Liver Dialysis

Liver failure is associated with a high mortality. Treatment for such patients is liver transplantation if the candidate is considered. However, even if the patient is a suitable candidate for liver transplantation, the wait for a cadaveric organ may prove too long. These patients may therefore be candidates for the proposed liver dialysis machines to provide a bridge towards liver transplantation. The aim is to "buy time" either for the liver to recover or for a cadaveric organ to become available.

What Is Liver Dialysis?

Liver dialysis is a process which removes toxins from the liver in order to sustain patients until a liver transplant can be done. Unlike kidney dialysis, which can keep patients alive for months or years, liverdialysis is considered a very temporary solution for chronic liver failure. Filtration can be effective at removing toxins from the The act of liverliver for several weeks to a few months, taking some of the strain off the ailing organ.

Although liver dialysis treatments are still being developed and improved upon, they has been approved for use in patients with chronic hepatits C , as well as other severe liver disease. Patients who have to undergo this procedure have generally exhausted all other options other than a liver transplant. The outlook for dialysis patients is fair if a donor is found quickly enough. Unfortunately, it is often difficult to find a donor liver.

Many liver dialysis patients find donors through family. In these cases, only a portion of the donor liver is taken so that both patient and donor survive the surgery. This is called a live organ donation.

US surgeon offers free service in Jharkhand

17 Jun 2009, 2206 hrs IST,

RANCHI: The president-elect of the International College of surgeons (USA) and chairman of the Critical Care Task Force for the American Society of Transplant surgeons, Dinesh Ranjan, has offered to provide free medical service to the people of Jharkhand.

An alumnus of the Rajendra Medical College and Hospital (now Rajendra Institute of Medical Sciences RIMS), Ranjan addressed a gathering of the RMCH-RIMS alumni here on Tuesday.

After deliberating extensively on liver transplant techniques, a field in which he attained expertise after moving out to the USA in 1979, Ranjan said that liver transplant, considered one of the most sophisticated organ transplant techniques, is still in a primary stage in India.

Ranjan has conducted over 1000 liver transplants in the University of Kentucky and helped set up transplant facilities in Albama and Egypt. He acknowledged his association with this tribal-dominated state of the country. "In India, liver transplantation is practised in metros like Delhi and Mumbai. Since it is difficult for people to bear the cost of transplantation and lodging in metros, it would be convenient for patients if such a facility is available here," he said. Ranjan called upon the local medical fraternity to come up with a project here. He offered free medical service to such a facility on behalf of his team. He said even the state government could utilize his expertise and experience. "Recently, I facilitated set-up of transplantation facilities in Albama and Egypt. I would be happy to do this for my own state," he said. Speaking on the success of liver transplant and the intricacies involved in it, Ranjan said that the survival rate is more than 90 per cent in the first year of surgery and the risk gradually diminishes with time. "Liver is the only organ in the human body that grows to its normal size even if half of the portion is removed. This unique aspect of the liver encouraged surgeons to try liver transplants. The results, so far, have been highly encouraging," he said. As against over 16000 liver transplantation carried out all over the world annually, more than 5000 transplantation is done in the USA. Ranjan said that live donor transplantation and cadaveric transplantation are two different aspects in which surgeons have to be very cautious while dealing with the live donors. "Our expertise comes into play when we operate upon a healthy person and take a part of his liver for transplanting it into another patient and ensuring at the same time that the healthy person's condition remains fit," he said. Speaking about the medical expenses on liver transplantation, Ranjan said that the process is cheaper in India and involves an expenditure of around Rs 15-20 lakh. He said the same process is carried out in the USA at an expense of around $200,000. Via: http://timesofindia.indiatimes.com

New Treatment For Liver, Colon Cancer Patients

Doctors use a catheter to deliver tiny beads, called microspheres, which are coated with radiation, directly to a patient's tumor.

Some 200,000 Americans are diagnosed with liver or advanced colon cancer every year, but many of them aren't candidates for surgery or radiation. But one local hospital is using a novel new treatment, developed by a Massachusetts company, to help those patients live longer.

Annette Papa survived her battle with breast cancer 25 years ago.

So when she was diagnosed with inoperable liver cancer three years ago, she never gave up hope of finding a way to beat it. "I always wondered whey they couldn't just do the area. That's what I wanted -- my prayers were answered."

Dr. Stephan Wicky is using a new radiation therapy developed by Sirtex of Wilmington, Massachusetts.

He uses a catheter to deliver tiny beads, called microspheres, which are coated with radiation, directly to a patient's tumor.

"The advantage of the catheter-directed therapy, we can deliver very locally an extremely high dose to treat these lesions," said Dr. Stephan Wicky, Mass. General Hospital.

Without this treatment, most patients like Annette are only expected to survive six months, but this new therapy is dramatically improving survival rates with minimal side effects.

Doctors say it has stopped Annette's tumor from growing.

"I can honestly say I thank God for this procedure, it's has no effect to me right now at all, I have lived my life and taken care of my children and grandchildren," said Annette.

"With this therapy, we have seen patients survive one, two three years," explained Dr. Wicky. "The other advantage we can downsize the tumor and more patients are a candidate for surgery."

Doctors are also testing this new therapy on patients with breast, ovarian and endocrine cancers and other diseases that can spread to the liver.

If you'd like more information, visit www.sirtex.com.

Unique liver transplant in Delhi

Twenty specialists helped in 16-hour operation at Sir Ganga Ram Hospital

Shourya Verma, with Dr. A. S. Soin (left), and Siya Thakur, with Sir Ganga Ram Hospital’s chief paediatric hepatologist Dr. Neelam Mohan, during a press conference in the Capital on Thursday to announce the country’s first-ever domino liver transplant.

NEW DELHI: Doctors at Sir Ganga Ram Hospital here have performed a domino liver transplant, a unique procedure in which two life-saving liver transplants are performed using one donor liver.

While 22-month-old Shourya was cured of maple syrup urine diseases (MSUD) by a transplant performed using 20 per cent of his aunt’s liver, his own liver was in turn transplanted into two-year-old Siya, who was battling terminal liver failure due to rare condition called langerhan’s cell histiocytosis. It is due to the sequential nature of the transplants that the domino transplant is so named.

Hospital chairman B.K. Rao said: “Twenty specialists helped in performing this marathon 16-hour-long operation on January 31. Domino transplants are rare because there are very few conditions in which you can cure the patient with a transplant and then transplant his or her organ into someone else without passing on the disease and MSUD is one such disease.”

MSUD is caused by lack of an enzyme and a patient with MSUD who receives a liver transplant is able to make enough of the enzyme in the new liver to overcome the shortage elsewhere in the body. In turn, an MSUD patient’s liver which is otherwise entirely normal, can be transplanted into another person without passing on the disease, because that patient’s other cells still make the enzyme lacking in the liver.

For the surgery, the team at Sir Ganga Ram Hospital was divided into three units and it prepared the donor liver, Shourya’s own liver and Siya’s diseased liver for removal sequentially in three separate operating theatres. First the donor liver and then Shourya’s own liver were removed and prepared on the bench for transplantation by re-constructing the vital blood vessels with complex vein grafts. Shourya was transplanted first and then his liver was transplanted into Siya.

India’s first domino liver transplant saves lives of two kids

1. Doctors remove 20 per cent of Mukta's liver. This portion is transplanted into Shourya, who suffered from Maple Syrup Urine Disease.
2. Shourya's liver in turn given to Siya. The girl was battling terminal liver failure due to a rare condition called Langerhan's Cell Histiocytoma (LCH).
3. Siya is India's first and the world's youngest recipient of a domino liver transplant. She is also the first kid to be cured of LCH with a transplant.

While 22- month- old Shourya Verma was cured of the Maple Syrup Urine Disease ( MSUD) — a metabolic disease — by a transplant performed using 20 per cent of his aunt Mukta’s liver, his own liver was, in turn, transplanted into two- year- old Siya Thakur. Siya was battling terminal liver failure due to a rare condition called Langerhan’s Cell Histiocytoma ( LCH).

The unique transplant has also made Shourya India’s first

and the world’s youngest recipient of a living donor liver transplant for MSUD, and Siya the country’s first and the world’s youngest recipient of a domino liver transplant. Siya is also the first child to be cured of LCH with a transplant.

A team of 20 surgeons and anaesthetists led by Dr A. S. Soin, the chief liver transplant surgeon and director of liver transplantation, performed the surgery on January 31. The surgery took more than 16 hours.

Siya’s mother Swati Thakur said: “ My child has got a new lease of life. She was diagnosed with the disease when she was 19 months old. She was suffering from a cancer, which has a different type of protocol. It was a big challenge for us but we derived strength from God and our family.

It’s good to see her eat food of her choice,” she said.

Domino transplants are rare because there are very few conditions in which you can cure the patient with a transplant and then transplant his or her organ into someone else without passing on the disease. MSUD is one such disease and Shourya was suffering from it since birth.

In this disease, toxic levels of branched chain amino acids called leucine, isoleucine and valine build up due to the lack of the detoxifying dehydrogenase enzyme. Soon after birth, such children develop metabolic crises with vomiting, poor feeding, weight loss, convulsions and coma.

“ Before the operation, Shourya suffered from such attacks until his parents Niti and Prashant Verma moved to the US and put him permanently on the MSUD diet. Apart from the difficulties in procuring the diet and measuring amino acid levels in India, it was too restrictive on Shourya’s life. His family then decided to go ahead with a liver transplant and his aunt Mukta was found to be a suitable donor,” said Dr Neelam Mohan, the chief pediatric hepatologist.

High levels of acids in the urine result in a smell of burnt sugar, hence the name Maple Syrup.

To survive, patients need a special diet that is low in protein and devoid of amino acids, along with regular monitoring of leucine levels.

MSUD is caused by lack of an enzyme in the body, so the patient who receives a liver transplant is able to make enough of the enzyme in the new liver to overcome the shortage elsewhere in the body. In turn, an MSUD patient’s liver — which is otherwise normal — can be transplanted into someone else without passing on the disease because that patient’s other cells still make the enzyme lacking in the liver.

“ The domino procedure requires careful planning for several weeks.

This surgery was crucial as it had never been performed on such small children. For the surgery, we divided ourselves into three teams and prepared Mukta’s liver, Shourya’s liver and Siya’s diseased liver for removal sequentially in three separate operation theatres,” said Dr Soin.

“ First the donor liver and then Shourya’s liver were removed and prepared for transplantation by re- constructing the vital blood vessels with complex vein grafts.

Shourya was given Mukta’s liver first, and then his liver was transplanted into Siya. Both transplants kicked in immediately and the children are making excellent progress,” Dr Soin added.

The biggest challenge was to control amino acids, glucose and sodium levels in blood before and during surgery until the new liver started working.

“ We specially arranged to measure the amino acid levels at our hospital and Shourya’s father Prashant arranged special oral and intravenous MSUD diets. But the boy won’t need any of that now. It is such a joy to see Shourya on normal diet for the first time in his life,” Dr Mohan said.

Siya underwent many chemotherapy sessions to contain the LCH disease. Though the disease went into remission, her liver was damaged irreversibly, due to which she needed a life- saving transplant.

The two- year- old girl had become very weak due to the side- effects of chemotherapy and making her fit for the transplant was a challenge. “ Swati wanted to give a part of her liver but Shourya’s liver could be successfully used in this unique domino operation,” added Dr Mohan.

ChronVac-C Reducing HCV Viral Load by up to 99 % in Phase I/II Study

Although it is early in the process and only involves a few subjects, interim trial results for ChronVac-C show extremely high percentages of Hepatitis C viral load reduction.

Hepatitis C Therapeutic DNA Vaccine Delivered by Inovio Biomedical's Electroporation Technology Reduces Viral Load by Up to 99.7%

Clinical Data Presented at Annual Scientific Meeting of the American Association for the Study of Liver Diseases

SAN DIEGO, Nov 17, 2008 (BUSINESS WIRE) -- Inovio Biomedical Corporation (INO 0.22, +0.04, +20.2%), a leader in enabling the development of DNA vaccines using electroporation-based DNA delivery, announced today that its partner, Tripep AB, reported positive additional interim results from its ongoing phase I/II clinical study of its therapeutic DNA vaccine against hepatitis C virus (HCV). This vaccine is being delivered using Inovio's electroporation-based DNA delivery system. In the third and highest dose cohort of the study, two of three subjects demonstrated reductions in viral load of 93% and 99.7%. Previously reported middle dose cohort results demonstrated an 87% and 98% reduction in HCV in two of three subjects, while no anti-viral effect was observed in the low dose cohort. No safety issues have been noted to date in the trial. These data suggest a potential dose response of the vaccine and support the inclusion of three additional subjects in the high dose cohort.

These data were presented by Dr. Matti SAnllberg of Tripep at the recent American Association for the Study of Liver Diseases meeting held in San Francisco.

Avtar Dhillon, MD, Inovio's president and CEO, stated: "We continue to be encouraged by the data flowing out of the ChronVac-C study. This promising DNA vaccine candidate, in which Inovio has an ownership position, is one of the more advanced clinical vaccine candidates in the HCV field. ChronVac-C was designed to play a role as a first-line therapy or as an adjunct to existing therapies."

About ChronVac-C

ChronVac-C(R) is a therapeutic DNA-based vaccine given to individuals already infected with the hepatitis C virus with the aim of clearing the infection from the liver by boosting the body's immune response against the virus. Inovio's electroporation technology is being used to deliver the vaccine and is intended to enhance the potency of the DNA vaccine. This clinical study is being conducted at the Infectious Disease Clinic and Center for Gastroenterology at the Karolinska University Hospital in Huddinge and Solna, respectively, in Sweden. The intended enrollment of 12 patients is being divided into four groups, three with increasing doses of ChronVac-C and the fourth at the maximum tolerable dose. Each patient receives four vaccinations one month apart. After the last vaccination, patients are followed for another six months. The study's main purpose is to assess safety. It is also testing whether the treatment boosts the immune response (immunogenicity) to HCV and its effect on virus replication in the liver.

About Inovio Biomedical Corporation

Inovio Biomedical is focused on developing DNA vaccines for cancers and infectious diseases using its novel method for DNA delivery -- electroporation -- which uses brief, controlled electrical pulses to increase cellular uptake of useful biopharmaceuticals. Initial human data has shown that Inovio's electroporation-based DNA delivery technology can significantly increase gene expression and immune responses from DNA vaccines. Immunotherapy partners include Merck, Wyeth, Vical, University of Southampton, Moffitt Cancer Center, the U.S. Army, National Cancer Institute, and International Aids Vaccine Initiative. Inovio's technology is protected by an extensive patent portfolio covering in vivo electroporation. The company has entered into a definitive merger agreement with VGX Pharmaceuticals. More information is available at www.inovio.com.

This press release contains certain forward-looking statements relating to our plans to develop our electroporation drug and gene delivery technology. Actual events or results may differ from our expectations as a result of a number of factors, including the uncertainties inherent in clinical trials and product development programs (including, but not limited to, the fact that pre-clinical and clinical results referenced in this release may not be indicative of results achievable in other trials or for other indications and that results from one study may not necessarily be reflected or supported by the results of other similar studies), the availability of funding to support continuing research and studies in an effort to prove safety and efficacy of Inovio's technology as a delivery mechanism, the availability or potential availability of alternative therapies or treatments for the conditions targeted by Inovio or its collaborators, including alternatives that may be more efficacious or cost-effective than any therapy or treatment that Inovio and its collaborators hope to develop, evaluation of potential opportunities, issues involving patents and whether they or licenses to them will provide Inovio with meaningful protection from others using the covered technologies, whether such proprietary rights are enforceable or defensible or infringe or allegedly infringe on rights of others or can withstand claims of invalidity and whether Inovio can finance or devote other significant resources that may be necessary to prosecute, protect or defend them, the level of corporate expenditures, assessments of our technology by potential corporate or other partners or collaborators, capital market conditions, and other factors set forth in our Annual Report on Form 10-K for the year ended December 31, 2007, our 10-Q for the nine months ended September 30, 2008 and other regulatory filings from time to time. There can be no assurance that any product in our product pipeline will be successfully developed or manufactured, that final results of clinical studies will be supportive of regulatory approvals required to market licensed products, or that any of the forward-looking information provided herein will be proved accurate.

SOURCE: Inovio Biomedical Corporation

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-DNA-Vaccine/story.aspx?guid=%7B50998DF9-516F-4207-84D6-1948D
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Antivirals Combined Without Interferon: New Trial

Three companies unite to begin an innovative Hepatitis C trial, where two oral antiviral drugs will be combined in the absence of interferon.

Pharmasset Announces Initiation of Hepatitis Antiviral Combination Study

Tuesday, 11 November 2008

Pharmasset, a clinical-stage pharmaceutical company, Roche and InterMune, a biotechnology company, have announced that the first patients have been dosed in an innovative clinical trial in patients chronically infected with the hepatitis C virus.

The trial is said to be the first to investigate the combination of two oral antiviral molecules in the absence of interferon. The initial study will evaluate the safety and combined antiviral activity of R7227 (ITMN-191), a protease inhibitor, and R7128, a polymerase inhibitor, in 14 days of combination therapy in treatment-naive patients infected with hepatitis C virus (HCV) genotype 1.

This direct antiviral combination study represents an important first step in evaluating the therapeutic potential of an all-oral, interferon-free combination treatment for HCV, the three companies said.

Dan Welch, chairman, CEO and president of InterMune, said: "The goal is to develop a treatment regimen that is better tolerated, shorter in duration and delivers higher sustained viral response rates. We are pleased to participate in the first clinical exploration of an all-oral, direct antiviral regimen towards that goal."

Source: Datamonitor

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FDA Approves Roche's Hep C Viral Load Measurements Test

Roche's COBAS® AmpliPrep / COBAS® TaqMan® Test brings improved ease, speed and accuracy to Hepatitis C viral load measurements, and was just approved by the FDA.

Roche Receives FDA Approval for Hepatitis C Viral Load Test on Its Fully Automated Real-Time PCR Platform

Improved laboratory efficiencies and standardization to personalize patient care

PLEASANTON, Calif., Oct 30, 2008 /PRNewswire via COMTEX/ -- Roche Molecular Diagnostics today announced that the U.S. Food & Drug Administration (FDA) has approved the COBAS(R) AmpliPrep / COBAS(R) TaqMan(R) HCV Test for use in the United States. The test uses Roche's proprietary real-time PCR technology to quantify the amount of Hepatitis C RNA in a patient's blood. Physicians use Hepatitis C viral load testing results to establish a baseline level of hepatitis C infection and to serially monitor viral load levels and treatment effectiveness in patients on therapy.

"This new Roche test enables laboratories to deliver reliable healthcare information with ease and allows physicians to more efficiently monitor their patients and improve treatment outcomes," said Daniel O'Day, President and CEO of Roche Molecular Diagnostics. "We are pleased to offer this new solution for laboratories and physicians to optimize their turnaround time, workflow and patient care with simultaneous processing of HIV and HCV patient samples."

The new test offers a broad dynamic range from high levels of virus in a patients blood to the "undetectable" low levels of viremia -- the goal of therapy. To ensure accurate quantification, the test has been calibrated to World Health Organization (WHO) traceable standards and can detect down to 18 IU/mL with 100% certainty. In a 1,281 patient clinical trial, the COBAS(R) AmpliPrep / COBAS(R) TaqMan(R) HCV Test confirmed the importance of viral load testing to personalize Hepatitis C patient care by accurately predicting treatment response, from onset of therapy through end of treatment.

About the COBAS(R) AmpliPrep/COBAS(R) TaqMan(R) System
The COBAS(R) AmpliPrep / COBAS(R) TaqMan(R) HCV Viral Load Test is designed for use on the first fully automated, FDA approved, real-time PCR platform, providing sample-in/results-out capability. The platform is flexible and customizable to meet the space and workflow needs of any laboratory. In the United States, more than 130 laboratories already utilize this fully automated platform for HIV testing.

The COBAS(R) AmpliPrep / COBAS(R) TaqMan(R) HCV Test is the third Roche COBAS(R) TaqMan(R) real-time PCR test approved by the FDA in the last eighteen months. The COBAS(R) AmpliPrep / COBAS(R) TaqMan(R) System menu includes an FDA approved HIV viral load test, with continuous loading of samples in addition to parallel processing of HIV and HCV tests. In September 2008, Roche received FDA approval of the COBAS(R) TaqMan(R) HBV Test to monitor Hepatitis B viral load in patients on therapy.

About Hepatitis C
According to the Centers for Disease Control and Prevention, each year in the U.S. approximately 8,000-10,000 people die from hepatitis C-related liver disease.

An estimated 3.2 million persons in the United States have chronic hepatitis C virus infection. Most people do not know they are infected because they don't look or feel sick. However, approximately 75%-85% of people who become infected with hepatitis C virus develop chronic infection. (1)

Hepatitis C infections can range in severity from a mild or "acute" illness lasting a few weeks to a serious, lifelong or "chronic" illness. For most people, acute infection leads to chronic infection. Chronic hepatitis C infection is a serious disease that can result in long-term health problems, including liver damage, liver failure, liver cancer, or even death. Hepatitis C is the leading cause of cirrhosis and liver cancer and the most common reason for liver transplantation in the United States.

Hepatitis C virus is passed from person to person when infected blood enters the body of someone who is not infected. Different ways people can be infected with the hepatitis C virus include sharing contaminated needles, high risk sex with an infected partner, and from an infected mother to her infant during pregnancy and childbirth.

About Roche and the Roche Diagnostics Division
Headquartered in Basel, Switzerland, Roche is one of the world's leading research-focused healthcare groups in the fields of pharmaceuticals and diagnostics. As the world's biggest biotech company and an innovator of products and services for the early detection, prevention, diagnosis and treatment of diseases, the Group contributes on a broad range of fronts to improving people's health and quality of life. Roche is the world leader in in-vitro diagnostics and drugs for cancer and transplantation, and is a market leader in virology. It is also active in other major therapeutic areas such as autoimmune diseases, inflammatory and metabolic disorders and diseases of the central nervous system. In 2007 sales by the Pharmaceuticals Division totaled 36.8 billion Swiss francs, and the Diagnostics Division posted sales of 9.3 billion francs. Roche has R&D agreements and strategic alliances with numerous partners, including majority ownership interests in Genentech and Chugai, and invested over 8 billion Swiss francs in R&D in 2007. Worldwide, the Group employs about 80,000 people. Additional information is available on the Internet at http://www.roche.com.
All trademarks used or mentioned in this release are legally protected by law.

(1) U.S. Centers for Disease Control. http://www.cdc.gov

For further information please contact:

Jessica E. Brillant
Molecular Diagnostics Communications
925.730.8503

Melinda Baker
Molecular Diagnostics Communications
925.730.8379

SOURCE Roche Molecular Diagnostics: http://www.roche.com

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New Drug Finds Viral Hiding Spots

A new, experimental drug helps the immune system locate a virus by flagging cells that have turned inside out. Hepatitis C is among the viruses that could benefit from Bavituximab's unique strategy of exposing a virus in hiding.

Inside-out cells offer target for antiviral drugs

By Julie Steenhuysen

CHICAGO, Nov 23 (Reuters) - An experimental drug cured guinea pigs infected with a fatal hemorrhagic fever virus, raising hope for its use in a broad range of viral diseases including influenza, hepatitis C, HIV, Ebola and others, U.S. researchers said on Sunday.

"This is a whole new strategy for making antiviral drugs," said Dr. Philip Thorpe, professor of pharmacology at the University of Texas Southwestern Medical Center at Dallas, whose research appears in the journal Nature Medicine.

Instead of attacking the virus directly, bavituximab, made by Peregrine Pharmaceuticals Inc (PPHM.O: Quote, Profile, Research, Stock Buzz), takes advantage of a defense mechanism used by the virus to hide from the immune system, Thorpe said.

When cells are under attack by a virus, this stress causes a fat molecule called phosphatidylserine, which normally lines the inside of the cell, to flip to the outside. "It's like wearing your clothes inside out," Thorpe, a scientific adviser to Peregrine, said in a telephone interview.

Bavituximab, a genetically engineered antibody, seeks out and attaches itself to these turncoat cells, flagging them for the immune system, which can then mount an attack,

"When injected into the bloodstream, bavituximab circulates in the body until it finds these inside-out lipids and then binds to them," Thorpe said in a statement.

"In the case of virus infection, the binding raises a red flag to the body's immune system, forcing the deployment of defensive white blood cells to attack the infected cells."

Thorpe said conventional antiviral drugs try to exploit some property of the virus, but these drugs are often quickly defeated as the virus mutates.

By targeting an aspect of infected cells in the host, he thinks bavituximab is less likely to lose effectiveness, which commonly happens when a virus mutates.

In the study, Thorpe and his colleagues tested the compound on guinea pigs in an advanced stage of infection with a form of the Lassa fever virus, a disease that affects parts of West Africa.

Half of the animals treated with the drug alone were cured. When the researchers tested it in combination with the antiviral drug ribavirin, a drug that keeps a virus from replicating, 63 percent of the guinea pigs lived.

Thorpe said the findings suggest the drug might be effective on other types of hemorrhagic viruses, such as Ebola and Marburg. But this lipid flipping also occurs in cells infected with many other viral infections, including influenza, smallpox and rabies.

Peregrine is conducting early phase clinical trials of the drug in people with hepatitis C and human immunodeficiency virus, or HIV, which causes AIDS. And it has more advanced trials under way in cancer.

"We think it has tremendous potential," Steven King, president and chief executive of Peregrine, said in a telephone interview. Peregrine funded the research along with the National Institutes of Health. (Editing by Will Dunham and Todd Eastham)

© Thomson Reuters 2008 All rights reserved

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Treatment for Liver Tumors

Many patients – and even some physicians – believe that liver tumors are always fatal and that no treatment is possible. This is not true. Recent progress in surgical methods has significantly decreased the complications and mortality of liver operations.

Many patients are surprised to find out they have a liver tumor because they usually do not have pain or other symptoms and feel quite well. When significant symptoms exist, the tumors are often far advanced and treatment options are severely limited. But more recent treatments that have been developed can provide better outcomes than we were previously able to attain. These include destroying tumors by freezing or heating; or directing chemotherapy to the specific area which is affected.

Primary Liver Tumors
Many liver tumors are cancers that arise within the liver itself, rather than coming from another organ. These are termed "primary" tumors and can be hepatocellular cancers (sometimes referred to as hepatomas) or cholangiocarcinomas.

Hepatocellular cancers most often occur in livers that are damaged by hepatitis B or C or by alcohol and the development of cirrhosis. This fact influences the treatment options and the outcome because:

1) surgery on cirrhotic livers is more risky and removing too much may cause liver failure and death, and

2) new and multiple tumors may occur anywhere in the liver even if others have been adequately treated.

Surgical treatments include surgical resection and cryoablation (or freezing) of the tumors. Many treatments are done by interventional radiologists in the x-ray department, including alcohol injection, radiofrequency ablation chemo-embolization.

Chemoembolization is performed by placing a catheter into the specific artery that supplies blood to the tumor. A chemotherapy drug is then infused and the section is plugged to stop further blood flow to the area. This is generally done on an outpatient basis and requires only sedation, not general anesthesia.

Only rarely it is possible to perform a liver transplantation. The decision process is very complex and requires individual evaluation.

Metastatic Liver Tumors
Liver tumors that originate in another part of the body and then migrate to the liver are called "metastatic tumors." The most common tumor type in the liver actually starts in the colon or rectum. About 25% of patients with these metastases have a tumor that has only spread to the liver and therefore local treatment with surgery is likely to be beneficial.

Tumor treatments are classified as systemic or local.

Systemic treatment reaches all tumors in the body. The majority of patients with colon cancer that metastasizes to the liver will get one or two specific chemotherapy drugs during their treatment course. While these chemicals are useful, they rarely kill all of the tumor in the liver and chemotherapy alone rarely allows patients to survive 5 years; the average (median) survival length is 12 to 14 months.

Local treatment of liver tumors is appropriate when there is no identifiable tumor outside the liver. Local treatments include surgical resection, cryoablation or radiofrequency ablation. Ideally, surgical resection is combined with one of the ablation techniques to achieve complete removal or killing of all the tumor in the liver.

Cryoablation kills a tumor by freezing it. This is done by placing a metal tube into the tumor while watching the process with intra-operative ultrasound. The tube is then cooled to -190°C (-360°F) and an iceball engulfs the tumor. The killed tumor is later re-absorbed by the body.

Radiofrequency ablation is a similar process that uses radio waves to heat the tumor to kill it.

Hepatic artery infusion is a technique that infuses chemotherapy drugs through a catheter into the artery that goes to the liver. The catheter may be inserted at the time of the liver surgery or in another subsequent operation. This technique produces better tumor response to treatment with less toxicity than systemic chemotherapy.

The appropriateness of using these local approaches is determined by the number of tumors in the liver, their size and their location. Whether this approach should be used for any particular patient is a decision only an experienced liver surgeon should make.

The actual surgical approach used is determined by findings in the operating room when the surgeon feels the liver and uses the intra-operative ultrasound machine. Often the number of tumors found is greater than the number predicted by CT or MRI scanning.

If all tumors can be removed or ablated during the surgery, approximately 25% to 30% of patients can live for 5 years or more. If tumors recur in the liver after the surgery, a repeat operation or ablation can often be performed.

Large amounts of liver can be removed during surgery, since the liver does regenerate back to near normal size. Even removal of large amounts of tumor is relatively safe and in the hands of experienced surgeons the mortality is generally less than 2%.

Other Tumors in the Liver
In addition to the tumors that metastasize from the colon and rectum, there are a large number of other cancers that can spread to the liver. Some of these can be treated by surgical therapies in the liver and others must rely on systemic chemotherapy. Some tumors can be treated with surgery if they are few in number and grow slowly. Tumors that are not usually candidates for local treatments are those from the lung, stomach, pancreas and skin.

Benign Tumors
Not all tumors of the liver are malignant cancers. There are three common benign tumors of the liver:

Hemangiomas arise from blood vessel tissue. They are the most common benign tumor of the liver. Most often these tumors are not treated and are only observed. Under some circumstances they might be removed, for instance if the tumors continue to grow while the patient’s progress is being monitored with ultrasound or CT scan, or if the patient experience pain.

Focal nodular hyperplasias are also often not treated. However they should be removed if growth continues, if they are very large or are causing pain – suggesting they may rupture or bleed.

Adenomas are usually removed when found due to their (infrequent) change to a malignant tumor and also because they are more likely to rupture and bleed.

In addition to the newer treatments described above – such as cryoablation, radiofrequency ablation, chemoembolization and hepatic artery infusion – progress in tumor imaging has allowed us to detect tumors while they are in the earlier stages of development. These tools, including CT scans, MRI, and intra-operative ultrasound, let us detect of even small tumors, not previously seen, allowing us to help plan the treatments that will achieve the best results for each patient.

Via: http://healthlink.mcw.edu

What's New?

ENTECAVIR (Baraclude)- Newest drug for hepatitis-B viral infection:

A London New drugs group publication- February-2007

1. 
   
   Entecavir is a guanosine analogue with marked activity against HBV DNA polymerase.
2. 
   
   The European Medicines Evaluation Agency (EMEA) has granted marketing authorisation for Entecavir (Baraclude) for the treatment of chronic hepatitis B virus (HBV) infection in adults with compensated liver disease and evidence of active viral replication, persistently elevated serum ALT levels and histological evidence of active inflammation and/or fibrosis.
3. 
   
   The Scottish Medicines Consortium approved the use of Entecavir for the treatment of chronic hepatitis B virus infection, in adults with liver disease and evidence of active viral replication, persistently elevated alanine aminotransferase levels and evidence of active inflammation and or fibrosis.
4. 
   
   Phase III trials in nucleoside-naive patients with both HBeAg-positive and -negative chronic hepatitis B have been carried out.
5. 
   
   In nucleoside-naive patients with HBeAg-positive and HBeAg-negative chronic hepatitis B, the use of entecavir was associated with significantly higher rates of histologic, virologic and biochemical improvements compared with lamivudine. This appears to be due to its potent suppression of HBV replication, as seen by the higher number of patients with undetectable levels of HBV DNA (less than 300 copies/ml) after 48 weeks.
6. 
   
   The higher rates of histologic improvement seen with Entecavir suggest that long-term use could result in a reduced risk of end-stage liver disease and heptatocellular carcinoma. Entecavir was tolerated as well as lamivudine, though long-term safety needs to be determined. ALT flares were less frequent in the entecavir group, and those that did occur where associated with lowered HBV DNA levels.
7. 
   
   A phase III trial of Entecavir in lamivudine-refractory patients with HBeAg-positive chronic hepatitis B showed that Entecavir treatment was associated with superior responses across histologic, virologic, serologic and biochemical endpoints. Entecavir strongly suppressed HBV DNA levels compared with lamivudine. The higher seroconversion rates in the Entecavir group suggests that longer term treatment will result in a higher proportion of patients achieving HBeAg seroconversion and resolution of chronic hepatitis.
8. 
   
   Resistance to Entecavir was not seen in any trial of nucleoside naive patients after 96 weeks of treatment. In lamivudine refractory patients, resistance to Entecavir occurred in 15% of patients after 3 years of follow up.
9. 
   
   In all trials ALT flares were seen in both Entecavir- and lamivudine treated patients, though more were linked with lamivudine use. The majority of the flares seen with entecavir were not associated with hepatic decompensation or rising HBV DNA levels.
10. 
    
    Other adverse events did not differ significantly between the groups.