAware’s systems found errors in 3 percent of the hospitalized patients and 1 percent of the outpatient clients.

Among the errors were incorrect drugs prescribed, wrong patients given a prescription, new clinical information missed or ignored, and failure to change dose or discontinue a drug on time. Examples of the errors were a chemotherapy drug prescribed for a patient without cancer instead of an antibiotic with a somewhat similar name, and a diabetes drug prescribed for a healthy 45-year old patient with no history of diabetes.

MedAware plans to use the proceeds of the financing to support initial sales to health care providers, insurance companies, and large drug store chains. Funding for MedAware was the first investment for the partnership between OurCrowd and GE Ventures.

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Micro-Needle Capsule Designed to Replace Drug Injections

Micro-needle capsule

Micro-needle capsule (Massachusetts Institute of Technology)

2 October 2014. Researchers designed and tested in animals a pill with tiny needles that could deliver some of the same biologic drugs now using injections. The team of engineers and medical researchers from the lab of Robert Langer at Massachusetts Institute of Technology, with colleagues from Massachusetts General Hospital and Technion in Israel, published its findings last week in Journal of Pharmaceutical Sciences (paid subscription required, but open access version available).

Most patients prefer taking pills rather than injections, but pills are not feasible for insulin and other biologic therapies made of large proteins, such as antibodies and recombinant DNA or RNA,  which are not easily absorbed or degraded in the gastrointestinal tract. Biologics are used to treat cancer and auto-immune disorders, such as rheumatoid arthritis and multiple sclerosis. Creating oral versions of biologics often involve creating micro- or nanoscale particles, which require designing new formulations of each drug.

The MIT team, led by first author Giovanni Traverso, sought a different approach that would maintain the original drug formulation, but transport it in a capsule with tiny needles that could survive the gastrointestinal track, and still deliver the payload. The researchers created a capsule made of acrylic, 2 centimeters long and 1 centimeter in diameter, with hollow needles 5 millimeters in length protruding from it. The capsule used for the study also has a chamber to store the drug payload and a metal core to make it visible on X-rays.

If ingesting an object with sharp points — no matter how small — seems unsafe, the authors note that the gastrointestinal tract has no pain receptors, and can pass an object that small without complications. A review of cases where humans accidentally swallow foreign objects, even sharp objects, shows surgical removal was needed for sharp objects 3 centimeters and longer, much larger than the 5 millimeter length of the micro-needles on the capsule. In addition, micro-needles are used or being tested for drug delivery in other parts of the body.

The researchers tested the micro-needle capsule as a delivery mechanism for insulin in pigs, weighing 75 to 80 kilograms (165 to 176 lbs.), which were sedated and given the capsules with a feeding tube into the stomach. The capsules were followed through the pigs’ gastrointestinal tracts with endoscopes and X-rays, and observed for any damage to internal organs. Other pigs were given subcutaneous (under the skin) insulin injections for comparison. Blood glucose levels of both sets of animals were measured.

The team found the micro-needle capsules delivered insulin into the pigs’ stomach linings, and small and large intestines, with faster response to insulin and with greater blood glucose decreases than in pigs receiving injections. The capsules took from 1 to 8 weeks to pass completely. Subsequent examinations showed no tissue damage to the pigs receiving the capsules.

While these first proof-of-concept tests used insulin, the researchers believe the technology can be applied to other biologics. They are working on alternatives to metal for micro-needles, such as degradable polymers, to address safety concerns. The team is also redesigning the capsule to take advantage of contractions in the digestive tract that could squeeze out the drug payload in waves rather than a continuous flow.

Traverso and other authors filed a provisional patent with the U.S. Patent and Trademark Office for the technology. The following video tells more about their invention.

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Smart Bandage Monitors Severe Wound Healing

Conor Evans

Conor Evans (Massachusetts General Hospital)

1 October 2014. Researchers at Massachusetts General Hospital in Boston developed a paint-on covering for severe wounds that changes color to indicate the extent of healing taking place. The team from the lab of Conor Evans in Mass. General’s photomedicine center published its findings in today’s issue of Biomedical Optics Express, published by the Optical Society.

The Evans team — including colleagues from Harvard Medical School, affiliated hospitals, U.S. Army, and institutions in Germany and Korea — sought a technique for non-invasively monitoring healing progress of severe wounds, such as burns and ischemic wounds, where blood flow to the injury is blocked. Chronic wounds of this kind, including those caused by combat, are estimated to affect 6.5 million people in the U.S., leading to some $25 billion in health care costs each year.

The bandage technology measures the extent of oxygen concentration in the wound area, an indicator of the extent of healing. It uses porphyrin-dendrimer materials, called Oxyphor R2 made by Oxygen Enterprises in Philadelphia, that give off a phosphorescent glow in the presence of oxygen. The bandage compound also has a green dye that acts as a baseline reference and with which clinicians can measure the extent of healing as it changes to red.

The bandage is painted on the wound as a viscous liquid using as its base New-Skin liquid bandage, an over-the-counter product made by Prestige Brands that dries to a solid film. A transparent barrier layer is then applied over the film to keep out ambient air, thus responding to oxygen concentrations generated as a result of the healing process.

The third part of the technology is a camera-like device that first gives off light to excite the phosphors in the porphyrin-dendrimer materials, and then measures the light emissions from the bandage. Zongxi Li, a research fellow in Evans’s lab and first author of the paper, says in an Optical Society statement that the camera can be configured to “measure either the brightness or color of the emitted light across the bandage or the change in brightness over time.”

The researchers tested proof-of-principle technology to measure burn healing in lab rats and pigs, as well as a monitor for healing of skin grafts with pigs. The lab plans to extend the bandage’s sensory capabilities to other healing indicators such as pH and bacterial load, as well as adapting the technology to on-demand release of drugs.

Evans and colleagues are seeking industry partners to bring the technology to market. One potential application is hand-held or smartphone-based field devices, since the light emitted from the bandage is bright enough to be read by those systems.

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Gold Nanoparticles Boost Heart Tissue Patch Performance

Gold Bars (Brian Giesen/Flickr)

(Brian Giesen/Flickr)

1 October 2014. Medical and materials scientists at Tel Aviv University in Israel designed a heart tissue repair patch that adds in gold nanoparticles to improve electrical signaling and muscle performance. The team from the lab of life sciences professor Tal Dvir published its findings last month in the journal Nano Letters (paid subscription required).

The researchers aim to build on previous work engineering tissue patches to repair damage from heart attacks. Heart muscle does not easily repair itself, requiring a collagen structure from outside the heart on which new tissue can develop. Heart cells from the patient can then grow on that structure into new muscle that responds to electrical signals and contracts like the original.

Experiments with synthetic matrices or scaffolds up to now use decellularized collagen from pigs that approximates human tissue, but residual sugar and other cells on the collagen matrix can trigger an immune response and rejection by the recipient. Instead of a scaffold made of animal collagen, the Tel Aviv team harvested fatty tissue from an individual’s abdomen for the scaffold, which removes the chance for an immune response and rejection.

A drawback of harvested abdomen tissue for the scaffold, however, is its limited ability to establish a network for electrical signals like that found in original heart tissue. “Biomaterial harvested for a matrix,” says Dvir in a university statement, “tends to be insulating and thus disruptive to network signals.”

To improve electrical conductivity of the engineered tissue, the researchers deposited gold nanoparticles on the surface of the harvested matrix. Engineered heart tissue with the gold nanoparticles, say the authors, develops connexin 43 electrical coupling proteins that form signaling channels and allow for coordinated contraction of heart muscles. Tests show adding the the gold nanoparticles enables the engineered heart tissue to transmit electrical signals faster and more efficiently than the same tissue without the added gold.

The Tel Aviv team conducted preliminary tests with the engineered heart tissue on lab animals with positive results. They next plan to extend the tests to larger animals and eventually to human clinical trials.

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Johnson & Johnson Acquires Biotech Developing Anti-Virals

Respiratory syncytial virus

Respiratory syncytial virus (NIH.gov/NIAID)

30 September 2014. The biotechnology company Alios BioPharma Inc., a developer of anti-viral medications, is being acquired by health care products enterprise Johnson & Johnson for $1.75 billion. The all-cash deal will add Alios BioPharma’s pipeline to the portfolio of Janssen Pharmaceuticals, a division of Johnson & Johnson.

Alios BioPharma, in South San Francisco, California, develops therapies for viral diseases from its library of nucleoside analogs, compounds designed to act like derivatives of nucleic acids that block the assembly of genetic molecules, thus preventing the replication of the virus. Nucleoside analogs are the basis of therapies for a range of diseases including various types of cancer and bacterial infections, as well as viral infections.

The company’s lead candidate, code-named AL-8176, is a nucleoside analog treatment for respiratory syncytial virus, or RSV, that infects lungs and breathing passages, for which there is not yet a cure. Among children under 1 year of age, RSV is the most common cause of bronchiolitis — inflammation of small airways in the lungs — and pneumonia. Centers for Disease Control and Prevention says between 75,000 and 125,000 children in the U.S. are hospitalized for RSV each year.

In July, Alios BioPharma released initial results of an intermediate-stage clinical trial of AL-8176, where healthy volunteers were infected with RSV, then treated with one of 3 dose levels of AL-8176 or a placebo for 5 days. The company says the trial met its primary objective of lower viral loads among the infected patients taking AL-8176 compared to the placebo. By day 12, none of the patients treated with AL-8176 had detectable RNA from the RSV virus in their systems, while RNA was still evident in the patients receiving the placebos.

Alios is recruiting participants for a trial of AL-8176 among infants hospitalized with RSV, at sites outside the U.S. The company is also developing therapies for the common-cold virus (rhinovirus), influenza, and hepatitis C.

Janssen Pharmaceuticals, a division of Johnson & Johnson, is expected to add the Alios pipeline to its current research and development of treatments for infectious diseases including HIV/AIDS, hepatitis C, and tuberculosis.

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Hat tip: FirstWord Pharma

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Nerve-Blocking Treatment for Diabetes Approved in Europe

Diabetes Test (NIH)

(National Institutes of Health)

29 September 2014. EnteroMedics Inc., a medical device developer in St. Paul, Minnesota, says marketing approval in Europe for its vagus nerve blocking device for obesity is extended to cover type 2 diabetes. A CE Mark, which signifies approval to market regulated products such as medical devices in the European Union and associated countries, is expanded in this case for EnteroMedics’ Maestro Rechargeable system.

EnteroMedics develops devices to treat obesity and metabolic disorders by blocking vagus nerve signaling between the brain and stomach. The vagus nerve extends from the brain to the abdomen, through the esophagus, lungs, and heart, and is part of the involuntary nervous system controlling various bodily functions including digestion.

The company’s technology, called Vbloc, controls signaling along the vagus nerve, targeting perceptions of hunger and fullness that respond to expansion of the stomach and contractions of stomach muscles. Blocking these signals is believed to help individuals better control their appetite and food intake, thus encouraging weight loss. These same signals are also believed to affect secretion of digestive enzymes and blood glucose levels.

The Maestro Rechargeable system incorporates Vbloc technology in a device about the size of a heart pacemaker implanted in the abdominal region. EnteroMedics tested the Maestro system in a clinical trial with 28 obese patients also with type 2 diabetes, over a 3-year period, and reported initial findings last month at a meeting of the International Federation for the Surgery of Obesity and Metabolic Disorders.

After 3 years, patients with the device reported a decrease in blood sugar (glycated hemoglobin) and fasting blood glucose levels, as well as lower body weight compared to baseline measures. In addition, patients with the Maestro device reported improvements in blood pressure among those having hypertension at the beginning of the trial.

The Maestro device is not yet approved in the U.S. However, EnteroMedics is testing the device in a late-stage clinical trial among 234 obese patients, including those with type 2 diabetes, in the U.S. and Australia, where participants receive either a Maestro device blocking vagus nerve signals or a sham device not blocking the signals. Initial results reported earlier this month show patients receiving the Maestro device had more weight loss than patients with the sham device, but the amount of weight loss between the groups, while statistically reliable, did not meet the study’s target of a 10 percentage-point difference.

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Investment Fund Launches to Support Stem Cell Ventures

Induced pluripotent stem cells cluster

Induced pluripotent stem cells cluster (National Institute of Neurological Disorders and Stroke)

29 September 2014. ReproCell Inc., a developer of stem cell lines for research and therapies in Yokohama, Japan, is starting an investment fund that aims to back new biotechnology companies bringing stem cell research to market. The fund, called Cell Innovation Partners, begins with ¥800 million ($US 7.3 million) in capital, provided by Shinsei Corporate Investment Limited, a division of Shinsei Bank in Tokyo.

Cell Innovation Partners plans to support enterprises developing commercial products and services based on research in induced pluripotent stem cells and regenerative medicine. Induced pluripotent stem cells are adult stem cells, genetically reprogrammed to a similar state as embryonic stem cells, expressing genes and factors that enable them to grow and transform into various cells in the body. While basic research on regenerative medicine from induced pluripotent stem cells continues, they have already shown value as tools for drug discovery, development, and testing.

In a discussion on the fund’s Web site, ReproCell’s CEO Chikafumi Yokoyama says the market for regenerative medicine is expected to grow substantially and new companies in the field are being formed, but “in reality, sufficient risk money is not available to stem cell and regenerative medicine venture companies both domestically and overseas.” Cell Innovation Partners, says Yokoyama, aims to provide financing for companies in the U.S. and Europe, as well as Japan, commercializing these technologies.

In the partnership, ReproCell says it brings expertise in stem call science and biotechnology industry, while Shinsei Corporate Investment provides its finance and fund management experience. Cell Innovation Partners expects to evaluate funding candidates by not only their scientific bases and intellectual property, but also their business models and plans. Shinsei Corporate Investment’s CEO Ippei Matsubara says the candidate’s growth potential over the next 5 to 7 years, competitive advantages, and leadership will also be assessed.

ReproCell was founded in 2003 to commercialize research in stem cells by Norio Nakatsuji at Kyoto University and Hiromitsu Nakauchi at University of Tokyo. The company provides reagents for research on stem cells, as well as stem-cell derived precursors for heart, liver, and brain cells. ReproCell also provides animal cell models for diabetes research.

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