Benitec Provides Update On Phase I/IIa clinical trial of TT-034 for hepatitis C

Benitec Provides Update On TT-034 Trial

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SOURCE Benitec Biopharma Limited

- shRNA detected in liver biopsies at levels in line with expectations

- no treatment-related adverse events reported

SYDNEY, April 7, 2015 /PRNewswire/ -- Benitec Biopharma (ASX:BLT; OTCPK:BTEBY), a biopharmaceutical company focused on providing potentially curative therapies with its proprietary gene-silencing technology called ddRNAi or "expressed RNAi," is pleased to advise that laboratory results from liver biopsies in the company's 'first in man', Phase I/IIa clinical trial of TT-034 for hepatitis C confirmed that the trial is proceeding according to expectations.

TT-034 works by producing (in the liver) three silencing short hairpin RNAs (shRNAs), each responsible for targeting a different part of the hepatitis C virus' genome. The expression of the three shRNAs in patients' liver cells is thus an essential requirement for TT-034 to exert a clinical reduction of hepatitis C viral load. The most recent assay of the biopsies confirmed this expression occurred in all three patients dosed to date. These results were obtained from the biopsies of the first two patients in cohort 1 and the first patient in cohort 2. The second patient in cohort 2 has not yet been biopsied, and the third patient in cohort 2 is yet to be dosed due to a personal issue.

In cohorts 1 and 2, the dose of TT-034 is sub-therapeutic and, therefore, the amount of shRNA produced will not result in reduction of hepatitis C viral load.

Furthermore, to date there have been no treatment-related serious adverse effects (SAEs) in any of the four patients dosed.

More detail on the TT-034 trial

TT-034 is a ddRNAi-based therapeutic, designed to treat and potentially cure hepatitis C (HCV) with a single administration. TT-034 targets the hepatitis C viral RNA at three separate, highly conserved sites. As such it acts as a "triple therapy" even though it is a monotherapy, and minimises the ability of the virus to mutate and escape the therapy. Once it reaches the liver cells it enters the nucleus and produces three separate short hairpin RNAs continuously for the life time of the cell. Thus it has the potential to not only treat the existing HCV infection but to guard against reinfection for months to years without the need to re-treat. It has been extensively tested in pre-clinical in vivo studies and no adverse effects were seen at any therapeutic dose. However, as it is regulated as a gene therapy, the trial design is to primarily ensure that treatment with TT-034 is safe, hence the gradual dose escalation.

About Benitec Biopharma Limited

Benitec Biopharma Limited is an ASX-listed biotechnology company (ASX:BLT; OTC:BTEBY) which has developed a patented gene-silencing technology called ddRNAi or 'expressed RNAi'. Based in Sydney, Australia with labs in Hayward CA (USA) and collaborators and licensees around the world, the company is developing ddRNAi-based therapeutics for chronic and life-threatening human conditions including Hepatitis C and B, drug resistant lung cancer and wet age-related macular degeneration. Benitec has also licensed ddRNAi to other biopharmaceutical companies for applications including HIV/AIDS, Huntington's disease, chronic neuropathic pain and retinitis pigmentosa.

For further information regarding Benitec and its activities, please contact the persons below, or visit the Benitec website at www.benitec.com.

States ask U.S. Congress to launch inquiry of herbal supplements

States ask U.S. Congress to launch inquiry of herbal supplements
NEW YORK | By Karen Freifeld

NEW YORK (Reuters) - A group of 14 state attorneys general on Thursday asked the U.S. Congress to investigate the herbal supplements industry after a New York probe of the products turned up ingredients that were not listed on labels and raised safety concerns.

The group, led by New York Attorney General Eric Schneiderman and Indiana Attorney General Greg Zoeller, also asked Congress to consider giving the U.S. Food and Drug Administration more oversight of herbal supplements.

"We believe the safety and efficacy of these supplements is a matter of deep public concern across the country," the attorneys general said in the letter, urging "swift action."

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(Reporting By Karen Freifeld; Editing by David Gregorio)

High price of specialty drugs prompts backlash

High price of specialty drugs prompts backlash

BY HUDSON SANGREE
HSANGREE@SACBEE.COM
04/04/2015 11:00 AM 

For hepatitis C patients, new drugs introduced in the past two years offer a cure that’s miraculous when compared with former treatments for the potentially fatal virus.... 

Patients can quickly shell out thousands of dollars before insurance starts to cover a drug’s full cost. Some say the cost sharing discriminates against those with conditions such as hepatitis C, HIV/AIDS and multiple sclerosis by charging more for life-saving treatments....

Insurance companies used to deny coverage or charge high premiums to patients with chronic conditions that were pricey to treat. The federal Affordable Care Act prohibited health plans from discriminating against enrollees with pre-existing conditions... 

“There is evidence, however, that insurers are resorting to other tactics to dissuade high-cost patients from enrolling,” researchers Douglas Jacobs and Benjamin Sommers, with the Harvard School of Public Health, wrote in an article published in the New England Journal of Medicine in January...

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Readers’ Favorite Online Health Stories:Rashes, Sore Throats, Kidneys, and More

Readers’ Favorite Online Health Stories
Rashes, Sore Throats, Kidneys, and More

NIH News in Health aims to bring you a wide range of health-related stories, including articles about healthy lifestyles and both common and rare diseases. Some topics are consistently popular, viewed by hundreds or thousands of people month after month on the NIH News in Health website.

Here are 5 reader favorites, representing our most-viewed Web articles over the past 2 years. See if any of these topics might be useful to you or someone you know.

1. Red, Itchy Rash?
You’ve probably had a rash at some point or another, whether from poison ivy, soggy diapers, or something more unusual. Why does your skin break out in red blotches like that? More important, is there anything you can do about it? Dr. Stephen I. Katz, director of NIH’s National Institute of Arthritis and Musculoskeletal and Skin Diseases, answers these questions and more while also addressing specific conditions, such as skin allergies, eczema, and psoriasis. “If you have any significant rash, you should see a dermatologist,” Katz says. A dermatologist, or skin doctor, is specially trained to figure out what’s causing a rash and help you get the right treatment.

2. Soothing a Sore Throat.
When you’ve got a sore throat, your throat may feel scratchy, and it may hurt when you swallow. Most sore throats are caused by viral infections such as the common cold or the flu. The best way to protect yourself from the germs that cause these infections is to wash your hands often. Try to steer clear of people who have colds or other contagious infections. And avoid smoking and inhaling second-hand smoke, which can irritate your throat.

3. Keep Your Kidneys Healthy.
Your kidneys aren’t very big—each is about the size of your fist—but they do important work. They keep you healthy by maintaining just the right balance of water and other substances inside your body. Unfortunately, if your kidneys start to malfunction, you might not realize it for a long while. Kidney disease usually won’t make you feel sick until the problem is serious and irreversible. That’s why it’s important to catch kidney disease early, so you can try to prevent or delay health problems. You’re at increased risk for kidney disease if you have diabetes, high blood pressure, heart disease, or a family history of kidney failure. Talk with your health care provider about whether you should be screened for kidney disease.

4. Should You Take Dietary Supplements?
More than half of all Americans take one or more dietary supplements daily or on occasion. Common supplements include vitamins, minerals, and herbal products, also known as botanicals. People take these supplements to maintain or improve their health. But not everyone needs to take supplements. “Learn about their potential benefits and any risks they may pose first,” says Dr. Paul M. Coates, director of NIH’s Office of Dietary Supplements. “Speak to your health care providers about products of interest and decide together what might be best for you to take, if anything, for your overall health.”

5. Waking Up to Anesthesia.
When you face surgery, you might have many concerns, including worries about going under anesthesia. General anesthesia is a combination of drugs that dampens pain, knocks you unconscious, and keeps you from moving during the operation. Although anesthesia is typically considered quite safe for most patients, many people have concerns about possible risks and side effects. Some people, especially elderly patients and children, can have lingering confusion and thinking problems for several days after anesthesia. Talk with your doctor if you have concerns, but don’t delay important surgery because of fear of anesthesia.

http://newsinhealth.nih.gov/issue/apr2015/feature2

NIH - Sharing Reliable Health Information

Sharing Reliable Health Information
10 Years of NIH News in Health

You hear and read health advice all the time—from friends, online sources, radio, TV, and more. How do you know what health information you can trust? This issue marks the 10-year anniversary of NIH News in Health, the monthly newsletter based on research supported by the U.S. National Institutes of Health—the nation’s medical research agency. Every article in this newsletter is carefully reviewed by NIH experts, so you can be confident that the health news you read here is trustworthy.

So far, we’ve brought you 600 articles on all kinds of topics. They’ve ranged from healthy eating and physical activity to the microbes within you, personalized medicine, and the hazards of stress. We’ve learned from our tens of thousands of readers that you appreciate these stories and often share the information with your friends, family, and others.

People love exchanging health information. More than half of adults nationwide say they turn to friends or family for health information or support when facing a serious health issue. People also share health information within their communities—at school, work, places of worship, and various events.

The quality of the health information you get depends on the source. “When looking online for health information, it’s a good idea to start with reputable websites, such as government websites,” says NIH’s Stephanie Dailey, who specializes in sharing health information with older adults. “Government agencies have well-researched information that’s been vetted by expert scientists and doctors.”

“Students and others can be drawn to websites with quirky or ‘amazing’ health stories that may be inaccurate,” says Timothy Keady, who heads the student wellness center at the Rochester Institute of Technology in New York. “We always try to steer them back toward more appropriate health information that’s based on science. We know that information from NIH, the CDC, and other agencies is going to be accurate.”

Like all the information available from NIH, the stories in NIH News in Health undergo multiple levels of review before you ever see them. Researchers interviewed for each story read and comment on draft articles to make sure they’re correct. NIH health and science experts also review each story before it’s published. The goal is to give you reliable, science-based information so you can make informed decisions about staying healthy and seeking medical care.

In recognition of the newsletter’s 10th year, we turned to readers like you to learn how you’ve been sharing NIH News in Health and other health information with your community. We’ve learned that the articles are shared in many different ways. Teachers in California and elsewhere have shared stories with their students on how sleep affects learning and health (Why You Need a Good Night's Sleep and How Snoozing Strengthens Memories). A middle school nurse in Texas copies and shares articles with school staff and makes the newsletter available to visiting parents. And the staff of a hospital in Montana says they read the online version and discuss the newsletter’s stories, which ultimately helps to improve their conversations with patients.

Community health clinics, senior centers, libraries, and nonprofit organizations across the country share copies of NIH News in Health with their communities. In Florida, the Franklin County Health Department distributes the newsletter to patients and staff in 2 rural, remote public health clinics. At the Friend Family Health Center in Illinois, NIH News in Health is shared at large neighborhood clinics in the southeast and southwest sides of Chicago.

In the Rocky Mountains, a nonprofit agency has been sharing NIH News in Health with older adults and their caregivers for nearly a decade. “The newsletter regularly offers relevant health information for our seniors. It’s something they really look forward to each month,” says Stephen M. Holland, director of the Upper Arkansas Area Agency on Aging, based in Salida, Colorado. The newsletter is available at the agency’s meal sites. It’s also given to older adults who receive home-delivered meals. “Although some of our participants are active users of the Internet, others for the most part are not computer literate, so they really rely on the printed information,” Holland says.

In rural Oregon, copies of NIH News in Health are distributed to a largely Native American community by the Confederated Tribes of Grand Ronde, a tribal organization that provides a range of services, including home health care visits and transportation to medical facilities. “We place the newsletter in our elders’ meal site and in the lobby of the community health clinic, in adult foster care, and next to the pharmacy, so people can read it while waiting for prescriptions,” says community health director Kari Culp. “We’ve found the newsletters to be very informative and much appreciated by our community members and also our medical staff.”

Many people share health information by putting it where people are waiting and where it will be seen. At several colleges and universities, for instance, officials have been placing easy-to-read health information in common bathrooms—an approach sometimes called “stall talk.”

In Rochester, Keady puts NIH News in Health in the school’s health clinic and counseling waiting rooms. He also brings the newsletters to lectures and presentations on health and wellness. “Although students search for a lot of health information online, they still like to read some information on paper, especially while they’re waiting or relaxing in a common area,” Keady says. “Stories on stress and other psychological issues are of special interest to students. And they tend to gravitate to stories on exercise, sleep, and nutrition.”

School, church, and community newsletters often reprint NIH News in Health stories in their publications because they know they can trust the content. Organizations focused on diabetes, healthy aging, mental illness, and other medical issues also reprint NIH News in Health stories in their own publications. The articles aren’t copyrighted, so they can be freely republished, as long as NIH News in Health is credited as the source (see http://newsinhealth.nih.gov/about for details).

No matter where you gather and read health information, it’s a good idea to discuss what you’ve found with your health care provider. Your provider can help you understand and interpret what you’ve found.

“Being well informed about a condition can be helpful when you visit your doctor,” Dailey says. “You may wish to print out some of the information you find to share with your doctor during your appointment.”

We love hearing from readers who let us know how they share and use health information, including NIH News in Health. Thanks for sharing your feedback, story ideas, and other comments over the past decade. We look forward to bringing you 10 more years of evidence-based health information. Share your thoughts with us at nihnewsinhealth@od.nih.gov or send us a photo of how you or others use the newsletter, and we may post it to our Facebook page.

http://newsinhealth.nih.gov/issue/apr2015/feature1

WHO Issues Guideline For Manufacturers Of Generic Hepatitis C Medicine

WHO Issues Guideline For Manufacturers Of Generic Hepatitis C Medicine
02/04/2015 BY CATHERINE SAEZ, INTELLECTUAL PROPERTY WATCH

The World Health Organization has issued a guidance document on the design of bioequivalence studies for a leading hepatitis C medicine. Generic drug companies seeking prequalification by the WHO need to demonstrate that their generic version is equivalent to the originator drug.

According to a WHO official, the document provides technical guidance for the prequalification process as generics companies have to do bioequivalence studies to get prequalified.

WHO prequalification of medicines is a service assessing the quality, safety and efficacy of medicinal products, according to WHO. At the end of 2012, WHO List of Prequalified Medicinal products contained 316 medicines for priority diseases, the fact sheet said.

“Every year, billions of US dollars worth of medicines are purchased by international procurement agencies for distribution in resource-limited countries. Prequalification is intended to give these agencies the choice of a wide range of quality medicines for bulk purchase,” according to the WHO fact sheet.

The guidance document [pdf] issued last week concerns sofosbuvir, which is protected by a Gilead Sciences patent. Sofosbuvir, commercialised under the name Sovaldi by Gilead, has been denounced by some for its high price, reaching US$1,000 per pill.

According to the WHO official, the patent was not granted in Egypt, so the generic version can be manufactured by local producers. The same applies to Bangladesh, which is a least-developed country, and does not grant patents. Several India-based generics companies also benefit from a licence from Gilead, he told Intellectual Property Watch.

On 15 September 2014, Gilead Sciences announced non-exclusive licensing agreements with seven India-based generic pharmaceutical manufacturers “to expand access to its chronic hepatitis C medicines in developing countries.” The agreements allow the companies to manufacture sofosbuvir and “the investigational single tablet regimen of ledipasvir/sofosbuvir for distribution in 91 developing countries,” according to the Gilead press release.

The WHO has carried out an analysis of the patent situation for seven new hepatitis treatments.

“These landscapes provide clarity on whether the medicines are patent protected or not in individual countries,” according to the WHO.

The WHO has published an updated version (March 2015) of the patent situation for sofosbuvir in about 20 countries. This update, according to the WHO, is based on data received from national and regional patent offices, including the African Regional Intellectual Property Organization (ARIPO), Brazil, the Gulf Cooperation Council, Chile, Georgia, Morocco, The Organisation Africaine de la Propriété Intellectuelle (OAPI), the Philippines, and Tunisia.

INTELLECTUAL PROPERTY WATCH

Related Articles:
Patent Landscape For Hepatitis Issued By WHO
Gilead Monopoly Prevails Over Non-Discriminatory Access As Debated Hepatitis C Deal Sets Off
WHO Guidelines May Help With Price Reductions For Hepatitis C Drugs

New drugs available in Saskatchewan for treating hepatitis C

New drugs available in Saskatchewan for treating hepatitis C

By David GilesSenior Web Producer Global News

REGINA – Two new drugs to treat hepatitis C have been approved for coverage in Saskatchewan. The government announced Wednesday that Harvoni and Sovaldi, which have high success rates in treating hepatitis C, will be available to patients in the province.

The new drugs cure 90 to 98 per cent of patients in as little as eight to 12 weeks. Traditional therapies cure 60 to 75 per cent of patients in 24 to 48 weeks.

“These two drugs offer effective, simple and fast treatment,” said Saskatchewan Health Minister Dustin Duncan.

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Cirrhosis better treated without ribavirin/All-oral simeprevir-sofosbuvir beat interferon-based regimen for HCV

All-oral simeprevir-sofosbuvir beat interferon-based regimen for HCV with compensated cirrhosis

By: AMY KARON, GI & Hepatology News Digital Network

April 1, 2015

Vitals

Key clinical point: An all-oral simeprevir-sofosbuvir combination outperformed peginterferon/ribavirin/sofosbuvir in patients with genotype 1a HCV infection and compensated cirrhosis.

Major finding: Rates of sustained virologic response at 12 weeks were 93% for the simeprevir-sofosbuvir regimen and 75% for the interferon-containing regimen (P = .02).

 

Data source: Prospective open-label study of 82 treatment-naive and treatment-experienced patients with HCV infection and Child’s grade A cirrhosis.

Disclosures: Dr. Pearlman reported having contracted research for Johnson & Johnson, Gilead, Abbvie, Bristol-Myers Squibb, Boehringer Ingelheim, and Merck; and having served on speaker and advisory boards for Johnson & Johnson, Gilead, and Abbvie. Dr. Pearlman also reported having been an investigator and author in the COSMOS trial of sofosbuvir and simeprevir. The other authors reported no conflicts of interest.

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Cirrhosis better treated without ribavirin

At the time of sofosbuvir (SOF) and simeprevir (SMV) approval, efficacy results of the combinations assessed in this study were still limited, especially in patients with cirrhosis, GT-1a, and/or previous nonresponse. The recent study by Dr. Pearlman and his associates aims to give light to some of the questions raised.

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