Research & Treatment News
August 28, 2009
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Justifying its use to protect the liver, many of us know that milk thistle is a potent antioxidant and liver detoxifier. However, find out four more compelling reasons why milk thistle helps in the battle against Hepatitis C.
by Nicole Cutler, L.Ac.
Worldwide, those with Hepatitis C choose to take milk thistle more than any other vitamin or herbal supplement. Even though taking it orally does not boast any antiviral properties, milk thistle has helped many people with Hepatitis C prevent liver disease progression and have a better chance at successful treatment. Until they understand exactly how milk thistle can fight Hepatitis C, many are unaware of this natural herb's ability to support their liver.
While there is no refuting its potent antioxidant properties, hundreds of clinical trials have examined the reproducibility of milk thistle's claims of liver protection. Primarily based on the design of their study, some scientists have found the evidence inconclusive while others insist that milk thistle may be superior to standard Hepatitis C treatment. Although most responsible practitioners would never advise substituting an herbal supplement for a viable treatment regimen, an increasing number of physicians are encouraging their Hepatitis C patients to combine the two for an optimal outcome.
Milk thistle can benefit someone with Hepatitis C in the following ways:
1. Milk thistle lowers aspartate aminotransferase (AST) levels - A blood marker that indicates tissue damage in the liver, AST is an enzyme frequently measured during Hepatitis C treatment. Presented at the 2008 International AIDS Conference, a report from a small milk thistle study showed that in participants co-infected with Hepatitis C and HIV, those taking milk thistle had an average 8.4 decline in AST, while the placebo group showed an average increase of 27.9 in their ASTs.
2. Intravenous milk thistle demonstrates antiviral activity - Published in the November 2008 edition of the journal Gastroenterology, investigators found that high dosages of silybin (the most active component of milk thistle) administered intravenously was well tolerated by study participants. In addition, the intravenous silybin showed a substantial antiviral effect against Hepatitis C in full-dose pegylated interferon/ribavirin non-responders. This decrease in Hepatitis C viral load was determined to be dose dependent.
3. Milk thistle helps regenerate liver tissue - For those with chronic Hepatitis C, the ability of the liver to regenerate is crucial for repairing damaged liver cells. Milk thistle actually helps the liver regenerate itself by stimulating the growth of liver cells to replace the parts of the liver that are damaged. As published in the January-June 2008 edition of Pharmacognosy Reviews, milk thistle stimulates vital protein synthesis through the enzyme RNA polymerase I. Believed to be responsible for this process silibinin may accomplish this by imitating a steroid hormone.
4. Milk thistle reduces the body's iron stores - Experimental and clinical studies suggest that excess iron might exacerbate liver injury in patients with chronic viral hepatitis, increasing the risk of hepatic fibrosis and cirrhosis, favoring the development of liver cancer and preventing a sustained virologic response to antiviral therapy. A study published in the September 2008 edition of the Journal of Clinical Gastroenterology demonstrated that treatment with silybin phytosome (the same ingredient in UltraThistle) was associated with reduced body iron stores, especially among patients with advanced fibrosis.
A majority of its advocates believe in milk thistle as a liver protector because it is a potent antioxidant and helps detoxify poisons. However, the lesser-known four properties described above make supplementing with milk thistle a no-brainer for anyone living with chronic Hepatitis C.
References:
http://www.medscape.com/viewarticle/517511, Iron Accumulation in Chronic Hepatitis C, Chiara Corengia, MD, et al, Retrieved March 22, 2009, American Journal of Clinical Pathology, 2005.
http://www.naturalnews.com/023997.html, Milk Thistle: The Herb for Liver Health and More, Barbara Minton, Natural News Network, August 2008.
http://www.ncbi.nlm.nih.gov/pubmed/17213517?ordinalpos=1&itool=EntrezSystem2.PEntrez.Pubmed.Pubmed_ResultsPanel.Pubmed_DiscoveryPanel.Pubmed_Discovery_RA&linkpos=2&log$=relatedreviews&logdbfrom=pubmed, Hepatoprotective herbal drug, silymarin from experimental pharmacology to clinical medicine, Pradhan, SC, et al, The Indian Journal of Medical Research, November 2006.
http://www.ncbi.nlm.nih.gov/pubmed/18458640?ordinalpos=2&itool=EntrezSystem2.PEntrez.Pubmed.Pubmed_ResultsPanel.Pubmed_DefaultReportPanel.Pubmed_RVDocSum, Silybin treatment is associated with reduction in serum ferritin in patients with chronic hepatitis C, Bares JM, et al, Retrieved March 22, 2009, Journal of Clinical Gastroenterology, September 2008.
http://www.ncbi.nlm.nih.gov/pubmed/18771667?ordinalpos=12&itool=EntrezSystem2.PEntrez.Pubmed.Pubmed_ResultsPanel.Pubmed_DefaultReportPanel.Pubmed_RVDocSum, Silibinin is a potent antiviral agent in patients with chronic hepatitis C not responding to pegylated interferon/ribavirin therapy, Ferenci P, et al, Retrieved March 22, 2009, Gastroenterology, November 2008.
http://www.phcog.net/reviews/issue3/10.pdf, Hepatoprotective herbal Drug, Silymarin from experimental pharmacology to clinical medicine-A review, Parmar Mihir Y, et al, Retrieved March 22, 2009, Pharmacognosy Reviews, January - June, 2008.
http://www.projectinform.org/info/pip/46/13.shtml, Milk thistle may help improve liver health in people with HIV and hepatitis C, Alan McCord, Retrieved March 22, 2009, Project Inform Perspective, September 2008.
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August 25, 2009
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Often regarded as the premiere anti-aging fruit, nutritionists have long known that blueberries contain potent antioxidants. Discover why new research gives those with Hepatitis C reason to fully comprehend the value of blueberries.
by Nicole Cutler, L.Ac.
A new study has recently emerged that puts blueberries in the spotlight. According to Japanese researchers, blueberries are nature's answer to the Hepatitis C virus. For the estimated 200 million people living with chronic Hepatitis C worldwide, the claim surrounding this popular little blue fruit is hard to believe. To benefit from this discovery, make sure you know exactly what this study demonstrated, which part of the blueberry is most beneficial and realize what else contains blueberry's Hepatitis C-fighting compound.
To identify better treatment options, Japanese researchers Hiroaki Kataoka and colleagues at the University of Miyazaki searched for agricultural products containing a natural agent to fight the Hepatitis C virus. They discovered that blueberry leaves contained a potent inhibitor of Hepatitis C viral replication. Upon persistent purification of their most effective Hepatitis C-halting extract, the blueberry leaf ingredient responsible was determined to be the antioxidant known as proanthocyanidin.
Antioxidants
Antioxidants are known for having the ability to fight everything from colds to cancer to aging to liver disease. Found in many types of foods, antioxidants protect the body's cells and tissues from toxic, unstable molecules called free radicals. Because they stabilize free radicals by binding with them, antioxidants are adept at preventing tissue damage. However, all antioxidants are not alike:
· Roughly 10,000 chemicals in food act as antioxidants.
· Different antioxidants bind with different kinds of free radicals.
· Different antioxidants gravitate toward different locations.
· Some antioxidants cooperate with one another.
While there are several categories, two of the more celebrated classes of antioxidants include:
1. Carotenoids - Consisting mostly of yellow-to-red pigments, some examples include beta-carotene (found in carrots and sweet potatoes), lycopene (found in tomatoes and watermelon) and lutein and zeaxanthin (found in kale and corn).
2. Flavonoids - Diverse in their health benefits as well as in the foods that harbor them, examples of flavonoids include proanthocyanidins (found in grape seeds and cranberries), anthocyanins (found in berries), catechins (found in tea and chocolate) and quercetin (found in onions and apples).
The recent finding by Japanese researchers about the value of blueberries in fighting Hepatitis C revolves around proanthocyanidins - an antioxidant abundant in blueberry leaves. Both the fruit and leaves of the blueberry contain high concentrations of flavonoids. The difference between the two is that the fruit is high in anthocyanins, while the leaves are high in proanthocyanidins. Consequently, eating bushels of blueberries may not yield inhibition of the Hepatitis C virus.
More About Proanthocyanidins
Proanthocyanidins are powerful, multi-functioning antioxidants. While many antioxidants are able to inactivate a single pro-oxidant (a precursor to free radicals), proanthocyanidins possess multiple antioxidant capabilities. Besides exhibiting an anti-inflammatory effect, proanthocyanidins can neutralize the following list of harmful cellular substances:
· Superoxide Anions
· Hydroxyl Radicals
· Lipid Peroxide
· Iron
· Xanthine Oxidase
In addition, proanthocyanidins cooperate with vitamin C by helping to neutralize ascorbic oxidase (an enzyme that breaks down vitamin C). Based on Kataoka's study, we can now add suppression of Hepatitis C viral replication to the long list of health benefits provided by proanthocyanidins.
Finding Proanthocyanidin
In actuality, there are some proanthocyanidins in blueberry fruit. However, the amount is minimal, especially when compared to its leaf. Purifying the extract of blueberry leaves is likely to spark a new movement towards natural Hepatitis C treatments. In the interim, there are other sources of this powerful antioxidant.
Pycnogenol is a trademark name for a type of flavonoid found in the bark of the French maritime pine tree. Due to claims of having 50 times the antioxidant capabilities of vitamin E and 20 times that of vitamin C, sales of pycnogenol have boomed recently. Believed to be a precursor to the red, blue and violet pigment in plants, pycnogenol is a proanthocyanidin. Besides pine bark and blueberry leaves, a high concentration of proanthocyanidins can be found in:
· Sorghum
· Red Kidney Beans
· Hazelnuts
· Ground Cinnamon
· Grape Seeds
· Cranberries
The outcome of Kataoka's work on blueberry leaves and Hepatitis C viral suppression is sure to initiate more research and investigation into proanthocyanidins. Until the mechanism for this flavonoid's effect on Hepatitis C is better known and quantified, those with Hepatitis C might benefit from eating food sources high in proanthocyanidins or supplementing with extracts of this multi-functioning antioxidant.
References:
http://jn.nutrition.org/cgi/content/full/134/3/613#T1, Concentrations of Proanthocyanidins in Common Foods and Estimations of Normal Consumption, Liwei Gu, et al, Retrieved August 21, 2009, The Journal of Nutrition, March 2004.
http://www.actahort.org/members/showpdf?booknrarnr=715_91, Levels and Distribution of Anthocyanins, Proanthocyanidins, Flavonols, and Hydroxycinnamic Acids in Vaccinium Angustifolium, D. Percival, Retrieved August 21, 2009, ISHS Acta Horticulturae 715: VIII International Symposium on Vaccinium Culture, International Society for Horticultural Science, 2009.
http://www.blueberry.org/health.htm, Blueberries for Health, Retrieved August 21, 2009, U.S. Highbush Blueberry Council, 2009.
http://www.chiroweb.com/mpacms/dc/article.php?id=40247, Proanthocyanidins, G. Douglas Andersen, DC, DACBSP, CCN, Retrieved August 21, 2009, Dynamic Chiropractic, May 1995.
http://www.emaxhealth.com/1020/83/32704/blueberry-leaves-can-fight-hepatitis-c.html, Blueberry Leaves Can Fight Hepatitis C, Kathleen Blanchard, RN, Retrieved August 21, 2009, emaxhealth, 2009.
http://www.ncbi.nlm.nih.gov/pubmed/19531480?ordinalpos=1&itool=EntrezSystem2.PEntrez.Pubmed.Pubmed_ResultsPanel.Pubmed_DefaultReportPanel.Pubmed_RVDocSum, Proanthocyanidin from blueberry leaves suppresses expression of subgenomic hepatitis C virus RNA, Takeshita M, et al, Retrieved August 21, 2009, The Journal of Biological Chemistry, August 2009.
http://www.wholeliving.com/article/a-is-for-antioxidants?backto=true, A is for Antioxidants, Retrieved August 21, 2009, Body & Soul Magazine, July/August 2009.
Posted by Editors at 10:28 AM --- Printer-friendly version
August 24, 2009
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Learn about a recent discovery that sheds light on how the Hepatitis C virus can persist for so long in the human body.
Hepatitis C Virus Channels Efforts Into Cell Survival
ScienceDaily (Aug. 18, 2009) -- Researchers at the University of Leeds have discovered a previously unknown mechanism that allows the hepatitis C virus (HCV) to remain in the body for decades.
A study published in the Proceedings of the National Academy of Sciences (PNAS) shows that the virus blocks the actions of a specific ion channel in the cell membrane that would usually trigger apoptosis - the cell's self-destruct programme - and in doing so, has evolved another way of protecting itself from being eliminated from the body.
Apoptosis occurs naturally in the body to allow the removal of unhealthy cells or the replacement of worn-out cells. One of the ways in which apoptosis can be triggered in a cell is to reduce its potassium levels. This can happen when the cell is exposed to oxidative stress that activates a specific ion channel (which acts as a pore in the cell membrane) causing it to open and allow out potassium ions.
However, the research team has discovered that a protein made by HCV, known as NS5A, is able to block the activation of this ion channel in liver cells, enabling these cells to resist cell death for longer.
"For a virus to persist in the body over a long time, it has to find a way of manipulating the host cell so that it becomes resistant to apoptosis," says lead researcher Professor Mark Harris of the University's Faculty of Biological Sciences. "We know of many ways that viruses have evolved to do this, but this is the first observation of a virus preventing cell death by manipulating an ion channel."
HCV affects some 170 million people globally and only around half of these will respond to treatment. Many sufferers will be asymptomatic - some for twenty or even thirty years - but the virus remains in the liver, and its long-tem damage can ultimately cause cirrhosis or cancer.
"Cells in the liver are often exposed to high levels of oxidative, and other, stresses as they work to detoxify the blood of foreign compounds such as drugs and alcohol, and to remove chemicals produced by our own bodies," says Professor Harris. "In addition, the virus itself causes oxidative stress as it replicates in the cells. The research shows that the virus has evolved another way of protecting itself from this natural process, and to avoid elimination from the body for longer."
The research team believes that continued research may offer a potential target for drug development, perhaps through combination therapy.
"We need to find out exactly how the blocking action works, but it's possible that two drugs could be coupled together, one to prevent the virus from blocking the ion channel and another to induce stress to force apoptosis," says Professor Harris.
"It's a very exciting discovery, and ideally we'd like to expand our investigations to see whether other viruses that cause long term or chronic infections - such as HIV - have evolved the same ability."
The research was funded by the Medical Research Council.
Adapted from materials provided by University of Leeds, via EurekAlert!, a service of AAAS.
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http://www.sciencedaily.com/releases/2009/08/090817190642.htm
Posted by Editors at 10:18 AM --- Printer-friendly version
August 19, 2009
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A research team from Duke University has detected a specific genetic difference between races accounting for successful (or unsuccessful) Hepatitis C treatment.
Genes Tied to Gap in Treatment of Hepatitis C
By NICHOLAS WADE
Published: August 16, 2009
The standard treatment for infection with the hepatitis C virus is a grueling 48-week course of the antiviral drugs interferon and ribavirin that gives some patients flulike symptoms and severe depression. The treatment varies in its effectiveness, being much more successful in Americans of European descent than in African-Americans.
A Duke University team has now uncovered the principal reason for the disparity between the races. It lies not in differing compliance to the treatment or access to health care, as some have assumed, but in genetics.
Using a genetic test called a genome-wide association study, the Duke team, led by David B. Goldstein and John McHutchison, found that the coding at a single site on the DNA, out of the three billion sites in the human genome, made all the difference in people's response to the treatment.
The site is close to the gene for a special kind of interferon, known as interferon-lambda-3, and may help control the gene's activity. Some people have the DNA unit T at this site, and others have C. Since a person inherits two copies of the genome, one from each parent, individuals may have T's on both copies, C's on both, or one T and one C.
People with the CC version, or allele, respond much better to the standard hepatitis treatment than do those with the TT allele. The C versions are more common in Europeans than in Africans, and this explains half of the difference in the response between the two races, the Duke team said in a report released Sunday on the Web site of the journal Nature.
The C versions are even more common among East Asians, about 75 percent of whom respond well to the standard treatment, compared with 55 percent of European-Americans and 25 percent of African-Americans.
People with the CC versions may produce more interferons, which are virus-fighting substances produced by cells, than those with TT, though the exact mechanism has yet to be worked out.
Dr. Goldstein, a population geneticist, said the different frequencies of the T and C versions were the result of natural selection, which is particularly effective in the case of disease resistance.
"We have clearly had very strong selection in the human population for resistance to different infectious agents, which have been of different importance in different parts of the world," he said.
Presumably in the past some virus struck with particular severity in East Asia but was less potent in Europe and even milder in Africa. Dr. Goldstein said this virus might not have been the hepatitis C virus, which is spread by blood-to-blood contact, as when needles are shared, a practice common only in modern times. But he said he did not know what other virus might have been responsible.
He and Dr. McHutchison, a clinician, said a genetic test based on the finding would be of great interest to patients and physicians as a component of the decision on whether to undergo the standard treatment.
The study was financed by Schering-Plough, which owns the intellectual property rights on any diagnostic test developed from the discovery. Robert Consalvo, a spokesman for the company, said that the finding was an important first step but that he did not know of immediate plans to develop a diagnostic test. "Schering-Plough is not a diagnostic company," Mr. Consalvo said.
Dr. McHutchison said a test would not be used to deny anyone treatment, but rather to determine a patient's best options.
People who have a lower chance of benefiting from the grueling treatment because they have the TT allele might decide to wait until better drugs become available, especially if their liver damage is not severe. On the other hand, African-Americans with the CC allele might be more confident in accepting the treatment, Dr. McHutchison said.
In the United States, hepatitis C infects about three million people and causes 10,000 deaths a year, according to the Centers for Disease Control and Prevention.
A version of this article appeared in print on August 17, 2009, on page A10 of the New York edition.
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http://www.nytimes.com/2009/08/17/health/research/17hepatitis.html?_r=2&hpw
Posted by Editors at 10:39 AM --- Printer-friendly version
August 13, 2009
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Japanese researchers have found evidence that an extract from blueberry leaves hinders Hepatitis C viral replication.
CORRECTION: The author of this article indicates that Hepatitis C is "spread from dirty needles, at unsanitary tattoo parlors, and from body fluids" which is not entirely accurate. Hepatitis C is contracted when the blood from a person infected with the Hepatitis C virus enters the body of someone who is not infected - not through 'body fluids'. While many people do become infected with Hepatitis C through the sharing of needles or other equipment it is also commonly spread through blood transfusions and organ transplants.
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Blueberry supplement could help treat hepatitis C
August 8, Charlotte Health and Happiness Examiner Kathleen Blanchard RN
Results of a new and promising study show that a supplement made from blueberry leaves could help treat hepatitis C. Researchers from Japan found that beneficial chemicals in blueberry leaves can stop replication of the hepatitis C virus.
So far, treatment of hepatitis C yields standard results that are fairly successful, but with no guarantees. Click link below for full article:
http://www.examiner.com/x-14041-Charlotte-Health-and-Happiness-Examiner~y2009m8d8-Blueberry-supplement-could-help-treat-hepatitis-C">
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Posted by Editors at 9:29 AM --- Printer-friendly version
August 10, 2009
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Possibly representing a new era in Hepatitis C treatment and prevention, MassBiologics has begun Phase I testing of a human monoclonal antibody designed to neutralize the Hepatitis C virus.
Public release date: 6-Aug-2009
Contact: Michael Cohen
Michael.Cohen@umassmed.edu
508-868-4778
University of Massachusetts Medical School
First human gets new antibody aimed at hepatitis C virus
Phase 1 clinical trial in healthy subjects designed to advance novel treatment to prevent
Boston, Mass. -- Building upon a series of successful preclinical studies, researchers at MassBiologics of the University of Massachusetts Medical School (UMMS) today announced the beginning of a Phase 1 clinical trial, testing the safety and activity of a human monoclonal antibody they developed that can neutralize the Hepatitis C virus (HCV).
The first volunteer received the antibody known as MBL-HCV1 on July 28, 2009, and the study is now proceeding and will eventually involve 30 healthy subjects in a dose-escalation trial expected to conclude later this year. "We are pleased that this program has now entered the clinical trial phase," said Donna Ambrosino, MD, executive director of MassBiologics and a professor of pediatrics at the Medical School. "This trial will test the safety of the antibody and measure its activity in the subjects. This will help us determine the useful dose and other parameters as we plan for the next step in this program, which will be a Phase 2 study in liver transplant patients."
HCV attacks the liver and can eventually lead to liver failure. According to the U.S. Centers for Disease Control and Prevention, 3.2 million Americans are chronically infected with HCV and some 10,000 die annually of the disease. Globally, as many as 170 million people are estimated to suffer from HCV infection. For the most serious cases of HCV that do not respond to antiviral drugs, liver transplantation is the only option.
HCV is the leading indication for liver transplantation, diagnosed in about half of the 6,000 liver transplants done each year in the United States. Transplantation can be a life-saving treatment; however, in nearly all cases the patient's new liver is eventually infected by HCV because the virus remains in the patient's bloodstream during surgery. The powerful antiviral drugs now used to attack HCV prior to end-stage liver failure are not routinely used during surgery due to the patients' weakened condition and because of the strong medication that must be used to prevent the body from rejecting the new liver. After re-infection with HCV, nearly 40 percent of patients suffer rapid liver failure, with markedly reduced survival rates.
To close that clinical gap, the new antibody developed at MassBiologics is designed to be a therapy shortly before and after transplant surgery. By giving a patient the new antibody before and during the time when the donor liver is implanted, researchers hope the HCV virus left in the bloodstream will be neutralized and rendered unable to infect the new liver. Then, because monoclonal antibodies are highly specific and typically have little or no side-effects, additional dosages of the new antibody could, theoretically, be given immediately after transplant surgery to continue neutralizing any remaining virus.
It is also possible, researchers theorize, that the antibody could be used in combination with new antiviral drugs for treatment in patients with newly diagnosed HCV infection. "There is still more work to be done, but we are encouraged by the progress of this program to date," Dr. Ambrosino noted. "And we are grateful to the people who have volunteered to participate in this Phase 1 study. These subjects' participation will help others and advance the cause of human health."
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About MassBiologics
MassBiologics, also known as the Massachusetts Biologic Laboratories, is the only non-profit FDA- licensed manufacturer of vaccines and other biologic products in the United States. MassBiologics produces 30 percent of the US tetanus/diphtheria vaccine supply. In addition to the HCV program, MassBiologics has discovered and developed human monoclonal antibodies to severe acute respiratory syndrome (SARS), and to Clostridium difficile (C. difficile), which have shown efficacy in Phase 2, and to rabies which will be starting Phase 1 soon in collaboration with the Serum Institute of India. MassBiologics traces its roots to 1894, and since then has maintained a mission to improve public health through applied research, development and production of biologic products. MassBiologics has been a part of the University of Massachusetts Medical School since 1997.
About the University of Massachusetts Medical School
The University of Massachusetts Medical School has built a reputation as a world-class research institution, consistently producing noteworthy advances in clinical and basic research. The Medical School attracts more than $200 million in research funding annually, 80 percent of which comes from federal funding sources. The work of UMMS researcher Craig Mello, PhD, an investigator of the prestigious Howard Hughes Medical Institute (HHMI), and his colleague Andrew Fire, PhD, then of the Carnegie Institution of Washington, toward the discovery of RNA interference was awarded the 2006 Nobel Prize in Physiology or Medicine and has spawned a new and promising field of research, the global impact of which may prove astounding. UMMS is the academic partner of UMass Memorial Health Care, the largest health care provider in Central Massachusetts. For more information, visit www.umassmed.edu.
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URL for Article Source:
http://www.eurekalert.org/pub_releases/2009-08/uomm-fhg080609.php
Posted by Editors at 10:43 AM --- Printer-friendly version
August 7, 2009
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For populations who are less responsive to current licensed Hepatitis B vaccines, Dynavax is continuing its plans to resume development of HEPLISAV™ , the company's Phase 3 investigational Hepatitis B vaccine.
Dynavax Announces Path for HEPLISAV™ Hepatitis B Vaccine Development
August 4, 2009
BERKELEY, Calif.--(BUSINESS WIRE)--Dynavax Technologies Corporation (Nasdaq:DVAX) today announced it has met with the U.S. Food and Drug Administration (FDA) to discuss its plans to resume development of HEPLISAV™ , the Company's Phase 3 investigational hepatitis B vaccine.
Dynavax proposed the continued clinical development of HEPLISAV in populations that are less responsive to current licensed hepatitis B vaccines, including adults over 40 years of age, individuals with chronic kidney disease, and other groups such as individuals infected with HIV or diagnosed with chronic liver disease. The FDA expressed a general agreement that these populations are appropriate for further clinical development, pending the review of the study protocols and additional supportive data.
Dynavax plans to submit this information to the FDA in August 2009 with a goal of having the agency remove the clinical hold in September 2009. The Company is prepared to restart clinical trials in individuals with chronic kidney disease upon removal of the clinical hold.
About HEPLISAV
HEPLISAV is a Phase 3 investigational hepatitis B vaccine targeted for adults who are less responsive to current licensed hepatitis B vaccines, including adults over 40 years of age, individuals with chronic kidney disease (including end-stage renal disease, or ESRD, patients), and individuals infected with HIV or diagnosed with chronic liver disease (including hepatitis C virus).
Phase 3 data from the PHAST clinical trial demonstrate subjects over 40 years of age receiving two doses of HEPLISAV over one month achieved a seroprotection rate of 92%, compared to 75% of subjects receiving 3 doses of a licensed vaccine over six months. Over 2,500 individuals have been vaccinated with HEPLISAV to date.
Dynavax has worldwide commercial rights to HEPLISAV, which combines hepatitis B surface antigen (HBsAg) with a proprietary Toll-like Receptor 9 agonist to enhance the immune response.
Hepatitis B Vaccines and Market Opportunity
Hepatitis B is a chronic disease which can lead to cirrhosis of the liver and hepatocellular carcinoma. There is no cure for hepatitis B and disease prevention through effective vaccination is critical to reducing the spread of the disease. The total worldwide market for adult hepatitis B vaccines is estimated at over $500 million annually.
ESRD Market - The ESRD market is large and growing rapidly. In the United States alone, there are approximately 500,000 ESRD patients and 100,000 new patients annually, with similar numbers in Europe. CDC recommends universal vaccination of ESRD patients. Since ESRD patients are less responsive to current vaccines, hepatitis B vaccination regimens for ESRD consist of 8 doses of Engerix-B® over six months (versus 3 doses for the general population). Many ESRD patients do not respond to vaccination and boosters or revaccination is recommended. As ESRD patients are vaccinated regularly at dialysis centers, this is a highly concentrated, renewable market that can be served by cost-effective, targeted sales distribution networks.
Other Markets - In addition to ESRD patients, other populations such as individuals infected with HIV or diagnosed with chronic liver disease are also less responsive to current hepatitis B vaccines and represent a large, poorly served market opportunity.
About Dynavax
Dynavax Technologies Corporation, a clinical-stage biopharmaceutical company, discovers and develops novel products to prevent and treat infectious diseases. The Company's lead product candidate is HEPLISAV, a Phase 3 vaccine targeted for individuals who are less responsive to current licensed hepatitis B vaccines. For more information visit www.dynavax.com.
Forward Looking Statements
This press release contains "forward-looking statements," that are subject to a number of risks and uncertainties, including statements related to the nature and timing of communications with the FDA regarding HEPLISAV, submissions of documents, and potential clinical trials. Actual results may differ materially from those set forth in this press release due to the risks and uncertainties inherent in our business, including whether and when the FDA will remove the clinical hold on HEPLISAV, whether HEPLISAV can be further developed, financed or commercialized, or even if further development is permitted, that successful clinical development and regulatory approval can occur in a timely manner or without significant additional studies or difficulties or delays in development, the Company's ability to obtain additional financing to support its operations, possible claims against the Company based on the patent rights of others; and other risks detailed in the "Risk Factors" section of our current periodic reports with the SEC. We undertake no obligation to revise or update information herein to reflect events or circumstances in the future, even if new information becomes available.
Contacts:
Dynavax Technologies
Amy Figueroa, 510-665-7211
Investor Relations and Corporate Communications
afigueroa@dynavax.com
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Posted by Editors at 11:49 AM --- Printer-friendly version
August 6, 2009
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Besides reducing your risk of itchy welts and mosquito-transmitted diseases, DEET can aggravate a liver with Hepatitis C. Luckily, these ten tips can help repel mosquitoes without DEET's toxicity.
by Nicole Cutler, L.Ac.
Mosquitoes are emerging as more of a nuisance than ever. To keep up with their infestations, the market for DEET-containing mosquito repellants is booming. While DEET (diethyl-meta-toluamide) is fairly effective at repelling mosquitoes, its toxicity is a concern for those who are infected with Hepatitis C.
Hepatitis C, a potentially chronic viral infection of the liver, slows the liver's ability to filter and cleanse the blood. The livers of those with Hepatitis C have to work harder to neutralize toxins in the blood because they must battle the virus and function despite inflammation and liver scarring. Thus, chemicals that have been inhaled, absorbed or ingested put an added strain on the liver of someone with Hepatitis C.
About Mosquitoes
We usually think about mosquitoes as annoying pests that leave itchy swellings on exposed skin. However, mosquitoes can also spread disease. Worldwide, mosquitoes are carriers of malaria, yellow fever and dengue fever. However, the diseases they spread in the United States are primarily encephalitis and West Nile Virus. Although mosquitoes don't transmit hepatitis viruses, protecting yourself from these insects poses an additional threat to those already battling hepatitis.
One of summer's best-known pests, mosquitoes breed in stagnant water such as
storm drains, wading pools, rain gutters, tree holes, buckets, old tires and birdbaths. Some facts about these irritating insects include:
· Mosquitoes develop from egg to adult in as few as 10 days.
· Mosquitoes are most active from dusk to dawn.
· Only female mosquitoes feed on human blood.
· One female mosquito may lay 100 to 300 eggs at a time.
· One female mosquito can average 1,000 to 3,000 offspring during her life span.
· Most mosquitoes remain within a 1-mile radius of their breeding site.
Why They Are So Abundant
While some areas of the country have always had more than their share, there are two reasons that mosquito populations have exploded recently:
1. Climate Change - Blamed on global warming by environmentalists, much of this country has recently endured unusually heavy rains and rising temperatures. Of course, these two conditions create a perfect breeding environment for mosquitoes.
2. Struggling Economy - Evidence of our economical recession, the increasing numbers of foreclosures heightens the potential for mosquito infestations especially in and around foreclosed properties with backyard pools.
DEET
DEET is an insect repellent that is used in products to prevent bites from insects such as mosquitoes, biting flies, fleas and other small, flying insects. Developed by the U.S. Army in 1946 for protecting soldiers in insect-infested areas, insect repellants containing
DEET have been used by the general public in the United States since 1957.
DEET is a chemical that can find its way into the bloodstream via:
· Absorption - Typically applied directly to the skin, DEET is absorbed more readily when combined with a skin product containing alcohol. Drinking alcohol may also cause more DEET to be absorbed through the skin. Sunscreen products that contain DEET also cause more absorption. After it is applied to the skin, DEET can be found in the blood for up to 12 hours.
· Inhalation - DEET can be inhaled when sprays are used around the body, especially in indoor spaces where the vapors can remain for some time.
· Ingestion - Although people don't purposefully ingest mosquito repellants, it is possible to swallow DEET if the hands are not washed thoroughly after using DEET on the skin.
There are a variety of reports confirming DEET's toxicity. Duke University research shows that regular use of chemical repellents like DEET may damage brain cells and interact with medications. The pharmacologist conducting this study observed brain cell death and behavioral changes in animals exposed to DEET after frequent and prolonged use. Another study showed that up to 15 percent of DEET is absorbed by the skin into the bloodstream. Because it is metabolized by the liver, DEET's toxicity is worrisome to those with Hepatitis C.
10 Alternatives to DEET
Because the most effective way to repel these insects puts an additional burden on the liver, the following suggestions represent alternatives to using this toxic chemical:
1. Replace all standing water weekly. This includes birdbaths, ponds and unfiltered pools.
2. Remove unneeded vegetation or trash from around any standing water sources.
3. Screen windows, doors and other openings with mesh.
4. Avoid going outdoors during dusk and dawn when mosquitoes are most active.
5. Apply high quality citronella essential oil to your skin.
6. Reported by The New England Journal of Medicine as an effective solution, apply a natural repellent made with soybean oil.
7. An Iowa State University research group showed that the essential oil found in the herb catnip is about 10 times more effective than DEET in repelling mosquitoes in the laboratory.
8. An ingredient in Neem seed oil has also been found to be more effective than DEET by researchers at the Malaria Institute in India. Both the U.S. National Research Council and the Journal of the American Mosquito Control Association have confirmed this finding.
9. Because mosquitoes are naturally repelled by the smell, eat lots of fresh garlic.
10. Avoid eating bananas and other high-potassium foods, because mosquitoes are attracted to the lactic acid given off after consuming these foods.
Even with zillions of mosquitoes swarming around, you can achieve peace of mind. For those who are not concerned with their liver's well-being, DEET is one way to repel these insects. But, if you have Hepatitis C and are concerned with helping your liver and not harming it, consider non-toxic alternatives for surviving mosquito infestations.
References:
http://docs.google.com/gview?a=v&q=cache%3Aeq5a6ngaUqoJ%3Anpic.orst.edu%2Ffactsheets%2FDEETgen.pdf+Deet+toxic+liver&hl=en&gl=us&pli=1, DEET General Fact Sheet, Retrieved August 1, 2009, National Pesticide Information Center, 2009.
http://www.bizjournals.com/washington/stories/2009/06/01/daily24.html, Mosquitoes prosper a second summer as foreclosures swell, Tucker Echols, Retrieved August 2, 2009, Washington Business Journal, June 2009.
http://www.care2.com/greenliving/mosquito-free-naturally.html, Mosquito-Free Naturally, Michelle Schoffro Cook, DNM, DAc, RNCP, ROHP, Retrieved August 1, 2009, Care2.com, Inc., 2009.
http://www.control-mosquitoes.com/#mf2, Mosquito Facts, Retrieved August 1, 2009, Mosquito Solutions, 2009.
http://www.madwahm.com/articles/mosquito-facts-prevention-and-bite-treatment/, Mosquito Facts, Prevention and Bite Treatment, Retrieved August 1, 2009, madWAHM, 2009.
http://www.naturalnews.com/001586.html, Chemical Mosquito Repellant DEET Causes Neurological Damage, Gets Absorbed Through The Skin, Mike Adams, Retrieved August 1, 2009, Natural News Network, 2009.
http://www.reuters.com/article/pressRelease/idUS126599+05-May-2009+BW20090505, Heavy Rains and Temperatures Contribute to Increasing Mosquito Infestations, Retrieved August 2, 2009, reuters.com, 2009.
http://www.theregister.co.uk/2006/11/10/the_odd_body_mosquitos/, Why are some people more attractive to mosquitos?, Dr. Stephen Juan, Retrieved August 1, 2009, The Register, 2009.
Posted by Editors at 10:59 AM --- Printer-friendly version
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A leading research and advisory firm has found that physicians will prescribe telaprevir to a majority of their patients with Hepatitis C genotype 1.
Surveyed Physicians Will Treat Over 50 Percent of Hepatitis C Genotype 1-Infected Patients With the Protease Inhibitor Telaprevir
Forty Percent of Surveyed MCOs Will Place Only One Protease Inhibitor on Their Formularies, According to a New Report from Decision Resources
WALTHAM, Mass., Aug. 4 /PRNewswire/ -- Decision Resources, one of the world's leading research and advisory firms for pharmaceutical and healthcare issues, finds that, based on profiles provided to them of emerging protease inhibitors, surveyed physicians indicate that they will prescribe Vertex/Johnson & Johnson/Mitsubishi Tanabe's telaprevir to more than 50 percent of their hepatitis C virus genotype 1-infected patients and will prescribe Schering-Plough's boceprevir to less than 30 percent of these patients. Although surveyed physicians perceive both telaprevir and boceprevir as efficacious drugs, they value (among other factors) telaprevir's shorter duration of treatment as compared to treatment duration using boceprevir.
The new Physician & Payer Forum report entitled Hepatitis C: Impact of and Receptivity to Novel Antivirals Among Payers and Prescribers finds that, among the surveyed physicians who indicate they will use both telaprevir and boceprevir for the treatment of hepatitis C virus genotype 1-infected treatment-naive patients, over 60 percent expect to start treatment for most or all of their patients with telaprevir. Surveyed physicians cite improved efficacy as the most important attribute influencing their prescribing decisions for hepatitis C virus.
"Eighty percent of the physicians we surveyed indicate that long-term efficacy is the most important attribute of novel therapies for hepatitis C virus," said Decision Resources Analyst Alexandra Makarova, M.D., Ph.D. "Nearly all surveyed physicians said that improvements in sustained virologic response in genotype 1-infected patients is the most important endpoint that will persuade them to use a novel treatment in place of currently-available therapies."
The report also finds that 40 percent of surveyed managed care organization's (MCOs) pharmacy directors indicate that they will place only one of the protease inhibitors on their formularies. Of these pharmacy directors, 10 percent expect to choose telaprevir while 30 percent say that they do not have a preference regarding telaprevir or boceprevir based on clinical data provided to them but will use cost as the basis for their selection.
Hepatitis C: Impact of and Receptivity to Novel Antivirals Among Payers and Prescribers is based on a U.S. survey of 84 gastroenterologists, 16 hepatologists and 20 MCO pharmacy directors. Their responses were compared to assess similarities and differences of opinion regarding clinical, economic and scientific factors.
Webinar
Members of the media are welcome to attend our upcoming webinar entitled On the Verge of a Paradigm Shift in the Hepatitis C Virus Market: Physician and Payer Perceptions of Telaprevir, Boceprevir and Other Key Novel Antivirals. This webinar will be held on Thursday, September 3, 2009 at 10 a.m. U.S. Eastern Time. For more information, contact Christopher Comfort at 781-296-2597.
About Decision Resources
Decision Resources (www.decisionresources.com) is a world leader in market research publications, advisory services, and consulting designed to help clients shape strategy, allocate resources, and master their chosen markets. Decision Resources is a Decision Resources, Inc. company.
About Decision Resources, Inc.
Decision Resources, Inc. is a cohesive portfolio of companies that offers best-in-class, high-value information and insights on important sectors of the healthcare industry. Clients rely on this analysis and data to make informed decisions. Please visit Decision Resources, Inc. at www.DecisionResourcesInc.com.
All company, brand, or product names contained in this document may be trademarks or registered trademarks of their respective holders.
For more information, contact:
Decision Resources Decision Resources, Inc.
Christopher Comfort Elizabeth Marshall
781-296-2597 781-296-2563
ccomfort@dresources.com emarshall@dresources.com
SOURCE Decision Resources
Website: http://www.decisionresources.com
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URL for Article Source:
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Posted by Editors at 9:51 AM --- Printer-friendly version
