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Week Ending: August 13th, 2005
Alan Franciscus
Editor-in-Chief
To download pdf version click here
This Issue:
• Hep C Virus Produced from Cloned Viral Genome
• Tiny Gold Particles Help Diagnose Hepatitis
• Hepatitis B: It Can Happen to You
• Cubist Pharmaceuticals Announces the End of Patient Dosing in HepeX-B(TM) Hepatitis B Phase 2 Trial
• OREGON: Needleswap Proposal Moves Ahead
• Double Liver Transplant Survivor Calls for Negative-Option Donation in Canada
• Combo Therapy for HCV Is Best, Docs Determine
• Keeping His Promise
• Gene Polymorphism Risks Infection after Liver Transplants
• Get Tested for Hepatitis C
• MIGENIX Receives Approval to Initiate MX-3253 Phase IIb Combination Study in HCV Non-Responders
• Eligibility for Antiviral Therapy in Hep C
August 8th, 2005
Hep C Virus Produced from Cloned Viral Genome
SourceURL:http://www.gastrohep.com
Nature Medicine reports a system of cell-culture generated Hep C that provides a powerful tool for studying the viral life cycle and developing antiviral strategies.
Hepatitis C virus infection causes chronic liver diseases and is a global public health problem.
Detailed analyses of Hepatitis C virus have been hampered by the lack of viral culture systems.
Subgenomic replicons of the JFH1 genotype 2a strain cloned from an individual with fulminant hepatitis replicate efficiently in cell culture.
Dr Takaji Wakita and colleagues show that the JFH1 genome replicates efficiently.
The JFH1 genome replicates efficiently, and infectivity is neutralized by CD81-specific antibodies - Nature Medicine
The investigators also found that the JFH1 genome supports secretion of viral particles after transfection into a human hepatoma cell line, Huh7.
The investigative team report that particles have a density of about 1.15 to 1.17 g/ml and a spherical morphology with an average diameter of about 55 nm.
The team noted that the secreted virus is infectious for Huh7 cells.
Infectivity can be neutralized by CD81-specific antibodies and by immunoglobulins from chronically infected individuals.
The investigators add that the cell culture generated Hepatitis C virus is infectious for chimpanzee.
Dr Wakita's team concludes, “This system provides a powerful tool for studying the viral life cycle and developing antiviral strategies.”
Nature Med 2005: 11: 791-96
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Tiny Gold Particles Help Diagnose Hepatitis
SourceURL:http://www.scidev.net
Wagdy Sawahel
Researchers have developed a cheap, fast and simple way of diagnosing two forms of the liver disease hepatitis.
They say that while existing methods of detecting the hepatitis virus are effective, they are costly, time-consuming and can only be done by skilled people in a laboratory setting.
The new approach uses a 'protein chip', a small, portable device that makes it easy to find specific proteins in a blood sample.
It could make it easier to diagnose and treat both forms of the disease in developing countries, where they are most problematic.
The researchers, led by Yefu Wang of China's Wuhan University, created a protein chip that detects the B and C strains of the hepatitis virus in blood samples by recognising 'antibodies' that people produce in response to infection.
The chip is a small piece of glass coated with viral proteins. When blood from a patient infected with the virus is added to it, the antibodies stick to the viral proteins.
The chip also contains tiny gold particles that are engineered to stick to the antibodies and makes them visible to the naked eye.
These remain after the chip is washed, indicating that the patient is infected by the hepatitis virus.
According to the research, published online by BMC Infectious Diseases on 6 July, the method produces results in just 40 minutes.
Wang's team add that it is just as effective as existing but costly and time-consuming ways of diagnosing hepatitis.
"It is a technology tailored for developing countries' needs at both technical and economic levels," says Abdallah Daar, co-director of the Canadian Program on Genomics and Global Health at the University of Toronto, Canada.
Daar told SciDev.Net that there is a great need for simple and inexpensive technologies for diagnosing and monitoring infectious diseases in developing countries. He added that the protein chip approach could be used to create diagnostic tests for other infections such as HIV/AIDS.
Hepatitis B is a leading cause of liver cancer.
Reference: BMC Infectious Diseases 5, 53 (2005) doi: 10.1186/1471-2334-5-53
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August 9th, 2005
Hepatitis B: It Can Happen to You
SourceURL:http://www.sunstar.com.ph
Henrylito D. Tacio
QUICK, what kills more Asians each year than AIDS and is a hundred times more infectious? If you answered hepatitis B, you're right. According to the Geneva-based World Health Organization (WHO), there are 350 million chronic hepatitis B carriers worldwide, and over half of them live in Asia. In the Philippines, for instance, 40 out of every 100,000 Filipinos are suffering from the disease.
The word hepatitis simply means "inflammation of the liver". So far, medical scientists have discovered six different kinds of hepatitis. A different virus causes each but the most important in terms of public health is hepatitis B virus (HBV).
Like most hepatitis viruses, HBV is all too easy to catch. It is more common than the human immunodeficiency virus (HIV), the microorganism that causes AIDS and far more infectious. "While 90 percent of the people who get hepatitis B recover spontaneously with their body's defenses, the 10 percent who maintain the infection for six months or longer and who do not produce an effective antibody response are considered chronic carriers," explains Dr. Ernesto Domingo, a hepatologist at the College of Medicine, University of the Philippines.
A small percentage of these chronic carriers will ultimately develop cirrhosis (scarring of the liver) or liver cancer. "Hepatitis B virus is the most common cause of liver cancer around the world," says Professor Mei-Hwei Chang, chairman of the Department of Pediatrics at the National Taiwan University Hospital in Taipei. "Although hepatitis C virus is the most prevalent cause of liver cancer in some countries where HBV infection is not prevalent, HBV is still the most prevalent cause worldwide."
The HBV may be found in blood, semen, vaginal fluids, tears, and saliva. The virus, however, is not spread by contaminated food or water, and cannot be spread casually in the workplace. You can't also get HBV from a mosquito bite.
"All viruses transmitted by a mosquito must go through a replication before sufficient viruses is available for infection," explains Professor John S. Tam, of the Department of Microbiology at the Chinese University of Hong Kong. "HBV doesn't grow in mosquitoes."
The main ways of getting infected with HBV are perinatal (from mother to baby at birth), child-to-child transmission, unsafe injections and transfusions, and sexual contact. "Worldwide, most infections occur from infected mother to child, from child to child contact in household settings, and from reuse of unsterilized needles and syringes," the WHO says.
There are reports that HBV may also be transmitted by puncturing the skin with sharp instruments--such as those used for acupuncture, dental, and medical procedures, even for ear piercing and manicures--that have been contaminated.
"But the most effective means of transmission is sexual contact other than kissing," says Dr. Dominic Garcia, an infectious disease specialist. "The scary thing is that a lot of people don't know they have it."
The UN health agency says that the incubation period of the HBV takes a long 45 to 180 days usually without any manifestations or symptoms.
Thus, people infected with hepatitis B may not even realize that they have it until the latter stages of the disease. And even when symptoms are present, they are vague, often mimicking other, less life threatening diseases.
What happens to a person infected with HBV? "When a person becomes infected by the hepatitis B, the virus travels to the liver where it enters individual liver cells," said Prof. Nancy Leung, consultant and honorary associate professor and chief of hepatology at the Prince of Wales Hospital in the Chinese University of Hong Kong.
"Here, it replicates and may reenter the blood stream or reinfect other liver cells. Symptoms of initial infection with hepatitis B result from the body's attempt to defend itself against infection.
Prof. Leung continues: "Those individuals with the most severe of symptoms are therefore most likely to eliminate the virus from their body while those with no symptoms or have very mild complaints--typically children--are most likely to retain the virus and become long-term carriers."
Prof. Leung added that the HBV may remain in some individuals after the initial infection and the patients are said to be chronic hepatitis B carriers when part of the surface of the virus remains in the blood for more than six months. "The result of long-term carriage of the HBV is continuing inflammation of the liver, which may lead to serious liver damage and cancer," she said.
Liver cancer is almost always fatal, and usually develops between the age of 35 and 65 years of age, when people are maximally productive and are trying to raise their own children. It occurs more commonly among Asians.
In Singapore, for instance, liver cancer is the third most common cancer and the second most common cancer among males. "The risk of liver cancer increases with smoking and consumption of alcohol," says Professor Mei-Hwei Chang, chairman of the Department of Pediatrics at the National Taiwan University Hospital in Taipei.
For feedback, write me at tasyo2002@yahoo.com.
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Cubist Pharmaceuticals Announces the End of Patient Dosing in HepeX-B(TM) Hepatitis B Phase 2 Trial
SourceURL:http://www.rednova.com
Plans to Review Data with the FDA
Cubist Pharmaceuticals, Inc. (Nasdaq: CBST) today announced that Cubist and XTLbio have ended patient dosing in the second of two Phase 2 hepatitis B clinical trials of HepeX-B(TM). Cubist plans to review data from this trial with the FDA as part of a discussion of design elements of a Phase 3 trial. A Data Safety Monitoring Board recently reviewed safety data from all patients in the second Phase 2 trial and no concerns were raised.
About Hepatitis B (HBV)
Hepatitis B is most commonly caused by the Hepatitis B virus, which, according to Datamonitor, has infected over 2 billion people around the world. Although a vaccine against HBV was introduced in 1982, globally, 350 million people are infected chronically with the disease and approximately 1 million people die each year as a result of complications from HBV infection. Current treatment regimens for chronic HBV often include use of interferon alpha or an antiviral drug. Despite these treatment options, chronic HBV can lead to severe liver damage and patients may require liver transplantation To prevent re-infection of the new liver with HBV, patients are currently treated with hepatitis B immune globulin (HBIg) combined with an antiviral compound, such as lamivudine. The global market for HBIg is estimated to be about $100 million annually.
About HepeX-B(TM)
HepeX-B(TM) is a combination of two fully human monoclonal antibodies, selected using XTLbio's pre-clinical Trimera(TM) model, that target HBV surface antigens. It is currently in evaluation for the prevention of infection by HBV in liver transplant patients who have been maintained on HBIg. HepeX-B(TM) has already been granted Orphan Drug Status in both the U.S. and the European Union.
About Cubist
Cubist Pharmaceuticals, Inc. is a biopharmaceutical company focused on the research, development and commercialization of antiinfective products that address unmet medical needs in the acute care environment. In the U.S., Cubist markets CUBICIN(R) (daptomycin for injection), the first antibiotic in a new class of antiinfectives called lipopeptides. CUBICIN is currently the only once-daily bactericidal antibiotic approved in the U.S. with activity against both methicillin-susceptible and methicillin-resistant Staphylococcus aureus (MSSA and MRSA) in complicated skin and skin structure infections. The Company has announced that its Phase 3 Staphylococcus aureus (S. aureus) endocarditis and bacteremia trial of CUBICIN(R) (daptomycin for injection) at 6 mg/kg once daily met its primary endpoints of non-inferiority in the intent-to-treat (ITT) and per protocol (PP) populations. Cubist expects to file a supplemental New Drug Application (sNDA) before year-end 2005 seeking priority review for approval to add S. aureus endocarditis and bacteremia to the indication statement for CUBICIN. Cubist's pipeline includes HepeX-B(TM), a monoclonal antibody biologic being evaluated to determine its potential for the prevention of infection by the Hepatitis B virus (HBV) in liver transplant patients, and research efforts focused on novel members of the lipopeptide class of molecules and on natural products discovery. Cubist is headquartered in Lexington, MA.
About XTLbio
XTL Biopharmaceuticals Ltd. (XTLbio) is a biopharmaceutical company developing drugs against hepatitis. Established in 1993, XTLbio became a public company in 2000 and its ordinary shares are listed on the Official List of the UK Listing Authority and are traded on the London Stock Exchange under the symbol XTL and in the Tel Aviv Stock Exchange, Israel.
Cubist Safe Harbor Statement
Statements contained herein that are not historical fact may be forward-looking statements within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934, and such statements are subject to a variety of risks and uncertainties. There are a number of important factors that could cause actual results to differ materially from those projected or suggested in any forward-looking statements made by Cubist. These factors include, but are not limited to: (i) the level of acceptance of CUBICIN by physicians, patients, third-party payors, and the medical community generally; (ii) Cubist's ability to continue to develop, secure additional regulatory approvals for, and successfully market, CUBICIN; (iii) Cubist's expectations regarding our ability to continue to manufacture sufficient quantities of CUBICIN in accordance with current Good Manufacturing Practices; (iv) commercialization of products that are competitive with CUBICIN; (v) Cubist's ability to discover or in-license drug candidates; (vi) Cubist's ability to successfully develop drug candidates in its pipeline, including HepeX-B; (vii) Cubist's ability to successfully commercialize any product or technology developed by Cubist; (viii) Cubist's ability to establish and maintain successful manufacturing, sales and marketing, distribution, and development collaborations; (ix) legislative or regulatory changes adversely affecting Cubist or the biopharmaceutical industry; (x) Cubist's expectations regarding the future market demand and medical need for CUBICIN; (xi) Cubist's ability to protect its intellectual property and proprietary technologies; and (xii) Cubist's ability to finance its operations . Additional factors that could cause actual results to differ materially from those projected or suggested in any forward-looking statements are contained in Cubist's recent filings with the Securities and Exchange Commission, including those factors discussed under the caption "Risk Factors" in such filings.
Cubist and CUBICIN are registered trademarks of Cubist Pharmaceuticals, Inc.; HepeX-B is a trademark of XTL Biopharmaceuticals Ltd.
Additional information can be found at Cubist's web site at www.cubist.com
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OREGON: Needleswap Proposal Moves Ahead
The Bulletin (Bend, Ore.)
Chris Barker
On Monday, the Deschutes County Commission endorsed a proposed needle-exchange program to prevent HIV and hepatitis C transmission among intravenous drug users (IDUs), but it made a vote on the matter contingent on reviewing health department implementation plans. "I would like to have an opportunity to review the program before it's kicked off," said Commissioner Dennis Luke.
Already, the committee representing the courts, law enforcement and the county public health advisory board have endorsed the proposal. If approved, the program would initially cost about $2,500 for supplies, paid through a grant, according to Shannon Dames, the county's communicable-disease coordinator.
Research shows that HIV and hepatitis C transmission rates among IDUs can be reduced through needle-exchange programs. And such programs do not increase IV drug use or crime, said health officials, who added that seven other Oregon counties - Benton, Douglas, Jackson, Josephine, Lane, Multnomah and Tillamook - already operate needle exchanges.
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August 10th, 2005
Double Liver Transplant Survivor Calls for Negative-Option Donation in Canada
SourceURL:http://news.yahoo.com
ROGER WARD
TORONTO (CP) - A two-time liver transplant recipient is calling on provincial governments to follow the lead of European countries by allowing negative-option organ donor registration in Canada.
Such a system would automatically put everyone on a donor list, unless people choose to opt out by signing a form indicating they don't want to donate their organs upon death. "What could be more important than trying to do everything we can do to save lives?" asked George Marcello, who takes his ongoing crusade to the Ontario legislature Thursday with a plea to enact presumed consent.
Marcello is recovering from his second liver transplant - received on his 50th birthday, 10 years to the day after receiving his first transplant due to hepatitis C.
He beat almost impossible odds by getting a second liver, and he still can't believe how lucky he was after he fell ill in Paris during an organ donation fact-finding mission this summer.
"I thought I was going to die in Paris, I had my funeral planned already," said Marcello, who suffered a blocked artery that caused him to develop abscesses in the first transplant.
Marcello got well enough to fly home to Toronto and then received the amazing news that a second liver had been found for him.
He will take his story to the Ontario legislature Thursday, where provincial politicians have been grappling with ways to increase donations.
A new regulation takes effect this fall that would increase the number of donors in the province.
It would require hospitals to notify the Trillium Gift of Life Network - which oversees organ donation in Ontario - when a patient passes away and has organs that can be harvested.
It would also allow Trillium to require hospitals to ask relatives of brain-dead patients for their organs.
David Spencer, a spokesman for Health Minister George Smitherman, said the province is intent on encouraging more donors.
"It's something we can all improve upon, but one of our foremost messages is really asking people to think about signing that organ donation card," Spencer said.
Ontario's third-placed New Democratic Party, meanwhile, has a bill before the legislature to create a negative option system.
In New Brunswick, Health Minister Elvy Robichaud suggested in April that surgery patients be given the option of signing a donor form before going under the knife.
But his ministry later backtracked, saying that was just an idea being looked at.
On his trip to Europe, Marcello brought a video camera to put together a documentary that would show Canadians how much more efficient donor systems are in other countries.
"We want to make sure that most Canadians will be able to see this, but as well as (ordinary) Canadians, our government officials," Marcello said.
"The material that we have gathered is an eye-opener."
Marcello points to Spain as a paragon of organ transplant planning.
In addition to having negative option donor lists, they transplant organs from people who no longer have beating hearts. In Canada, organs are harvested only from people who are brain-dead, with hearts still beating.
Marcello said Spain increased its organ availability by 20 per cent by using non heart-beating donors.
"I believe that the government will finally realize, why not look at another way?" he said.
Canada has one of the poorest organ donation rates in the developed world, but recent figures suggest the tide is turning.
The Canadian Institute for Health Information reported in April that the number of transplants in Canada went up 22 per cent between 1994 and 2003. But the number of brain-dead donors remained the same.
Still, the figures suggest awareness of the need for organ donation has improved.
Marcello was certain his planned documentary would improve the rate of donation even more, and after his latest brush with death he said he's more determined than ever to push for reform.
"The reason to do this feels that much stronger," he said. "There's a lot of spirituality in this (second transplant) as well. Maybe I had to be around a little longer to get this work done."
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Combo Therapy for HCV Is Best, Docs Determine
SourceURL:http://www.hepatitisneighborhood.com
by John C. Martin
Combining interferon with ribavirin is the most effective treatment option for people with hepatitis C compared to interferon alone, say doctors from Denmark in a new review of prior medical studies on the topic.1
"Adding ribavirin to any type of interferon should be considered the treatment of choice for patients with hepatitis C," said the study's lead researcher, Jesper Brok, MD, a research fellow at Copenhagen University Hospital.
However, there are some caveats: only one in four patients treated with the combination therapy in the studies reviewed by Brok and his colleagues had a sustained virologic response, defined as a sustained loss of detectable virus for at least 6 months following the end of treatment. In addition, the combination treatment increases the risk of side effects.
'Gold Standard' Therapy
Pegylated interferon – a form of the medication that provides a longer half-life than standard interferon – combined with the oral antiviral drug, ribavirin, is the most common form of treatment for hepatitis C today. The protocol may halt liver inflammation, but hepatitis can often recur after therapy ends, and the success rate, on average, ranges from between 30% to 40%, according to estimates.2
The interferon drug is a man-made version of naturally-produced interferon, a protein in the body released in response to invasion by the hepatitis virus. While the way interferon works is complex, it's known that it selectively blocks the virus' ability to expand by replicating, or making copies of itself.3
Ribavirin belongs to a class of drugs known as nucleoside analogs, the research authors explain, adding that the drug taken alone apparently has no effect on HCV. Exactly how it works is also unknown; however, it appears to also block viral replication, experts have learned.4
Head-to-Head Comparison
Brok's team wanted to find out whether interferon monotherapy versus interferon combined with ribavirin had any impact on morbidity and mortality rates related to hepatitis. They reviewed 72 randomized, controlled clinical trials involving nearly 10,000 patients for their analysis, published in a recent issue of The Cochrane Library, a publication of The Cochrane Collaboration, an international organization that evaluates medical research. The patients in the previous studies had not been previously treated, had relapsed following therapy, or hadn't responded to other types of treatment.
The research team wanted to measure rates of treatment failure relative to different courses of therapy. They found that based on hepatitis C tests among those who had never been treated for the disease, 83 percent of those on interferon monotherapy did not respond six months after treatment ended. But that compares to just 58 percent on those receiving interferon plus ribavirin, Brok and his group found.
Among relapsers, 87 percent of patients taking interferon alone in the studies reviewed failed treatment, compared to 51 percent on combination treatment who did not achieve a sustained virologic response.
Finally, among patients who had not responded to other types of therapy previously, 95 percent of those taking interferon monotherapy did not respond, compared to 81 percent of those on combination treatment, the study authors found.
In other measures of treatment outcome, including patients' quality of life and level of liver inflammation after therapy, those taking the combination of interferon plus ribavirin did better in all categories.
The Downside
Still, side effects were much more common in the patients who were given combination therapy in these studies, Brok and his associates point out. The most common was anemia, caused by ribavirin, which occurred in just over one-fifth of all of the patients taking combination treatment. That compares to a mere 1 percent of those given monotherapy in the studies. Other side effects that occurred much more frequently in the patients on combination treatment included a reduced number of white blood cells (leukocytopenia); skin disorders like dry skin and rash; stomach complaints like a loss of appetite, nausea, or indigestion; infections; insomnia; difficulty breathing; cough; and fatigue.
"The beneficial effect of adding ribavirin to interferon is not fully understood," Brok's team wrote. "Ribavirin might have an independent beneficial effect on chronic hepatitis C, in addition to interferon, or might have a beneficial effect on patients who do not respond to interferon."
"Alternatively, ribavirin may [heighten] some of the effects of interferon or vice versa," the researchers added.
1. Brok J, Gluud L, Gluud C. Ribavirin plus interferon versus interferon for chronic hepatitis C. Cochrane Database Syst Rev 2005 Jul 20;(3):CD005445.
2. The Merck Manual. Chronic Hepatitis. Available at: http://www.merck.com/mmhe/sec10
/ch137/ch137c.html?qt=interferon&alt=sh. Accessed August 3, 2005.
3. Beers, MH, Bogin RM, Fletcher AJ. Infectious Diseases. Antiviral Drugs. Interferons. In: The Merck Manual of Diagnosis and Therapy 17th ed. Whitehouse Station, NJ: Merck Research Laboratories;1999:1132.
4. Beers, MH, Bogin RM, Fletcher AJ. Infectious Diseases. Antiviral Drugs. Ribavirin. In: The Merck Manual of Diagnosis and Therapy 17th ed. Whitehouse Station, NJ: Merck Research Laboratories;1999:1130-31.
John Martin is a long-time health journalist and an editor for Priority Healthcare. His credits include overseeing health news coverage for the website of Fox Television's The Health Network, and articles for the New York Post and other consumer and trade publications.
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Keeping His Promise
SourceURL:http://myopr.com/
Sarah Villicana, The Porterville Recorder
Robert Katz spoke to a minister minutes before was about to undergo a liver and kidney transplant. Knowing he may not come back from the operating room, he made a last-minute promise to God.
"If I make it through; I will dedicate my life to helping others," said Katz, reciting the vow he made in 2001.
Robert Katz talks about his life and death battle with Hepatitis C, a disease he contracted as an intravenous drug user.
Katz required a double transplant because his own organs suffered extensive damage from cirrhosis - a condition resulting, in his case, from hepatitis C.
Back in the 1960s, Katz was tattooed, pierced and living in San Francisco during a decade made famous by the music, free love - and drugs.
"I was living in San Francisco and I got sick in '65," Katz said. "My mom took me to the doctor and he didn't have a name for it."
The doctor diagnosed Katz, who lives in the Lindsay area, with a type of hepatitis, however, it did not have a name and there was no medical treatment.
"I asked him what I should do," Katz said. "He said not to do anything."
According to the National Library of Medicine, hepatitis C, known as "the silent epidemic," did not receive a name until the late 1980s after doctors identified the pathogen responsible for the hepatitis C virus.
Katz continued to experience symptoms of fatigue, itching, memory loss and weight change.
"I went on and, in the 70s, I started getting sick again," Katz said.
This time, Katz found out he had diabetes. Individuals with hepatitis C, 40 years and older, are four times more likely to have Type-2 diabetes than those without it, according to an April 2000 report by researchers at Johns Hopkins University.
"I got my diabetes under control, but I was still getting sick," Katz said.
In 1984, Katz took part in a clinical study in Ventura County. There was still no name for the virus, but a new drug treatment was being tested.
The flu-like side effects were too great and Katz dropped out of the clinical trial after two weeks. Three years later, a second clinical trial yielded similar results.
"In 1991, I found out they were doing liver transplants on people with hepatitis C," Katz said.
Katz was added to the long list of patients waiting for organ transplants in 1996. Meanwhile the virus, which attacks cells in the liver, took a toll on his health and kept Katz in the hospital and in and out of several comas.
"The longest I was in a coma was 44 days," Katz said.
Through the sickness, confusion and frustration, there was always Katz' wife, Linda.
"She was remarkable," Katz said. "She was working eight hours a day, did a little volunteer work and then she would be at the hospital with me or at home."
Katz lost Linda to liver cancer in June of last year, following a diagnosis of hepatitis C in 1991. Because hepatitis C can severely damage liver function, the virus has been shown to increase the risk of cancer, according to the Hepatitis C Information Center.
"I believe I gave it to her," said Katz. "She was always taking care of me and she didn't take care of herself."
Remembering the promise he once made, Katz has dedicated his time and efforts to helping others understand the condition he has lived with for more than 30 years.
According to the Tulare County Health and Human Services Agency, hepatitis C is the second most commonly reported communicable disease in the county, second only to chlamydia.
Last October, Katz started a hepatitis C support group in Visalia after receiving certification from the Hepatitis C Support Project, based out of San Francisco.
"I started getting calls from people in the south county, who said Visalia was too far away to drive," said Katz.
On the Sept. 24, at 10 a.m., Katz will host the first meeting of a hepatitis C support group in Porterville; in the old lobby at Sierra View District Hospital.
"A lot of people fear the treatments and the side effects," said Katz. "Back in the 60s nobody knew what to do and a lot of us old timers died and nobody knew why. Now doctors are using the C-word, meaning a cure. But there's nothing going on in the south county; no education."
So, Katz has made it his job to educate, and it doesn't stop with patients. He takes new literature to doctors, too.
"I'm doing this for myself," said Katz. "This is my ministry - and for my wife."
Hepatitis C Support Group of Tulare County
Purpose: To provide support and information
When: The third Saturday of every month from 10 a.m. to noon, beginning September 24th
Where: The old lobby at Sierra View District Hospital, 465 W. Putnam Ave in Porterville
Contact: Robert Katz at 562-0853 or at liny12@netzero.com
Contact Sarah Villicana at 784-5000, Ext. 1045, or svillicana@portervillerecorder.com
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August 11th, 2005
Gene Polymorphism Risks Infection after Liver Transplants
SourceURL:http://www.gastrohep.com
The donor's serum mannose binding lectin genotype, produced by the liver under strong genetic control, is a major risk determinant for life-threatening infections after liver transplantation, finds this month's Gastroenterology.
Infection is the primary cause of death after liver transplantation.
Mannose binding lectin is a recognition molecule of the lectin pathway of complement and a key component of innate immunity.
Mannose binding lectin variant alleles have been described in the coding region of the mannose binding lectin gene.
These are associated with low mannose binding lectin serum concentration and impaired mannose binding lectin structure and function.
Dr Bouwman and colleagues established the role of the liver in production of serum mannose binding lectin.
The investigative team evaluated the effect of mannose binding lectin variant alleles on the susceptibility to infection after liver transplantation.
Serum conversion was associated with the disappearance of high molecular weight mannose binding lectin - Gastroenterology
The team investigated 49 patients undergoing orthotopic liver transplantation.
Mannose binding lectin exon 1 and promoter polymorphisms were determined in patients and in liver donors.
The team determined mannose binding lectin serum concentration before and during 1 year after transplantation.
The incidence of clinically significant infections during this period was assessed.
Transplantation of mannose binding lectin wildtype recipients with donor livers carrying mannose binding lectin variant alleles resulted in a rapid and pronounced decrease of serum mannose binding lectin levels.
The investigators found that this serum conversion was associated with the disappearance of high molecular weight mannose binding lectin.
The team could not obtain an indication for extrahepatic production of serum mannose binding lectin.
The team found an association between the presence of mannose binding lectin variant alleles in the mannose binding lectin gene of the donor liver and an increase clinically significant infections after transplantation.
However, mannose binding lectin variant alleles in the mannose binding lectin gene in the recipient was not associated with a strongly increased infections after transplantation.
Dr Bouwman's team concluded, "Serum mannose binding lectin is produced by the liver under strong genetic control."
"After liver transplantation, the mannose binding lectin genotype of the donor liver is a major risk determinant for life-threatening infections."
Gastroenterol 2005: 129(2): 408-14
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Get Tested for Hepatitis C
SourceURL:http://www.eldiariony.com
People marching through Lower Manhattan on Tuesday were making noise about a silent killer: hepatitis C. A person can have hepatitis C for years and not realize it. If it goes untreated for too long, hepatitis C can damage the liver beyond repair.
Yet all we have to do to find out if we have it is get a simple blood test. Of course, that`s easier said than done.
Tuesday`s march was organized by the Latino Organization for Liver Awareness to make all New Yorkers, and Hispanics in particular, aware of the hepatitis C virus (HCV) and the importance of getting tested and treated.
The scope of this disease is stunning. It is the number one epidemic in the world. In the U.S., 3.9 million people have hepatitis C. It has infected 200,000 to 300,000 New Yorkers, 40 percent of whom are Hispanic.
The people who are most at risk for contracting hepatitis C are intravenous drug users, those who had a blood transfusion or transplant before 1987, those who have had multiple sex partners, or those who have had body piercings or tatoos in unsanitary conditions.
But anyone can be infected. On Monday in this newspaper, we published the story of a woman named Blanca Trasobares, who had none of the risk factors but contracted the virus nonetheless.
Blanca, a young married woman with a small child, related how she had probably been carrying the virus in her system for 25 years before she was diagnosed. Initially she did not feel sick and hoped the illness would go away on its own. But eventually she had to get treatment because hepatitis C was damaging her liver. She underwent treatment for a year and is now healthy. She may never know how she got the virus.
Many of us may be afraid to know whether we have hepatitis C. Like Blanca, we may want to pretend that it will go away on its own. But it won’t. We must all get tested. And if we are found to have the hepatitis C virus, we must get treatment, for our own sake, and for the sake of the people who love us.
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MIGENIX Receives Approval to Initiate MX-3253 Phase IIb Combination Study in HCV Non-Responders
SourceURL:http://biz.yahoo.com
VANCOUVER, BC, Canada & SAN DIEGO, CA, USA, Aug. 11 /CNW/ - MIGENIX Inc. (TSX: MGI - News; OTC: MGIFF - News), a clinical-stage developer of drugs for infectious and degenerative diseases, has received a Notice of Authorization from Health Canada for a clinical trial application (CTA) to begin a Phase IIb combination study of MX-3253 (celgosivir), a compound in development for the treatment of chronic hepatitis C virus (HCV) infections. Enrollment in the study is expected to commence in the next few weeks with results expected around mid- year calendar 2006.
"This is an important step in the development of celgosivir", stated Jim DeMesa, MD, President and CEO of MIGENIX. "Our recent agreement with Schering- Plough, the strong preclinical synergy of celgosivir with interferon-alpha plus ribavirin, and the participation of many of the same investigators from our Phase IIa trial - combined with this regulatory approval - give us great encouragement for success in this Phase IIb trial".
About MX-3253 and the Phase IIb Combination Study
MX-3253 (celgosivir) is an alpha-glucosidase I inhibitor and is currently the only oral anti-HCV drug in development that acts through host-directed glycosylation. In preclinical studies, celgosivir has demonstrated strong synergy with interferon-alpha plus ribavirin and has the potential to be included as part of a combination therapeutic approach to improve efficacy. Celgosivir is currently being evaluated in a Phase IIa monotherapy study in treatment-naive and interferon-intolerant genotype I HCV patients with results of the study expected before the end of the third quarter of calendar 2005.
The Phase IIb combination study of MX-3253 is a randomized, multi-center, active-controlled, 12 week evaluation of MX-3253 in three treatment arms of up to 20 chronic HCV patients each: celgosivir plus peginterferon alfa-2b plus ribavirin (3-way combination); celgosivir plus peginterferon alfa-2b (2-way combination); and placebo plus peginterferon alfa-2b plus ribavirin (control). An agreement was completed in July with Schering-Plough for (a) the supply of PEGETRON(TM) (peginterferon alfa-2b powder for solution plus ribavirin 200 mg capsules) and (b) certain technical and laboratory support and other services for the study.
Patients for the Phase IIb study will be selected based on having genotype 1 chronic HCV and having failed to respond to pegylated alpha interferon plus ribavirin therapy (non-responders). Today, there are very limited treatment options for the 40% to 50% of hepatitis C patients who have failed treatment with the current standard of care, pegylated interferon plus ribavirin. Among this patient population, approximately 10% respond to retreatment with pegylated interferon plus ribavirin. Patients who respond to therapy during the Phase IIb trial will have the option to continue on treatment for up to 48 weeks. The study will measure viral load at various time points, as well as a number of safety parameters.
About MIGENIX
MIGENIX is committed to advancing therapy, improving health, and enriching life by developing and commercializing drugs in the areas of infectious and degenerative diseases. The Company's clinical programs include drug candidates for the treatment of chronic HCV infections (Phase II), the prevention of catheter-related infections (Phase III), the treatment of neurodegenerative diseases (Phase I) and the treatment of acne (Phase II). MIGENIX is headquartered in Vancouver, British Columbia, Canada with US operations in San Diego, California. Additional information can be found at www.migenix.com.
"Jim DeMesa"
James M. DeMesa, M.D., President & CEO
Forward-looking Statements
Certain statements in this new release constitute "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995, which involve known and unknown risks, uncertainties and other factors that may cause our actual results to be materially different from any future results, performance or achievements expressed or implied by such statements. Forward-looking statements in this release include, but are not limited to statements concerning: expecting results of the MX-3253 Phase IIa monotherapy study before the end of the third quarter of calendar 2005 and having results from the MX-3253 Phase IIb combination study around mid-year calendar 2006. These statements are only predictions and actual events or results may differ materially from those reflected in the forward-looking statements. Factors that could cause actual events or results expressed or implied by such forward looking statements to differ materially from any future results expressed or implied by such statements include, but are not limited to: uncertainties related to early stage of technology and product development; government regulation; dependence on corporate collaborations; management of growth; dependence on key personnel; dependence on proprietary technology and uncertainty of patent protection; intense competition; and manufacturing and market uncertainties. Certain of these factors and other factors are described in detail in the Company's Final Prospectus, Annual Information Form and Annual Report on Form 20-F, news releases and other filings with the Canadian securities regulatory authorities and the U.S. Securities & Exchange Commission. Forward-looking statements are based on our current expectations and MIGENIX assumes no obligations to update such information to reflect later events or developments.
The Toronto Stock Exchange has not reviewed and does not accept responsibility for the adequacy or accuracy of this release.
For further information
Jonathan Burke, MIGENIX Inc., Tel: (604) 221-9666, Extension 241, jburke@migenix.com
Gino de Jesus or Dian Griesel, Ph.D., Investor Relations Group, Tel: (212) 825-3210, Theproteam@aol.com
To request a free copy of this organization's annual report, please go to http://www.newswire.ca and click on reports@cnw
Source: MIGENIX Inc.
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August 12th, 2005
Eligibility for Antiviral Therapy in Hep C
SourceURL:http://www.gastrohep.com
The majority of veteran patients are not suitable candidates for Hep C treatment, while many who are candidates decline therapy, reports this month's American Journal of Gastroenterology.
Many veterans may not be candidates for Hepatitis C virus treatment due to contraindications to therapy.
Dr Edmund Bini determined the proportion of Hepatitis C-infected veterans who were eligible for interferon alfa and ribavirin therapy.
The investigators evaluated the barriers to Hepatitis C virus treatment.
The investigative team prospectively enrolled 4084 veterans who were referred for Hep C treatment over a 1-yr period at 24 Veterans Affairs Medical Centers.
Treatment candidacy was assessed using standardized criteria and the opinion of the treating clinician.
Substance abuse is a strong predictor of not being a treatment candidate - American Journal of Gastroenterology
The team reported that 32% were candidates for Hepatitis C treatment according to standardized criteria, and 41% were candidates in the opinion of the clinician.
The team used multivariable analysis to identify predictors of not being a treatment candidate.
The investigators found that ongoing substance abuse, and comorbid medical disease, were the strongest predictors of not being a treatment candidate.
In addition, the team noted psychiatric disease, and advanced liver disease as the strongest predictors of not being a treatment candidate.
Among patients who were considered treatment candidates, 76% agreed to be treated.
Using multivariable analysis in these patients, the team showed that persons 50 years of age are more likely to decline treatment.
The investigators noted that those with more than 50 lifetime sexual partners were more likely to decline treatment.
Dr Bini's team concludes, "The majority of veteran patients are not suitable candidates for Hepatitis C treatment because of substance abuse, psychiatric disease, and comorbid medical disease."
"Many who are candidates decline therapy."
"Multidisciplinary collaboration is needed to overcome barriers to Hepatitis C therapy in this population."
Am J Gastroenterol 2005: 100(8): 1772
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