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Memorial Day 2015

Vietnam War Memorial

25 May 2015. Today is Memorial Day in the U.S., and Science & Enterprise is observing the holiday. We will return to our regular postings tomorrow. (Photo: A. Kotok)

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Space Object Taxonomy Sought in $50K Challenge

Space debris in orbit

Computer-generated image of space debris in orbit around the earth (NASA.gov)

22 May 2015. A new challenge on InnoCentive seeks a scientifically-based method for describing orbiting space objects with the fewest characteristics possible, but still predicts the objects’ behavior. The competition has a total purse of $50,000 and a deadline for submissions of 20 July 2015.

InnoCentive in Waltham, Massachusetts conducts open-innovation, crowdsourcing competitions for corporate and organization sponsors. The sponsor, in this case, is Wright Brothers Institute in Dayton, Ohio that runs occasional challenges on InnoCentive to support its work for the U.S. Air Force. Free registration is required to see details of the competition.

Wright Brothers Institute is seeking a technique for classifying and describing space objects that are growing in number and becoming an increasing hazard for collisions in space. Current methods, says the sponsor, do not allow objects to be accurately tracked in space because they do not fully represent the objects’ physical characteristics or models of behavior.

The goal of the competition is to generate a taxonomy that can uniquely describe any space object with a minimum number of descriptive, but realistic, characteristics. In addition, the variables making up the taxonomy need to accurately predict behavior of the objects in space, as verified through sensor measurements.

InnoCentive calls this type of competition a theoretical challenge requiring a written proposal that fleshes out an idea before it becomes a proven concept. Proposals submitted in a theoretical challenge usually offer detailed descriptions and specifications showing how the idea can become an actual product or service.

The challenge has a total purse of $50,000 although neither the sponsor nor InnoCentive indicate the number of awards planned or value of individual awards.  The sponsor asks competitors receiving awards to grant a non-exclusive license to their intellectual property. Entrants not receiving awards will retain all intellectual property rights after the evaluation period.

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Study IDs Advanced Prostate Cancer Genome Mutations

Micropgraph of prostate cancer

Micrograph of prostatic acinar adenocarcinoma, the most common form of prostate cancer (Nephron, Wikimedia Commons)

22 May 2015. An analysis of biopsy samples from men with prostate cancer that spread to other parts of their bodies identifies genomic anomalies found in nearly 90 percent in men with the condition, for which treatments may be available. Findings from the team at eight institutions in the U.S. and U.K. appear today in the journal Cell (paid subscription required).

The researchers led by Arul Chinnaiyan at University of Michigan in Ann Arbor and Charles Sawyers at Memorial Sloan Kettering Cancer Center in New York developed a comprehensive genetic map of metastatic castration resistant prostate cancer, an advanced form of the disease that spreads to other parts of the body. Their study collected biopsy samples from 150 men who were not responding to standard hormone-based treatments, taken from bone, soft tissue, lymph nodes, and liver — areas previously considered difficult to access for this genomic analysis.

The results found about two-thirds of the men with mutations in the androgen receptor gene that provides the code for making testosterone and other hormones related to male sexual development. This finding was expected given the lack of response by participants to standard hormone therapies, but it also provides targets for alternative hormone-based treatments.

Some 14 percent of participants were found with mutations in BRCA1 and BRCA2 genes, usually associated with breast and ovarian cancer. However, identifying these mutations could make available new drugs known as PARP inhibitors designed to treat ovarian cancer from BRCA gene mutations, for patients with prostate cancer having these mutations. Another 8 percent of the individuals were found with germline or inherited genetic alterations that made them more predisposed to the disease, which supports arguments for screening people with a family history of the disease.

As important as the findings, say the authors, is the process designed for capturing and analyzing genetic data that could be applied to diagnosing underlying causes of an individual’s prostate cancer and identifying appropriate treatments. Most previous studies focus on genomics of the primary prostate cancer, with few results that point to available therapies. In this case, however, the researchers investigated where prostate cancer spreads and found in most cases, actions of some kind could be taken.

“One of the surprising findings in this study was that approximately 90 percent of cases harbored some kind of genetic anomaly that was clinically actionable, meaning we have potential treatments to target that specific aberration,” says Chinnaiyan in a university statement. “This suggests that clinical genomic sequencing could impact treatment decisions in a significant number of patients with disease.”

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Mobile App Data Provided for Chronic Pain Study

App home screen

Manage My Pain app home screen (Google Play)

21 May 2015. Data collected by a mobile app designed to help individuals manage their pain are being provided to a research lab at York University to reveal patterns in painful experiences by the app’s users. York’s Human Pain Mechanisms Lab in Toronto, Ontario, Canada will analyze data provided by the app Manage My Pain, developed by ManagingLife Inc., also in Toronto. Financial and intellectual property details of their agreement were not disclosed.

Manage My Pain is designed to capture real-time experiences of individuals with chronic pain in a running diary that physicians can use to monitor their patients’ conditions, as well as provide people suffering from chronic pain with feedback on their progress. The company says the app, written only for Android devices, helps people cope with fibromyalgia — a condition causing muscle pain, fatigue, and tender pressure points — migraines, arthritis, and back pain.

ManagingLife offers the app in a free Lite version and Pro version costing $3.99 that provides an ability to view more than 10 records and background synchronizing of data to the cloud. Google Play says the Lite version has between 50,000 and 100,000 installations, while between 5,000 and 10,000 users installed the Pro version.

In addition to recording real-time pain experiences, Manage My Pain also tracks use of  pharmaceuticals and links people’s medications and dosages with their specific pain experience records. Data from the app can also be used to support medical insurance and disability claims, according to the company.

The large number of installations and capturing of individual records in a cloud database attracted the attention of Joel Katz, a health psychology professor at York and director of the Human Pain Mechanisms Lab. “These patient-reported outcomes will help us reveal previously unexplored patterns in pain, both in terms of intensity and the number of occurrences,” says Katz in a university statement. “Most chronic pain studies involve hundreds of participants but thanks to this app, we have several thousands of patients’ data to work with including hundreds of thousands of data points.”

Katz and colleagues study psychological, emotional, and biomedical factors surrounding acute and chronic pain. The lab examines processes that change episodes of acute pain into chronic and pathological pain conditions. The lab also studies medication solutions for preventing pain and interventions for minimizing pain and stress among hospitalized patients.

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Orphan Status Granted Eye Cancer Treatment

Woman's eyes

Public Domain Pictures, Pixabay)

21 May 2015. Food and Drug Administration designated an experimental treatment for uveal melanoma, a rare and aggressive form of cancer in the eye, as an orphan drug that qualifies for incentives to expedite its development. Aura Biosciences also revealed results of preclinical tests showing the ability of its lead biologic therapy code-named AU-011 to treat eye tumors in lab animals.

Uveal melanoma, also called intraocular melanoma, is a disease where cancer cells form in the middle layer of tissue in the wall of the eye known as the uvea. Like the more well-known and prevalent melanoma skin cancer, older and fair-skinned people are more likely to develop uveal melanoma. While the disease occurs infrequently, it is still the most common form of eye cancer among adults, according to National Cancer Institute. Current treatment options for uveal melanoma are radiation therapy, which runs risks of damaging the eye, or surgery to remove the eye.

Aura Biosciences is a biotechnology company in Cambridge, Massachusetts that licenses research conducted at the lab of John Schiller at National Cancer Institute, part of National Institutes of Health. Schiller and colleagues study the ability of virus-like particles that prevent or treat cancers such as cervical cancer caused by human papillomavirus.

Aura Biosciences adapts Schiller’s concept to design synthetic viral protein shells about 55 nanometers in diameter. These shells then become the mechanism for transporting therapeutic molecules, in this case that bind to the uveal melanoma tumor cells. AU-011, says the company, is designed to deliver cancer cell-killing molecules to the tumors, while leaving normal eye tissue untouched. The protein shells with molecules are injected into they eye, then activated by standard ophthalmologic lasers, such as those used in outpatient clinics.

Aura Biosciences reported findings of preclinical tests of AU-011 at McGill University in Montreal with lab rabbits that had uveal melanoma grafted on their eyes, presented last week at a meeting of the Association for Research in Vision and Ophthalmology. The team found after three AU-011 treatments, from 80 to 100 percent of the tumor cells in the animals were killed, without damaging other tissue in their retinas.

Orphan drug designation is granted by FDA for diseases affecting fewer than 200,000 people in the U.S. Drugs and biologics with orphan status qualify for tax credits covering their clinical trials, as well as exemption from normal prescription drug user fees.

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Phillips, MIT Form Health Technology Collaboration

Henk van Houten and Karen Gleason

Henk van Houten, head of Philips Research, left, and MIT Associate Provost Karen Gleason at signing of research collaboration agreement (Dominick Reuter, Massachusetts Institute of Technology)

20 May 2015. Electronics manufacturer Royal Phillips and Massachusetts Institute of Technology are collaborating on research into health care technology and digital urban lighting systems. The 5-year, $25 million agreement also includes moving the company’s North American research and development center to Cambridge, Massachusetts near the MIT campus.

Phillips, headquartered in the Netherlands, designs and manufactures electronics systems for consumers, lighting, and health care, including solutions for cardiac and acute care, as well as health care in the home. The company says it plans devote 70 percent of its funding with MIT to support joint research teams investigating cardiovascular disease management, cancer treatment and diagnosis, high-resolution medical imaging, and health care informatics.

“By moving to Cambridge and collaborating with MIT, its staff and its partners” says Philips’s research chief Henk van Houten in a company statement, “Philips can work with some of the best minds in the world on health care delivery, looking at ways to better prevent, manage or treat common diseases across the health continuum.”

One of the MIT researchers supported by Phillips under the agreement is Peter Szolovits, a computer science and engineering professor that works in the health technology field. Szolovits says Phillips is interested in working with MIT on improving its ultrasound and other non-invasive diagnostic technologies, as well as gaining insights from data stored in large health care databases, including individuals’ health records. “That, in turn,” says Szolovits in an MIT statement, “would allow MIT students and faculty to do follow-up studies on how well these things work in the real world.”

The collaboration includes as well studies on performance and functionality of urban lighting systems. Researchers are expected to investigate ways of turning home, office, and municipal lighting in urban areas into data collection tools to monitor air quality, track energy usage, and detect emergencies, such as fires or floods. Phillips says it plans to share its expertise in developing cloud-managed LED street lights in Los Angeles, as well as energy-efficient LED lighting on the new bridge to replace the Tappan Zee Bridge over the Hudson River north of New York City.

Under the collaboration, Phillips agreed to move its North American research and development lab from Briarcliff Manor, New York near New York City to Cambridge, Massachusetts. The company and university say the research center will be located in Kendall Square, the site of many new biotechnology companies as well as the MIT campus. Earlier in May, Eli Lilly and Company unveiled plans to open a new research facility in Cambridge concentrating on drug delivery and medical devices.

Philipps’s research Web site says the Briarcliff Manor facility, established in 1942, conducts studies in the fields of health care and lighting, and employs some 125 employees. The company also has its regional health care sales and services unit, as well as intellectual property and standards offices at the Briarcliff Manor site, but did not indicate whether they would be moving as well to Cambridge.

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FDA Approves Four-Times-Per-Year Schizophrenia Drug

Brain synapses illustration

(Allan Ajifo, Wikimedia Commons)

19 May 2015. Food and Drug Administration approved for sale in the U.S. a drug for controlling schizophrenia symptoms that individuals need to take only four times per year. Janssen Pharmaceuticals, a division of Johnson & Johnson, markets the three-month version of the drug paliperidone palmitate under the brand name Invega Trinza.

Schizophrenia is a common and chronic, yet severe and disabling disorder that affects about 1 percent of the U.S. population, but takes a wider toll on families and society. Symptoms of schizophrenia include hallucinations such as hearing voices, delusions, or agitated movements, as well as disrupted emotions and behavior affecting interactions causing lack of focus or loss of memory. Schizophrenia affects men and women, mainly adults, about equally and occurs at similar rates among ethnic groups around the world.

Medications are helping people with schizophrenia manage their symptoms since the 1950s, with a new class of drugs known as second-generation or atypical antipsychotics available since the 1990s. Among this newer type of drug is paliperidone, a small-molecule compound that affects neurotransmitters such as dopamine and serotonin in the brain. Janssen markets paliperidone as Invega, both as an extended release tablet and injections.

FDA approved Invega Trinza as a treatment for individuals with schizophrenia given by injection every three months who are first successfully treated for at least four months with once-a-month injections of Invega Sustenna. Less-frequent dosages of symptom control medications are considered an advantage in therapy programs that often require individualized attention because of the range of symptoms and personal circumstances of people with the disorder.

FDA approved Invega Trinza based in part on results of a late-stage clinical trial that measured the median time for a relapse of schizophrenia to occur among people receiving the three-month injections or a placebo. More than 500 individuals with schizophrenia took part in the trial at 56 locations in the U.S., Europe, and Latin America.

All participants first received a monthly injection of Invega Sustenna, then a single dose of the three-month paliperidone to stabilize their symptoms. Participants were then randomized to continue receiving paliperidone or a placebo every three months during the test phase. The results, published in March 2015 in the journal JAMA Psychiatry, show 93 percent of of participants taking the three-month dose of paliperidone experienced no serious schizophrenia symptoms, while the placebo participants relapsed in a median time of 274 days.

Because of the positive results, an independent monitoring committee decided to end the clinical trial early. The researchers found the rate of adverse events about the same between the paliperidone and placebo groups, with those in the paliperidone group experiencing more weight gain, headache, common cold, and akathisia — restlessness and fidgeting.

FDA approved Invega Trinza under priority review, a program that expedites review of drugs designed to treat serious conditions and offer significant improvements in safety or effectiveness.

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Disclosure: The author owns stock in Johnson & Johnson, the parent company of Janssen Pharmaceuticals.

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Lab-On-Chip Device Captures Circulating Tumor Cells

Tumor cell cluster in Cluster-Chip

Fluorescent tagged tumor cell cluster captured in a Cluster-Chip (Mehmet Toner, Massachusetts General Hospital)

19 May 2015. Engineers and medical researchers designed a microchip that detects clusters of circulating tumor cells that break away from tumors and can spread cancer throughout the body. The team from a joint Harvard-MIT health sciences technology program and Massachusetts General Hospital in Boston published its findings yesterday in the journal Nature Methods (paid subscription required).

Circulating tumor cells are individual cells that break off from original tumors or those formed from where cancer spreads, and flow through the blood stream. These cells make up a minute proportion of blood volume, but are implicated in the spread of cancer to other parts of the body. Because of their tiny amounts, circulating tumor cells are difficult to find, but when detected can offer an early warning about the spread of cancer in a patient.

The team from the lab of Harvard-MIT engineering professor Mehmet Toner designed a microfluidic device — a miniature chip with tiny channels through which blood or other fluid specimens can flow — that captures clusters of circulating tumor cells from whole blood. The chip is configured in rows of channels interspersed with triangle-shaped posts, and the top of the triangles in the following row pointed at the open space between posts in the row before it. Blood is forced through the channels, allowing individual cells to flow, but blocking circulating tumor cells in clusters.

Toner and colleagues tested the device, which they call Cluster-Chip, by attaching fluorescent tags to clusters of circulating tumor cells and found the rows of triangles in the device can trap clusters of up to 30 cells, and with as few as 2 cells. The authors report Cluster-Chip is able to trap nearly all (99%) of clusters with 4 or more cells, and a majority (70%) of 3-cell clusters, but only about 4 in 10 (41%) clusters of 2 tumor cells. Inspection of the clusters before and after flowing through the device show the integrity of the clusters remains largely intact.

Maintaining the integrity of the cell clusters likely adds to Cluster-Chip’s diagnostic potential. The researchers tested blood samples from 60 individuals with metastatic cancer, where the cancer spreads from the original tumor to other parts of the body. The results, confirmed through RNA sequencing, show the device captured circulating tumor cells in 41 percent of participants with breast cancer and 3 of 10 prostate (31%) and melanoma (30%) participants. Other analyses revealed additional properties of some captured tumor cell clusters, including a biomarker indicating a tendency for tumor cells to proliferate and, in a few cases, immune system cells not associated with the tumor.

Massachusetts General Hospital filed a patent for the Cluster-Chip technology, with Toner and first author Ali Fatih Sarioglu, now on the engineering faculty at Georgia Tech, as inventors. The research was funded by a Quantam grant from National Institute of Biomedical Imaging and Bioengineering, in National Institutes of Health, supporting research leading to technologies that make a profound impact on major diseases or public health problems.

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National Academies to Develop Gene-Editing Guidelines

Cas9 protein editing a gene

Artist depiction of Cas9 protein editing a gene (Jennifer Doudna, University of California – Berkeley)

18 May 2015. National Academy of Sciences and Institute of Medicine plan to write guidelines governing an emerging technology for editing human genomes. The initiative includes an international meeting in the fall to discuss the scientific, ethical, and policy issues associated with the technology known as CRISPR-Cas9.

CRISPR, short for clustered, regularly interspaced short palindromic repeats is adapted from a natural process used by bacteria to protect against attack by viruses, where a protein that deactivates or replaces genes binds to targeted RNA molecules generated by the genome. The RNA molecules then guide the editing protein, known as CRISPR-associated protein 9 or Cas9, to specific genes needing changes.

CRISPR-Cas9 techniques are becoming more efficient, widespread, and relatively easy to implement, raising concerns about their being applied to select desired traits in human embryos. In April 2015, a research team at Sun Yat-sen University in Guangzhou, China published a report of their attempts to modify a gene in human embryos rejected for in vitro fertilization.

The gene in this case causes the inherited blood disorder beta thalassemia that reduces production of hemoglobin, and the research team reported minimal success editing the problem gene. While the team concluded the technique was not ready for clinical use, reports of the experiments increased the urgency of calls for the establishment of guidelines before research with CRISPR-Cas9 goes much farther.

Among the calls for guidelines in the clinical use of CRISPR-Cas9 is a commentary published online in the journal Science on 19 March by 18 researchers in the field urging restraint in its application because of the potential for grave unintended consequences. The authors reported on discussions at a meeting of stakeholders in January 2015 held in Napa, California on medical, ethical, and legal implications of the research. Among the more urgent concerns raised by the group are modifications to genes in sperm and egg cells, known as germline cells, that are passed on to children.

The commentary’s authors include Jennifer Doudna, a molecular biologist at University of California in Berkeley and George Church, a geneticist at Harvard University, despite being on opposite sides of an intellectual property dispute over the technology. Both Doudna and Church founded businesses to commercialize their discoveries — Caribou Biosciences and Editas Medicine respectively — which are contesting the technology’s invention history and thus rights to patent the invention.

National Academy of Science and Institute of Medicine — scheduled to become National Academy of Medicine on 1 July — plan to apply their experience with a similar conference held in Asilomar, California in 1975 to develop rules for recombinant DNA research. No date for the meeting has yet been announced.

In addition to the summit meeting, the academies plan to appoint an international committee to explore the science of human gene editing, as well as get a better understanding of its clinical, ethical, legal, and social implications. An advisory group to guide the initiative is expected to be announced soon.

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AstraZeneca Building New Biologics Plant

AstraZeneca laboratory

AstraZeneca laboratory in Södertälje, Sweden (AstraZeneca)

18 May 2015. The pharmaceutical company AstraZeneca plans to build a new facility in Södertälje, Sweden to manufacture biologic medications. The $285 million plant is expected to employ from 150 to 250 workers when it goes into operation in 2019.

Södertälje is the site of AstraZeneca’s largest factory for making tablets and capsules, as well as its facility for launching new medication products. The plant now employs some 3,800 workers, with the ability to produce large quantities of new specialized pharmaceuticals. The company says the new biologics plant is the first of a three-part initiative to expand its biologics manufacturing capacity, but neither details of the next phases nor timelines were revealed.

The need for additional biologics capacity, notes company CEO Pascal Soriot, is a result of the prominent role now played by biologics in AstraZeneca’s corporate strategy, representing nearly half of the company’s overall pipeline. “We expect to bring a significantly increased number of new specialty care medicines to patients in the coming years, driven in large part by biologics,” says Soriot in a company statement. “This new plant will give us greater capacity and flexibility to handle clinical trials, and will also play an important role in our future commercial production.”

Most of AstraZeneca’s biologic therapies are developed by its MedImmune biotechnology subsidiary in Gaithersburg, Maryland. MedImmune is the maker of Synagis, an engineered antibody to prevent children’s lower respiratory tract infections caused by respiratory syncytial virus, as well as FluMist influenza vaccines. MedImmune says it has 120 biologics in its research pipeline addressing respiratory, automimmune, cardiovascular, and metabolic disorders, as well as cancer.

The new biologics plant in Södertälje joins Frederick, Maryland near MedImmune’s headquarters for production of biologics. In November 2014, AstraZeneca announced a $200 million expansion of the Frederick plant to build more biologics manufacturing capacity, eventually adding some 300 employees.

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Hat tip: FirstWord Pharma

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