Tuesday, April 5, 2011

Hepatitis C In The News For April 5; Mericitabine (formerly RG7128)

EASL;
View all the slides, data and coverage of the EASL at NATAP .
Also from NATAP
Brief Recap Report from EASL Liver Conference in Berlin: state of HCV Now- policy, treatment, access

New Capsule Summaries at CCO
You can view the EASL updates on this blog here also.
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From HIV and Hepatitis
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Mericitabine (formerly RG7128)
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First Sustained Response Data for Polymerase Inhibitor Mericitabine
SUMMARY: 76% of treatment-naive genotype 1 or 4 hepatitis C patients achieved 12-week sustained response to mericitabine (formerly RG7128) plus pegylated interferon/ribavirin, according to a report at EASL 2011.
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Polymerase Inhibitor PSI-7977 Works with Interferon or Companion Drug
SUMMARY: Almost all treatment-naive hepatitis C patients treated with Pharmasset's candidate PSI-7977 plus pegylated interferon/ribavirin experienced 12-week sustained response, and more than 90% treated with a PSI-7977 + PSI-938 all-oral combo had undetectable HCV at 14 days, researchers reported at EASL.
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Telaprevir Improves HCV Cure Rates Regardless of IL28B Status
SUMMARY: The Vertex experimental protease inhibitor telaprevir, taken with pegylated interferon plus ribavirin, increased sustained response in people with all IL28B gene patterns, researchers reported at EASL 2011.
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Pegylated Interferon Lambda Boosts Response with Few Side Effects
SUMMARY: Hepatitis C patients taking an experimental interferon formulation -- pegylated interferon lambda -- had higher rates of rapid and early virological response, with fewer flu-like symptoms and blood cell deficiencies, according to a report at EASL 2011.
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I know we have all read this......but I just love to see it in print
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Quadruple therapy shows 100 percent SVR for HCV patients

Exciting new data presented today at the International Liver CongressTM 2011 show that quadruple treatment in chronic hepatitis C (HCV) patients suppressed the emergence of resistant variants and resulted in a 100% rate of sustained virological response - undetectable HCV RNA - 12 weeks after therapy (SVR12).1.

In the quadruple treatment study, HCV patients were given four drugs in combination; pegylated Interferon-alpha (PegIFN-alpha); ribavirin (RBV); and two different direct-acting antivirals (DAAs) BMS-650032 (an HCV NS3 protease inhibitor) and BMS-790052 (an HCV NS5A replication complex inhibitor).

The current standard of care (SoC) for HCV treatment is PegIFN-alpha plus RBV � a dual treatment. The addition of DAAs (currently in phase-III clinical trials) marks the next step in therapy evolution � a triple treatment. However, the new data presented today suggests that quadruple treatment could be the next generation of therapy for chronic HCV patients.

Professor Heiner Wedemeyer, EASL'S Secretary General, said: "Quadruple treatment is possibly the future of HCV therapy; this study goes a way to confirming that. While it's expected that the first DAAs and triple treatment will be approved for use later this year, quadruple treatment appears to have a more profound effect on virological response, with less of a resistance problem".

The study may also provide new hope for a growing number of HCV patients who cannot be effectively treated for chronic hepatitis with current therapys.

The Phase-IIa trial looked at a cohort of 21 HCV genotype 1 null responders (patients who have failed to respond to prior therapy), of whom 19 had an unfavourable IL28B genotype, which predisposes HCV patients to therapy failure.

Only about 30% of null responders to PegIFN-alpha/RBV therapy achieve sustained virological response (SVR) when retreated with PegIFN-alpha/RBV plus telaprevir, demonstrating a high unmet medical need.1

You can view the slides at NATAP  here...

In The News

Tainted Prep Pads

Pharmalot has a great article on the tainted wipes this HCV community has been following from the beginning..check it out.

FDA Tries To Wipe Up A Wipe Maker
After nearly two years of failed inspection reports and an order last week from the FDA to halt production and distribution, a little-known company that was accused of making contaminated medical pads and wipes shut its doors yesterday. But the move came only after US Marshals showed up with seizure orders, as MSNBC notes.
The move came three months after H  &  P Industries and a related company, Triad Group, recalled a huge amount of alcohol wipes and pads potentially contaminated with Bacillus cereus, which was blamed for serious infections and at least one death - a two-year-old boy in Texas (look here). Triad also recalled potentially contaminated lubricating jelly used in medical procedures and exams, and iodine prep wipes (see this)........Continue Reading....

Side Note; Dr. Gordon was my doctor when I treated in 1999..........

Hepatitis C drugs could be cure

DETROIT — — Two three-drug regimens appear to cure most people of the most common type of hepatitis C in the U.S.

“We’re closing in on a cure,” said Dr. Stuart Gordon, a hepatitis C researcher at Henry Ford Hospital in Detroit. Gordon coauthored one of the drug studies, which appeared in the New England Journal of Medicine.

The cocktails consist of two new drugs: boceprevir from Merck & Co., and telaprevir from Vertex Pharmaceuticals. Each is paired with two drugs used to treat hepatitis C for more than a decade — interferon and ribavirin.

Although interferon and ribavirin have worked in some people, thousands took the drugs only to see the virus return. Adding a third drug appears to significantly boost a person’s chance of beating the disease for good.

“I can go and go and go,” said Detroiter Rhonda Gilbert, who is living without a trace of the disease for the first time in a decade. She takes no medicines for it now after participating in a Ford study with the boceprevir cocktail.

Merck & Co. of Whitehouse Station, N.J., and Vertex Pharmaceuticals of Cambridge, Mass., hope to hear in the next two months about whether they can distribute the drugs that make up three-drug cocktails shown to be effective in eradicating the disease.
The companies already have fast-track status from the Food and Drug Administration.
Gordon expects to prescribe both regimens once they are approved.
He considers the therapies “a major advance in the cure of a very common disease.”

An estimated 4 million Americans have hepatitis C, according to the federal Centers for Disease Control and Prevention.
Many are unaware that they have the disease because the virus is slow-growing and can linger for years without symptoms.

“ ‘Cure.’ That’s the four-letter word we’ve been somewhat reluctant to use, but we’re increasingly more comfortable using now,” said Gordon, chief of the division of hepatology at Henry Ford Hospital.
Chances of a recurrence are “almost negligible,” Gordon said, citing the sustained response in clinical trials.
In the New England Journal of Medicine, Gordon and researchers at 10 U.S. and European centers report that two-thirds of the 403 patients eliminated all traces of the hepatitis C virus as long as six months.
Similar results were reported in another trial last year of the other regimen.

Telaprevir and boceprevir have different side effects. Telaprevir is associated with a rash, and boceprevir can cause an altered, metallic sense of taste.

HBV

PlantPharm Biomed On Target To Introduce First Plant-Based Hepatitis B Vaccine
Article Date: 05 Apr 2011

PlantPharm Biomed, a leader in plant-derived biomanufacturing, is on the cusp of introducing one of the first Plant-Made Pharmaceuticals (PMPs) with the release of an oral Hepatitis B vaccine proven to work in human subjects in a double-blind, placebo controlled Phase I clinical trial. The company is currently seeking FDA approval of the product, with other Plant-Made Pharmaceuticals products to follow.

Plant-Made Pharmaceuticals offer a faster, lower cost, more efficient method of producing pharmaceuticals, however, the industry has been struggling for years to find a method of production that is safe and effective. To achieve success, pharmaceutical proteins in plants must be grown in a zero-tolerance, 100% containment method for the public safety, with no potential to co-mingle with the food or seed supply. PlantPharm Biomed developed a proprietary, closed-environment growing system that has been perfected in cooperation with NASA. This biomanufacturing technology includes 30 patents and registrations worldwide, and the controlled environment production of fast growth, pathogen-free seed potatoes has been perfected by the company for more than a decade. PlantPharm is pleased to announce that the technology is now ready for use in biomanufacturing Plant-Made Pharmaceuticals.

Recognized with Current Good Manufacturing Practices (cGMP) certification and supported the US National Institutes of Health (NIH), PlantPharm's technology is designed to control all plant growth needs in a completely closed production system that is computer-controlled to provide for as many as six crops annually. Plants are grown with precise duplication of conditions to provide for optimum production for each harvest, and with full containment security for prevention of plant genetic migration into the wild.

PlantPharm Biomed is on track to be the first-to-market with an oral dose hepatitis B vaccine produced completely in potato plants. The global demand is evident for a low-cost, shelf-stable, orally administered vaccine. According to the World Health Organization (WHO), goals to reduce hepatitis B infections by 2012 are at risk due to immunization and surveillance gaps. Nearly 2 billion people are infected with hepatitis B, and 350 million more have chronic infections. With PlantPharm's patented technology, cost of production for a hepatitis B vaccine will reduce the per dose costs to recipients by nearly 50%. The dosage is also oral rather than injected, making it is easier to administer in mass quantities with a greater shelf life than liquid vaccines, a particular problem in places with inadequate refrigeration and infrastructure limitations, such as in third-world countries.

Source:
PlantPharm Biomed

Liver Cancer

Jennerex And Transgene Announce The Presentation Of Positive Clinical Data Of JX-594 In Patients With Liver Tumors
05 April 2011
Jennerex, Inc., a private clinical-stage biotherapeutics company focused on the development and commercialization of first-in-class targeted oncolytic products for cancer, and Transgene (Paris:TNG) (NYSE Euronext Paris...

Liver Cancer;PS-Targeting Antibody Significantly Improves Anti-Tumor Effect of Sorafenib
Peregrine's PS-Targeting Antibody Significantly Improves Anti-Tumor Effect of Sorafenib in Models of Advanced Liver Cancer

AACR Data Presentation Supports Phase I/II Investigator-Sponsored Clinical Trial in Advanced Liver Cancer

TUSTIN, CA and ORLANDO, FL--(Marketwire - April 5, 2011) - Peregrine Pharmaceuticals, Inc. (NASDAQ: PPHM), a clinical-stage biopharmaceutical company developing first-in-class monoclonal antibodies for the treatment of cancer and viral infections, today announced that its phosphatidylserine (PS)-targeting antibody significantly enhanced the anti-tumor effects of sorafenib (Nexavar®) in models of hepatocellular carcinoma (HCC), with 69% less tumor growth compared to sorafenib alone. This study, one of four poster presentations on Peregrine's PS-targeting antibodies at the Annual Meeting of the American Association of Cancer Research (AACR), was the basis for initiating a Phase I/II investigator-sponsored trial (IST) evaluating the company's lead antibody bavituximab with sorafenib in patients with advanced HCC. Bavituximab is currently in three randomized Phase II clinical trials in lung cancer and pancreatic cancer and several ISTs for additional oncology indications.

AACR: Diabetes Linked to Cancer Risk and Mortality
Diabetes tied to lower risk of prostate cancer but higher risk of other cancers in men and women

MONDAY, April 4 (HealthDay News) -- Diabetes appears to be associated with a decreased risk of prostate cancer in men but an increased risk of other cancer types in both men and women, according to research presented at the annual meeting of the American Association for Cancer Research, held April 2 to 6 in Orlando, Fla.

In a prospective study, Gabriel Lai, Ph.D., of the National Cancer Institute in Rockville, Md., and colleagues evaluated 295,287 men and 199,665 women. The investigators found that diabetes was associated with an 8 percent increased risk for cancer among women and a 4 percent decreased risk for men. However, after excluding prostate cancer from the assessment, the investigators found that diabetes was associated with a 9 percent increased risk for cancer in men.

The investigators also found that diabetes was associated with an 11 percent increased risk of mortality in women and a 17 percent increased risk in men. In both men and women, diabetes was associated with a significant increase in risk for colon (hazard ratio [HR], 1.15), rectal (HR, 1.28), and liver cancers (HR, 2.40). In women, diabetes was associated with an increased risk for stomach (HR, 1.74), anal (HR, 2.44), and endometrial cancers (HR, 1.20). However, in men, diabetes was tied to an elevated risk for pancreatic (HR, 1.47) and bladder (HR, 1.10) cancers. In another study, Katherine McGlynn, Ph.D., of the National Cancer Institute, and colleagues found that metabolic syndrome was associated with an increased risk of hepatocellular carcinoma and intrahepatic cholangiocarcinoma.

"Follow-up studies to identify the biologic mechanisms involved should be performed to build upon confirmed findings," Lai said in a statement

Off The Cuff

Staying Healthy -- It's Complicated
A personal wake-up call gave health policy expert David Nash, MD, MBA, a new perspective on the health and economic impact of diabetes and pre-diabetes.

Merck, J&J’s New Hepatitis C Treatment Fetches $31,000 in France

U.S. Pricing Of New HCV Drugs

J&J and Vertex Pharmaceuticals Inc. (VRTX)’s telaprevir costs 22,000 euros under a French program for seriously ill patients for whom there is no other effective treatment on the market, according to patient association SOS Hepatites. Merck & Co. said its boceprevir costs 30,000 euros under the same program.

The price may drop once the drugs are approved for the broader market, Merck and J&J executives said. Still, the French model shows the new drugs may triple the cost of hepatitis C treatment, leaving England, Russia and eastern Europe likely to delay use or restrict which patients are allowed access, said Antonio Craxi, director of gastroenterology and internal medicine at the University of Palermo.

In the U.S., the new drugs may be priced at $35,000 to $40,000, estimates Howard Liang, a Boston-based analyst at Leerink Swann & Co.
“A cure saves a lot of money down the road,” Liang said in an interview. “It’s a shock to physicians, but I think it can be justified because it’s a cure.”

Meanwhile, the next generation of drugs with even higher cure rates and fewer side effects is likely to reach the market within three years, Liang said.

Swedish drugmaker Medivir AB (MVIRB) has said it expects to begin selling a competitor pill to be used with interferon by 2013. Boehringer Ingelheim GmbH, Gilead Sciences Inc. (GILD) and Bristol- Myers Squibb Co. are among a dozen companies aiming for drug cocktails to replace the existing interferon combination........Read More...

U.S.: When a Half-Truth Is the Best Medicine

Opinion
Meghan MacLean Weir, pediatrician and author

"In discussing a diagnosis with worried parents…I try to defuse the anxiety in the room so that we can deal with things as they actually are…But every once in a while I am faced with a patient…[where] I find it hard to know exactly what to say…New doctors are not given a handbook that says how much of the truth we need to tell. We are not meant to lie to our patients, of course, even when lies might be kinder. But neither are we meant to inflict harm…I find it difficult to engage in this kind of half-truth, but I also realize that sometimes it is the best thing I can do."...continue reading

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