Ingredient In Red Bull Helps Treat Psychotic Episodes

Many of us have relied on energy drinks like Red Bull or Monster to pull all-nighters in college, alleviate hangovers, or as a pick-me-up before hitting the gym. These 20-ounce sugar-laden drinks are not the healthiest beverages to consume, but researchers now suggest they may possess medicinal properties. A study presented at the annual meeting of the International Early Psychosis Association found taurine, an additive in energy drinks, can significantly help with psychosis.

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“Although taurine supplementation did not improve cognition, it appears to improve core symptoms and depression in patients with FEP,” concluded the authors. (FEP is an individual’s first episode of psychosis.)

Taurine is a naturally occurring amino acid in the body that aids a variety of functions. It helps control cardiovascular function, and has been found to both protect the paths of neurons in the brain, and help stimulate the creation of new neurons via neurogenesis. The amino acid is also known to have a calming effect on the brain.

Keeping this in mind, the team of researchers sought to observe if taurine could be utilized to stabilize the neurological activity occurring in people experiencing their first episode of psychosis. A total of 86 participants, aged 18 to 25, who had been previously diagnosed as suffering from a mental disorder with psychosis as a symptom, were recruited for the study. Every day for 12 weeks, half of the participants got four grams of taurine along with their antipsychotic medication, while the other half got a placebo.

Signs of early or FEP include hearing, seeing, tasting or believing things that others don’t; sudden decline in self-care; and trouble thinking clearly or concentrating, according to the National Alliance on Mental Illness. These warning signs often point to a person’s deteriorating health, requiring a physical and neurological evaluation to help identify the problem. The severity of the participants’ symptoms was measured using the Brief Psychiatric Rating Scale (BPRS) and the Calgary Depression Scale for Schizophrenia (CDSS). The researchers also used a scale called the MATRICS consensus cognitive battery (MCCB) to measure changes in cognition.

After 12 weeks, those who received taurine has significantly improved scores on the BPRS, indicating a reduction in psychotic symptoms. They also experienced a significant decrease in depression, although there were no notable changes in cognition. The researchers suggest taurine could potentially act as an effective nutritional therapy in treating FEP.  However, they caution: “The use of taurine warrants further investigation in larger randomised studies, particularly early in the course of psychosis.”  Previous research supports taurine’s ability to aid symptoms in mental disorders. Its been used as an alternative to lithium, by blocking the effects of excess acetylcholine that contributes to bipolar disorder.

Researchers are still a long ways away from prescribing taurine to help with psychosis. It clear that the substance could potentially play an influential role in treating mental illness. But the dose used in the experiment is equivalent to drinking about four 250-millimeter cans of Red Bull in one sitting every day: This is not recommended, and for most people, it’s likely to lead to more problems than it would solve.

Source: Trial finds Red Bull additive taurine improves symptoms of young people suffering first episode psychosis. International Early Psychosis Association Meeting in Milan, Italy. 2016.

By Lizette Borreli, Displayed with permission from Medical Daily
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Most Women Are Confused About Cancer Screenings

A new survey courtesy of Planned Parenthood finds that many women are unfortunately in the dark about the basics of breast and cervical cancer screenings.
FREE PIXABAY question banner-1090830_1280 CC0 LICThe nonprofit organization teamed up with an independent research institution, NORC at the University of Chicago, to survey over 1,000 adult women across the country this past March. Among other questions, the women were asked about the age they should first get screened for either type of cancer and how often they should return for a follow-up. When it came to cervical cancer, around 70 percent of women said they knew the correct answer to each question, but only nine percent actually got it right for either. For breast cancer, it was even worse, with more than 80 percent saying they understood the correct time frames, but only four percent getting the first question right and 10 percent the second.

For both breast and cervical cancer, the age that an average woman should get their first screening is 21. With cervical cancer, follow-up screenings should happen every three years for women in their 20s, and every three to five years for women ages 30 to 64; with breast cancer, the rate of screenings should be every one to three years, depending on your family history. In particular for breast cancer, women often confused mammograms as the primary form of screening rather than physical breast exams. Thirty percent guessed the first screening should happen at age 40, which is actually the recommended age of the first mammogram, and 55 percent guessed that women under the age of 40 should receive both types of screenings.

“The survey shows that not enough women have accurate information about their recommended cancer screenings,” said Dr. Raegan McDonald-Mosley, Chief Medical Officer for Planned Parenthood Federation of America, in a statement. The survey is the first of its kind commissioned by the organization, which wanted to understand how much women understood about cancer screenings given the updated recommendations issued by health agencies in recent years, according to Planned Parenthood spokesperson, Catherina Lozada.

Additionally, the survey demonstrated that a significant chunk of women haven’t gotten screened at all. Nineteen percent said they hadn’t been checked for cervical cancer, compared to 16 percent who said the same about breast cancer. And 39 percent and 23 percent of women said they weren’t sure when they should next get screened for cervical and breast cancer, respectively. These gaps were especially pronounced among Black and Hispanic women, who were not only less likely to get screened, but expressed facing more barriers to proper health care.

For instance, 42 percent of Hispanic women and 32 percent of Black women said that financial cost made them wary of cervical cancer screenings, compared to only 18 percent of white women. Similarly, these women felt more fearful of the test and of the potential results than their white counterparts. The findings only reaffirm a steady stream of research showing the disparities of cancer care experienced by people of color.

“The unfortunate reality is that women of color in the U.S. face more barriers to accessing health care than white women, and so are less likely to get preventive screenings, more likely to be diagnosed at later stages, and more likely to experience worse health outcomes when it comes to breast and cervical cancer,” explained McDonald-Mosley. Sadly, less than half of the women were aware that the Affordable Care Act has now made all insurance policies cover both types of screening completely free of charge.

“The survey revealed that almost half of women have never encouraged other women in their lives to get screened for cervical cancer, one of the most preventable cancers when caught early,” said McDonald-Mosley. “We hope more women will talk with their loved ones — mother, siblings, aunts, cousins, partners, and friends — about the importance of getting screened for breast and cervical cancer. You can simply ask when the last time they had a check-up was — and if they aren’t going in for screenings, ask what’s preventing them from getting care.”

Read More:  For Cancer Screenings, When Do The Benefits Outweigh The Risks? Read here
Ovarian Cancer Screening May Soon Be Conducted With A Simple Blood Test. Read here

Source:  National Survey of Women’s Knowledge of Recommended Screenings for Breast and Cervical Cancer. Planned Parenthood. 2016.

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Are NYC Rats Disease ‘Sponges’?

Scientists want to track them to find out.

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Rats are commonplace in urban areas yet remain a mystery in many ways. But researchers plan to track New York City rats to get a better idea of what pathogens they may spread.

But despite how commonplace rats are in cities around the world, they remain in many ways mysterious, including in the potential threat they pose to public health, experts say.  To combat that, a trio of scientists outlined in the journal Frontiers in Public Health step-by-step recommendations for how they say public health officials should capture rats, implant them with microchips, test them for pathogens, and track their activity. The methods were developed and tested with rats in New York City.

“There’s not a lot of research being done with rodents, and because of that, we don’t have a lot of information about the pathogens they harbor,” said Michael Parsons, the report’s lead author and a chemical and behavioral ecologist.  .

Rats – and rodents more broadly – aren’t responsible for nearly as many disease cases or deaths as, say, mosquitoes. But they can transmit fevers, a type of meningitis, and, yes, plague. The diseases are spread through bites and scratches, pathogens in the animals’ feces and urine, and via fleas. (People are not susceptible to all pathogens that rats harbor.)

“Instead of sampling animals periodically, on a punctuated basis,” Parsons said, “we need to implement something on a continual basis.”  In 2015, the city’s rat budget got a $2.9 million boost and its program has about 170 people on staff, including exterminators and scientists.

The paper, which Parsons wrote with a fellow Hofstra scientist and a medical entomologist from an extermination company, outlines the steps the researchers developed to trap rats and then monitor them.  After being released, the rats were drawn back to sensors that weighed them, providing regular insights into their health. The researchers also recaptured some rats for tests to see if pathogen levels changed over time.

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Scientist Helps NASA Develop Medical Device

In the future, NASA astronauts journeying into deep space may give themselves a health check-up with the aid of a small medical device developed by a team of scientists, including one from LLNL.

Laboratory radiobiologist Matt Coleman is part of the six-scientist team, including researchers from NASA’s Ames Research Center, the University of California, Davis and Sandia National Laboratories/California, that has developed a small, portable medical diagnosis instrument. The team members have filed for a patent for their medical device.

NASA MColeman Med Device

Radiobiologist Matt Coleman displays a device like the medical diagnosis instrument he helped develop for NASA for use in deep space. | Photo by Lawrence Livermore National Laboratory.

The patent covers the development of a comprehensive in-flight medical diagnostic system in a hand-held format weighing less than one pound for human deep-space missions such as a mission to Mars, which is expected to take six months each way.

 

 

 

“The point of developing tools like this one is for detecting disease from long-term exposure to microgravity and ionizing radiation,” Coleman said, adding that exposures from space exploration can potentially cause degenerative diseases of the bone, heart and eye, along with raising concerns about cancer.  “Since we don’t fully understand the long-term impacts of space travel, there has been a push by NASA to better understand these effects.”

The new medical device will use biomarkers in three different sample types – breath, saliva and blood – to detect information that is indicative of health and exposure to radiation. (A biomarker is any protein, DNA, RNA or small molecules that provide information about current or future health status).

Breath and saliva are non-invasive samples and can rapidly provide health assessment information, which can be critical immediately following space walks, and prior to removal of any spacesuits.

Key features of the device include the ability to handle multiple sample types and the ability to measure virtually any biomarker, including future biomarkers as they emerge. Small blood samples can provide information about macromolecular biomarkers as well as blood cell counts.  “Some of the tools we’re developing will be among the first multi-function health diagnostic devices used in space,” Coleman said.

The team conceptualized the device in 2012 and wrote a paper about its development that appeared in 2013 in the journal, Recent Patents in Space Technology. The team has built a conceptual mock-up of the portable medical device and its individual technologies have been tested.

The team’s lead scientist is Tore Straume of NASA’s Ames Research Center, a former LLNL researcher and Lab retiree. Straume is a radiobiologist, conducting research that focuses on the effects of ionizing radiation on human health. In addition to Coleman and Straume, the team includes David Loftus and Jing Li of NASA Ames, Cristina Davis of UC Davis and Anup Singh of Sandia National Laboratories/California.

By Stephen Wampler | Lawrence Livermore National Laboratory; Displayed with permission from Breaking Energy

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IMMUNO-ONCOLOGY: Targeting the immune system, not the tumor

Immuno-oncology is based on the concept of harnessing the body’s own immune system to fight cancer.

One of the most exciting areas of cancer research today is immuno-oncology, and while it’s an approach that scientists first considered more than 100 years ago, recent scientific discoveries and clinical advances have ushered in a truly historical time in cancer research.

Immuno-oncology Video Capture

Image Courtesy of PhRMA (Video Capture)

Recently, PhRMA released a new video highlighting immuno-oncology, which is currently being researched and developed by Bristol-Myers Squibb and several other bio-pharmaceutical companies.

Cancer is clever and has found ways to outwit the immune system. Rather than killing these cancer cells directly with traditional tools like radiation or chemotherapy, immunotherapy seeks to intensify the immune system’s power to eliminate them. Immuno-oncology is already improving outcomes and survival rates for some patients, including melanoma, kidney and lung cancer, and researchers are urgently working to gain new insights into the complex interactions between patients’ immune systems and the cancer cells growing in their bodies with the goal of markedly improving outcomes in many more tumor types.

While the science has advanced rapidly in recent years, there is more work to do. Researchers hope to replace chemotherapy as the first line treatment for many cancers and help as many patients as possible achieve long-term survival. This new treatment approach has the potential to help patients live longer, healthier lives.

Learn more about advancements in science at From Hope to Cures.

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New Drug Holds Promise Against Zika

MV-4 Based On Research That Unlocks Key to Breaking Down Viruses

A New York pharmaceutical company, TGV-Laboratories, says it has unlocked the key for breaking down the protective barriers of viruses, a breakthrough that it believes can be developed into antiviral drugs to treat Zika and host of life-threatening viruses, including Ebola, HIV and Bird Flu.  The company’s lead researchers, Victor and George Tetz, said lab tests show their discovery, called MV-4, can break down the protective barriers of both enveloped and non-enveloped viruses, indicating it can be developed into targeted synthetic antiviral drugs to kill a wide variety viruses.

ZIKA Virus WordleArtIn laboratory tests, the researchers said they were able to kill influenza viruses, HIV, Herpes viruses, polio and adenoviruses, and are eager to test their discovery against Zika, Ebola and Bird Flu.  In a letter to the CDC, the researchers outlined their findings, and offered their help in developing new treatments against these global health threats.

“We are very excited about our findings to date, and are eager to expand the testing of our drugs on these dangerous and highly contagious viruses,” said Victor Tetz, scientific head of TGV-Laboratories. The Zika virus is primarily a mosquito-transmitted infection. However, it was recently isolated from semen, and there is evidence it can be transmitted through sexual intercourse — opening new frontiers for global spreading and raising the need for an antiviral drug that can attack it at many levels. “The studies we have conducted to date show MV-4 can inactivate viruses in the outer environment, on human skin and at intravenous administration, so we believe discovery shows huge promise against Zika, Ebola and Bird flu.”

TGV Laboratories, along with its Institute of Human Microbiology, are finalizing a paper that details their discovery and what they believe to be its strong potential for safely treating a broad range of life-threatening and non-life threatening viruses. Currently, there are no broad-spectrum antiviral drugs.  MV-4 is the second broad-spectrum drug candidate developed by TGV Laboratories, whose Mul-1867 has shown potential for being developed into drugs that can treat an extensive range of antibiotic-resistant bacterial and fungal infections. TGVs subsidiary, TGV-Inhalonix, recently filed an application with the Food and Drug Administration seeking Orphan Drug Status for Mul-1867 to be tested on cystic fibrosis patients with life-threatening antimicrobial-resistant pulmonary infections.

“Developing broad-spectrum drugs that can treat viruses and the growing list of antibiotic-resistant infections is one of the most important, but elusive, goals in infectious research today,” said George Tetz, head of research for the Institute of Human Microbiology. “With MV-4 and Mul-1867, we believe we have unlocked the key for developing the next-generation of antibiotics and anti-viral drugs.”

The drugs in TGV’s pipeline were discovered as the result of years of research by Victor and George Tetz using a new concept they developed called Pangenome, (http://www.ncbi.nlm.nih.gov/pubmed/15990697), which acts like a guide that helps mark new therapeutic targets for drugs. The Institute of Human Microbiology assisted TGV with Mul-1867’s discovery.

TGV-Laboratories Group of Companies. (http://tgv-labs.com) is a research-based pharmaceutical company headquartered in New York that provides a broad range of innovative products to treat currently untreatable infectious, autoimmune and neurodegenerative diseases. TGV operates under two divisions: the Division of Drug Discovery & Development and the Division of Medical & Industrial Microbiology.

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Quick Takes: the Pharma C-Suite with John Hudak, President: Outsourcing & Strategic Partnerships

In the recent PharmaVoice Feb 2016 PV MagCover FEB16 issue highlighting Outsourcing, PV asked Pharma’s KOL’s to answer some key questions regarding the current state of Outsourcing & Strategic Partnerships.

John Hudak, President & Founder of Criterium Inc Global CRO

John Hudak, President & Founder of Criterium Inc Global CRO

John M. Hudak, President and Founder, Criterium Inc., Global CRO answered these 2 questions for them:

  • What barriers continue to limit CROs and sponsors from becoming true development partners?

Sponsors can have unrealistic expectations of CRO partners. Most partnerships work top-down at both Sponsors and CROs, and are evidenced in timelines and budgets. But top-down management may not always translate into trickle-down commitment. There are some discouraging figures out there about the high percentage of studies that don’t meet their timelines. When timelines and budgets are estimated to satisfy board members or project committees, it’s imperative to include all key factors that affect early planning stages, and be grounded in fiscal reality.

  • What are the key ingredients to a successful outsourcing partnership?

Planning needs transparency and communication, in concert. Sponsors can sometimes have impractical expectations regarding timelines and budgets. And CROs can end up having the same unrealistic expectations of study sites. Everyone wants to meet expectations and win the job – but this sometimes results in unworkable time estimates and budgets. There needs to be more open discussion among stakeholders, Sponsors, CROs and sites regarding the environments in which studies are conducted — and realistic strategies for successful completion.

About John M. Hudak, MBA, President and Founder
John has more than 40 years of experience in the pharmaceutical research and business development arena serving the pharmaceutical and contract clinical services sectors. He has extensive expertise in strategic planning and competitive analysis, market development, promotional planning and tracking, proposal design and custom-services development, international project management and clinical study completion, protocol design and implementation, electronic data capture, and market communications and has worked with drugs, biologics, generics and medical devices.

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Study Shows Many People With Obesity Still Consider Themselves Healthy

New study finds that many people with obesity consider themselves healthy despite having obesity-related comorbidities

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Initial data from Awareness, Care & Treatment In Obesity MaNagement (ACTION), the first nationwide U.S. study to investigate barriers to obesity management, were presented on November 6 at ObesityWeek 2015, the 3rd annual combined congress of the American Society for Metabolic and Bariatric Surgery and The Obesity Society. Notably, results highlight a general lack of understanding of obesity as a disease and its impact on the body, with the majority of people with obesity (75%) indicating that they perceive themselves as “healthy,” although nearly three-quarters had obesity-related comorbidities. 1

“People with obesity often struggle to successfully manage their weight and obtain the help they need to maintain weight loss and improve their health,” said Joseph Nadglowski, president of the Obesity Action Coalition, a non-profit coalition helping individuals affected by obesity. “The findings from the ACTION study indicate that the challenges many people with obesity face may stem from their misperception that obesity is a lifestyle issue that can be overcome simply by eating less and exercising more, instead of a complex disease that requires a comprehensive care approach.”

Other findings from this early qualitative phase of the ACTION study highlight differences in perception of obesity between people with obesity and health care professionals. While people with obesity and health care professionals considered obesity a combination of disease and lifestyle, their primary emphasis differed widely—the majority of people with obesity (65%) considered obesity primarily a lifestyle issue, while the majority of health care professionals (88%) considered obesity a disease. 1 All results were drawn from focus groups and interviews conducted with people with obesity (n=43) and health care professionals (n=24).

“These variances in perception of obesity and its causes may be one reason why patients and clinicians are not engaging in the necessary conversations that lead to solution-based strategies to address weight-related health problems and its long-term management. The aim of ACTION is to gain a better understanding of all the barriers that prevent effective obesity care and to devise successful approaches to overcome modifiable barriers,” said Dr. Nikhil Dhurandhar, president of The Obesity Society and member of the Steering Committee for the ACTION study.

Additional disparities between people with obesity and health care professionals related to perceptions of key barriers to weight management were identified in this initial qualitative phase of the ACTION study. The disparities relate to food habits, social relationships, and limited understanding of how to lose weight. 1

The initial qualitative findings of the ACTION study indicate that multiple barriers prevent effective obesity care; this will be further investigated on a larger scale in the subsequent phase of quantitative research. Currently underway, the quantitative study draws from an online survey conducted with 3,000 people with obesity, 600 health care professionals, and 150 employers. The full results of the ACTION study will be released in 2016.

The ACTION study is conducted in the United States and led by a multidisciplinary Steering Committee consisting of representatives from The Obesity Society (TOS), the Obesity Action Coalition (OAC), Integrated Benefits Institute (IBI)—representing employers, as well as obesity experts in the fields of primary care, endocrinology, psychology and nursing. The study is sponsored by Novo Nordisk.  For more information, visit novonordisk-us.com

About Obesity    Obesity is a disease 2 that requires long-term management. It is associated with many serious health consequences and decreased life expectancy. 3, 4 It is a complex and multifactorial disease that is influenced by genetic, physiological, environmental and psychological factors. 5  The global increase in the prevalence of obesity is a public health issue that has severe cost implications to health care systems. 6,7 In the United States, approximately 35% of adults, or nearly 79 million adults, live with obesity. 8,9 Despite the high prevalence of obesity, many people with obesity lack support in their efforts to lose weight and the disease remains substantially underdiagnosed and underreported. 10

About ACTION    Awareness, Care & Treatment In Obesity MaNagement (ACTION) is a U.S. study investigating the barriers to obesity management by examining the perspectives of three groups: health care professionals, people with obesity and employers. The ultimate objectives of ACTION are to create a better understanding of the barriers that prevent people with obesity from receiving the medical care and support they need to improve health, to generate insights to guide collaborative action to improve care, education and support for people with obesity, and to create a platform for communication, to help change how patients, health care professionals and employers approach obesity care.

References  1 Kaplan L Golden A, O’Neil P, et al. Divergence of patient and clinician perceptions of obesity and weight management. Poster presented at: ObesityWeek 2015; November 2-6, 2015; Los Angeles, CA. 2 American Medical Association. Business of the American Medical Association House of Delegates 2013 Annual Meeting annotated reference committee reports: reference committee D. http://www.ama-assn.org/assets/meeting/2013a/a13-addendum-refcomm-d.pdf. Approved June 8, 2014. Accessed September 8, 2014.  3 Guh DP, Zhang W, Bansback N , et al . The incidence of co-morbidities related to obesity and overweight: a systematic review and meta-analysis. BMC Public Health. 2009;9(88):1-20. 4 Peeters A, Barendregt JJ, Willekens F, et al . Obesity in adulthood and its consequences for life expectancy: a life-table analysis. Ann Intern Med. 2003;138:24-32. 5 Wright SM, Aronne LJ. Causes of obesity. Abdom Imaging. 2012;37(5):730-732. 6 World Health Organization. Fact sheet no. 311: obesity and overweight. http://www.who.int/mediacentre/factsheets/fs311/en/. Updated January 2015. Accessed October 6, 2015. 7 Cawley J, Meyerhoefer C. The medical care costs of obesity: an instrumental variables approach. J Health Economics. 2012;31(1):219-230. 8 Ogden CL, Carroll MD, Kit BK, Flegal KM. Prevalence of childhood and adult obesity in the United States, 2011-2012. JAMA. 2014;311(8):806-814. 9 Centers for Disease Control and Prevention. Adult obesity facts. http://www.cdc.gov/obesity/data/adult.html. Updated September 21, 2015. Accessed October 26, 2015.  10 Crawford AG, Cote C, Couto J, et al. Prevalence of Obesity, Type II Diabetes Mellitus, Hyperlipidemia, and Hypertension in the United States: Findings from the GE Centricity Electronic Medical Record Database. Popul Health Manag. 2010;13:151–161.

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Clinical Trials Monthly Case Study Analysis: Cost Reductions / Hematology

Each month, we investigate a different Clinical Trial Case Study that posed us with a challenging question – this time it’s a look at an orphan indication in HEMATOLOGY, and significant cost reductions for the sponsor:

We asked ourselves:

Scenario: A Phase IV study was required by the FDA as a condition of approval of an orphan drug. The sponsor was faced with monitoring, managing, and locking data for a 12-month study conducted at 100 sites.

•    Criterium offered an integrated technology-enhanced solution that allowed the sites to register ePRO Patient Diaries Input-Output Diagrampatients and allowed the patients to record their event data directly into our remote systems.
•    Criterium’s solution enabled the client to eliminate most of the scheduled monitoring visits. Criterium’s diligence and centralized system meant that monitors only had to visit sites that had problems.

What If:  If the client had used traditional methods, the cost would have soared for a product that has modest revenue and it would have taken much longer to provide the data to the FDA and the prescribing community.

Results:  Criterium’s centralized real-time data accession utilizing Automated CRFs and Interactive Voice Response (IVR) medical history and patient diary application saved the client $1 million to $1.5 million in clinical monitoring and data management costs. In addition, the data were satisfactory for rapid submission to the FDA for conditional approval, were provided to the medical community to support the indication for which the drug was approved and numerous publications resulted from this fairly large body of data for this orphan indication.

Read more of our successful case studies: http://www.criteriuminc.com/case_studies.php

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For Cancer Patients, The Possibility Of DNA-Tailored Care

Holly Boehle looked at the expression on the face of her radiologist and knew something was wrong. Boehle had felt a lump just before the holidays and had decided to schedule a mammogram, even though she wasn’t due to start standard screening for another eight years. The mammogram was followed up with an ultrasound, and then a biopsy. Finally, she was given the formal diagnosis: invasive ductal carcinoma, the most common type of breast cancer.

The next week she traveled to Mayo Clinic’s oncology office in Rochester, Minn., where she met with clinical breast surgeon Dr. Judy Boughey who suggested Boehle consider participating in a new, ongoing study. She quickly agreed and became one of 140 women to take part in the Breast Cancer Genome-Guided Therapy Study, affectionately called “BEAUTY.”

By the end of the month, the first phase of the study was underway. Tumor tissue was taken from Boehle, and promptly brought into a lab where the sample was injected into mice with compromised immune systems. With her tumor tissue growing inside of them, the avatar mice are given different chemotherapy drugs in order to test the efficacy of treatment before they try it out on human Boehle.

BEAUTY’s Beginnings

Each patient in BEAUTY was given a biopsy, imaging, and chemotherapy treatment, followed by a second round of biopsy and imaging before they headed into the operating room. This gave researchers information on each patient’s blood and genetic makeup, and the sequencing information for their tumor before, during, and after chemotherapy treatment. The mouse avatars, known as patient xenografts, took up the patient’s individualized tumor 40 percent of the time, ultimately serving as a preview into the patient’s treatment outcome.

DNA Strand Free CCLicenseA class of chemo drug called taxanes are the standard of treatment for breast cancer, but doctors currently don’t have a genetic marker to indicate who will respond to taxane therapy and who won’t. That’s why anthracyclines and cyclophosphamide, a separate chemotherapy drug regimen, are typically given in conjunction as the first step in treatment followed by taxane therapy. However, Boughey’s team reversed the sequence for BEAUTY patients whose mice reacted well to the taxane treatment first. It turned out that those patients who responded best to the flipped treatment sequence also shared the same gene in their genetic makeup.

Based on how her mice reacted to treatment, Boehle was one of those patients who were treated with a reverse chemotherapy schedule than what the typical patient with invasive ductal carcinoma is treated with. Within six months of her diagnosis, Boehle’s tumor shrank considerably as a reaction to the chemotherapy.

Being part of the trial has long-term implications for Boehle, too. If the cancer were to recur, she says, “we would already know…what works for me and what doesn’t. It really opens up a whole new world for me and other breast cancer patients in terms of individualized medicine and knowing that I don’t need to be the person who they experiment on and say, ‘Let’s try this medication or chemotherapy and see if it works and we hope that it does.’”

Four years ago, when Boughey and her team began setting up the BEAUTY study, they wanted to be able to design a treatment plan with a relatively accessible patient population. Because breast cancer is so common among women, the research team chose to start work on individualized medicine with those patients with plans to eventually work their way to other solid tumor cancers such as prostate.

By sequencing the genome for both the tumor and the patient’s inheritable DNA, researchers are able to pull the curtain back and see what’s driving the tumor to grow, why it’s different from another tumor, and how the tumor might react to drug treatments. Harnessing the genetic sequence of a tumor in conjunction with a person’s DNA will allow doctors to expand personalized cancer treatments beyond breast cancer.

Standard of Care Tumor Sequencing

Sequencing a tumor for its complete genetic information can take as little as a few days, and as long as several weeks, depending upon the stage of cancer. Once they have the results, researchers then compare them to a patient’s individual germline cells, which contain hereditary mutations that occur during conception. Patients born with germline mutations can pass on to future generations. Somatic mutations can be caused by a number of different environmental factors and can occur spontaneously. As researchers unravel which gene mutations are responsible for causing each corresponding disease, it sets the foundation for creating individualized treatments through trial-and-error.

“From there potential drugs can be identified that act on genes and/or pathways,” Boughey and her colleague Dr. Matthew Goetz, a clinical oncologist at the Mayo Clinic, told Medical Daily in an email. “One novel aspect of the BEAUTY clinical trial is our ability to link drug response in the patients with both germline and somatic genomic information and validate using the patient derived xenografts [mouse avatars].”

Mayo Clinic’s research team is currently writing the protocol for BEAUTY 2 based on the types of tumors they identified, and the drug resistance and successes discovered in BEAUTY 1. Because they were able to prove mouse avatars, when administered the same drug that patients were treated with, mirror the drug response seen in patients, pharmaceutical companies will be involved with this next stage by designing medications based on study participants’ response to treatment.

BEAUTY, Boughey says, will “drive forward breast cancer treatments for the future.”

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