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August 28, 2007
Clinical Trial, New Drug for Hepatitis C Viral Infection
Learn about Implicit Bioscience's drug, Oglufanide Disodium, now in a Phase IIa clinical trial to test its ability for overpowering Hepatitis C.
Drug in New Hepatitis C Clinical Trial
www.earthtimes.org
RISBANE, Australia, Aug. 24 /PRNewswire/ -- Physicians at Southern Health have started a phase IIa clinical trial designed to test the efficacy of a new strategy for defeating hepatitis C viral infection, one of the toughest infectious diseases in the modern world.
Implicit Bioscience's drug, oglufanide disodium, which works as a regulator of the body's immune response, is being given by intranasal administration to patients with chronic hepatitis C viral infection.
"The drugs currently in use fail to control this disease in about one half of all patients," said Dr Ian Frazer, Implicit's Chief Scientific Officer. "So there is a compelling need for new and better therapies, and we hope that oglufanide disodium may control or reverse the suppression of the immune system which the hepatitis virus uses to defeat our normally healthy defenses."
Dr Frazer is well known as the co-inventor of the recently approved vaccine for papillomavirus, which is designed to prevent cervical cancer.
Dr William Sievert, who is the Principal Investigator for the trial, welcomed the opportunity to study the action of oglufanide disodium in his busy liver diseases clinic at the Monash Medical Centre, which is part of the Southern Health network. "It is an important opportunity for patients to be involved in a new trial such as this, in which new treatment prospects are explored."
Oglufanide disodium was originally developed to treat severe infectious disease in Russia (where it is a registered pharmaceutical), and was extensively studied in cancer clinical trials in the United States before being acquired by the privately-owned Brisbane biotech company Implicit Bioscience Pty Ltd in 2005.
The phase IIa trial of intranasal oglufanide disodium will complement the ongoing phase Ib study of subcutaneously administered drug at the Princess Alexandra Hospital in Brisbane.
Oglufanide disodium regulates the body's innate immune response to defeat invading germs and cancer cells. The drug is also under development by Implicit as a biodefense therapy and for ovarian cancer.
Implicit Bioscience, Inc.
Posted by Editors at 12:00 PM --- Printer-friendly version
August 27, 2007
Breaking the Hepatitis C Social Stigma
More people are currently living with Hepatitis C than any other chronic blood-borne infectious disease. Many patients still suffer with the associated stigma in many social circles. Discover two ways to reduce this unfortunate perception of a Hepatitis C diagnosis. Your efforts can help make the changes required.
by Nicole Cutler, L.Ac.
The MSN Encarta Dictionary defines stigma as “a sign of social unacceptability: the shame or disgrace attached to something regarded as socially unacceptable.” According to the US Department of Health and Human Services, “stigma is about disrespect.”
For some people, the stigma of living with Hepatitis C is more harmful than the virus itself. While medical research and treatment primarily target prevention and viral eradication, there is a lot more effort required to change public perception and attitudes toward Hepatitis C. There are two parts to breaking a disease-related stigma: education and self-respect. By educating communities on Hepatitis C and learning to feel good about yourself (regardless of viral status), Hepatitis C can be removed from the category of socially unacceptable conditions.
Why?
The primary reasons for any condition to be stigmatized are the lack of compassion, fear and ignorance. Hepatitis C is a prime candidate for such an attitude for several reasons:
· Fear of Transmission – Because Hepatitis C is an infectious disease without a definitive cure, people are afraid of getting it. Although not easily transmitted, people are nevertheless fearful and may shun those who have the disease. Fear and ignorance have cost those with Hepatitis C their jobs, friendships and marriages.
· Fear of Illness – Some people do not like to be around people who are sick. Being uncomfortable around others who have an illness is how certain people protect themselves from their personal fears. This discomfort may cause them to socially reject people with diseases instead of risking exposure to suffering and/or death.
· Judgment – Despite the many ways of acquiring Hepatitis C, misinformed people sometimes assume that everyone with Hepatitis C has a history of injection drug use. Even if this is a person’s mode of viral acquisition, our society lacks compassion and understanding about injection drug use. Those without personal exposure to injected drugs may judge people who have. Former injection drug users may feel haunted by their pasts and judge themselves. Additionally, many active injection drug users carry shame about their addiction. Regardless of the situation, casting judgment on a person for their past addiction or viral status is devoid of compassion for their very personal situation.
Several of Hepatitis C stigma’s negative consequences include reduced self-esteem, diminished mental health, less access to medical care and fear of disclosing a positive status. Additionally, this attitude may contribute to hesitancy on the part of some medical providers to treat people infected with Hepatitis C.
In the January 2006 issue of Hepatitis magazine, the staff conducted an informal web poll about stigma and viral hepatitis. On the plus side, 42 percent of poll participants felt they had not faced any stigma due to living with hepatitis. However, more than half of all respondents reported being treated differently due to their disease. Of those who participated in the poll, 20 percent felt they had experienced job discrimination due to having Hepatitis B or Hepatitis C, 13 percent reported hepatitis-related social stigma and 13 percent had been alienated from family and friends because of viral hepatitis.
Education
Any social stigma finds its roots in fear of the unknown. Many Americans have misconceptions about the way Hepatitis C is transmitted. Once diagnosed with the virus, most affected people diligently study how the disease is spread, and how they likely acquired it. However, a person without firsthand experience with Hepatitis C may mistakenly assume it can be transmitted through sharing a glass of water or even from being coughed or sneezed on by an infected person. Until all reaches of society learn the facts about this virus, inaccurate stereotypes fueled by fear will persist.
Educating yourself and others will break down the stigma associated with Hepatitis C. Many communities have Hepatitis C task forces to promote community awareness. Getting involved with Hepatitis C informational training sessions targeting local schools, hospitals, drug treatment programs, government agencies and similar community organizations will fill replace fear with knowledge, helping to remove the negative perspectives about this disease. In the words of Margaret Mead, “Never doubt that a small group of thoughtful, committed citizens can change the world. Indeed, it is the only thing that ever has.”
Self-Respect
If you have Hepatitis C, the first step in breaking the stigma is to start with your own attitude toward your illness. Some questions to ask in uncovering this include:
· Do you label yourself as a sick person?
· Do you expect to be shunned from co-workers, friends and family?
· Do you feel like you deserve to have Hepatitis C?
Honestly examining your own feelings of shame and working to shift those feelings into pride makes a tremendous difference when facing the world with any illness. Living in the present and looking to the future are the best ways to leave negativity in the past. By learning how other people live with the disease, many people find help in discussing their feelings at Hepatitis C support groups. In order to garner the respect from others, it is absolutely necessary to first develop respect for yourself. Additionally, feeling good is the single most important factor in living a long, healthy and rewarding life. Compiled by the Hepatitis C Support Project, below are nine tips for developing a healthy attitude:
1. Make sure you know the truth. Get accurate information about Hepatitis C. Some people mistakenly believe Hepatitis C is an automatic death sentence. The truth is, the majority will die with Hepatitis C, not of Hepatitis C.
2. Don’t make things worse by imagining a future with pain, disability or loss. Improve your odds by visualizing your future the way you want it. Visualizing health, not illness, is a powerful tool for self-transformation.
3. Maintain perspective of the big picture. Focus your attention on something that brings peace, joy, laughter and meaning. Tell yourself that difficult moments will pass.
4. Watch your words. If you hear yourself talking negatively, substitute positive phrases. Say, “I will find a way to live with Hepatitis C” rather than “Hepatitis C is ruining my life.”
5. Practice gratitude. Make it a habit to find things for which you are grateful.
6. Learn what you can control and what you cannot. There are things you cannot control, such as the fact that you have Hepatitis C. However, there are things you can control, such as your attitude and what you say to yourself about having Hepatitis C.
7. Learn from the virus. Ask yourself what Hepatitis C can teach you about living.
8. Get support. Being with others who are dealing with the same issues can bring encouragement and hope.
9. Help others. When it comes to stepping outside of ourselves, probably nothing works as well as reaching out to others who are also struggling.
By cultivating self-respect through a positive attitude and through active participation in educating your community on Hepatitis C, you can take an active role in breaking the Hepatitis C stigma and helping those diagnosed with the disease to finally receive the compassion they deserve.
References:
Conrad, S., Garrett, LE, et al., Living with chronic hepatitis C means 'you just haven't got a normal life any more', Chronic Illness, June 2006.
www.encarta.msn.com, Stigma, Microsoft, 2007.
www.hcvadvocate.org, Hepatitis C and Drug Abuse, Janetta Astone-Twerell, PhD, Shiela M. Strauss, PhD, Corrine Munoz-Plaza, MPH, Hepatitis C Support Project, 2007.
www.hcvadvocate.org, Stigma and Hepatitis C, Lucinda K. Porter, RN, April 2006.
www.mentalhealth.samhsa.gov, Discrimination and Stigma, US Department of Health and Human Services, 2007.
www.thebody.com, Policy Facts: AIDS-Related Stigma, AIDS Action Council, 2007.
Posted by Editors at 01:48 PM --- Printer-friendly version
August 24, 2007
Alinia Tablets and Hepatitis C
For HCV genotype 1 patients who have failed to respond to standard therapy (peginterferon and ribavirin), Romark Laboratories has designed a clinical trial to test the safety and effectiveness of Alinia (nitazoxanide). Learn more about the Phase II clinical trial during which nitazoxanide tablets are administered in combination with Pegasys and Copegus, in 60 patients with the most common genotype in North America.
RxTrials Institute Drug Pipeline Alert
Aug. 20, 2007 | Vol. 5 No. 163
http://fdanews.com
Romark Begins Trial of Alinia for Chronic Hepatitis C
Romark Laboratories has initiated a Phase II clinical trial of Alinia for treating chronic hepatitis C in the U.S.
According to Romark, the clinical trial is designed to evaluate the effectiveness and safety of Alinia (nitazoxanide) tablets administered in combination with Pegasys (peginterferon alfa-2a) and Copegus (ribavirin) in 60 patients with chronic hepatitis C genotype 1 who have failed to respond to standard therapy (peginterferon and ribavirin).
The trial is part of the company’s Studies to Evaluate Alinia for Treatment of Hepatitis C (STEALTH C) clinical development program, a series of clinical trials designed to evaluate the safety and efficacy of Alinia tablets in combination with peginterferon or peginterferon and ribavirin in patients with chronic hepatitis C.
The trial is designed to evaluate the effectiveness and safety of Alinia administered 500 mg twice daily for four weeks followed by Alinia-Pegasys-Copegus combination therapy for 48 weeks compared to placebo for four weeks followed by placebo-Pegasys-Copegus combination therapy for 48 weeks, which is the standard of care.
Posted by Editors at 04:21 PM --- Printer-friendly version
August 15, 2007
New Treatment Recommended for Asian Chronic Hepatitis C Patients
The Chinese University of Hong Kong recently made public the results of its three-year study, which evaluated the use of interferon beta-1a and its combination with ribavirin in the treatment of Asian chronic Hepatitis C patients. Find out how it compares to the existing peginterferon-alfa based therapy.
New treatment for chronic hepatitis C leads to less side effects: study
August 14, 2007
http://english.people.com.cn
A study result made public Monday by the Chinese University of Hong Kong reveals that combination of interferon beta-1a and ribavirin treatment for chronic hepatitis C creates less side effects.
Chronic hepatitis C is an important cause of liver cirrhosis and liver cancer. Currently, the standard treatment of chronic hepatitis C is combination of peginterferon-alfa and ribavirin, which, however, leads to common adverse effects including fever and flu-like symptoms, injection site reaction, depression and bone marrow suppression. This decreases patients' compliance and in turn reduces the treatment effect, the university said.
The university hence carried out a three-year study to assess the use of interferon beta-1a and its combination with ribavirin in the treatment of Asian chronic hepatitis C patients.
About 250 Asian chronic hepatitis C patients with active disease were recruited and randomly assigned into two groups which received placebo treatment and interferon beta-1a plus ribavirin combination treatment respectively for 12 weeks, it said.
The result shows that interferon beta-1a and ribavirin combination treatment can achieve a similar rate of viral clearance but a low rate of adverse event and patient discontinuation as compared to the existing peginterferon-alfa based treatment.
The university recommended that interferon-beta-1 and ribavirin combination treatment be considered as an alternative to the existing peginterferon-alfa based therapy for Asian patients with chronic hepatitis C infection.
Source: Xinhua
Posted by Editors at 01:42 PM --- Printer-friendly version
Tattoo, Piercing Shop Creates HIV and Hepatitis Risk
Learn why the Durham Region Health Department is concerned that nearly 2,000 people may have been exposed to diseases such as Hepatitis B, Hepatitis C and HIV over an eight-month time span at a tattoo and body-piercing shop in Oshawa, Ontario (Canada).
Tattoo, piercing shop put up to 2,000 at risk
Warned to undergo tests for HIV, hepatitis
CanWest News Service
Published: Saturday, August 11
www.canada.com
The Durham Region Health Department is looking for 1,500 to 2,000 people who were customers at an Oshawa tattoo and body-piercing shop because of concerns about communicable diseases.
The department recently closed Longhorn Custom Body-art after inspectors determined during a routine visit that a sterilizer was malfunctioning and that contaminated equipment may have been used between Nov. 17, 2006, and Aug. 1, 2007.
While describing the risk as low, the department is still concerned that such diseases as hepatitis B, hepatitis C and HIV could have been spread to customers. It is urging them to visit a doctor for blood tests.
Ross MacEachern, manager of environmental health for Durham Region, said, "At this time, we have no evidence of transmission of infectious diseases, but because of the potential use of non-sterile equipment, there is a risk."
The operators of the business kept records on every customer and are co-operating with health officials in trying to track them down.
It has yet to be determined whether charges will be laid against the business.
© The Gazette (Montreal) 2007
Posted by Editors at 12:18 PM --- Printer-friendly version
Drinking Coffee May Reduce Risk of Liver Cancer
Discover the results of a recent study in Italy that examined the relationship between coffee consumption and the risk of liver cancer, as well as the favorable effects of some of coffee's components.
Coffee and liver cancer
Medical Studies/Trials
Published: Sunday, 5-Aug-2007
www.news-medical.net
After lung and stomach cancer, liver cancer is the third largest cause of cancer deaths in the world.
A new study on the relationship between coffee drinking and the risk of hepatocellular carcinoma (HCC) confirmed that there is an inverse association between coffee consumption and HCC, although the reasons for this relationship are still unresolved.
The results of this study appear in the August 2007 issue of Hepatology, the official journal of the American Association for the Study of Liver Diseases (AASLD). Published by John Wiley & Sons, Inc., Hepatology is available online via Wiley InterScience at http://www.interscience.wiley.com/journal/hepatology.
At least eleven studies conducted in southern Europe and Japan have examined the relationship between coffee drinking and the risk of primary liver cancer. The current study, led by Francesca Bravi of the Istituto di Ricerche Farmacologiche Mario Negri in Milan, Italy, was a meta-analysis of published studies on HCC that included how much coffee patients had consumed. Researchers combined all published data to obtain an overall quantitative estimate of the association between coffee consumption and HCC.
The results showed a 41 percent reduction of HCC risk among coffee drinkers compared to those who never drank coffee. "Moreover, the apparent favorable effect of coffee drinking was found both in studies from southern Europe, where coffee is widely consumed, and from Japan, where coffee consumption is less frequent, and in subjects with chronic liver diseases," the researchers state.
They point out that animal and laboratory studies have indicated that certain compounds found in coffee may act as blocking agents by reacting with enzymes involved in carcinogenic detoxification. Other components, including caffeine, have been shown to have favorable effects on liver enzymes. Coffee has also been related to a reduced risk of liver diseases and cirrhosis, which can lead to liver cancer.
"Despite the consistency of these results, it is difficult to derive a causal inference on the basis of the observational studies alone," the authors note. It may be that patients with digestive tract diseases, including liver disorders, naturally reduce their coffee consumption, even though avoidance of coffee is not routinely recommended. Also, they note that the assessment of coffee intake was based on patients self-reporting, although recall of coffee drinking has been shown to be accurate. The fact that the inverse relationship between coffee drinking and HCC was shown in both southern Europe and Japan suggests a lack of bias in these studies. Allowance for other confounding factors, such as hepatitis B and C, cirrhosis, social class indicators, alcohol use and smoking, also suggests that such factors did not influence the results.
"In conclusion, the results from this meta-analysis provide quantitative evidence of an inverse relation between coffee drinking and liver cancer," the authors state. "The interpretation of this association remains, however, unclear and the consequent inference on causality and worldwide public health implications is still open for discussion."
http://www.interscience.wiley.com/journal/hepatology
Posted by Editors at 11:35 AM --- Printer-friendly version
August 14, 2007
Hepatitis Transmission and Swimming Pools
Learn why a certain hepatitis virus can pose trouble in communal waters, as well as ways to prevent and minimize this swimming pool risk.
by Nicole Cutler, L.Ac.
For millions of overheated Americans, the perfect summer activity involves a swimming pool. According to U.S. census data, swimming ranks as the second most popular exercise activity in the country. In the age of seemingly mysterious illnesses infecting every age, sex, race and income bracket, sharing the same body-enveloping fluid as strangers can initiate fear of communal waters. Whether in the backyard, local recreation center, fitness club, neighborhood pool or vacation hotel, swimming is a healthy pursuit deserving of an equally healthy, water-filled basin.
As one of the most prevalent infectious disease categories today, a growing number of people are concerned about exposing themselves to a hepatitis virus by swimming in a pool. However, there is only one hepatitis-related danger to swimming in a pool, and infection is preventable.
Hepatitis Risk
Although approximately 10 percent of people infected with a hepatitis virus are unsure of how they contracted it, scientists do know which bodily fluids can transmit the different strains of hepatitis illnesses. While there are three prevalent hepatitis viruses, only one has the potential to contaminate a maintained pool.
· Hepatitis A – Since this virus is primarily transmitted via fecal matter, this is the hepatitis strain that could become a problem in a swimming pool.
· Hepatitis B – Transmitting this strain of hepatitis is not a concern for swimmers because it involves blood-to-blood contact.
· Hepatitis C – Transmitting this strain of hepatitis is not a concern for swimmers because it involves blood-to-blood contact.
Hepatitis A
A self-limiting viral infection of the liver, hepatitis A typically does not cause chronic disease. While hepatitis A causes liver inflammation, most people’s livers can fully recover without any long-term damage. However, people already afflicted with chronic liver disease are more susceptible to serious illness as a result of hepatitis A infection. Since this disease is caused by a virus, it does not respond to antibiotics.
The most common symptoms of hepatitis A include:
· Nausea, vomiting, diarrhea
· Low-grade fever and loss of appetite
· Rash
· Fatigue
· Jaundice and dark urine
· Liver pain
Transmitted primarily by the fecal-oral route, hepatitis A infection can occur by swallowing pool water containing feces. Additionally, hepatitis A is a potential problem when large numbers of people congregate and where overcrowding and inadequate sanitation exist. Because hepatitis A is easily spread by raw sewage, it can become a danger in the recreational swimming environment when:
· a person accidentally has a bowel movement in the pool
· sewage systems become overburdened from heavy rainfall or flooding and infects swimming waters.
Once someone has hepatitis A, lifelong immunity is established preventing re-infection with this disease. For those who have never contracted this virus, the hepatitis A vaccination provides immunity.
Prevention
In addition to getting vaccinated for hepatitis A, there are ways to minimize swimming pool risks. Proper chlorination to kill waterborne germs, good sanitation practices and suitable personal hygiene in and around the swimming area can make the difference between a healthy and unhealthy swimming experience. According to CDC epidemiologist Dr. Michael Beach, "It's crucial that public health professionals, pool operators and the general swimming public work in partnership to increase everyone's chances for healthy swimming experiences."
· Disinfecting – Water filtration is not an effective means of removing contamination from a pool in a timely manner. The ability to kill pathogens in the water is based on the contact time a pathogen has with a disinfectant and the concentration of the disinfectant. While a majority of systems rely on chlorine, there are a few disinfectant alternatives. Considered to be moderately chlorine-resistant, experts approximate it takes chlorine at least 16 minutes to kill hepatitis A in pools that do not use stabilizers such as cyanuric acid. Additionally, all pools should maintain a stringent policy for water disinfection in case any fecal matter is detected.
· Evaluate the Pool – Before diving in, first evaluate the pool’s hygiene. The water should appear clean and clear, with painted stripes on the bottom clearly visible. The pool walls should feel smooth, not sticky or slippery. Listen for pump and filtration system noise to confirm the pool equipment is working. Lastly, smell the pool. Contrary to popular belief, a well-chlorinated pool has little odor. A heavy chemical odor is typically due to chloramines, not chlorine. The well-known strong chlorine odor means that unhealthy chloramines have formed in the water, created from the mix of chlorine and contaminants. Chloramines are not as effective in disinfecting swimming pool water.
· Don’t Swallow – Since hepatitis A is spread through the fecal-oral route, infection typically involves swallowing contaminated pool water. Teach children and train yourself not to swallow pool water – and even avoid getting it in your mouth.
As swimming continues its popularity as a preferred summer activity, people can take control of their health by being a hepatitis A prevention advocate. Make sure your swim spot is well maintained. Inform pool personnel about any concerns you have. Especially important for people already living with some other form of liver disease, refrain from getting pool water in your mouth. In addition, make sure you are protected with the hepatitis A vaccine in case you are exposed. By being educated about the potential for hepatitis A infection in a swimming pool, you can avoid being affected by this liver illness.
References:
www.cdc.gov, Chlorine Disinfection Time Table, Centers for Disease Control and Prevention, 2007.
www.cdc.gov, Pool User Information, Centers for Disease Control and Prevention, 2007.
www.ehagroup.com, Diseases Acquired via Recreational Bathing (Public Swimming Pools), EHA Consulting Group, Inc., 2007.
www.havuz.org, Waterborne Pool Illnesses, Larry Katz, 2007.
www.healthstate.mn.us, Public Swimming Pools, Minnesota Department of Public Health, 2007.
www.healthypools.org, What You Think You Know and What You Should Know About Healthy Pools, U.S. Centers for Disease Control and Prevention, the National Consumers League, the Water Quality and Health Council, the Chlorine Chemistry Council and the National Spa & Pool Institute, 2007.
www.medicalnewstoday.com, Make a splash for public health this summer - Swimming pool health, MediLexicon International Ltd., 2007.
www.pponline.co.uk, A quick look at the medical hazards of swimming in pools, P2P Publishing Ltd., 2007.
Posted by Editors at 02:51 PM --- Printer-friendly version
August 06, 2007
New Technology and Methods to Fight Hepatitis C
Recent technology has allowed researchers to safely and effectively kill blood-borne diseases. In July 2007, researchers announced favorable results in Ultraviolet Blood Irradiation (UBI) outside the body. Discover what scientists have to say about using this new method to fight Hepatitis C and AIDS.
by Nicole Cutler, L.Ac.
The purpose of light goes beyond warming the earth’s surface or illuminating a room. Referred to by scientists as electromagnetic radiation, light has wavelengths both visible and invisible to the human eye. Various attempts to help people fight Hepatitis C have included electromagnetic radiation, with reports of success spanning both visible and invisible light.
Invisible Light
With shorter wavelengths than visible light, ultraviolet (UV) radiation is a confirmed environmental human carcinogen. While our sun emits light at all different wavelengths in the electromagnetic spectrum, ultraviolet waves are the portion of light responsible for causing sunburns. However, UV radiation used specifically to target Hepatitis C and other illnesses has been recognized for its potential healing ability.
Ultraviolet Blood Irradiation
Ultraviolet radiation is well-known to purify and deodorize air, sterilize water and destroy bacteria in waste products. First introduced in the 1930s to combat the polio virus, Ultraviolet Blood Irradiation (UBI) was used to remove infections from a person’s bloodstream. Although problems with sterile equipment hampered its success, UBI was considered the first line of defense against infection until the advent of antibiotics and polio’s Salk vaccine.
In modern times, the prevalence of new viral epidemics without a cure or vaccine, including Hepatitis C, has brought back this alternative form of healing. Due to more recent developments in the instrumentation for UBI, controlled application of UV irradiation to the blood within the accepted therapeutic band of light has produced favorable results for infectious diseases of the blood. Additional benefits of UBI are the ability to annihilate several pathogens from the blood at once, and the absence of side effects typically caused by antibiotics or anti-viral medications.
In 2005, Energex Systems, Inc. conducted a successful trial of this technology by reducing viral loads in patients with Hepatitis C. Under investigational device exemption status granted by the U.S. Food and Drug Administration, the trial subjects all had significant viral loads who had previously received Interferon/Ribavirin therapy without a sustained response to treatment.
Researchers extracted three to four percent of the patient’s blood, exposed it to exact amounts of UV light for 20 to 30 minutes, and then returned the irradiated blood to the patient. In each subject, this procedure was repeated five times over a 16-day period. Measured ten weeks after completion of therapy, the results were as follows:
· Three subjects sustained viral load reductions of 90 percent or more
· Eight subjects sustained reductions of 50 percent or more
· Two subjects had no change
While no treatment-related complications from this trial were reported, critics of UBI claim that exposing viruses to UV light can cause genetic mutations. Since a mutation of the Hepatitis C virus would render it even more resistant to therapies currently in development, UBI therapy has remained a fringe alternative therapy in the United States.
Visible Light
Visible light is light that can be perceived by the human eye. When looking at the visible light of the sun, it appears to be colorless, which we call white. Although this light is visible, white light is not considered to be part of the visible spectrum because it is not of a single color or frequency. Instead, white light is a combination of many color frequencies.
In July 2007, scientists from Arizona State University and Johns Hopkins School of Medicine discovered a new method aimed at safely and effectively killing viruses. By using an intense pulse of visible light, the researchers claim that mechanical vibrations rock the virus shell (capsid) causing irreversible damage to its reproduction and ending in the virus’ disintegration. Since UV irradiation is known to cause viral mutations and damage to the DNA of surrounding, healthy cells, the use of visible light is turning heads in the fight against infectious diseases.
The researchers used a power density of 50 megawatts per square centimeter, a quantity low enough to leave surrounding human cells and tissue undamaged, but high enough to produce large-amplitude vibrations in a virus's capsid. It was also too low to cause genetic mutations, meaning the virus would not build up resistance to this treatment over time.
According to Kong-Thon Tsen of Arizona State University and his colleagues, this method may be especially important in designing novel treatments for blood-borne viral diseases. By irradiating a patient’s blood outside the body, cleansing it of infection, and then reintroducing it back to the patient, mortality associated with diseases like Hepatitis C and AIDS can be greatly reduced.
As medical science refines its use of light’s amazing properties, people with Hepatitis C are likely to benefit. While UBI has been an alternative treatment helping people for many years, the risk of mutating a virus or healthy cells has prevented it from being a popular choice. However, as this technology is refocused on the spectrum of visible light, the risks of irradiating blood may disappear and Hepatitis C may finally meet its match.
References:
O’Brien, CB, et al., Extracorporeal photopheresis alone and with interferon-alpha2a in chronic hepatitis C patients who failed previous interferon therapy, Digestive Diseases and Sciences, May 1999.
http://en.wikipedia.org, Ultraviolet, Wikimedia Foundation, Inc., 2007.
http://in.news.yahoo.com, Visible light pulses to zap HIV, Hepatitis C, Ani-Asian News International, July 2007.
http://science.howstuffworks.com, How Light Works, Craig Freudenrich, PhD, How Stuff Works, Inc., 2007.
http://science.hq.nasa.gov, Ultraviolet Waves, National Aeronautics and Space Administration, 2007.
www.fflt.org, Understanding UV Light Therapy, Health and Wellness Foundation, 2007.
www.hemophilia.org, New Therapy Reduces Hepatitis C Viral Loads in Trial, Drug Law Weekly, National Hemophilia Association, April 2005.
www.newscientisttech.com, Visible light pulses knock out viruses in blood, Belle Dume, July 2007.
www.venicehousepizza.com, IBC Hospital - Blood Ultraviolet Irradiation, Victor Loustaunau MD, Serenelli Desktop Publishing, December 2003.
Posted by Editors at 02:24 PM --- Printer-friendly version
The Skinny on Fatty Liver Disease
Visceral fat, or "internal flab" associated with fatty liver disease, is manifesting into a big liver problem. Learn about fatty liver disease, lifestyle factors that may increase the likelihood of developing this liver condition, as well as why being thin does not guarantee having a healthy liver.
A "Growing" Liver Problem: Thin Outside, Fat Inside
www.prweb.com/releases
"Internal flab" associated with fatty liver disease is becoming a bigger liver problem than cirrhosis in the United States and Canada, and most people have no idea that they're at risk.
San Antonio, TX (PRWEB) July 30, 2007 -- Thin is in, but being thin on the outside doesn't necessarily mean you're thin on the inside, especially where your liver is concerned.
That's the conclusion of a team on researchers including Professor Jimmy Bell of the Imperial College, London.
A recent 14-year study revealed that even people who would be described as "thin" could have invisible "internal flab" that might pose a danger to their health, and could be an especially dangerous liver problem.
Fatty liver disease is a liver condition that occurs when there's a buildup of fat cells in the liver. The buildup can grow unnoticeably but could eventually lead to a range of liver problems, including enlarged liver, cirrhosis and liver cancer. Symptoms are rare in the early stages, so most people don't even know the problem is developing.
Fatty liver disease usually occurs in people with a poor diet and a sedentary lifestyle. Excessive alcohol use can also be a factor.
Professor Bell recently told the Daily Telegraph that many people who look normal and healthy on the outside may actually be obese on the inside, especially where the liver is concerned.
Bell's research used MRI scans to map the "internal flab" or visceral fat people carry inside the body, especially in the liver. Such visceral fat can be much more of a problem than fat that is more obvious on the outside.
Bell noted that "thin" women can actually carry more than twice the amount of visceral fat of someone who is considered to be "heavy" or "obese."
"If you maintain your weight through diet alone, you'll probably have higher levels of visceral fat," Bell adds. "You need to burn visceral fat away with activity." In other words, exercise is necessary.
Canadian health authorities recently said obesity and fatty liver disease have overtaken cirrhosis as the number one liver problem in Canada. According to Gary Fagan, president of the new Canadian Liver Foundation, fatty liver disease is now the fastest growing and most common liver ailment in Canada.
Posted by Editors at 01:51 PM --- Printer-friendly version
Development Suspended for Hepatitis C Drug
After two, 13-week long toxicology studies, Anadys Pharmaceuticals, Inc. and Novartis have decided to halt the development for ANA975, a phase 1b compound for the treatment of infections due to the Hepatitis C virus.
Development Discontinued for ANA975, an Early Stage Compound for Treatment of Hepatitis C Virus Infection
http://ir.anadyspharma.com
SAN DIEGO, July 26, 2007 /PRNewswire-FirstCall via COMTEX News Network/ -- Anadys Pharmaceuticals, Inc. (Nasdaq: ANDS) today announced that it and Novartis have decided to discontinue the development of ANA975, a phase 1b compound for the treatment of hepatitis C virus (HCV) infection. The parties have determined that the results received to date from the ongoing 13 week toxicology study together with the results observed in the previous 13 week toxicology study do not support further clinical evaluation of chronic daily dosing of ANA975 in hepatitis C patients.
"Although we are disappointed to discontinue development of ANA975, our animal toxicology results have convinced us that chronic daily dosing of this compound is inappropriate for further clinical development," said Lawrence C. Fritz, Ph.D., president and chief executive officer of Anadys. "However, we remain optimistic that TLR7 agonists offer therapeutic potential as effective immunomodulators in multiple disease areas, albeit using alternative dosing schedules, and our plans to develop ANA773 for cancer treatment continue unabated," Dr. Fritz said.
Anadys continues its development of ANA773, another TLR7 agonist prodrug distinct from ANA975, and expects to file an IND by the end of 2007. Anadys plans to evaluate ANA773 in Phase 1 clinical trials for the treatment of advanced cancer. This program is independent of the Novartis collaboration and is not affected by the decision to discontinue development of ANA975.
First and Second Toxicology Study Results
In June 2006, Anadys and Novartis suspended dosing in their 28-day phase 1b clinical trial of ANA975 in HCV infected patients due to then recently obtained information from pre-clinical 13-week toxicology studies. No clinical observations contributed to this decision. Preliminary analysis of the toxicology information revealed various new observations which appeared consistent with intense immune stimulation in animals. Subsequently, the FDA put the ANA975 IND on full clinical hold. In November 2006, Anadys and Novartis initiated a second 13-week toxicology study to understand better the observations from the first toxicology study and to assist in determining a future course of action for the program.
Analysis of available data from the second 13-week toxicology study, together with the results from the initial 13-week toxicology study led the parties to determine that: 1) chronic daily dosing of ANA975 was unlikely to provide an adequate therapeutic index; and 2) additional preclinical evaluation would be necessary to determine if alternate dosing schedules of ANA975 would support a safety margin sufficient for further development of this compound for the treatment of patients chronically infected with hepatitis C.
About TLR-7
Toll-like receptor 7 (TLR7) is a pattern-recognition receptor that activates the innate immune response. Stimulation of TLR7 induces the release of interferon-alpha and other type I interferons from immune cells, the release of various pro-inflammatory cytokines, the upregulation of co-stimulatory molecules and the development of an adaptive immune response. Small-molecule TLR7 agonists have been shown to have broad antiviral and anticancer effects in preclinical models and in some clinical settings.
Webcast of Conference Call
Anadys will host a conference call tomorrow at 8:30 a.m. Eastern Daylight Time to discuss the discontinuation of ANA975 development in HCV. A live webcast of the call is available online at http://www.anadyspharma.com. A telephone replay will also be available approximately one hour after completion of the call. To access the telephone replay, dial 888-286-8010 (domestic) or 617-801-6888 (international), passcode 38857175. The webcast and telephone replay will be available through August 10, 2007.
About Anadys
Anadys Pharmaceuticals, Inc., http://www.anadyspharma.com, is a biopharmaceutical company committed to advancing patient care by discovering, developing and commercializing novel small molecule medicines for the treatment of viral diseases and cancer. The Company's programs focus on Toll-Like Receptor-based small molecule product candidates and direct antiviral compounds that inhibit key steps in viral proliferation. The Company has core expertise in medicinal chemistry coupled with cell biology and structure-based drug design, and is developing compounds for the treatment of hepatitis C infection, hepatitis B infection and cancer.
Safe Harbor Language
Statements in this press release that are not strictly historical in nature constitute "forward-looking statements." Such statements include, but are not limited to, references to the belief that TLR7 agonists offer therapeutic potential as effective immunomodulators in multiple disease areas, the believed effect of using alternate dosing schedules, as well as the timing and plans for filing an IND for ANA773 and pursuing development activities with ANA773 in advanced cancer. Such forward-looking statements involve known and unknown risks, uncertainties and other factors, which may cause Anadys' actual results to be materially different from historical results or from any results expressed or implied by such forward- looking statements. In particular, the results of in vitro studies and initial in vivo studies may not be predictive of future results, and Anadys cannot provide any assurances that any of its product candidates will not have unforeseen safety issues, will have favorable results in future clinical trials or will receive regulatory approval. In addition, Anadys' results may be affected by other factors. In particular, there is no guarantee regarding Anadys' future involvement with, or value recognition from, the ANA380 program. Anadys' results may be further affected by risks related to its collaborative relationships with Novartis and LG Life Sciences, competition from other biotechnology and pharmaceutical companies, its effectiveness at managing its financial resources, its ability to successfully develop and market products, the level of effort that its collaborative partners devote to development and commercialization of its product candidates, difficulties or delays in its pre-clinical studies or clinical trials, difficulties or delays in manufacturing its clinical trials materials, the scope and validity of patent protection for its products, regulatory developments involving future products and its ability to obtain additional funding to support its operations. Risk factors that may cause actual results to differ are more fully discussed in Anadys' SEC filings, including Anadys' Form 10-K for the year ended December 31, 2006 and the "Risk Factors" section of Anadys' Form 10-Q for the quarter ended March 31, 2007. All forward-looking statements are qualified in their entirety by this cautionary statement. Anadys is providing this information as of this date and does not undertake any obligation to update any forward-looking statements contained in this document as a result of new information, future events or otherwise.
SOURCE Anadys Pharmaceuticals, Inc.
James Glover, Chief Financial Officer of Anadys Pharmaceuticals, Inc., +1-858-530-3763
Posted by Editors at 12:16 PM --- Printer-friendly version
August 02, 2007
Popular Restaurant Causes Hepatitis Scare
A well-known restaurant in Arizona created a hepatitis alarm in late July. Immune globulin (IG) injections were offered to all patrons of the restaurant who might have been exposed.
Cheesecake Factory in Arizona May have Exposed Diners to Hepatitis A
Jul. 30, 2007
www.newsinferno.com
Patrons of a Biltmore, Arizona Cheesecake Factory Restaurant may have been exposed to Hepatitis A, a potentially dangerous food borne infection. Last week, the Maricopa County Health Department announced that a worker at the restaurant had tested positive for the disease, and there is a chance that Hepatitis A could have been transmitted to some customers who ate at the Cheesecake Factory on July 20. So far, no other cases of Hepatitis A have been reported, and health officials in Arizona believe that the chance of transmission is low.
Hepatitis A is a contagious liver infection. The virus is found in the stool of infected people, and can be spread if they do not wash their hands thoroughly after using the bathroom. Symptoms of Hepatitis A include low-grade fever, nausea, vomiting, diarrhea, rash, yellowing of the skin, dark brown urine, loss of appetite and fatigue. Symptoms of Hepatitis A can last from two to nine months. Most people who contract Hepatitis A make a full recovery, however, in some rare instances the disease can progress to the point of causing liver failure or even death.
Once someone has been infected with Hepatitis A, there is no real treatment. Usually, bed rest is prescribed, and efforts are made to make the patient’s symptoms more tolerable until the disease runs its course. In some instances, a patient will be hospitalized to treat dehydration or liver problems. Sometimes patients with a severe case of Hepatitis A will require a liver transplant.
Immune globulin (IG), a preparation of antibodies can prevent Hepatitis A if it is administered within two weeks of exposure. The Maricopa County Health Department is offering IG injections to anyone who ate at the Biltmore Cheesecake Factory on July 20. The vaccinations will be available at the Maricopa County Public Health Clinic on July 30 and 31. Anyone with questions can call the Health Clinic at 602-747-7500.
Outbreaks of Hepatitis A have been linked to popular restaurants in the past. The largest Hepatitis A outbreak in US history occurred in Pennsylvania in 2005. More than 500 people contracted Hepatitis A, and three died after eating at a Chi-Chi’s Mexican Restaurant. That outbreak was linked to tainted green onions. Generally restaurant-related outbreaks of Hepatitis A infect between 25 and 200 people.
Posted by Editors at 04:17 PM --- Printer-friendly version
August 01, 2007
Mistletoe, Iscador® and Hepatitis C
Learn about mistletoe's therapeutic applications, including convincing evidence for its potential role in preventing long-term complications associated with Hepatitis C.
by Nicole Cutler, L.Ac.
As the most prevalent infectious disease of the liver, an estimated 3 percent of the world’s population carries Hepatitis C. Over time, Hepatitis C infection can lead to liver cancer, liver failure or cirrhosis—irreversible and potentially fatal scarring of the liver. Since only a small percentage of those infected can be cured, medical pioneers are striving to find innovative ways for inhibiting the virus’ growth and preventing these long-term complications from developing.
While researchers are hard at work to develop new drugs for treating and preventing the advancement of Hepatitis C, complementary medical practitioners are always investigating alternative, less toxic means for achieving the same goal. When it comes to alternative medical treatments, European physicians often lead the way. Used as a cancer therapy in Europe since the 1920s, the extract of mistletoe is often administered to people battling various types of illnesses.
Mistletoe
Most people associate mistletoe with the leafy, flowering vine to kiss underneath during the Christmas holiday. However, mistletoe is also used medicinally with a wide array of therapeutic applications ranging from epilepsy, infertility, hypertension, cancer, hepatitis and certain connective tissue disorders. Rudolf Steiner first advocated a special preparation of mistletoe to be injected for cancer treatment. In lectures to doctors in the early 1920s, Steiner mentioned the immune system as an important defense mechanism against cancer.
The Immune Link
The immune system’s role in defeating Hepatitis C and fighting cancer is very similar. Every day, hundreds of cells in our body degenerate because of viral infections or genetic changes, both which can become cancerous. Various types of white blood cells, including natural-killer cells, recognize these harmful cells and destroy them. A healthfully functioning immune system defends against the formation of tumors daily with this process.
In cancer patients, this function of the immune system has been weakened rendering it unable to eliminate cancerous cells. According to Steiner, when prepared in a special way and then injected, the mistletoe enhances the immune system by killing off cancerous cells and cells which are damaged by a viral infection or toxic influences from the environment.
Iscador®
An unlicensed, experimental drug, Iscador® is the trade name for an extract of mistletoe produced by the Hiscia Institute in Switzerland and Weleda in the U.S. In test-tube studies Iscador® has been shown to do the following:
· Improve the ability of immune cells to engulf foreign organisms.
· Increase natural-killer cell activity against foreign organisms or infected cells that have been “tagged” by antibodies.
In many countries, including those within the European Union, Iscador® is a licensed medication for monotherapy and as an adjuvant therapy in cancer treatment. Because mistletoe is potentially poisonous, Iscador® must be prescribed and administered by a physician.
Treatment
The common route of administering Iscador® is via injection just under the skin. As each day of therapy progresses, a more concentrated version is administered. A short-term fever is a typical effect of Iscador® injections. Many doctors theorize that this fever is a sign of immune system activation, an indication that Iscador® is working. Upon reaching the highest concentration of Iscador®, the injections typically continue for a week or longer, depending upon the clinical situation as judged by the treating physician. The most common side effects of Iscador® therapy include low-grade fever, redness and irritation at the injection sites.
Efficacy for Hepatitis C
Although used for decades as an alternative cancer therapy, reports of Iscador’s results for treating liver disease are primarily anecdotal. Evidence of this treatment helping people with Hepatitis C is limited to shared observations by physicians and recipients. While a few scientifically controlled medical trials have been conducted on Iscador® for this purpose, there is not yet enough proof for Iscador’s general acceptance by the American medical community. Although more human research on Iscador® is warranted, the existing evidence is compelling:
· A 2005 study in the Netherlands evaluated 21 patients with chronic Hepatitis C who were treated with a mistletoe preparation as monotherapy for one year. The treatment was well tolerated by the participants and significantly lowered liver enzyme levels. Although few effects on viral load were seen, researchers concluded that mistletoe’s ability to improve liver inflammation could reduce the likelihood of long-term complications developing in people with Hepatitis C.
· A 2001 study also from the Netherlands evaluated 5 patients with chronic Hepatitis C who were treated for one year with Iscador®. Two patients showed 6-20 fold decreases in viral load and normalization of liver inflammation. The treatment was well tolerated meaning that no serious side effects were observed. The authors concluded that Iscador® has potential as a non-toxic therapy for chronic Hepatitis C treatment.
Because of its route of administration and possible toxicity, Iscador® can only be obtained, administered and monitored by a licensed physician. As this is not a mainstream pharmaceutical therapy, doctors of naturopathic medicine are the most likely type of doctor to work with Iscador®.
Until a Hepatitis C cure that works for everyone is available, healthcare practitioners will exhaust every sensible option to conquer this disease. Although there is not yet enough evidence to conclude Iscador® is a person’s best choice to prevent Hepatitis C’s long-term complications like cirrhosis or liver cancer, it is an option to keep our eyes on.
References:
Mansky PJ, Mistletoe and Cancer: Controversies and Perspectives, Seminars in Oncology, December 2002.
Tusenius KJ, et al, Exploratory study on the effects of treatment with two mistletoe preparations on chronic hepatitis C, Arzneimittel-Forschung, 2005.
Tusenius KJ, et al., Iscador Qu for chronic hepatitis C: an exploratory study, Complementary Therapies in Medicine, March 2001.
www.aidsmap.com, Iscador, NAM Publications, 2007.
www.cancure.org, Iscador/Mistletoe, The Cancer Cure Foundation, 2007.
www.healthy.net, Two Studies of Iscador, Robert Gorter, MD, HealthWorld Online, 2007.
www.mayoclinic.com, Hepatitis C, Mayo Foundation for Medical Education and Research, 2007.
www.selfgrowth.com, Iscador: Victory Over Cancer, Phillip Minton, MD, Selfgrowth.com, April 2007.
www.usa.weleda.com, What is Iscador?, Weleda, 2007.
Posted by Editors at 02:14 PM --- Printer-friendly version