The information will included the dosing regimen using Incivek in combination with pegIFN/RBV, and a list of drugs that could cause drug interactions if used while taking Incivek. For instance in the medication guide, St. John's wort or products containing St. John’s wort can decrease the effectiveness of Incivek.
AASLD-protease inhibitor BI 201335 and polymerase inhibitor BI 207127 Interferon Free Combo-New Data to be presented by Boehringer
AASLD-Santaris Pharma to Report New Clinical Data From Miravirsen Phase 2a Study to Treat Hepatitis C
Naturally Occurring Genotype 2b/1a Hepatitis C Virus in the United States
AASLD-Achillion Presents Updated Data on Multiple Compounds
In The News
KEN EULER reports on a recent breakthrough in broad-spectrum antiviral treatment
KEN EULER
Recently published research in PLoS ONE reported a breakthrough in the development of broad-spectrum antiviral therapy, theoretically capable of working against all types of viruses, from naturally emerging viruses such as influenza and SARS to clinical viruses like hepatitis and HIV.
Viruses are very small acellular organisms that, when introduced into another organism, invade and commandeer cells in order to replicate and spread themselves. When viruses attempt to replicate themselves, the host organism usually has an immune system response which disrupts the replication process. Yet many viruses such as HIV can outsmart the immune system, leading to continued vira
l replication that can cause serious damage to the organism.
There are both preventative and therapeutic treatment options available to deal with viruses, but they have several limitations. For instance, vaccines can be used to build up strong immune system responses to specific viruses, which ensure that if the organism does become exposed to the virus, it is able to fight the virus off. However, vaccines usually need to be administered prior to (or in some cases shortly after) exposure of the virus, which is not always possible. In addition, when dealing with emerging infectious diseases such as SARS (which was unpredictable and quickly spread between people in Toronto), there is often little time to develop and administer vaccines to the public.
Therapeutic treatment options also exist, which can be used to treat viral infections post-exposure. The success of this type of treatment can be seen in how it has helped prolong the life of people who have contracted HIV. Nevertheless, this class of treatment is also subject to the same limitations as vaccines and can moreover become ineffective if the virus mutates and becomes resistant to the drug.
In response to these treatment limitations, Dr. Todd Rider and his colleagues from the Massachusetts Institute of Technology developed a new antiviral drug called Double-Stranded RNA Activated Caspase Oligerizer (DRACO), which targets cells that have been infected by a virus. When viruses attempt to replicate themselves in cells, they often create long strings of double-stranded RNA that are not found in regular human or animal cells. This approach works by specifically targeting the cells that have these long strings of double-stranded RNA and causes them to undergo apoptosis (programmed cell suicide) while ignoring all the other healthy cells.
In his research, Dr. Rider tested the new drug on 15 different viruses (including the common cold, H1N1 influenza, and polio virus) and it was effective against them all. Although his earlier research was primarily conducted on mammalian cells cultured in a lab (which leaves open the possibility that the drug might not work on living animals), his most recent work has focused on the effect of the drug on mice infected with influenza and has led to some promising results. As a broad-spectrum antiviral drug, the development of DRACO has tremendous potential to impact the treatment of viral diseases. More research and time will tell whether this drug ends up being safe and effective for the treatment of viral infections in humans.
Obesity May Explain Liver Cancer Hike Among Latinos
By: ALICIA AULT, Oncology Report Digital Network
WASHINGTON – A combination of risk factors may be driving a large increase in liver cancer among Latinos in the United States, researchers said at a conference sponsored by the American Association for Cancer Research.
Although liver cancer, or hepatocellular carcinoma (HCC), is most common in Asia and Africa, the incidence is on the rise in the United States, primarily due to hepatitis C virus infection. There are 20,000 new HCC cases in this country each year, and liver cancer is the fifth most common cancer in men and the seventh most common in women, according to a recent review article in the New England Journal of Medicine (2011;365:1118-27).
The main risk factors for HCC in Africa and Asia have been infection with hepatitis B or hepatitis C, and alcoholic liver disease. More recently, evidence has suggested that fatty liver disease and metabolic syndrome may be significant risk factors in Western countries, according to the NEJM review.
In the United States, HCC incidence was 1.7 cases per 100,000 in 1980, but by 2005, this figure had increased to 5 per 100,000, noted the lead author of the Texas study, Amelie Ramirez, Dr.P.H., who presented the data at the conference. Dr. Ramirez, director of the Institute for Health Promotion Research at the University of Texas Health Science Center at San Antonio, and her colleagues decided to see if they could tease out some risk factors for HCC and thereby help to explain the increase among Latinos living in that state.
The investigators used data from the U.S. Surveillance, Epidemiology, and End Results (SEER) program, the Texas Cancer Registry, and the Texas Department of State Health Services. They examined the time period 1995-2006 and calculated age-adjusted and age-specific HCC incidence rates as well as the prevalence of obesity, diabetes, heavy alcohol use, and smoking.
Dr. Ramirez and her colleagues found that Latinos accounted for one third of HCC cases in Texas, and about 75% of cases in South Texas. The rates were 10.6 cases per 100,000 in South Texas and 9.7 per 100,000 in the state, compared with 7.5 per 100,000 among Latinos nationally in the SEER database. About 70% of cases were in men, an observation that held across all three populations – SEER, Texas, and South Texas.
Latinos are the fastest-growing U.S. minority group, accounting for 20% of the total U.S. population and 36% of the population of Texas; by the year 2030, Latinos will constitute a majority of Texas’ census, Dr. Ramirez noted (U.S. Census Bureau, 2010). This pattern is especially pronounced in South Texas, a large region that is currently almost 70% Latino.
The researchers also documented increases in the prevalence of obesity and diabetes among Texas and South Texas Latinos. When they analyzed the time periods 1995-1997 and 2004-2006 separately, the researchers found that obesity for all Latinos increased. During 2004-2006, Texas and South Texas Latinos had higher rates of obesity than U.S. Latinos overall. For U.S. Latinos, the obesity rate was 27%, compared with 30% for Texas Latinos and 35% for South Texas Latinos.
Diabetes prevalence also increased among U.S. Latinos overall, while the prevalence figures for South Texas and Texas Latinos showed increases, but they were not significant.
Heavy alcohol use and smoking did not appear to be significant risk factors for HCC in the analyses. However, the study shows that obesity and diabetes, both of which are preventable and treatable, should receive more attention in the Latino population, especially in Texas, Dr. Ramirez said.
Dr. Arthur Reingold, witness for the defense in the second hepatitis C trial in Nevada, was called to the stand today offering expert testimony as an epidemiologist. During questioning by the defense, Dr. Reingold testified transference of the deadly virus hepatitis C could have occurred from a lack of hand washing, ungloved hands, bite blocks, biopsy equipment, gowns and aprons, and that cross contamination of bacteria may have occurred on a daily basis.
Salmonella outbreak traced to cantaloupes in Guatemala
GUATEMALA CITY – When an Albany, Ore., church group gathered for a dinner in February 2011, three people ate salmonella-tainted cantaloupe and fell ill.
They were the first confirmed victims of an outbreak involving a rare strain of salmonella that eventually reached 10 states – from California and Nevada to Pennsylvania and Maryland – and was linked to 20 illnesses this spring.
Federal and state officials traced the outbreak to a farm in Guatemala 2,800 miles away that grows cantaloupe for Del Monte Fresh Produce N.A. Inc. Despite the company’s reluctance, the U.S. Food and Drug Administration urged a recall of nearly 60,000 cantaloupes imported into the U.S. from the farm in Asunción Mita, located about four hours from here.
Researchers identify cancer blocking properties of thistle – Portugal
The thistle, a plant used in the manufacture of cheese, has potential anti-tumor properties that could prevent and treat two types of cancer, breast and liver cancer, two uncommon but often fatal forms of cancer, Portuguese researchers have claimed.
The claim is based on res
earch using potential anti-tumor thistle leaf extract by researchers at CEBAL — the Center for Agricultural Biotechnology and Agricultural
Science — based in Beja, Portugal.
Since 2008, that a team of CEBAL researchers, led by Fatima Duarte, has been studying the potential of the thistle to prevent and treat diseases, including cancer.
Previous studies and folk medicine had suggested that the use of milk thistle in potions and infusions could treat digestive problems, indicating that the plant “may have some very interesting attributes” at the phytotherapeutic level (use of natural compounds to prevent and treat diseases), said Fatima Duarte.
After dividing the thistle in parts, each one for its natural extract, the CEBAL researchers have concluded that the leaf extract “seems to be more active, or has the most phytotherapeutic potential.”
“Right now, I can’t say that the leaf extract can be an effective treatment,” but, through testing in vitro, using a triple negative phenotype model of a type of breast cancer, research has shown that “it can block the growth of tumor cells” when they are incubated with the leaf extract of the thistle, she said.
Milk Thistle, Cardo-de-Santa-Maria or Cardo Mariano, (Silybum Marianum) is an annual or biannual plant of the Asteraceae family. The plant, originally a native of Southern Europe through to Asia, is very common in Portugal where it is used to curdle milk for cheese making and in folk medicine and herbalism to treat various ailments. It has been suggested that Milk Thistel extract has antifungal effects and may be as effective as fluoxetine in treatment of obsessive-compulsive disorder. The extract is also used in beverages as an energy enhancing agent.
(Credit: iStockphoto/Henrik Jonsson)
ScienceDaily (Oct. 3, 2011) — The Nobel Assembly at Karolinska Institutet has awarded the Nobel Prize in Physiology or Medicine 2011 to Bruce A. Beutler and Jules A. Hoffmann for their discoveries concerning the activation of innate immunity and the other half to Ralph M. Steinman for his discovery of the dendritic cell and its role in adaptive immunity.
This year's Nobel Laureates have revolutionized our understanding of the immune system by discovering key principles for its activation. Scientists have long been searching for the gatekeepers of the immune response by which man and other animals defend themselves against attack by bacteria and other microorganisms. Bruce Beutler and Jules Hoffmann discovered receptor proteins that can recognize such microorganisms and activate innate immunity, the first step in the body's immune response.
Ralph Steinman discovered the dendritic cells of the immune system and their unique capacity to activate and regulate adaptive immunity, the later stage of the immune response during which microorganisms are cleared from the body.
The discoveries of the three Nobel Laureates have revealed how the innate and adaptive phases of the immune response are activated and thereby provided novel insights into disease mechanisms. Their work has opened up new avenues for the development of prevention and therapy against infections, cancer, and inflammatory diseases.
Two lines of defense in the immune system
We live in a dangerous world. Pathogenic microorganisms (bacteria, virus, fungi, and parasites) threaten us continuously but we are equipped with powerful defense mechanisms. The first line of defense, innate immunity, can destroy invading microorganisms and trigger inflammation that contributes to blocking their assault. If microorganisms break through this defense line, adaptive immunity is called into action. With its T and B cells, it produces antibodies and killer cells that destroy infected cells. After successfully combating the infectious assault, our adaptive immune system maintains an immunologic memory that allows a more rapid and powerful mobilization of defense forces next time the same microorganism attacks. These two defense lines of the immune system provide good protection against infections but they also pose a risk. If the activation threshold is too low, or if endogenous molecules can activate the system, inflammatory disease may follow.
The components of the immune system have been identified step by step during the 20th century. Thanks to a series of discoveries awarded the Nobel Prize, we know, for instance, how antibodies are constructed and how T cells recognize foreign substances. However, until the work of Beutler, Hoffmann and Steinman, the mechanisms triggering the activation of innate immunity and mediating the communication between innate and adaptive immunity remained enigmatic.
Discovering the sensors of innate immunity
Jules Hoffmann made his pioneering discovery in 1996, when he and his co-workers investigated how fruit flies combat infections. They had access to flies with mutations in several different genes including Toll, a gene previously found to be involved in embryonal development by Christiane Nüsslein-Volhard (Nobel Prize 1995). When Hoffmann infected his fruit flies with bacteria or fungi, he discovered that Toll mutants died because they could not mount an effective defense. He was also able to conclude that the product of the Toll gene was involved in sensing pathogenic microorganisms and Toll activation was needed for successful defense against them.
Bruce Beutler was searching for a receptor that could bind the bacterial product, lipopolysaccharide (LPS), which can cause septic shock, a life threatening condition that involves overstimulation of the immune system. In 1998, Beutler and his colleagues discovered that mice resistant to LPS had a mutation in a gene that was quite similar to the Toll gene of the fruit fly. This Toll-like receptor (TLR) turned out to be the elusive LPS receptor. When it binds LPS, signals are activated that cause inflammation and, when LPS doses are excessive, septic shock. These findings showed that mammals and fruit flies use similar molecules to activate innate immunity when encountering pathogenic microorganisms. The sensors of innate immunity had finally been discovered.
The discoveries of Hoffmann and Beutler triggered an explosion of research in innate immunity. Around a dozen different TLRs have now been identified in humans and mice. Each one of them recognizes certain types of molecules common in microorganisms. Individuals with certain mutations in these receptors carry an increased risk of infections while other genetic variants of TLR are associated with an increased risk for chronic inflammatory diseases.
A new cell type that controls adaptive immunity
Ralph Steinman discovered, in 1973, a new cell type that he called the dendritic cell. He speculated that it could be important in the immune system and went on to test whether dendritic cells could activate T cells, a cell type that has a key role in adaptive immunity and develops an immunologic memory against many different substances. In cell culture experiments, he showed that the presence of dendritic cells resulted in vivid responses of T cells to such substances. These findings were initially met with skepticism but subsequent work by Steinman demonstrated that dendritic cells have a unique capacity to activate T cells.
Further studies by Steinman and other scientists went on to address the question of how the adaptive immune system decides whether or not it should be activated when encountering various substances. Signals arising from the innate immune response and sensed by dendritic cells were shown to control T cell activation. This makes it possible for the immune system to react towards pathogenic microorganisms while avoiding an attack on the body's own endogenous molecules.
From fundamental research to medical use
The discoveries that are awarded the 2011 Nobel Prize have provided novel insights into the activation and regulation of our immune system. They have made possible the development of new methods for preventing and treating disease, for instance with improved vaccines against infections and in attempts to stimulate the immune system to attack tumors. These discoveries also help us understand why the immune system can attack our own tissues, thus providing clues for novel treatment of inflammatory diseases.
Bruce A. Beutler was born in 1957 in Chicago, USA. He received his MD from the University of Chicago in 1981 and worked as a scientist at Rockefeller University in New York and the University of Texas in Dallas, where he discovered the LPS receptor. Since 2000 he has been professor of genetics and immunology at The Scripps Research Institute, La Jolla, USA.
Jules A. Hoffmann was born in Echternach, Luxembourg in 1941. He studied at the University of Strasbourg in France, where he obtained his PhD in 1969. After postdoctoral training at the University of Marburg, Germany, he returned to Strasbourg, where he headed a research laboratory from 1974 to 2009. He has also served as director of the Institute for Molecular Cell Biology in Strasbourg and during 2007-2008 as President of the French National Academy of Sciences.
Ralph M. Steinman was born in 1943 in Montreal, Canada, where he studied biology and chemistry at McGill University. After studying medicine at Harvard Medical School in Boston, MA, USA, he received his MD in 1968. He has been affiliated with Rockefeller University in New York since 1970, has been professor of immunology at this institution since 1988, and is also director of its Center for Immunology and Immune Diseases.
For further information, including a graphic illustrating innate and adaptive immunity, see: http://www.nobelprize.org/nobel_prizes/medicine/laureates/2011/press.html
Patient benefits from marijuana FERNDALE — When his cancer came back for a fifth time, Michael McShane was desperate for treatment outside of traditional medicine.
The last time squamous cell carcinoma left lumpy tumors around his mouth, doctors cut it away and reconstructed his bottom lip by turning out a portion of its inner layer.
“You can only do most facial tricks once,” McShane, 51, said. “I needed another option.”
As a qualifying medical marijuana patient, he tried “Simpson oil” derived from cannabis plants by a Canadian named Rick Simpson. McShane bought some from an Oak Park dispensary that has since closed and puts a few drops every day on his face. Over the course of about 10 weeks, the tumors faded and then seemed to disappear.
His dermatologist, Dr. Ali Moiin, has said McShane isn’t cured but his cancer cells have decreased by about 60 percent.
“You still have some residual ones, but the size has definitely decreased,” Moiin told a WWJ-AM (950) reporter in late August, adding he thinks the results merit further scientific study.
Moiin didn’t return phone calls for an interview for this story. He isn’t the doctor who signed the physician certification form for McShane, who has another qualifying medical problem.
In all, since the Michigan Medical Marijuana Program started in April 2009, 2,215 of the state’s licensed physicians have certified that a patient suffers from one of the debilitating conditions identified in the act, and that the patient might find therapeutic and palliative relief from the medical use of marijuana. A total of 105,458 patient registry cards have been issued in that time.
An estimated 55 doctors signed 70 percent of the certification forms, according to one review; most of the others aren’t talking about it publicly.
“I imagine it is a fairly sensitive issue because it is politically charged,” said Colin Ford, director of state and federal government relations for the Michigan State Medical Society. Continued...
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