January 21, 2014

Better insights into treating hepatitis C

[Date: 2013-10-22]

20131022-1

With nearly 200 million infected people worldwide, hepatitis C virus (HCV) represents a significant public health issue. One of the most important challenges is that although the immune system seems to be responsible for much of the disease-associated morbidity, including liver cirrhosis, it is also successful at clearing viral infection for a significant number of patients.

In his European Research Council (ERC)-funded project entitled HCV_IMMUNOLOGY ('The paradoxical role of type I interferons in hepatitis C disease pathogenesis and treatment'), Dr Albert and his team are attempting to elucidate the complex interplay between HCV and the host's immune response from the perspective of type I interferons (IFNs) and IFN-induced gene products.

The project is aimed primarily at developing more effective treatments. Indeed, the team has already formulated a better approach to predicting whether patients will respond to a particular therapy.

Prior to HCV_IMMUNOLOGY, Dr Albert had spent several years working at the French National Institute of Health and Medical Research, developing partnerships with clinicians and epidemiologists in France, Egypt and the United States. This gave him a clearer insight into the way the disease develops and the immune response responds in both acute and chronic HCV infection.

IFNs are proteins made and released by host cells in response to the presence of pathogens such as viruses, bacteria, parasites or tumour cells. They allow communication between cells and trigger the immune system's protective defences.

HCV_IMMUNOLOGY research is divided into three strands. First, the role of endogenously produced IFNs in the clearance of HCV during acute infection is examined in patient samples. The paradoxical role these endogenous IFNs play in making chronically infected patients resistant to exogenous IFN therapy is being investigated.

Secondly, Dr Albert is working to characterise the effect of IFN and IFN-induced gene products on the indirect activation of HCV-reactive CD8+ T cells by a mechanism called cross-priming.
Finally, mouse models are being used determine the in vivo pro- and counter-inflammatory effects of IFN and IFN-induced gene products and disease pathogenesis.

Dr Albert believes his team's work will contribute to a deeper understanding of HCV disease pathogenesis, and lead to the development of new diagnostic tools and better therapeutic strategies.

The team has already discovered biomarkers predictive of viral clearance. This could help clinicians to identify, before treatment, which individuals will respond to IFN-based therapy.

Dr Albert received a European Research Council (ERC) Starting grant of around EUR 1.1 million. The project ends in June 2014.

For more information, please visit:
Project factsheet
http://cordis.europa.eu/projects/rcn/89072_en.html
French National Institute of Health and Medical Research
http://www.inserm.fr/

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The deadly toll of drug-approval drag

Winnipeg Free Press - PRINT EDITION

By: Don Marks
Posted: 01/20/2014 1:00 AM | Comments

A recent survey of general practitioners by the Canadian Liver Foundation revealed 57 per cent of GPs don't know hepatitis C can be cured despite the fact more than 70 per cent of hep C patients who undergo treatment with available medicines are being cured right now.

Obviously, we must create more public awareness about hepatitis C when even medical professionals seem so unaware of what's going on. Especially when there are thousands of people who don't even know they are carrying the virus (hep C is a "silent disease" -- symptoms often don't appear until the liver is severely damaged).

A simple blood test will indicate the presence of hep C, but what is the use of that if over half of our family doctors don't know there are treatments and cures they can refer patients to? Meanwhile, 1,000 people die needlessly each year and thousands more cannot work or provide for themselves because they waited too long to get diagnosed and allowed the hep C to do its damage when it could have been treated.

There are still thousands of people in that remaining 30 per cent who cannot be cured by the present treatment of pegylated interferon, ribavirin and a protease inhibitor. For them, there is good news and there is bad news.

Many new advances in drug development in the United States have increased cure rates to greater than 90 per cent and approaching 99 per cent. The bad news is that 1,000 to 1,500 more may die in the time it may still take for a new drug developed by Gilead Industries of California to be approved for use in Canada.

The new drug is called sofosbuvir (brand name Sovaldi) and Gilead has obtained almost complete "clearance" with patients so far. Unfortunately, Health Canada requires up to 225 days to review the research and findings made by Gilead in order to issue a "notice of compliance." Then the drug must go through CDR (common drug review process), which "is a pan-Canadian process for conducting objective, rigorous reviews of the clinical, cost-effectiveness and patient evidence for drugs." CDR also provides formulary listing recommendations to Canada's publicly funded drug plans (except Quebec)."

Following that, the Pan Canadian Pricing Alliance (PCPA) gets together to develop a national price for the drug and then, finally, all the information is turned over to the provinces, basically to repeat the entire process because health care is, after all, a provincial responsibility. Currently, Sovaldi has been assigned a notice of compliance and is through the CDR process. But it may be another 12 to 18 months before Manitobans will have access to this therapy.

The total time it takes for the drug to be researched and then made available in Canada by prescription? At least five years.

Current estimates have 1,000 people per year dying from hep C in Canada, so that's at least 5,000 needless deaths. And nobody really knows how many people are out there carrying this virus without knowing it themselves, and then when they find out, not seeking treatment because their family doctor isn't up to speed.

Why do I know all this?

Because I have hepatitis C and I am in the fourth and final stage of liver damage. Fortunately for me, I have lucked into a clinical trial.

I can't speak for other patients, but I can tell you I will endure whatever side-effects that go along with the new treatment because I don't have any other option; most likely not five years, unless somebody wants to spot me a liver (pun intended).

On behalf of the many others who I assume might feel the same way, I can only hope and respectfully request that the process to approve this drug for use in Canada be sped up.

And if you might be one of the estimated 300,000 people in Canada who are carrying the hep C virus, but you are one of those who just don't know, it's a simple, routine blood test.

Ask them to check for the hepatitis C virus.

Don Marks is a Winnipeg writer.

Republished from the Winnipeg Free Press print edition January 20, 2014 $sourceSection0

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January 15, 2014, 1:41 PM

By Russ Britt

Intercept Pharmaceuticals’ chief executive said Wednesday the company’s new drug could tap into a vast market to treat what he called “the next tsunami of liver disease.”

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Image of liver afflicted with NASH

Intercept ICPT +8.03% CEO Mark Pruzanski told the J.P. Morgan Healthcare Conference in San Francisco the liver disease his company hopes to treat — nonalcoholic steatohepatitis, or NASH — could affect 6 million adults. NASH also is expected to become the leading cause of liver transplants, and the market for treatments of the disease could be bigger than hepatitis C, Pruzanski said.

The disease creates fatty deposits in the liver and can lead to cirrhosis in roughly 10% of patients with 10 years, regardless of whether they drink alcohol. NASH patients are 10 times more susceptible to liver-related mortality. One-third of all patients with non-alcoholic fatty liver disease develop NASH, he added.

“This is considered to be irreversible on its own,” he said.

The company’s obeticholic acid, or OCA, met goals early in Phase 2 testing for treatment of NASH and was discontinued last week. That set off massive buying of the company’s shares last week. Now the company hopes to begin Phase 3 tests next year and seek expedited approval for the treatment from the U.S. Food and Drug Administration.

On Wednesday, Intercept was trading around the break-even point — up marginally to $255.97 in recent action. That’s relative calm compared with what the stock experienced over the last week, with its value multiplying almost seven times, from the low $70s to nearly $500 a share Thursday and Friday, then falling 18% Monday and 30% on Tuesday.

“It’s been an interesting few days,” Pruzanski said.

Some analysts reportedly believe the potential for OCA is strong. Bank of America analyst Rachel McMinn reportedly put a price target of $872 on the company’s shares; B. of A. won’t make its research notes public.

There is at least one caveat, however, as the National Institutes of Health pointed out over the weekend that OCA users experienced larger-than-expected levels of bad cholesterol after taking the drug. Pruzanski said those levels were up about 20% in some cases.

Follow Russ Britt on Twitter @russbrittmktw

Follow Health Exchange on Twitter @MWHealthBlog

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Liver cancer responds to Issels Integrative Immunotherapy

SCOTTSDALE, Ariz., Jan. 21, 2014 /PRNewswire/ -- The liver performs many vital tasks, including digestive and hormonal functions. As the body's main detoxification system, it is susceptible to developing secondary cancers from circulating cancer cells.

To view the multimedia assets associated with this release, please click: http://www.multivu.com/mnr/65144-issels-integrative-immunotherapy-liver-cancer-treatment-stage-four

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Primary liver cancer (hepatocellular carcinoma) arises from liver cells and has the worst prognosis among all liver cancers, with a relative survival rate of 15%, according to the American Cancer Society.

As with many cancers, highly toxic standard treatments can only be given sparingly for liver cancers, highlighting the importance of the non-toxic Issels Integrative Immunotherapy. While several leading Cancer Centers in the U.S. and abroad have only begun using immunotherapy, Issels has been a leader in Integrative Immunotherapy for decades.

In 1951, Dr. Josef M. Issels, MD founded the world's first hospital specializing in integrative oncology and achieved documented complete long-term remissions of standard therapy-resistant cancers. In view of his expertise, Dr. Issels was invited to serve as an expert member of the German Federal Government Commission in the Fight against Cancer from 1981 until his retirement in 1987.

Issels Integrative Immunotherapy distinguishes itself decisively from mere vaccine administration. The Issels strategy integrates specific autologous cancer vaccines, such as Dendritic Cell Vaccine, as well as autologous Lymphokine-Activated Killer (LAK) Cells and activated autologous Natural Killer (NK) Cells, which work on the cell-mediated level of the immune system, into a comprehensive immunobiologic core treatment. This core treatment addresses the tumor microenvironment and the body's complex defense mechanisms, enhancing the efficacy of vaccine and cell therapies.

The Issels medical team brings decades of expertise tailoring integrative immunotherapy for each patient and provides comprehensive treatment programs with vaccine and cell therapies at the most modern facility of the largest private hospital network of 22 hospitals in Mexico. The hospital meets the highest U.S. and international standards and is the only full-service hospital in Mexico offering integrative medicine.

Joseph Momot commenced the non-toxic Issels Integrative Immunotherapy for his chemotherapy-resistant hepatocellular carcinoma in June 2010. Within 4 weeks of exclusive immunotherapy, his total bilirubin decreased from 20.3 to 5.2 mg/dl, then to 2.1 mg/dl the next month. His jaundice and edemas disappeared; he regained his energy and felt like a "new person."

Please see the video of Joseph Momot at the top right of the Multimedia News Release.

Carl Swanberg shares his remarkable results from using solely Issels immunobiologic core treatment for his hepatocellular cancer, hepatitis C, and liver cirrhosis. He arrived at the Issels out-patient clinic in November 2004 with 3 months to live.  His AFP tumor marker of 4,500 dramatically decreased to 124 within 3 weeks, and to 60 after a year.

The Issels immunobiologic core treatment is available at the Issels U.S. out-patient facility, where patients can also receive genetically-tested advanced targeted cancer therapies.

Please see the video of Carl Swanberg at the top right of the Multimedia News Release.

Visit the Issels website www.issels.com to learn more about the Issels treatment programs and facilities, or watch more videos of patient testimonials.

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