Tuesday, August 9, 2011

Hepatitis News;Low Vitamin D Levels Could Cause Liver Disease

Portsmouth Launches New Treatment Service for Hepatitis C
Published: 9th August 2011 10:02
Portsmouth Hospitals NHS Trust has announced the launch of a new Hepatitis C treatment service at Queen Alexandra Hospital.

From Monday 8 August patients in Portsmouth and surrounding areas with Hepatitis C will be able to be treated more locally instead of travelling to Southampton to receive treatment.
Two new hepatitis nurse specialists are now at Queen Alexandra Hospital and will be working with the hepatology consultants to deliver antiviral therapy. They will also be going out into the community to treat people closer to home.
It is hoped the local service will mean more people in the area being able to get treatment for this curable condition.

Hepatitis C is a blood-borne virus that predominantly infects the cells of the liver and can result in inflammation and significant damage to the liver and can also affect the liver's ability to perform its essential functions.

Richard Aspinall, Consultant Hepatologist, leads the new service and said: "We know that Hepatitis C is a significant national and local health issue.

"Between 50 and 70 new cases from the Portsmouth city area are diagnosed every year but we know that only a small number of those people were able to travel to Southampton to get treatment. We hope this new service will improve access for people in Portsmouth.
"We also know that there is a certain stigma attached to Hepatitis C and some people maybe nervous about coming forward to get treated. We would urge anyone who has Hepatitis C or who thinks they may have it to contact their doctor as soon as possible."

Many people with Hepatitis C feel normal and have no symptoms or problems at all. However, there are others who suffer from symptoms which include loss of concentration, fatigue or aches and pains in their joints.

If anyone is concerned that they may have Hepatitis C they should contact their GP as soon as possible.

Anemia is a common clinical finding in HIV-infected patients and iron deficiency or redistribution may contribute to the development of low hemoglobin levels. Iron overload is associated with a poor prognosis in HIV and Hepatitis C virus infections.


Anemia and iron homeostasis in a cohort of HIV-infected patients in Indonesia
Iron redistribution may be caused by inflammation but possibly also by hepatitis C co-infection. We examined the prevalence of anemia and its relation to mortality in a cohort of HIV patients in a setting where injecting drug use (IDU) is a main mode of HIV transmission, and measured serum ferritin and sTfR, in relation to anemia, inflammation, stage of HIV disease, ART and HCV infection.

Methods: Patient characteristics, ART history and iron parameters were recorded from adult HIV patients presenting between September 2007 and August 2009 in the referral hospital for West Java, Indonesia.Kaplan-Meier estimates and Cox's regression were used to assess factors affecting survival.

Logistic regression was used to identity parameters associated with high ferritin concentrations.

Results: Anemia was found in 49.6% of 611 ART-naive patients, with mild (Hb 10.5 - 12.99 g/dL for men; and 10.5 - 11.99 g/dL for women) anemia in 62.0%, and moderate to severe anemia (Hb <10.5 g/dL) in 38.0%.Anemia remained an independent factor associated with death, also after adjustment for CD4 count and ART (p=0.008). Seroprevalence of HCV did not differ in patients with (56.9%) or without anemia (59.6%).Serum ferritin concentrations were elevated, especially in patients with anemia (p=0.07) and/or low CD4 counts (p<0.001), and were not related to hsCRP or HCV infection. Soluble TfR concentrations were low and not related to Hb, CD4, hsCRP or ART.

Conclusion: HIV-associated anemia is common among HIV-infected patients in Indonesia and strongly related to mortality.High ferritin with low sTfR levels suggest that iron redistribution and low erythropoietic activity, rather than iron deficiency, contribute to anemia. Serum ferritin and sTfR should be used cautiously to assess iron status in patients with advanced HIV infection.
Author: Rudi WisaksanaRachmat SumantriAgnes IndratiAleta ZwitserHadi JusufQuirijn de MastReinout van CrevelAndre van der VenCredits/Source: BMC Infectious Diseases 2011, 11:213

GI Bleeding-Cirrhosis

Antibiotic prophylaxis for cirrhotic patients with upper GI bleeding
A study in September's issue of the Alimentary Pharmacology & Therapeutics reviews antibiotic prophylaxis for cirrhotic patients with upper gastrointestinal bleeding.

Antibiotic prophylaxis seems to decrease the incidence of bacterial infections in patients with cirrhosis and upper gastrointestinal bleeding and is considered standard of care.
However, there is no updated information regarding the effects of this intervention.
Dr Chavez-Tapia and colleagues from Mexico assessed the benefits and harms of antibiotic prophylaxis in cirrhotic patients with gastrointestinal bleeding by performing a systematic review of randomised trials.

Antibiotic prophylaxis was associated with reduced mortality
Alimentary Pharmacology & Therapeutics

The researchers searched The Cochrane Hepato-Biliary Group Controlled Trials Register, The Cochrane Central Register of Controlled Trials in The Cochrane Library, MEDLINE, EMBASE and Science Citation Index EXPANDED until 2010.
The team identified 12 trials evaluating antibiotic prophylaxis against placebo or no antibiotic prophylaxis.

Antibiotic prophylaxis was associated with reduced mortality, mortality from bacterial infections, bacterial infections, rebleeding and days of hospitalization.
The research team noted that trials analyzing rebleeding rate and hospitalization length are still scarce, thus, caution should be exerted when interpreting the results.
Dr Chavez-Tapia's team concludes, "Antibiotic prophylaxis in patients with cirrhosis and upper gastrointestinal bleeding significantly reduced bacterial infections, and reduce all-cause mortality, bacterial infection mortality, rebleeding events and hospitalization length."
"Novel clinically significant outcomes were included in this meta-analysis."
"Some benefits are biased and the risks are not yet properly assessed, this encourages future research in this field."
Aliment Pharmacol Ther 2011: 34(5): 509–518
August 2011


‘Good’ Prion-Like Proteins Boost Immune Response
Released: 8/8/2011 5:00 PM EDT Source: UT Southwestern Medical Center
Newswise — DALLAS – Aug. 8, 2011 – A person’s ability to battle viruses at the cellular level remarkably resembles the way deadly infectious agents called prions misfold and cluster native proteins to cause disease, UT Southwestern Medical Center researchers report.

This study marks the first discovery of so-called “good” prion-like proteins in human cells and the first to find such proteins involved in innate immunity: the way the body recognizes and responds to threats from viruses or other external agents, said Dr. Zhijian “James” Chen, professor of molecular biology and senior author of the study in the Aug. 5 print edition of the journal Cell.

"An understanding of how cells maintain good prion-like proteins called MAVS [mitochondrial antiviral signaling] protein may help us understand how some prions turn bad,” said Dr. Chen, a Howard Hughes Medical Institute investigator at UT Southwestern. Moreover, the research may also deepen our knowledge of innate immunity and host defense, he said.
Prions are misfolded, self-perpetuating proteins responsible for fatal brain infections such as bovine spongiform encephalopathy – so-called mad cow disease – in cattle and the extremely rare variant Creutzfeldt-Jakob Disease (vCJD) in some people who eat beef from infected cattle. Currently all prion-related diseases are untreatable and are fatal.

The MAVS prion-like proteins usually are scattered on the membranes of the energy-producing organelles called the mitochondria that reside inside cells throughout the body, he explained.
UT Southwestern researchers, investigating the cellular response to invasion by a member of the family of viruses that includes influenza and hepatitis, discovered that the MAVS proteins change shape and recruit other MAVS proteins to misfold and aggregate [cluster] in tough clumps on the surface of the mitochondrial membranes to defend against viral assault, Dr. Chen said.

The researchers created a setup that mimicked the human immune response, but in a controlled laboratory environment where they were able to break open cells and study the cellular components. When those components were mixed with viral RNA (the genetic material also known as ribonucleic acid), the MAVS proteins still formed large clusters.
“Remarkably, the MAVS proteins behave like prions and effectively convert nearby proteins into aggregates on the mitochondrial membrane,” Dr. Chen said. He noted that the aggregates are necessary for the cells to churn out immunity-boosting interferon molecules. When the MAVS activity is blocked, the antiviral defense stops.

The MAVS’ prion-like mechanism gives no indication of the out-of-control replication seen in disease-causing prions, Dr. Chen said, providing an intriguing area for future research.
Other UT Southwestern researchers involved in the study were lead author Dr. Fajian Hou, instructor of molecular biology; Dr. Lijun Sun, assistant professor of molecular biology and an HHMI research specialist; Dr. Hui Zheng, postdoctoral fellow in cell biology; Brian Skaug, a student in the medical scientist training program; and Dr. Qui-Xing Jiang, assistant professor of cell biology.
The study was funded by grants from the National Institutes of Health and the Welch Foundation.
This news release is available on our World Wide Web home page at http://www.utsouthwestern.edu/home/news/index.html

Hepatitis A

Cumberland Co. officials warn of Hepatitis A exposure at specific Olive Garden
Full story: MSNBC
Anyone who visited a Fayetteville Olive Garden at 234 North McPherson Church Road on eight specific days in July and August, may have been exposed to Hepatitis A through a restaurant employee.

Hepatitis B

To treat or Not to Treat
by Ana Valenzuela
One out of 10 Filipinos is infected with Hepatitis B. Hepatitis B is one of today’s challenging and infectious diseases. It is threatening to the physical condition as it can lead to other diseases. There are two ways to get HBV(Hepatitis B Virus).

One is through blood to blood or bodily fluid contact, and the other is through mother to child transmission. “Bodily contact, exposure to blood, you had a needle prick when you were doing an injection, blood transfusion, sharing of needles, piercing, tattooing, multiple sexual partners, but here in the Philippines, the incidence is more on mother to child transmission.

Meaning the mother is a carrier of HBV, and during the process of delivery, the virus is transmitted to the newborn,” says Doctor Judy Lao-Tan, internal auditor of the Hepatology Society of the Philippines (HSP) at a recent press conference sponsored by the HSP and Roche. The HSP is rallying behind the mandatory vaccination of newborns so that the high numbers might see a decline. The first vaccine should be given at birth, so that it prevents the virus, followed by vaccination at one month and six months.

“Not everyone who is a carrier of Hepatitis B is a candidate for treatment. Two-thirds who have hepatitis B are just carriers, the only problem they have is that they can transmit the disease and nothing is going on inside their body. One-thirds have active hepatitis, they are the ones who will require treatment. Not all, not everybody is a candidate for treatment,” says Doc Judy. From Hepa B to Liver Cancer Majority of acute Hepatitis B carriers do not develop chronic Hepatitis B.

Still, the HSP is moving for prompt treatment of active Hepatitis B patients. Those who have chronic Hepatitis B are at risk of developing liver cirrhosis. “When you develop liver cirrhosis, you may develop liver cancer. The normal life span of a patient with liver cancer after diagnosis is anywhere between three to six months,” says Dr. Marilyn Aguillas, President of the HSP. Apart from liver cirrhosis those diagnosed with active Hepatitis B might also get infected with another Hepatitis virus. “With the HBV, you have the tendency to develop Delta Hepatitis. It requires the Hepatitis B to be infected. Fortunately, in our country, Delta Hepatitis is not a major problem, unlike in Mediterranean countries where dual infection is high,” says Doc Judy. “Hepatitis B is more faithful to you than your wife or husband, the only way to remove it is either through treatment or oral medication,” says Doc Marilyn. Medications, however, are not easy on the pocket. They would require you to shell out a whopping P12,000 a week, or more or less the minimum monthly wage. Even more saddening is that patients are troubled by the drawbacks of discrimination.

The Yellow Warriors Society is an online patients group. It has members that are skilled employees, lawyer, accountants, among others, and it became an online venue for them to share what they are going through. Pamela Chan, a speaker for the Yellow Warriors Society shares, “there are a lot of members who are competent. They have passed all the exams, submitted all the requirements, but when they have been tested positive, they are not given the job. Even though there is memorandum by the Department of Labor and Employment not to discriminate Hepatitis B carriers, the employers will say that it is company policy. It is no longer about the competencies, but about the stigma that the public has.”

How can the patient provide for his medical needs without work? This is where Roche, the world’s largest biotech company, comes in as it tries to help those who are financially incapable through its program the PEGASSIST.

“The PEGASSIST Easy Access Plan socializes the medication discount system. This means, patients who truly cannot afford the medication will get a higher discount accordingly,” says Doctor Dennis Dioko, Roche specialty business unit director. Patients can ask their doctors about this program or call the Hepatitis Hotline (718-7620). They can receive as much as 50 percent off on the medication and be provided with selected Hepatitis B laboratory tests. Not every Hepatitis B patient would require medical attention, but those needing so now have a viable alternative making it easier.

India, emerging as the global Hepatitis capital of the world
By: Priyanjali Ghose
Date: 2011-08-09

What you need to know about the potentially life-threatening liver infection caused by the Hepatitus B virusA recent finding by doctors from MIOT Hospital in Chennai claims that India is likely to emerge as the global capital of the dreaded Hepatitis B virus, which is responsible for 60 per cent of liver cancer cases. Ashok Borisa, a Gastrointestinal and Laparoscopic Hepato-Pancreato-Biliary surgeon, Fortis Hospitals says, "The number of HBsAg carriers in India is estimated to be over 40 million or four crores."

Lack of awareness about the virus is a large reason for the spread of the virus, claim doctors. Viral Patrawala, gastroenterologist, Hiranandani Hospital defines Hepatitis B as a serious liver inflammation and infection caused by the hepatitis B virus (HBV). Five kinds of virusA, B, C, D and E are the five kinds of Hepatitis. Patrawala broadly classifies A and C to be food and water-borne infections, while B and C are spread through contact with blood or other bodily fluids including saliva, semen and vaginal fluid of an infected person.

Patrawala explains that carrying the virus does not mean that an individual has the disease. He declares that HBV can cause both short-term (acute) disease and long-term (chronic) disease."Not everybody develops chronic infection. Only five per cent of those carrying the infection develop the chronic disease," clarifies Patrawala. He adds that being affected by Hepatitis B does not depend on age or gender though children are more prone to develop the chronic disease, as compared to adults.

Consultant gastroenterologist Prassana Shah from Breach Candy says, "Anybody can acquire acute Hepatitis B. However, in most cases the body produces antibodies and suppresses the virus with regular administration of drug tests. The person is cured mostly in six months," says Shah. He says that in India, 90 per cent cases show that the infection mostly spreads from mother to foetus and most of them are chronic. Most pregnant women suffering from Hepatitis B are given injections to protect the child from the virus. Also, according to him, blood transfusion, dental treatment and the use of infected needles and razors are other major causes of the spread of Hepatitis B.

Symptoms and cureBorisa says that the signs of Hepatitis B appear in about three months after being infected.

Abdominal and joint pain, dark urine, loss of appetite, nausea and vomiting, weakness and fatigue, and jaundice are some of the symptoms. In case of acute HBV, the doctors may not suggest any treatment and instead work to reduce the symptoms and recommend follow-up blood, liver and viral load tests to make sure the virus has left the body.However, Borisa informs that those suffering from chronic HBV infection often do not feel any discomfort even after carrying the infection for decades.

According to him, 15 to 20 per cent of the patients suffering from chronic Hepatitis B die of liver cancer and cirrhosis, the scarring of liver. "If you've been diagnosed with chronic hepatitis B infection, your doctor may recommend antiviral medications or getting a liver transplant," says Borisa. Vaccination, a must?Experts unanimously agree that vaccination is the best protection against the Hepatitis B virus. Ajay Choksi, gastroenterologist from Nanavati Hospital informs that World Health Organisation has recommended that HBV vaccination should be provided to all adults and infants at the time of birth. "The WHO has made a recommendation, but in India vaccination has not yet been made mandatory in all private and government hospitals. There is no such regulation though most pediatricians normally vaccinate children."Shah gives the example of Taiwan where Hepatitis B vaccination programme was implemented in 1984.
As a result, Taiwan saw a considerable decline of hepatocellular carcinoma or liver cancer in children. In India each shot, according to Choksi is priced between Rs 50 to 100.
Three shots of the vaccine are needed for proper protection. Though there is no age limit, it is advisable to take the HBV vaccine before the age of 40. Apart from proper vaccination, Borisa advises that maintenance of national registry for Hepatitis, treatment of carriers, educating the common man, availability of treatment for chronic HBV for all classes and proper check on blood blanks be done to curb the spread of the virus.

42 million Indians suffer from Hepatitis B: StudyA recent study by a team of doctors from MIOT Hospital in Chennai conducted a survey which showed that 42 million Indians suffer from chronic Hepatitis B. the virus is also responsible for 60 percent of liver cancer cases in the country, claim the doctors. It was also found that not even one per cent of school children are provided with HBV vaccine though it was developed in 1970. PVA Mohandas, director, MIOT Hospital, reveals that there are 400 million people chronically infected by the HBV and 40 per cent of them are at the risk of suffering from cirrhosis and liver cancer.

Do's and Don'ts for those living with HBV
Dos> Restrict alcohol intake to a peg twice or thrice a week if you have chronic HBV.
> Practice safe sex. Use condoms each time you have sex. If you are in a monogamous relationship and have had unprotected sex outside your relationship, confide in your partner, as you might be putting them at risk of contracting the virus or an STD (sexually transmitted disease).
> If you are pregnant and carrying the HBV tell the doctor immediately.

Don'ts> Alcohol, even wine, is an absolute no-no if you have contracted the virus.
> If you are infected with the Hepatitis B virus, don't donate blood or organs.
> Don't share razor blades or toothbrushes. These items may carry traces of infected blood. If you use IV drugs, never share your needles and syringes with anyone.

Myths and truths about
Hepatitis B

Myth: Hepatitis B can be transmitted through casual contact such as kissing, handshakes or sharing of food and water.
Truth: The disease can only be contracted on an intimate basis such as sharing bodily fluids through unprotected sex or sexual contact or through blood transfusions with an infected person.

Myth: There is no treatment available for chronic hepatitis B.
Truth: While the disease is not curable, it is manageable. Chronic HBV can be treated with a number of effective medications that can suppress, slow or reverse the liver disease. All chronically infected patients need life-long monitoring.

Myth: Healthy patients with chronic HBV (often called "carriers") do not need regular medical follow-ups.
Truth: Inactive carriers can progress to cirrhosis or liver cancer at any time. Continued screening should take place at regular intervals throughout the patient's lifetime.

Myth: Hepatitis B vaccine prevents liver cancer and enhances healing in infected patients.
Truth: The vaccine prevents infection and thereby cancer. There is no reason to vaccinate a patient who is already infected.

Liver Cancer

Tekmira Announces Additional Clinical Trial of TKM-PLK1 with the U.S. National Cancer Institute

FDA Approves Clinical Protocol for Additional Phase 1 Study of TKM-PLK1

VANCOUVER, British Columbia, Aug 9, 2011 (GlobeNewswire via COMTEX) -- Tekmira Pharmaceuticals Corporation a leading developer of RNA interference (RNAi) therapeutics, along with its collaborators at the United States National Cancer Institute (NCI), announced today that they have received approval from the United States Food and Drug Administration (FDA) to proceed with a new Phase 1 clinical trial for Tekmira's lead oncology product, TKM-PLK1. This trial, run in parallel with the ongoing Phase 1 trial of TKM-PLK1, provides Tekmira with an early opportunity to validate the drug's mechanism of action.

"Patients in this new study, who will have either primary liver cancer or liver metastases, will receive TKM-PLK1 delivered directly into the liver via Hepatic Artery Infusion (HAI). The trial design will allow us to measure tumor delivery, polo-like kinase 1 (PLK1) messenger RNA knockdown, and RNA interference (RNAi) activity in tumor biopsies from all of the patients treated," said Dr. Mark J. Murray, Tekmira's President and CEO.

"This NCI clinical trial will run in parallel with our multi-center TKM-PLK1 solid tumor Phase 1 trial, currently underway at three centers in the United States. Working together on this clinical trial with our collaborators at the NCI will allow us to develop an even more robust data package to inform subsequent TKM-PLK1 development. We expect to have interim TKM-PLK1 clinical data before the end of 2011," added Dr. Murray.

The NCI trial is a Phase 1 multiple-dose, dose escalation study testing TKM-PLK1 in patients with unresectable colorectal, pancreatic, gastric, breast, ovarian and esophageal cancers with liver metastases, or primary liver cancers. These patients represent a significant unmet medical need as they are not well served by currently approved treatments. The primary objectives of the trial include evaluation of the feasibility of administering TKM-PLK1 via HAI and to characterize the pharmacokinetics and pharmacodynamics of TKM-PLK1. Pharmacodynamic measurements will examine the effect of the drug on the patient's tumors, specifically aiming to confirm PLK1 knockdown and RNAi activity. Typically reserved for later stage trials, pharmacodynamic measurements are facilitated in this Phase 1 trial in part through the unique capabilities of the NCI Surgery Branch. Secondary objectives of the trial include establishing maximum tolerated dose and to evaluate response rate.

About the NCI
The NCI is one of the United States National Institutes of Health, the primary medical research agency in the U.S. The TKM-PLK1 trial will involve investigators at the NCI's Center for Cancer Research (CCR) on the main NIH campus in Bethesda, Maryland. The CCR is home to more than 250 scientists and clinicians working in intramural research at the NCI. CCR's investigators include some of the worlds most experienced basic, clinical, and translational scientists who work together to advance our knowledge of cancer and develop new therapies.
About TKM-PLK1
TKM-PLK1 targets polo-like kinase 1, or PLK1, a cell cycle protein involved in tumor cell proliferation and a validated oncology target. Cancer patients whose tumors express high levels of PLK1 have a relatively poor prognosis. Inhibition of PLK1 prevents tumor cells from completing cell division, resulting in cell cycle arrest and cancer cell death.
About RNAi and Tekmira's LNP Technology
RNAi therapeutics have the potential to treat a broad number of human diseases by "silencing" disease causing genes. The discoverers of RNAi, a gene silencing mechanism used by all cells, were awarded the 2006 Nobel Prize for Physiology or Medicine. RNAi therapeutics, such as "siRNAs," require delivery technology to be effective systemically. LNP technology is one of the most widely used siRNA delivery approaches for systemic administration. Tekmira's LNP technology (formerly referred to as stable nucleic acid-lipid particles or SNALP) encapsulates siRNAs with high efficiency in uniform lipid nanoparticles which are effective in delivering RNAi therapeutics to disease sites in numerous preclinical models. Tekmira's LNP formulations are manufactured by a proprietary method which is robust, scalable and highly reproducible and LNP-based products have been reviewed by multiple FDA divisions for use in clinical trials. LNP formulations comprise several lipid components that can be adjusted to suit the specific application.

About Tekmira
Tekmira Pharmaceuticals Corporation is a biopharmaceutical company focused on advancing novel RNAi therapeutics and providing its leading lipid nanoparticle delivery technology to pharmaceutical partners. Tekmira has been working in the field of nucleic acid delivery for over a decade and has broad intellectual property covering LNPs. Further information about Tekmira can be found at www.tekmirapharm.com . Tekmira is based in Vancouver, B.C.
The Tekmira Pharmaceuticals logo is available at http://www.globenewswire.com/newsroom/prs/?pkgid=8319

Forward-Looking Statements and Information
This press release contains "forward-looking statements" or "forward-looking information" within the meaning of applicable securities laws (collectively, "forward-looking statements"). Forward-looking statements are generally identifiable by use of the words "believes," "may," "plans," "will," "anticipates," "intends," "budgets", "could", "estimates", "expects", "forecasts", "projects" and similar expressions, and the negative of such expressions. Forward-looking statements in this news release include statements about Tekmira's strategy, future operations, clinical trials, prospects and plans of management; Tekmira's RNAi product development programs; the effects of TKM-PLK1 as a treatment of cancer; the efficacy of the Hepatic Artery Infusion (HAI) protocol for directly measuring PLK1 knockdown and RNAi activity; any future results from Tekmira's collaboration with the United States National Cancer Institute; and the timing for publication of interim data from the TKM-PLK1 Phase 1 clinical trials.
With respect to the forward-looking statements contained in this news release, Tekmira has made numerous assumptions regarding, among other things: LNP's status as a leading RNAi delivery technology; the effectiveness of Tekmira's LNP delivery technology; the effectiveness of Tekmira's RNAi product development programs; the effectiveness of Tekmira's TKM-PLK1 product candidate as a treatment for cancer; the effectiveness of the Hepatic Artery Infusion (HAI) protocol for directly measuring PLK1 knockdown and RNAi activity; and the extent of Tekmira's research, development and manufacturing capabilities and resources. While Tekmira considers these assumptions to be reasonable, these assumptions are inherently subject to significant business, economic, competitive, market and social uncertainties and contingencies.
Additionally, there are known and unknown risk factors which could cause Tekmira's actual results, performance or achievements to be materially different from any future results, performance or achievements expressed or implied by the forward-looking statements contained herein. Known risk factors include, among others: the possibility that other organizations have made advancements in RNAi delivery technology that Tekmira is not aware of and Tekmira's development programs, including its collaboration with the United States

National Cancer Institute, will not result in expected results on a timely basis, or at all.
A more complete discussion of the risks and uncertainties facing Tekmira appears in Tekmira's Annual Information Form dated March 30, 2011 and available at http://www.sedar.com/ or at www.sec.gov/edgar .
All forward-looking statements herein are qualified in their entirety by this cautionary statement, and Tekmira disclaims any obligation to revise or update any such forward-looking statements or to publicly announce the result of any revisions to any of the forward-looking statements contained herein to reflect future results, events or developments, except as required by law.
This news release was distributed by GlobeNewswire, http://www.globenewswire.com/
SOURCE: Tekmira Pharmaceuticals

Stem Cells

Perry's Surgery Included Experimental Stem Cell Therapy
Emily Ramshaw(Texas Tribune, August 3, 2011)
"[Texas governor] Rick Perry [underwent a spinal procedure that included]…an experimental injection of his own stem cells…The governor’s procedure did not involve embryonic stem cells…[it] involved removing his own adult stem cells from healthy tissue and injecting them back into his body at the time of surgery, with the belief that the cells would assist tissue regeneration and speed recovery…The FDA [Food and Drug Administration]...has not approved the use of adult stem cells for anything other than bone marrow transplants, which have been used for decades to treat cancer and sickle cell anemia patients…The infusion of adult stem cells to repair tissue and organ damage is highly controversial…The biomedical engineers and spinal clinics developing stem cell products and performing the procedure say they’re seeing terrific results…But researchers say that despite the great potential adult stem cells may have, so far they’ve seen nothing more definitive than the so-called 'placebo effect.'".....


The Feds Subpoena Merck Over Its Marketing
Merck has received a subpoena from the US Department of Justice as part of a criminal investigation into the marketing of various drugs. The feds want info about marketing and selling these drugs - Temodar, which treats brain tumors; the PegIntron hepatitis C treatment; and Intron A, which treats certain cancers - from 2004 through the present The subpoena was disclosed this morning in a filing with the US Securities and Exchange Commission in which Merck reported results for the second fiscal quarter. The drugmaker noted the subpoena was issued in connection with an investigation criminal statutes (see page 22). During most of that five-year period, by the way, the drugs were marketed by Schering-Plough, which Merck acquired in 2009. Read More At Pharmalot http://www.pharmalot.com/2011/08/the-feds-subpoena-merck-over-its-marketing/

Merck And J&J Sit On Piles Of Cash
As it turns out, giant companies like Prudential Financial and Johnson & Johnson aren’t so different than average consumers unnerved by the nation’s economic uncertainty.
Some of the largest companies are holding onto huge stashes of money because, like American families, they’re worried about the economy and its impact on their future finances. Prudential Financial and Merck have each added $1 billion in cash this year to their troves. And Johnson & Johnson has socked away $3 billion since January.

Incivek; Incivek Likely to Claim Significant Share Advantage in Coming Months
Study: Hep C Specialists Report Similar Trial Rates for Merck & Co. (Westpoint, PA) (MRK)/Roche (RHHBY)'s Victrelis and Vertex Pharmaceuticals Incorporated (VRTX)'s 8/9/2011 6:36:55
Results from a survey fielded one month after the launch of Incivek (telaprevir) and Victrelis (boceprevir) indicate that there is a high demand for triple therapy with the new protease inhibitors in patients with hepatitis C (HCV).

In LaunchTrends®: Incivek and Victrelis, BioTrends surveyed a total of 80 physicians (gastroenterologists, hepatologists, and infectious disease specialists) about their current perceptions, early experience and anticipated future use of these products. In addition, feedback around patient type, product satisfaction, obstacles to use, and promotional activities by Merck/Roche and Vertex is captured.

Not surprisingly, with the long-awaited anticipation of the new protease inhibitors, unaided awareness and familiarity is extremely high at one month post launch and more than half of surveyed participants have already initiated trial with Incivek or Victrelis. Trial rates do vary by physician specialty, but among physicians that have prescribed these agents, most are experimenting with both brands.

About 80% of surveyed physicians report seeing either a Victrelis or Incivek representative. Among those who have not seen a representative, the majority indicate that they would like to be called on, indicating the desire by practitioners for more information about these products.
Physicians report a high number of eligible patients for the new protease inhibitors, both in newly diagnosed patients and for a large base of patients that have been awaiting the approval of Incivek and Victrelis. Market share projections in the next six months suggest that Incivek will claim a significant share advantage over Victrelis.

About LaunchTrends
LaunchTrends®: Incivek and Victrelis is a series of three post-launch syndicated reports designed to track the uptake of Merck’s Victrelis and Vertex’s Incivek at one month, three months and six months following launch. LaunchTrends® assesses trial and use of new products, barriers to use, reasons to use, typical patient types, line of therapy, product perceptions, promotional efforts/messages and product satisfaction.
In the current wave of research, which measures INCIVEK’s and VICTRELIS’ market impact at one month post launch, BioTrends surveyed 80 physicians and conducted qualitative interviews with a subset of 20 of the respondents in July 2011. BioTrends will continue to track the uptake of both agents in follow up waves, which will be published in September and December 2011.
About BioTrends Research Group, LLC
BioTrends Research Group, LLC provides syndicated and custom market research to pharmaceutical manufacturers competing in clinically evolving, specialty pharmaceutical markets. For information on BioTrends publications and research capabilities, please contact us at (610) 363-3872 or www.bio-trends.com.

About Decision Resources Group
Decision Resources Group is a cohesive portfolio of companies that offers best-in-class, high-value information and insights on important sectors of the healthcare industry. Clients rely on this analysis and data to make informed decisions. Please visit Decision Resources Group at www.DecisionResourcesGroup.com .
All company, brand, or product names contained in this document may be trademarks of their respective holders.
BioTrends Research Group, LLCElisa Picardi, 610-363-9432epicardi@bio-trends.comorDecision Resources GroupChristopher Comfort, 781-993-2597ccomfort@dresources.com
Read at BioSpace.com

Healthy You

Low Vitamin D Levels Could Cause Liver Disease
by Dr. Simi Paknikar on August 08, 2011 at 12:16 PM

We are all aware that low levels of vitamin D can cause weak bones. A recent study indicates that it could be associated with liver disease as well! Researchers claim that low vitamin D could be one of the reasons behind the development of non-alcoholic fatty liver disease (NAFLD). NAFLD occurs due to accumulation of triglycerides in the liver cells.

Outpatients of suspected metabolic syndrome with normal liver enzymes, no excessive alcohol intake, negative for hepatitis B and hepatitis C, no cirrhosis or chronic liver disease were subjected to liver ultrasound to estimate the presence and degree of fatty liver disease. 25(OH) vitamin D levels were measured to estimate any deficiency of vitamin D. The researchers found that patients with NAFLD had low levels of 25(OH) vitamin D. They also found that the lower 25(OH) vitamin D levels, the worse is the degree of fatty liver disease. This association was independent of other possible influencing factors like age, sex, triglycerides, HDL and fasting blood glucose levels.

Vitamin D suppresses fibroblast (cell from which connective tissue develops) proliferation and collagen production, thus acting as an immune-modulator. It also appears to have a beneficial effect in patients with hepatitis C on treatment with interferon. Vitamin D normally plays a role in the metabolism of free fatty acids. Thus, the researchers suggest that in people with low vitamin D levels, the excess free fatty acids flow in the blood stream.

These deposit in the liver, resulting in NAFLD. Vitamin D’s anti-inflammatory properties and reduction in insulin resistance could also play an important role. Further studies are warranted to evaluate whether administration of vitamin D in patients with NAFLD could help to treat it, thus firmly establishing the association between fatty liver disease and vitamin D.
Reference: Barchetta I et al Strong association between non alcoholic fatty liver disease (NAFLD) and low 25(OH) vitamin D levels in an adult population with normal serum liver enzymes; BMC Medicine 2011; 9:85.Source-Medindia
Read more: Low Vitamin D Levels Could Cause Liver Disease MedIndia

Off The Cuff

The Sometimes Folly of Peer-Reviewed Journals
By George Lundberg, MD, Editor-at-Large, MedPage Today
August 08, 2011

Hello and Welcome. I'm Dr. George Lundberg and this is At Large at MedPage Today.
Picture this: A medical journal receives an unsolicited manuscript from an unknown author, and then ... Type 1 medical journal.
The peer review process employed by Type 1 medical journals uses secret, anonymous peer reviewers working behind an opaque shield hiding clueless and spineless editors who may use either no reviewers, or a few cronies, or those reviewers known to be opposed or known to be in favor of some medical theory, hypothesis, study, test, product, or procedure.
As such, the results of the entire review process may be rigged by any of that cast of journal decisionmakers, known collectively as "editors." They may promote whole fields of medicine into which vast sums of a nation's resources may be channeled and harvested. One famous medical school dean once described an American academic medical center as "the most efficient resource-trapping device in the history of the world." In sum, a vast medical cartel in conspiracy to assure the maintenance of its self-interest in perpetuity, cloaked in "peer review."
Or, Type 2 medical journal.
The peer review process employed by Type 2 medical journals revolves around a sacred trust relationship between a skillful, competent, unbiased, and eminently moral chief editor, who, with a similarly pristine staff with no conflicts of interest, attracts and selects the most scientifically pure and clinically useful articles.
To do so, he or she uses the unpaid voluntary talents of a host of similarly unbiased, rapid-response peer reviewers to help accept all articles that justify publication in that stellar venue based purely upon merit. These are rapidly published in electronic form with no page or length limitations and free, open access to all, unhampered by advertising or subscription requirements. The entire process is transparent, including names, dates, opinions, revisions, and decisions.
My insider bias is that many elements of Type 2 are more prevalent than many elements of Type 1. But, in fact, variations and blends of editorial and publishing conduct between these 2 types are the dominant mode in 2011.
Of course, post-publication peer review has always been the most important peer review of medical journal articles.
That is when potentially large numbers of readers, in contrast to only a few pre-publication readers, can have at an article.
Most published medical journal articles are ignored, and deservedly so. Very few advance scientific knowledge and medical thinking a great deal. Some of the messes medical journals make are made right by that journal publishing "corrections" or even "retractions," and by the "letters" column.
But, how about that more than 90% of submitted articles that "the best" journals reject and that more than 50% of submitted articles that the second-tier journals reject, many of which were never seen by eyes outside the editorial offices?
How many gems of observation, data, and thinking were simply lost by dogmatic suppression, narrowness of thinking, the fetters of paper-based decisions, or fear of taking on the status lucratus of the American Medical Marketing Machine (AMMM)?
As famed New York Times columnist and Princeton Nobelist Paul Krugman has sometimes written: "Be afraid; be very afraid," but only if your health and the health of your patients matter to you.
That's my opinion. I'm Dr. George Lundberg, At Large for MedPage Today.

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