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News Article | April 25, 2017
Site: www.eurekalert.org

VIDEO:  Scientists and physicians at University of California San Diego School of Medicine, working with colleagues at the U.S. Navy Medical Research Center (NMRC), Texas A&M University, a San Diego-based biotech... view more Scientists and physicians at University of California San Diego School of Medicine, working with colleagues at the U.S. Navy Medical Research Center - Biological Defense Research Directorate (NMRC-BDRD), Texas A&M University, a San Diego-based biotech and elsewhere, have successfully used an experimental therapy involving bacteriophages -- viruses that target and consume specific strains of bacteria -- to treat a patient near death from a multidrug-resistant bacterium. The therapeutic approach, which has been submitted to a peer-reviewed journal, is scheduled to be featured in an oral presentation tomorrow at the Centennial Celebration of Bacteriophage Research at the Institute Pasteur in Paris by Biswajit Biswas, MD, one of the case study's co-authors and chief of the phage division in the Department ?Genomics and Bioinformatics at NMRC-BDRD. April 27 is Human Phage Therapy Day, designated to mark 100 years of clinical research launched by Felix d'Herelle, a French-Canadian microbiologist at Institute Pasteur who is credited with co-discovering bacteriophages with British bacteriologist Frederick Twort. Authors say the case study could be another catalyst to developing new remedies to the growing global threat of antimicrobial resistance, which the World Health Organization estimates will kill at least 50 million people per year by 2050. Based on the success of this case, in collaboration with NMRC, UC San Diego is exploring options for a new center to advance research and development of bacteriophage-based therapies. "When it became clear that every antibiotic had failed, that Tom could die, we sought an emergency investigational new drug application from the FDA to try bacteriophages," said lead author Robert "Chip" Schooley, MD, professor of medicine, chief of the Division of Infectious Diseases in the UC San Diego School of Medicine and primary physician on the case. "To our knowledge, he is the first patient in the United States with an overwhelming, systemic infection to be treated with this approach using intravenous bacteriophages. From being in a coma near death, he's recovered well enough to go back to work. Of course, this is just one patient, one case. We don't yet fully understand the potential -- and limitations -- of clinical bacteriophage therapy, but it's an unprecedented and remarkable story, and given the global health threat of multidrug-resistant organisms, one that we should pursue." The story begins in late-2015. Tom Patterson, PhD, a 69-year-old professor in the Department of Psychiatry at UC San Diego School of Medicine, and his wife, Steffanie Strathdee, PhD, chief of the Division of Global Public Health in the Department of Medicine, were spending the Thanksgiving holiday in Egypt when Patterson became ill, wracked by abdominal pain, fever, nausea, vomiting and a racing heartbeat. Local doctors diagnosed pancreatitis -- inflammation of the pancreas -- but standard treatment didn't help. Patterson's condition worsened and he was medevacked to Frankfurt, Germany Dec. 3, 2015, where doctors discovered a pancreatic pseudocyst, a collection of fluid around the pancreas. The fluid was drained and the contents cultured. Patterson had become infected with a multidrug-resistant strain of Acinetobacter baumannii, an opportunistic and often deadly pathogen. The bacterium has proved particularly problematic in hospital settings and in the Middle East, with many injured veterans and soldiers returning to the U.S. with persistent infections. Initially, the only antibiotics with any effect proved to be a combination of meropenem, tigecycline and colistin, a drug of last resort because it often causes kidney damage, among other side effects. Patterson's condition stabilized sufficiently for him to be airlifted Dec. 12, 2015, from Germany to the Intensive Care Unit (ICU) at Thornton Hospital at UC San Diego Health. Upon arrival, it was discovered that his bacterial isolate had become resistant to all of these antibiotics. At Thornton Hospital, now part of Jacobs Medical Center, Patterson began to recover, moving from the ICU to a regular ward. But the day before scheduled discharge to a long-term acute care facility, an internal drain designed to localize his infection and keep it at bay slipped, spilling bacteria into his abdomen and bloodstream. Patterson immediately experienced septic shock. His heart began racing. He could not breathe. He became feverish and would subsequently fall into a coma that would last for most of the next two months. He was, in effect, dying. "That's a period of my life I don't remember," recalled Patterson. "There was so much pain that it's almost beyond your ability to cope. I'm happy not to remember." Strathdee, his wife, is no stranger to the terrors of disease. As an infectious disease epidemiologist and director of the UC San Diego Global Health Institute, she has worked around the world, from India to Afghanistan to Mexico, trying to lower HIV infection and mortality rates. "There came a point when he was getting weaker and weaker, and I didn't want to lose him. I wasn't ready to let him go and so I held his hand and said, 'Honey, they're doing everything they can and there's nothing that can kill this bug, so if you want to fight, you need to fight. Do you want me to find some alternative therapies? We can leave no stone unturned.'" Tom recalled the moment: "I vaguely remember you saying, 'do you want me to try or not because it's going to be a tough time and it's not certain that it will work.' I remember squeezing your hand, but it was just a flash in the whole process." Strathdee began doing research. A colleague mentioned a friend had traveled to Tblisi, Georgia to undergo "phage therapy" for a difficult condition and had been "miraculously cured." Strathdee had learned of bacteriophages while she was a student, but they were not part of mainstream medical doctrine. She turned to strangers in the phage research community and to her colleague Chip Schooley for help. Bacteriophages are ubiquitous viruses, found wherever bacteria exist. It's estimated there are more than 1031 bacteriophages on the planet. That's ten million trillion trillion, more than every other organism on Earth, including bacteria, combined. Each is evolved to infect a specific bacterial host in order to replicate -- without affecting other cells in an organism. The idea of using them therapeutically is not new. Described a century ago, phage therapy was popular in the 1920s and 1930s to treat multiple types of infections and conditions, but results were inconsistent and lacked scientific validation. The emergence of antibiotics in the 1940s pushed phage therapy aside, except in parts of Eastern Europe and the former Soviet Union, where it remained a topic of active research. With dwindling options, Strathdee, Schooley and colleagues went looking for help. They found many researchers willing to help. Three teams possessed suitable phages that were active against Patterson's particular bacterial infection: the Biological Defense Research Directorate of the NMRC in Frederick, MD; the Center for Phage Technology at Texas A&M University; and AmpliPhi, a San Diego-based biotech company specializing in bacteriophage-based therapies. A research team at San Diego State University, headed by microbial ecologist Forest Rowher, PhD, purified the phage samples for clinical use. With emergency approval from the Food and Drug Administration, each source provided phage strains to UC San Diego doctors to treat Patterson, with no guarantee that any of the strains would actually work. "That's one of the remarkable things to come out of this whole experience," said Schooley, "the incredible and rapid collaboration among folks scattered around the world. It was a desperate time and people really stepped up." Phage therapy is typically administered topically or orally. In Patterson's case, the phages were introduced through catheters into his abdominal cavity and intravenously to address a broader, systemic infection, which had not been done in the antibiotic era in the U.S. "That makes them more effective," said Schooley. "The action is at the interface of the patient and the organism." With tweaking and adjustments -- his physicians were learning on the fly -- Patterson began to improve. He emerged from his coma within three days of the start of IV phage therapy. "Tom woke up, turned to his daughter and said, 'I love you'," recalled Schooley. Patterson was soon weaned off of the respirator and blood pressure drugs. "As a treating doctor, it was a challenge," said Schooley. "Usually you know what the dosage should be, how often to treat. Improving vital signs is a good way to know that you're progressing, but when you're doing it for the first time, you don't have anything to compare it to. "A lot was really worked out as we went along, combining previous literature, our own intuition about how these phages would circulate and work and advice from people who had been thinking about this for a long time." By the time Patterson was airlifted to Thornton Hospital at UC San Diego Health, he was in dire straits. His abdomen had swelled, distended by the pseudocyst teeming with multi-drug resistant A. baumaunnii. His white blood cell count had soared -- a sign of rampant infection. Doctors tried various combinations of antibiotics. He developed respiratory failure and hypotension that required ventilation and recurrent emergency treatment. He became increasingly delirious. When he lapsed into a coma in mid-January, he was essentially being kept alive on life support. Eventually Schooley said there were no antimicrobial agents left to try. Strathdee recalled colleagues wondering aloud if she was prepared for Tom to die. She wasn't. Bacteriophage therapy began March 15, 2016, with a cocktail of four phages provided by Texas A&M and the San Diego-based biotech company AmpliPhi, pumped through catheters into the pseudocyst. If the treatment didn't kill him, Patterson's medical team planned to inject the Navy's phages intravenously, flooding his bloodstream to reach the infection raging throughout his body. As far as Patterson's doctors knew, such treatment had never been tried before. On March 17, the Navy phages were injected intravenously. There were fears about endotoxins naturally produced by the phages. No one knew what to expect, but Patterson tolerated the treatment well -- indeed there were no adverse side effects -- and on March 19, he suddenly awoke and recognized his daughter. "One of NMRC's goals with respect to bacteriophage science has been providing military members infected with multidrug-resistant organisms additional antimicrobial options so we were experienced and well-positioned to provide an effective phage cocktail for Dr. Patterson," said Theron Hamilton, PhD, head of Genomics and Bioinformatics at the Navy's Biological Defense Research Directorate. "Obviously, we are thrilled with the outcome and hope this case increases awareness of the possibility of applying phage therapy to tough cases like this one." Subsequent treatment, however, would not be easy. The learning curve was steep and unmarked. There were bouts of sepsis -- a life-threatening complication caused by massive infection. Despite improvement, Patterson's condition remained precarious. Doctors discovered that the bacterium eventually developed resistance to the phages, what Schooley would characterize as "the recurring Darwinian dance," but the team compensated by continually tweaking treatment with new phage strains -- some that the NMRC had derived from sewage -- and antibiotics. In early May, Patterson was taken off of antibiotics. After June 6, there was no evidence of A. baumannii in his body. He was discharged home August 12, 2016. Recovery has not been entirely smooth and steady. There have been setbacks unrelated to the phages. A formerly robust man, Patterson had been fed intravenously for months in the hospital and had lost 100 pounds, much of it muscle. He has required intense physical rehabilitation to regain strength and movement. "It's not like in the movies where you just wake up from a coma, look around and pop out of bed," Patterson said. "You discover that your body doesn't work right anymore." He said he could feel parts of his brain coming back alive. Nonetheless, Patterson described the experience as miraculous. Even comatose, when he often wrestled with imagined demons, he recalled hearing and recognizing voices and realizing that beyond his darkness, there was life and hope. And beyond him, he hopes his experience will translate into new treatments for others: "The phage therapy has really been a miracle for me, and for what it might mean that millions of people who may be cured from multidrug-resistant infections in the future. It's been sort of a privilege." Schooley said Patterson was lucky. His wife was a trained scientist and determined to find a remedy -- and they both worked at UC San Diego School of Medicine: "He was fortunate to be in a place that had all of the resources and courage necessary to support him while this innovative therapy was developed, which was essentially a home brew cocktail of viruses to be given to a desperately ill individual. I think a lot of other places would have hesitated. I think the response that he had clinically has been very gratifying and speaks to the strength of a multidimensional medical center with all of the pieces you need." Still, Schooley said any broad, future approved application of phage therapy faces fundamental challenges unlike past treatments. "What the FDA is used to saying is 'This is an antibiotic. We know what its structure is and how you can give it to multiple people.' With bacteriophage therapy, the FDA would be dealing with an approach in which doctors would have to develop phage cocktails for each patient tailored to their infecting organisms. It's the ultimate personalized medicine." The good news, Schooley said, is that new molecular tools, robotics and other advances make personalized medicine possible in a way it wasn't 10 or 15 years ago. "Then, it would have been impossible to contemplate. There's still much research to be done, but I think there are going to be a lot of clinical applications where this approach may be very beneficial to patients." Derived from the Greek words meaning "bacteria eater," bacteriophages are ancient and abundant -- found on land, in water, within any form of life harboring their target. According to Rowher at San Diego State University and colleagues in their book Life in Our Phage World, phages cause a trillion trillion successful infections per second and destroy up to 40 percent of all bacterial cells in the ocean every day. Thousands of varieties of phage exist, each evolved to infect only one type or a few types of bacteria. Like other viruses, they cannot replicate by themselves, but must commandeer the reproductive machinery of bacteria. To do so, they attach to a bacterium and insert their genetic material. Lytic phages then destroy the cell, splitting it open to release new viral particles to continue the process. As such, phages could be considered the only "drug"' capable of multiplying; when their job is done, they are excreted by the body.


News Article | April 26, 2017
Site: www.sciencedaily.com

Scientists and physicians at University of California San Diego School of Medicine, working with colleagues at the U.S. Navy Medical Research Center -- Biological Defense Research Directorate (NMRC-BDRD), Texas A&M University, a San Diego-based biotech and elsewhere, have successfully used an experimental therapy involving bacteriophages -- viruses that target and consume specific strains of bacteria -- to treat a patient near death from a multidrug-resistant bacterium. The therapeutic approach, which has been submitted to a peer-reviewed journal, is scheduled to be featured in an oral presentation at the Centennial Celebration of Bacteriophage Research at the Institute Pasteur in Paris by Biswajit Biswas, MD, one of the case study's co-authors and chief of the phage division in the Department ?Genomics and Bioinformatics at NMRC-BDRD. April 27 is Human Phage Therapy Day, designated to mark 100 years of clinical research launched by Felix d'Herelle, a French microbiologist at Institute Pasteur who is credited with co-discovering bacteriophages with British bacteriologist Frederick Twort. Authors say the case study could be another catalyst to developing new remedies to the growing global threat of antimicrobial resistance, which the World Health Organization estimates will kill at least 50 million people per year by 2050. Based on the success of this case, in collaboration with NMRC, UC San Diego is exploring options for a new center to advance research and development of bacteriophage-based therapies. "When it became clear that every antibiotic had failed, that Tom could die, we sought an emergency investigational new drug application from the FDA to try bacteriophages," said lead author Robert "Chip" Schooley, MD, professor of medicine, chief of the Division of Infectious Diseases in the UC San Diego School of Medicine and primary physician on the case. "To our knowledge, he is the first patient in the United States with an overwhelming, systemic infection to be treated with this approach using intravenous bacteriophages. From being in a coma near death, he's recovered well enough to go back to work. Of course, this is just one patient, one case. We don't yet fully understand the potential -- and limitations -- of clinical bacteriophage therapy, but it's an unprecedented and remarkable story, and given the global health threat of multidrug-resistant organisms, one that we should pursue." The story begins in late-2015. Tom Patterson, PhD, a 69-year-old professor in the Department of Psychiatry at UC San Diego School of Medicine, and his wife, Steffanie Strathdee, PhD, chief of the Division of Global Public Health in the Department of Medicine, were spending the Thanksgiving holiday in Egypt when Patterson became ill, wracked by abdominal pain, fever, nausea, vomiting and a racing heartbeat. Local doctors diagnosed pancreatitis -- inflammation of the pancreas -- but standard treatment didn't help. Patterson's condition worsened and he was medevacked to Frankfurt, Germany Dec. 3, 2015, where doctors discovered a pancreatic pseudocyst, a collection of fluid around the pancreas. The fluid was drained and the contents cultured. Patterson had become infected with a multidrug-resistant strain of Acinetobacter baumannii, an opportunistic and often deadly pathogen. The bacterium has proved particularly problematic in hospital settings and in the Middle East, with many injured veterans and soldiers returning to the U.S. with persistent infections. Initially, the only antibiotics with any effect proved to be a combination of meropenem, tigecycline and colistin, a drug of last resort because it often causes kidney damage, among other side effects. Patterson's condition stabilized sufficiently for him to be airlifted Dec. 12, 2015, from Germany to the Intensive Care Unit (ICU) at Thornton Hospital at UC San Diego Health. Upon arrival, it was discovered that his bacterial isolate had become resistant to all of these antibiotics. At Thornton Hospital, now part of Jacobs Medical Center, Patterson began to recover, moving from the ICU to a regular ward. But the day before scheduled discharge to a long-term acute care facility, an internal drain designed to localize his infection and keep it at bay slipped, spilling bacteria into his abdomen and bloodstream. Patterson immediately experienced septic shock. His heart began racing. He could not breathe. He became feverish and would subsequently fall into a coma that would last for most of the next two months. He was, in effect, dying. "That's a period of my life I don't remember," recalled Patterson. "There was so much pain that it's almost beyond your ability to cope. I'm happy not to remember." Strathdee, his wife, is no stranger to the terrors of disease. As an infectious disease epidemiologist and director of the UC San Diego Global Health Institute, she has worked around the world, from India to Afghanistan to Mexico, trying to lower HIV infection and mortality rates. "There came a point when he was getting weaker and weaker, and I didn't want to lose him. I wasn't ready to let him go and so I held his hand and said, 'Honey, they're doing everything they can and there's nothing that can kill this bug, so if you want to fight, you need to fight. Do you want me to find some alternative therapies? We can leave no stone unturned.'" Tom recalled the moment: "I vaguely remember you saying, 'do you want me to try or not because it's going to be a tough time and it's not certain that it will work.' I remember squeezing your hand, but it was just a flash in the whole process." Strathdee began doing research. A colleague mentioned a friend had traveled to Tblisi, Georgia to undergo "phage therapy" for a difficult condition and had been "miraculously cured." Strathdee had learned of bacteriophages while she was a student, but they were not part of mainstream medical doctrine. She turned to strangers in the phage research community and to her colleague Chip Schooley for help. Bacteriophages are ubiquitous viruses, found wherever bacteria exist. It's estimated there are more than 1031 bacteriophages on the planet. That's ten million trillion trillion, more than every other organism on Earth, including bacteria, combined. Each is evolved to infect a specific bacterial host in order to replicate -- without affecting other cells in an organism. The idea of using them therapeutically is not new. Described a century ago, phage therapy was popular in the 1920s and 1930s to treat multiple types of infections and conditions, but results were inconsistent and lacked scientific validation. The emergence of antibiotics in the 1940s pushed phage therapy aside, except in parts of Eastern Europe and the former Soviet Union, where it remained a topic of active research. With dwindling options, Strathdee, Schooley and colleagues went looking for help. They found many researchers willing to help. Three teams possessed suitable phages that were active against Patterson's particular bacterial infection: the Biological Defense Research Directorate of the NMRC in Frederick, MD; the Center for Phage Technology at Texas A&M University; and AmpliPhi, a San Diego-based biotech company specializing in bacteriophage-based therapies. A research team at San Diego State University, headed by microbial ecologist Forest Rowher, PhD, purified the phage samples for clinical use. With emergency approval from the Food and Drug Administration, each source provided phage strains to UC San Diego doctors to treat Patterson, with no guarantee that any of the strains would actually work. "That's one of the remarkable things to come out of this whole experience," said Schooley, "the incredible and rapid collaboration among folks scattered around the world. It was a desperate time and people really stepped up." Phage therapy is typically administered topically or orally. In Patterson's case, the phages were introduced through catheters into his abdominal cavity and intravenously to address a broader, systemic infection, which had not been done in the antibiotic era in the U.S. "That makes them more effective," said Schooley. "The action is at the interface of the patient and the organism." With tweaking and adjustments -- his physicians were learning on the fly -- Patterson began to improve. He emerged from his coma within three days of the start of IV phage therapy. "Tom woke up, turned to his daughter and said, 'I love you'," recalled Schooley. Patterson was soon weaned off of the respirator and blood pressure drugs. "As a treating doctor, it was a challenge," said Schooley. "Usually you know what the dosage should be, how often to treat. Improving vital signs is a good way to know that you're progressing, but when you're doing it for the first time, you don't have anything to compare it to. "A lot was really worked out as we went along, combining previous literature, our own intuition about how these phages would circulate and work and advice from people who had been thinking about this for a long time." By the time Patterson was airlifted to Thornton Hospital at UC San Diego Health, he was in dire straits. His abdomen had swelled, distended by the pseudocyst teeming with multi-drug resistant A. baumaunnii. His white blood cell count had soared -- a sign of rampant infection. Doctors tried various combinations of antibiotics. He developed respiratory failure and hypotension that required ventilation and recurrent emergency treatment. He became increasingly delirious. When he lapsed into a coma in mid-January, he was essentially being kept alive on life support. Eventually Schooley said there were no antimicrobial agents left to try. Strathdee recalled colleagues wondering aloud if she was prepared for Tom to die. She wasn't. Bacteriophage therapy began March 15, 2016, with a cocktail of four phages provided by Texas A&M and the San Diego-based biotech company AmpliPhi, pumped through catheters into the pseudocyst. If the treatment didn't kill him, Patterson's medical team planned to inject the Navy's phages intravenously, flooding his bloodstream to reach the infection raging throughout his body. As far as Patterson's doctors knew, such treatment had never been tried before. On March 17, the Navy phages were injected intravenously. There were fears about endotoxins naturally produced by the phages. No one knew what to expect, but Patterson tolerated the treatment well -- indeed there were no adverse side effects -- and on March 19, he suddenly awoke and recognized his daughter. "One of NMRC's goals with respect to bacteriophage science has been providing military members infected with multidrug-resistant organisms additional antimicrobial options so we were experienced and well-positioned to provide an effective phage cocktail for Dr. Patterson," said Theron Hamilton, PhD, head of Genomics and Bioinformatics at the Navy's Biological Defense Research Directorate. "Obviously, we are thrilled with the outcome and hope this case increases awareness of the possibility of applying phage therapy to tough cases like this one." Subsequent treatment, however, would not be easy. The learning curve was steep and unmarked. There were bouts of sepsis -- a life-threatening complication caused by massive infection. Despite improvement, Patterson's condition remained precarious. Doctors discovered that the bacterium eventually developed resistance to the phages, what Schooley would characterize as "the recurring Darwinian dance," but the team compensated by continually tweaking treatment with new phage strains -- some that the NMRC had derived from sewage -- and antibiotics. In early May, Patterson was taken off of antibiotics. After June 6, there was no evidence of A. baumannii in his body. He was discharged home August 12, 2016. Recovery has not been entirely smooth and steady. There have been setbacks unrelated to the phages. A formerly robust man, Patterson had been fed intravenously for months in the hospital and had lost 100 pounds, much of it muscle. He has required intense physical rehabilitation to regain strength and movement. "It's not like in the movies where you just wake up from a coma, look around and pop out of bed," Patterson said. "You discover that your body doesn't work right anymore." He said he could feel parts of his brain coming back alive. Nonetheless, Patterson described the experience as miraculous. Even comatose, when he often wrestled with imagined demons, he recalled hearing and recognizing voices and realizing that beyond his darkness, there was life and hope. And beyond him, he hopes his experience will translate into new treatments for others: "The phage therapy has really been a miracle for me, and for what it might mean that millions of people who may be cured from multidrug-resistant infections in the future. It's been sort of a privilege." Schooley said Patterson was lucky. His wife was a trained scientist and determined to find a remedy -- and they both worked at UC San Diego School of Medicine: "He was fortunate to be in a place that had all of the resources and courage necessary to support him while this innovative therapy was developed, which was essentially a home brew cocktail of viruses to be given to a desperately ill individual. I think a lot of other places would have hesitated. I think the response that he had clinically has been very gratifying and speaks to the strength of a multidimensional medical center with all of the pieces you need." Still, Schooley said any broad, future approved application of phage therapy faces fundamental challenges unlike past treatments. "What the FDA is used to saying is 'This is an antibiotic. We know what its structure is and how you can give it to multiple people.' With bacteriophage therapy, the FDA would be dealing with an approach in which doctors would have to develop phage cocktails for each patient tailored to their infecting organisms. It's the ultimate personalized medicine." The good news, Schooley said, is that new molecular tools, robotics and other advances make personalized medicine possible in a way it wasn't 10 or 15 years ago. "Then, it would have been impossible to contemplate. There's still much research to be done, but I think there are going to be a lot of clinical applications where this approach may be very beneficial to patients." Derived from the Greek words meaning "bacteria eater," bacteriophages are ancient and abundant -- found on land, in water, within any form of life harboring their target. According to Rowher at San Diego State University and colleagues in their book Life in Our Phage World, phages cause a trillion trillion successful infections per second and destroy up to 40 percent of all bacterial cells in the ocean every day. Thousands of varieties of phage exist, each evolved to infect only one type or a few types of bacteria. Like other viruses, they cannot replicate by themselves, but must commandeer the reproductive machinery of bacteria. To do so, they attach to a bacterium and insert their genetic material. Lytic phages then destroy the cell, splitting it open to release new viral particles to continue the process. As such, phages could be considered the only "drug"' capable of multiplying; when their job is done, they are excreted by the body.


PMC brings >20 years of expertise, research, studies, trials and insights developed in conjunction with NASA and the Department of Defense More than $30 million invested culminating in the issuance of 10 major patents across a range of benefits and need states for consumers Health Sciences Division now has the credibility and science underpinning a range of planned launches for the medical and pharmacy channels DENVER, CO / ACCESSWIRE / May 18, 2017 / New Age Beverages Corporation (NASDAQ: NBEV) the Colorado-based leading all-natural healthy functional beverage company whose brands include XingTea®, XingEnergy ®, Aspen Pure®, Búcha® Live Kombucha, Marley One Drop®, Marley Mellow Mood®, and CocoLibre® today announced the acquisition of Premier Micronutrient Corporation. The acquisition catapults the Company's Health Sciences Division and New Age's plans to develop the next generation of healthy functional beverages. The intellectual property addition of more than 10 major patents and patents pending significantly increases New Age's intangible assets and underpins the Company's planned portfolio launches targeted to the medical and pharmacy channels. One of the major drivers of growth that the Company recently shared with investors was the penetration of new, less competitively intense channels and market segments where our primary competitors do not operate. The Company has also always had on its roadmap the intent to redefine healthy functional beverages from the currently pervasive less bad or less sweet offerings, to beverages that can make a fundamental difference in improving everyday human life. The acquisition of Premier Micronutrient Corporation (PMC) and their wealth of patents, studies, research, clinical trial insight, science and medical expertise provides the foundation for and credibility behind New Age's planned penetration of the medical and pharmacy channels with a portfolio of truly healthy functional beverages. Dr. Jerry Haase, Chief Scientific Officer of New Age Beverage's Health Sciences Division commented, "As an internationally known clinician and medical researcher, I always seek unique opportunities to broadly impact human health. I am especially enthusiastic to join New Age concurrent with the acquisition of PMC, because of the Company's compelling vision to create the greatest healthy functional beverage enterprise in the world. We will expand upon our intellectual property portfolio and develop product platforms to address novel categories of public interest and need. We also anticipate leveraging our extensive relationships in the health care community to credibly promote New Age's medical product portfolio's acceptance in the global medical marketplace." "Use of Multiple Antioxidant Micronutrients as 1) US Navy CRADA - NMRC-06-2338 "Investigations into the Efficacy of an Antioxidant-containing Micronutrient Formulation for the Treatment of Hearing Loss and Balance Disorders Associated with Blast Injuries." 2) US Navy CRADA - NMRC-06-2383 "The Effects of Antioxidant Supplementation to Protect Against Cold at High Altitude." 3) US Army CRADA - W81XWH-07-0321 "Efficacy of Multiple Antioxidants in Reducing Damage Produced by Mustard Gas." 4) US Army CRADA - W81XWH-08-2007 "Efficacy of Multiple Antioxidants in reducing Damage Produced by Nerve Agents." 5) Space Act Agreement - NASA "Development of a Successful Protection Formula Against Radiation-Induced Oxidative Injury in Vulnerable Populations." 6) US Army CRADA - W91YTZ-10-P-0773 "Evaluation of Micronutrients in Combination with Standard Therapy in the Management of Type 2 Diabetes." 7) US Army CRADA - W81XWH-11-10746 "Efficacy of Multiple Antioxidants in Combination with Standard Therapy in Reducing VX-Induced Seizures and Associated Behavior Changes." In addition to the wealth of patents, patents pending, and cooperative research and development agreements, PMC has conducted over 14 prospective human clinical trials and animal studies validating the efficacy of their formulas and products. That body of work developed over the past 20 years in conjunction with the Department of Defense and NASA have formed the basis for justifying their distinctiveness leading to the issuance of their patents, and demonstrated their proven benefit for a range of human need states including: New Age Beverages acquired 100% of the assets and interests of Premier Micronutrient Corporation, their portfolio of products, their intellectual property, and the formulas for existing and envisioned healthy functional beverage products for the pharmacy, medical, sports, military, and other channels. Specific terms of the transaction were not disclosed, with the final closing of the transaction subject to certain closing conditions and expected to be complete within 30 days. Brent Willis, Chief Executive Officer of New Age Beverages remarked, "We made a commitment that we would make a difference for consumers with truly healthy, functional beverages. We believe the world doesn't need another slightly less bad carbonated soft drink or more drinkable sports drink. With the internalization of the expertise and insights from PMC we will compete in a spectrum that our major competitors are not in, and not even contemplating. Beverages are a significantly more efficacious and patient friendly delivery system than pills for example, just no one has done it, and we intend to be the first." Premier Micronutrient Corporation (PMC) was founded in 2000 to develop formulations in cooperation with the Department of Defense and NASA. Since inception, PMC has worked with the Marine Corps Systems Command that contracted PMC to adapt its formulations to protect high-risk military personnel. PMC operated for more than 10 years developing protective products and conducting research for the Department of Defense. PMC received Congressional support leading to eleven studies that have demonstrated the validity of PMC's formulations to decrease oxidative damage, improve immune function, reduce inflammation, protect against neurologic symptoms and recovery from concussions, recovery from hearing and balance disorders, reversal of vascular disease and lipid abnormalities, and protect against hostile environmental factors such as radiation. The products have been shown to be completely safe in all studies and in more than 10 years of public consumption. New Age Beverages Corporation is a Colorado-based, leading all-natural tea and healthy functional beverage company that was founded in 2003. The Company competes in the fast growing healthy functional beverage segments including Ready to Drink (RTD) Tea, RTD Coffee, Kombucha, Energy Drinks, Relaxation Drinks, Coconut Waters and Functional Waters with the brands XingTea®, Marley One Drop®, Búcha® Live Kombucha, XingEnergy®, Marley Mellow Mood®, Coco-Libre®, and Aspen Pure® PH and Aspen Pure® Probiotic Water. The Company's brands are sold across all 50 states within the US and in more than 10 countries internationally across all channels via direct and store door distribution systems. The company operates the websites www.newagebev.us, www.newagehealth.us, www.mybucha.com, www.xingtea.com, www.aspenpure.com, www.drinkmarley.com, and www.cocolibre.com. This press release contains forward-looking statements that are made pursuant to the safe harbor provisions within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. Forward-looking statements are any statement reflecting management's current expectations regarding future results of operations, economic performance, financial condition and achievements of the Company including statements regarding New Age Beverage's expectation to see continued growth. The forward-looking statements are based on the assumption that operating performance and results will continue in line with historical results. Management believes these assumptions to be reasonable but there is no assurance that they will prove to be accurate. Forward-looking statements, specifically those concerning future performance are subject to certain risks and uncertainties, and actual results may differ materially. New Age Beverages competes in a rapidly growing and transforming industry, and other factors disclosed in the Company's filings with the Securities and Exchange Commission might affect the Company's operations. Unless required by applicable law, nBev undertakes no obligation to update or revise any forward-looking statements. For investor inquiries about New Age Beverages Corporation please contact: PMC brings >20 years of expertise, research, studies, trials and insights developed in conjunction with NASA and the Department of Defense More than $30 million invested culminating in the issuance of 10 major patents across a range of benefits and need states for consumers Health Sciences Division now has the credibility and science underpinning a range of planned launches for the medical and pharmacy channels DENVER, CO / ACCESSWIRE / May 18, 2017 / New Age Beverages Corporation (NASDAQ: NBEV) the Colorado-based leading all-natural healthy functional beverage company whose brands include XingTea®, XingEnergy ®, Aspen Pure®, Búcha® Live Kombucha, Marley One Drop®, Marley Mellow Mood®, and CocoLibre® today announced the acquisition of Premier Micronutrient Corporation. The acquisition catapults the Company's Health Sciences Division and New Age's plans to develop the next generation of healthy functional beverages. The intellectual property addition of more than 10 major patents and patents pending significantly increases New Age's intangible assets and underpins the Company's planned portfolio launches targeted to the medical and pharmacy channels. One of the major drivers of growth that the Company recently shared with investors was the penetration of new, less competitively intense channels and market segments where our primary competitors do not operate. The Company has also always had on its roadmap the intent to redefine healthy functional beverages from the currently pervasive less bad or less sweet offerings, to beverages that can make a fundamental difference in improving everyday human life. The acquisition of Premier Micronutrient Corporation (PMC) and their wealth of patents, studies, research, clinical trial insight, science and medical expertise provides the foundation for and credibility behind New Age's planned penetration of the medical and pharmacy channels with a portfolio of truly healthy functional beverages. Dr. Jerry Haase, Chief Scientific Officer of New Age Beverage's Health Sciences Division commented, "As an internationally known clinician and medical researcher, I always seek unique opportunities to broadly impact human health. I am especially enthusiastic to join New Age concurrent with the acquisition of PMC, because of the Company's compelling vision to create the greatest healthy functional beverage enterprise in the world. We will expand upon our intellectual property portfolio and develop product platforms to address novel categories of public interest and need. We also anticipate leveraging our extensive relationships in the health care community to credibly promote New Age's medical product portfolio's acceptance in the global medical marketplace." "Use of Multiple Antioxidant Micronutrients as 1) US Navy CRADA - NMRC-06-2338 "Investigations into the Efficacy of an Antioxidant-containing Micronutrient Formulation for the Treatment of Hearing Loss and Balance Disorders Associated with Blast Injuries." 2) US Navy CRADA - NMRC-06-2383 "The Effects of Antioxidant Supplementation to Protect Against Cold at High Altitude." 3) US Army CRADA - W81XWH-07-0321 "Efficacy of Multiple Antioxidants in Reducing Damage Produced by Mustard Gas." 4) US Army CRADA - W81XWH-08-2007 "Efficacy of Multiple Antioxidants in reducing Damage Produced by Nerve Agents." 5) Space Act Agreement - NASA "Development of a Successful Protection Formula Against Radiation-Induced Oxidative Injury in Vulnerable Populations." 6) US Army CRADA - W91YTZ-10-P-0773 "Evaluation of Micronutrients in Combination with Standard Therapy in the Management of Type 2 Diabetes." 7) US Army CRADA - W81XWH-11-10746 "Efficacy of Multiple Antioxidants in Combination with Standard Therapy in Reducing VX-Induced Seizures and Associated Behavior Changes." In addition to the wealth of patents, patents pending, and cooperative research and development agreements, PMC has conducted over 14 prospective human clinical trials and animal studies validating the efficacy of their formulas and products. That body of work developed over the past 20 years in conjunction with the Department of Defense and NASA have formed the basis for justifying their distinctiveness leading to the issuance of their patents, and demonstrated their proven benefit for a range of human need states including: New Age Beverages acquired 100% of the assets and interests of Premier Micronutrient Corporation, their portfolio of products, their intellectual property, and the formulas for existing and envisioned healthy functional beverage products for the pharmacy, medical, sports, military, and other channels. Specific terms of the transaction were not disclosed, with the final closing of the transaction subject to certain closing conditions and expected to be complete within 30 days. Brent Willis, Chief Executive Officer of New Age Beverages remarked, "We made a commitment that we would make a difference for consumers with truly healthy, functional beverages. We believe the world doesn't need another slightly less bad carbonated soft drink or more drinkable sports drink. With the internalization of the expertise and insights from PMC we will compete in a spectrum that our major competitors are not in, and not even contemplating. Beverages are a significantly more efficacious and patient friendly delivery system than pills for example, just no one has done it, and we intend to be the first." Premier Micronutrient Corporation (PMC) was founded in 2000 to develop formulations in cooperation with the Department of Defense and NASA. Since inception, PMC has worked with the Marine Corps Systems Command that contracted PMC to adapt its formulations to protect high-risk military personnel. PMC operated for more than 10 years developing protective products and conducting research for the Department of Defense. PMC received Congressional support leading to eleven studies that have demonstrated the validity of PMC's formulations to decrease oxidative damage, improve immune function, reduce inflammation, protect against neurologic symptoms and recovery from concussions, recovery from hearing and balance disorders, reversal of vascular disease and lipid abnormalities, and protect against hostile environmental factors such as radiation. The products have been shown to be completely safe in all studies and in more than 10 years of public consumption. New Age Beverages Corporation is a Colorado-based, leading all-natural tea and healthy functional beverage company that was founded in 2003. The Company competes in the fast growing healthy functional beverage segments including Ready to Drink (RTD) Tea, RTD Coffee, Kombucha, Energy Drinks, Relaxation Drinks, Coconut Waters and Functional Waters with the brands XingTea®, Marley One Drop®, Búcha® Live Kombucha, XingEnergy®, Marley Mellow Mood®, Coco-Libre®, and Aspen Pure® PH and Aspen Pure® Probiotic Water. The Company's brands are sold across all 50 states within the US and in more than 10 countries internationally across all channels via direct and store door distribution systems. The company operates the websites www.newagebev.us, www.newagehealth.us, www.mybucha.com, www.xingtea.com, www.aspenpure.com, www.drinkmarley.com, and www.cocolibre.com. This press release contains forward-looking statements that are made pursuant to the safe harbor provisions within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. Forward-looking statements are any statement reflecting management's current expectations regarding future results of operations, economic performance, financial condition and achievements of the Company including statements regarding New Age Beverage's expectation to see continued growth. The forward-looking statements are based on the assumption that operating performance and results will continue in line with historical results. Management believes these assumptions to be reasonable but there is no assurance that they will prove to be accurate. Forward-looking statements, specifically those concerning future performance are subject to certain risks and uncertainties, and actual results may differ materially. New Age Beverages competes in a rapidly growing and transforming industry, and other factors disclosed in the Company's filings with the Securities and Exchange Commission might affect the Company's operations. Unless required by applicable law, nBev undertakes no obligation to update or revise any forward-looking statements. For investor inquiries about New Age Beverages Corporation please contact:


DENVER, CO / ACCESSWIRE / May 18, 2017 / New Age Beverages Corporation (NASDAQ: NBEV) the Colorado-based leading all-natural healthy functional beverage company whose brands include XingTea®, XingEnergy ®, Aspen Pure®, Búcha® Live Kombucha, Marley One Drop®, Marley Mellow Mood®, and CocoLibre® today announced the acquisition of Premier Micronutrient Corporation. The acquisition catapults the Company's Health Sciences Division and New Age's plans to develop the next generation of healthy functional beverages. The intellectual property addition of more than 10 major patents and patents pending significantly increases New Age's intangible assets and underpins the Company's planned portfolio launches targeted to the medical and pharmacy channels. One of the major drivers of growth that the Company recently shared with investors was the penetration of new, less competitively intense channels and market segments where our primary competitors do not operate. The Company has also always had on its roadmap the intent to redefine healthy functional beverages from the currently pervasive less bad or less sweet offerings, to beverages that can make a fundamental difference in improving everyday human life. The acquisition of Premier Micronutrient Corporation (PMC) and their wealth of patents, studies, research, clinical trial insight, science and medical expertise provides the foundation for and credibility behind New Age's planned penetration of the medical and pharmacy channels with a portfolio of truly healthy functional beverages. Dr. Jerry Haase, Chief Scientific Officer of New Age Beverage's Health Sciences Division commented, "As an internationally known clinician and medical researcher, I always seek unique opportunities to broadly impact human health. I am especially enthusiastic to join New Age concurrent with the acquisition of PMC, because of the Company's compelling vision to create the greatest healthy functional beverage enterprise in the world. We will expand upon our intellectual property portfolio and develop product platforms to address novel categories of public interest and need. We also anticipate leveraging our extensive relationships in the health care community to credibly promote New Age's medical product portfolio's acceptance in the global medical marketplace." 1) US Navy CRADA - NMRC-06-2338 "Investigations into the Efficacy of an Antioxidant-containing Micronutrient Formulation for the Treatment of Hearing Loss and Balance Disorders Associated with Blast Injuries." 2) US Navy CRADA - NMRC-06-2383 "The Effects of Antioxidant Supplementation to Protect Against Cold at High Altitude." 3) US Army CRADA - W81XWH-07-0321 "Efficacy of Multiple Antioxidants in Reducing Damage Produced by Mustard Gas." 4) US Army CRADA - W81XWH-08-2007 "Efficacy of Multiple Antioxidants in reducing Damage Produced by Nerve Agents." 5) Space Act Agreement - NASA "Development of a Successful Protection Formula Against Radiation-Induced Oxidative Injury in Vulnerable Populations." 6) US Army CRADA - W91YTZ-10-P-0773 "Evaluation of Micronutrients in Combination with Standard Therapy in the Management of Type 2 Diabetes." 7) US Army CRADA - W81XWH-11-10746 "Efficacy of Multiple Antioxidants in Combination with Standard Therapy in Reducing VX-Induced Seizures and Associated Behavior Changes." In addition to the wealth of patents, patents pending, and cooperative research and development agreements, PMC has conducted over 14 prospective human clinical trials and animal studies validating the efficacy of their formulas and products. That body of work developed over the past 20 years in conjunction with the Department of Defense and NASA have formed the basis for justifying their distinctiveness leading to the issuance of their patents, and demonstrated their proven benefit for a range of human need states including: New Age Beverages acquired 100% of the assets and interests of Premier Micronutrient Corporation, their portfolio of products, their intellectual property, and the formulas for existing and envisioned healthy functional beverage products for the pharmacy, medical, sports, military, and other channels. Specific terms of the transaction were not disclosed, with the final closing of the transaction subject to certain closing conditions and expected to be complete within 30 days. Brent Willis, Chief Executive Officer of New Age Beverages remarked, "We made a commitment that we would make a difference for consumers with truly healthy, functional beverages. We believe the world doesn't need another slightly less bad carbonated soft drink or more drinkable sports drink. With the internalization of the expertise and insights from PMC we will compete in a spectrum that our major competitors are not in, and not even contemplating. Beverages are a significantly more efficacious and patient friendly delivery system than pills for example, just no one has done it, and we intend to be the first." Premier Micronutrient Corporation (PMC) was founded in 2000 to develop formulations in cooperation with the Department of Defense and NASA. Since inception, PMC has worked with the Marine Corps Systems Command that contracted PMC to adapt its formulations to protect high-risk military personnel. PMC operated for more than 10 years developing protective products and conducting research for the Department of Defense. PMC received Congressional support leading to eleven studies that have demonstrated the validity of PMC's formulations to decrease oxidative damage, improve immune function, reduce inflammation, protect against neurologic symptoms and recovery from concussions, recovery from hearing and balance disorders, reversal of vascular disease and lipid abnormalities, and protect against hostile environmental factors such as radiation. The products have been shown to be completely safe in all studies and in more than 10 years of public consumption. New Age Beverages Corporation is a Colorado-based, leading all-natural tea and healthy functional beverage company that was founded in 2003. The Company competes in the fast growing healthy functional beverage segments including Ready to Drink (RTD) Tea, RTD Coffee, Kombucha, Energy Drinks, Relaxation Drinks, Coconut Waters and Functional Waters with the brands XingTea®, Marley One Drop®, Búcha® Live Kombucha, XingEnergy®, Marley Mellow Mood®, Coco-Libre®, and Aspen Pure® PH and Aspen Pure® Probiotic Water. The Company's brands are sold across all 50 states within the US and in more than 10 countries internationally across all channels via direct and store door distribution systems. The company operates the websites www.newagebev.us, www.newagehealth.us, www.mybucha.com, www.xingtea.com, www.aspenpure.com, www.drinkmarley.com, and www.cocolibre.com. This press release contains forward-looking statements that are made pursuant to the safe harbor provisions within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. Forward-looking statements are any statement reflecting management's current expectations regarding future results of operations, economic performance, financial condition and achievements of the Company including statements regarding New Age Beverage's expectation to see continued growth. The forward-looking statements are based on the assumption that operating performance and results will continue in line with historical results. Management believes these assumptions to be reasonable but there is no assurance that they will prove to be accurate. Forward-looking statements, specifically those concerning future performance are subject to certain risks and uncertainties, and actual results may differ materially. New Age Beverages competes in a rapidly growing and transforming industry, and other factors disclosed in the Company's filings with the Securities and Exchange Commission might affect the Company's operations. Unless required by applicable law, nBev undertakes no obligation to update or revise any forward-looking statements. For investor inquiries about New Age Beverages Corporation please contact:


The SIRveNIB abstract published on-line in the Journal of Clinical Oncology states that treatment of locally advanced Hepatocellular Carcinoma (HCC) with a single treatment of SIR-Spheres® Y-90 resin microspheres results in Overall Survival not significantly different from twice-daily oral sorafenib, but with significantly better tumour response and fewer and less severe adverse events The study was conducted by The Asia-Pacific Hepatocellular Carcinoma Trials Group (AHCC) in collaboration with the National Cancer Centre Singapore and Singapore Clinical Research Institute (SCRI) and supported by the National Medical Council Singapore and Sirtex Medical Limited The lead author of the SIRveNIB abstract, Professor Pierce Chow, Senior Consultant Surgeon at the National Cancer Centre Singapore and the Singapore General Hospital, reported that: "Asia Pacific patients with locally advanced primary liver cancer (HCC or hepatocellular carcinoma) with no spread (metastases) outside the liver who are treated with Y-90 resin microspheres have a significantly better tumour response rate (TRR) compared to sorafenib, despite 28.6% (n=52) of patients not receiving Y-90 therapy as planned (TRR - 16.5% for Y-90 resin microspheres vs 1.7% for sorafenib, respectively; p < 0.001).  Moreover, patients experienced fewer, less serious adverse events when compared with those treated with sorafenib. There were no statistically significant differences in the primary endpoint of overall survival (OS) between the two treatments." Although the median OS in the intent-to-treat group[1] was 8.54 months for Y-90 resin microspheres vs. 10.58 months for sorafenib, respectively (p=0.203), there was a trend in improvement in median OS in the treated group[2] for Y-90 resin microspheres (11.27 vs. 10.41 months, p=0.273). While Y-90 resin microspheres were not superior to sorafenib regarding OS, Professor Chow, who is also Professor and Course Director at the Duke-NUS Medical School, indicated that "the better tumour response and tolerability of Y-90 resin microspheres offers a compelling treatment alternative for patients with advanced hepatocellular carcinoma, for whom there are limited treatment options available." SIRveNIB was designed to compare the efficacy and safety of selective internal radiation therapy (SIRT) with yttrium-90 [Y-90] resin microspheres (SIR-Spheres; Sirtex Medical Limited, North Sydney, Australia) versus sorafenib (Nexavar®; Bayer HealthCare Pharmaceuticals, Berlin, Germany), a systemic treatment that is the current standard of care in advanced hepatocellular carcinoma. The patients in SIRveNIB were ineligible for potentially curative therapies, such as surgical resection, ablation or liver transplantation. "Each year we are making good progress in treating liver cancer. The deeper we go in our research the better we are able to understand how the cancer behaves and we are able to widen the treatments options for our patients. The results reinforced our belief that with the right people on the research project, we can get the best results. I am grateful to our partners for collaborating in this study," added Professor Soo Khee Chee, Director of NCCS. "Completion of the investigator-led SIRveNIB study represents a significant milestone in Asia Pacific liver cancer research, and underscores the strong private-public partnership that exists between Sirtex Medical Limited, the National Cancer Centre Singapore and Singapore Clinical Research Institute. We look forward to the presentation of more complete results of SIRveNIB at the impending ASCO Annual Meeting," said Associate Professor Teoh Yee Leong, CEO Singapore Clinical Research Institute. "This is the first time we have completed such a large-scale investigator-led clinical trial in the Asia Pacific region, whose results will be beneficial to liver cancer patients in our region." Hepatocellular carcinoma (HCC) is the most common form of primary liver cancer - cancer that starts in the liver - which is the sixth most-common cancer in the world and the second most-common cause of cancer-related death.[3] It affects mainly patients with cirrhosis from any cause, including viral hepatitis and alcohol abuse. HCC occurs with greatest frequency in regions where hepatitis is most often diagnosed, such as in the Asia Pacific region and Southern Europe. When diagnosed in its early stages, HCC can be treated by surgical resection, ablation or liver transplantation with expectation of improved long-term survival. However, these options are not available to the great majority of patients. For patients with unresectable HCC, the outlook is bleak, with survival ranging from a few months to about two years depending largely on the extent of their tumours and state of their liver at the time of diagnosis.[4] No new HCC treatment option has been tested successfully in large studies for almost a decade. National Cancer Centre Singapore (NCCS) provides a holistic and multi-disciplinary approach to cancer treatment and patient care. We treat almost 70 per cent of the public sector oncology cases, and they are benefiting from the sub-specialisation of our clinical oncologists. NCCS is also accredited by the US-based Joint Commission International for its quality patient care and safety. To deliver among the best in cancer treatment and care, our clinicians work closely with our scientists who conduct robust cutting-edge clinical and translational research programmes which are internationally recognised. NCCS strives to be a global leading cancer centre, and shares its expertise and knowledge by offering training to local and overseas medical professionals. http://www.nccs.com.sg Singapore Clinical Research Institute (SCRI) is a National Academic Research Organisation dedicated to enhance the standards of human clinical research. Its mission is to spearhead and develop core capabilities, infrastructure and scientific leadership for clinical research in Singapore. SCRI is a national clinical trials coordination centre that works with National Medical Research Council (NMRC) to assist the Ministry of Health in implementing clinical trials policy and strategic initiatives to support and develop clinical research competencies locally. In driving towards its vision, SCRI collaborates with clinicians to enhance Singapore's clinical research and strengthen its expertise in executing multi-site, multi-national studies and the development of regional clinical research networks. SCRI is a wholly-owned subsidiary of MOH Holdings. http://www.scri.edu.sg SIR-Spheres Y-90 resin microspheres are approved for the treatment of inoperable liver tumours in Australia, the European Union (CE Mark), Argentina (ANMAT), Brazil, and several countries in Asia, such as Turkey, India and Singapore. The product is also supplied for this use in countries and regions such as Hong Kong, Israel, Malaysia, New Zealand, Taiwan and Thailand. SIR-Spheres Y-90 resin microspheres also have a full Pre-Market Approval (PMA) by the FDA and are indicated in the United States for the treatment of non-resectable metastatic liver tumours from primary colorectal cancer in combination with intra-hepatic artery chemotherapy using floxuridine. [1] Intent-to-treat group includes all patients who were enrolled and randomly allocated to treatment and are analysed according to the group to which they were randomized.  The intent-to-treat-group included n=182 (Y-90 resin microspheres) and n=178 (sorafenib). [2] Treated group includes only those patients who completed the treatment originally allocated.  The treated group included n=130 (Y-90 resin microspheres) and n=162 (sorafenib). [3] Ferlay J et al.  Globocan 2012. v1.0, Cancer Incidence and Mortality Worldwide: IARC CancerBase No. 11 [Internet]. Lyon, France: International Agency for Research on Cancer; 2013. Available from: http://globocan.iarc.fr , accessed on 18/May/2017.


The study was conducted by The Asia-Pacific Hepatocellular Carcinoma Trials Group (AHCC) in collaboration with the National Cancer Centre Singapore and Singapore Clinical Research Institute (SCRI) and supported by the National Medical Council Singapore and Sirtex Medical Limited The lead author of the SIRveNIB abstract, Professor Pierce Chow, Senior Consultant Surgeon at the National Cancer Centre Singapore and the Singapore General Hospital, reported that: "Asia Pacific patients with locally advanced primary liver cancer (HCC or hepatocellular carcinoma) with no spread (metastases) outside the liver who are treated with Y-90 resin microspheres have a significantly better tumour response rate (TRR) compared to sorafenib, despite 28.6% (n=52) of patients not receiving Y-90 therapy as planned (TRR - 16.5% for Y-90 resin microspheres vs 1.7% for sorafenib, respectively; p < 0.001).  Moreover, patients experienced fewer, less serious adverse events when compared with those treated with sorafenib. There were no statistically significant differences in the primary endpoint of overall survival (OS) between the two treatments." Although the median OS in the intent-to-treat group[1] was 8.54 months for Y-90 resin microspheres vs. 10.58 months for sorafenib, respectively (p=0.203), there was a trend in improvement in median OS in the treated group[2] for Y-90 resin microspheres (11.27 vs. 10.41 months, p=0.273). While Y-90 resin microspheres were not superior to sorafenib regarding OS, Professor Chow, who is also Professor and Course Director at the Duke-NUS Medical School, indicated that "the better tumour response and tolerability of Y-90 resin microspheres offers a compelling treatment alternative for patients with advanced hepatocellular carcinoma, for whom there are limited treatment options available." SIRveNIB was designed to compare the efficacy and safety of selective internal radiation therapy (SIRT) with yttrium-90 [Y-90] resin microspheres (SIR-Spheres; Sirtex Medical Limited, North Sydney, Australia) versus sorafenib (Nexavar®; Bayer HealthCare Pharmaceuticals, Berlin, Germany), a systemic treatment that is the current standard of care in advanced hepatocellular carcinoma. The patients in SIRveNIB were ineligible for potentially curative therapies, such as surgical resection, ablation or liver transplantation. "Each year we are making good progress in treating liver cancer. The deeper we go in our research the better we are able to understand how the cancer behaves and we are able to widen the treatments options for our patients. The results reinforced our belief that with the right people on the research project, we can get the best results. I am grateful to our partners for collaborating in this study," added Professor Soo Khee Chee, Director of NCCS. "Completion of the investigator-led SIRveNIB study represents a significant milestone in Asia Pacific liver cancer research, and underscores the strong private-public partnership that exists between Sirtex Medical Limited, the National Cancer Centre Singapore and Singapore Clinical Research Institute. We look forward to the presentation of more complete results of SIRveNIB at the impending ASCO Annual Meeting," said Associate Professor Teoh Yee Leong, CEO Singapore Clinical Research Institute. "This is the first time we have completed such a large-scale investigator-led clinical trial in the Asia Pacific region, whose results will be beneficial to liver cancer patients in our region." Hepatocellular carcinoma (HCC) is the most common form of primary liver cancer - cancer that starts in the liver - which is the sixth most-common cancer in the world and the second most-common cause of cancer-related death.[3] It affects mainly patients with cirrhosis from any cause, including viral hepatitis and alcohol abuse. HCC occurs with greatest frequency in regions where hepatitis is most often diagnosed, such as in the Asia Pacific region and Southern Europe. When diagnosed in its early stages, HCC can be treated by surgical resection, ablation or liver transplantation with expectation of improved long-term survival. However, these options are not available to the great majority of patients. For patients with unresectable HCC, the outlook is bleak, with survival ranging from a few months to about two years depending largely on the extent of their tumours and state of their liver at the time of diagnosis.[4] No new HCC treatment option has been tested successfully in large studies for almost a decade. National Cancer Centre Singapore (NCCS) provides a holistic and multi-disciplinary approach to cancer treatment and patient care. We treat almost 70 per cent of the public sector oncology cases, and they are benefiting from the sub-specialisation of our clinical oncologists. NCCS is also accredited by the US-based Joint Commission International for its quality patient care and safety. To deliver among the best in cancer treatment and care, our clinicians work closely with our scientists who conduct robust cutting-edge clinical and translational research programmes which are internationally recognised. NCCS strives to be a global leading cancer centre, and shares its expertise and knowledge by offering training to local and overseas medical professionals. http://www.nccs.com.sg Singapore Clinical Research Institute (SCRI) is a National Academic Research Organisation dedicated to enhance the standards of human clinical research. Its mission is to spearhead and develop core capabilities, infrastructure and scientific leadership for clinical research in Singapore. SCRI is a national clinical trials coordination centre that works with National Medical Research Council (NMRC) to assist the Ministry of Health in implementing clinical trials policy and strategic initiatives to support and develop clinical research competencies locally. In driving towards its vision, SCRI collaborates with clinicians to enhance Singapore's clinical research and strengthen its expertise in executing multi-site, multi-national studies and the development of regional clinical research networks. SCRI is a wholly-owned subsidiary of MOH Holdings. http://www.scri.edu.sg SIR-Spheres Y-90 resin microspheres are approved for the treatment of inoperable liver tumours in Australia, the European Union (CE Mark), Argentina (ANMAT), Brazil, and several countries in Asia, such as Turkey, India and Singapore. The product is also supplied for this use in countries such as Hong Kong, Israel, Malaysia, New Zealand, Taiwan and Thailand. SIR-Spheres Y-90 resin microspheres also have a full Pre-Market Approval (PMA) by the FDA and are indicated in the United States for the treatment of non-resectable metastatic liver tumours from primary colorectal cancer in combination with intra-hepatic artery chemotherapy using floxuridine. [1] Intent-to-treat group includes all patients who were enrolled and randomly allocated to treatment and are analysed according to the group to which they were randomized.  The intent-to-treat-group included n=182 (Y-90 resin microspheres) and n=178 (sorafenib). [2] Treated group includes only those patients who completed the treatment originally allocated.  The treated group included n=130 (Y-90 resin microspheres) and n=162 (sorafenib). [3] Ferlay J et al.  Globocan 2012. v1.0, Cancer Incidence and Mortality Worldwide: IARC CancerBase No. 11 [Internet]. Lyon, France: International Agency for Research on Cancer; 2013. Available from: http://globocan.iarc.fr , accessed on 18/May/2017.

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