Back to News Review
Week Ending: February 10th , 2007
Alan Franciscus
Editor-in-Chief
To download pdf version click
here
This Issue:
Back to top
February 1st , 2007
Up to 60,000 Now Feared to Have Hepatitis C Virus
http://www.theherald.co.uk
MARTIN WILLIAMS
THE number of Scots with hepatitis C is at record levels, with some experts estimating nearly 60,000 people now have the virus.
According to the latest health service data, 19,100 Scots were officially diagnosed as having hepatitis C in September last year, a rise of 3000 in nearly three years.
However, analysts estimate up to three times that number have the virus, but have not yet been diagnosed.
advertisementThe figures have prompted calls for needles to be made more freely available to drug users to help prevent infection.
According to experts, the virus can lie undetected in infected people for decades and can be life-threatening to between 20% and 30% of people who develop the disease in its chronic form. Up to 2578 Scots have so far died from the illness.
The incidence in Scotland is now thought to be more than 1%, which compares with around 0.5% for the rest of the UK.
An analysis from Health Protection Scotland (HPS) shows that there were 396 new cases diagnosed between last July and September, 16% more than over the same period in 2005.
Of those that have been diagnosed, 60% are known to have injected drugs. Some 41% were aged 15 to 29 years, 44% were aged 30 to 44, and 12% were aged over 45.
People living in the new Greater Glasgow and Clyde NHS board area account for 41% of the cases, with 14% in Lothian.
Glenn Codere, of HPS, said: "There are a number of cases out there that remain undiagnosed. The number of new cases diagnosed has stabilised. The problem is not the kind of the thing that manifests itself for quite a length of time. People that have it can seem to be perfectly healthy for a long time. What we are finding is that we are picking up more cases of hepatitis C as the public become more and more aware of it."
Last year, the Scottish Executive launched a £4m action plan to curb the spread of hepatitis C, which it described as the "hidden killer".
People with haemophilia who contracted it through contaminated NHS blood products have been demanding a public inquiry for several years.
Claire Morris, co-ordinator of C-Level, the Glasgow and Scotland hepatitis C support charity, said yesterday it was not clear whether the executive's initiatives would work, and called for needles to be made freely available to addicts.
www.c-level.org.uk
Back to top
February 3rd, 2007
SLC Drug Conference Stresses Treatment over Incarceration
http://www.sltrib.com/
By Michael N. Westley
The Salt Lake Tribune
What should be done to help Americans who are using drugs and experiencing collateral consequences, such as HIV and hepatitis?
Those attending the second national Conference on Methamphetamine, HIV and Hepatitis in Salt Lake City this week voiced a clear consensus: More research about the effects of meth on women, an understanding about the universal draw to the drug and continued justice-system reform that emphasizes treatment over incarceration.
The focus needs to be on education, prevention and treatment, experts agreed.
The second day of the conference served as a platform to share research and ideas, and included an early-morning presentation by Utah's premier HIV physician Kristin Reis.
"People ask me, 'Kristen, why work at something that pays poorly and you have to work with patients who are mean and you can't help?' " she said.
Her presentation highlighted the need for increased funding for treatment and more accessibility for those who need help.
Much of the new data about who is using meth have been gained by researchers from syringe exchange programs throughout the country. Those using the programs - which have proven to be effective in lowering HIV and hepatitis transmission rates - have given researchers candid insight about their behavior, said Naomi Braine of the National Development and Research Institutes in New York City.
Her research used data from 23 needle exchange programs, which in 2000 placed more than 60,000 clean syringes in the hands of IV drug users. She found the lure of methamphetamine to be universal - no single demographic group was immune or had heavier users than others.
Utah's Harm Reduction Project director, Luciano Colonna, said Utah's small towns have been unprepared to deal with meth, in terms of health care and law enforcement.
"The reason we began these conferences is the impact meth has had in rural areas in Utah and the West," Colonna said.
The Harm Reduction philosophy aims to find sensible approaches to helping people who are using drugs and encouraging them to be safe. Michael Sever, director of the Stonewall Project in San Francisco, aptly embodied the outlook with his presentation debunking myths around meth and its users.
"I am a psychologist. I am a gay man. I am a person living with AIDS and I do drugs. I don't think the people I'm talking about are any different than me," Sever said.
mwestley@sltrib.com
Back to top
February 5th, 2007
Antipodean Pharmaceuticals Initiates Phase 2 Trial in Hepatitis C
http://biz.yahoo.com
Potential Additional Treatment Strategy to Reduce Liver Damage in Chronic Patients
SAN FRANCISCO, Feb. 5 /PRNewswire/ -- Antipodean Pharmaceuticals, Inc. today announced it has initiated a Phase 2 clinical trial of its lead compound MitoQ (mitoquinone) to investigate the drug's efficacy to reduce liver damage in patients with raised liver enzymes associated with the Hepatitis C virus (HCV). The principal investigator for the trial, Dr. Edward Gane, Associate Professor of Medicine, New Zealand Liver Transplant Unit at Auckland City Hospital, enrolled the first patient.
"Although new antiviral agents are in development, therapies are needed to reduce liver injury in patients with chronic hepatitis and to reduce inflammation and fibrosis," said Dr. Gane. "MitoQ's novel mechanism of action may provide an additional option to treat these occurrences as newer therapies become available."
The trial will enroll 36 patients, who have HCV but have been unresponsive to, or unsuitable for, treatment with pegylated interferon plus ribavirin. Patients will be randomized into three trial arms comparing two dosing regimens of MitoQ to placebo. MitoQ is orally administered once daily. The primary endpoint will be the change in the level of alanine aminotransferase (ALT), a liver enzyme that is produced in higher amounts when the liver is inflamed, at the end of the treatment period compared with baseline.
"Mitochondrial protective agents and mitochondria-directed antioxidants represent a unique direction for the development of drug candidates that can modify the pathogenesis of chronic Hepatitis C," said Dr. Ken Taylor, CEO of Antipodean. "MitoQ is a promising compound in this and other areas. We believe that MitoQ could be used to halt or decrease liver inflammation and fibrosis progression, even in the absence of sustained virologic response."
Evidence shows that HCV can directly alter mitochondrial function, leading to increased reactive oxygen species (free-radical) production that can lead to scarring of the liver and cirrhosis. MitoQ is based on a novel technology, targeted lipophilic cations, that transport and concentrate antioxidants into the mitochondria where they accumulate up to a thousand fold, and have been shown to significantly interrupt oxidative damage to the cell.
About Hepatitis C Virus (HCV)
HCV, a viral infection of the liver, affects over 170 million people worldwide. Approximately 3 million people in the United States have chronic Hepatitis C infections; however, the true prevalence may be underestimated, since newly infected people usually are asymptomatic for many years. HCV infection is the leading cause of cirrhosis, hepatocellular carcinoma, and liver failure. Current treatment strategies focus on achieving a sustained virologic response, but available therapies have poor side-effect profiles and eradicate HCV in only approximately 50% of individuals. New novel therapies for eradicating the HCV virus and slowing the progression of liver scarring are needed.
About Antipodean
Antipodean is a clinical-stage pharmaceutical company developing treatments for Parkinson's disease and other disorders associated with mitochondrial dysfunction. The company's lead product, MitoQ, is being investigated in Phase 2 trials in Parkinson's disease and Hepatitis C. MitoQ was invented by Professor Robin Smith at the University of Otago in New Zealand and Dr. Michael Murphy, a former colleague at Otago, who now works at the MRC Dunn Human Nutrition Unit in Cambridge. Antipodean recently opened its corporate headquarters in San Francisco, California and maintains an operational base in Auckland, New Zealand. The company works closely with researchers and investigators in New Zealand, Australia, the San Francisco Bay Area, and elsewhere in the United States to develop MitoQ and other therapeutics based on mitochondrial targeting. Antipodean investors include: Delphi Ventures, 5AM Ventures, GBS Venture Partners and Versant Ventures. Further information is available at www.antipodeanpharma.com.
Source: Antipodean Pharmaceuticals, Inc
Back to top
Event of the Heart
http://www.ukiahdailyjournal.com
By LAURA MCCUTCHEON
The Daily Journal
Tickets are still available for the 20th Annual Event of the Heart, where people can eat, drink, dance and be merry all for a good cause.
This Saturday's event, hosted by the Mendocino County AIDS Volunteer Network, will provide fundamental support for MCAVN's work preventing the transmission of HIV and Hepatitis C.
"Between 2000 and 2005, 773 new cases of Hepatitis C were reported in Mendocino County, averaging 155 cases per year, making this chronic disease the fastest growing infection in the county. Eighty percent will likely become carriers," states the 2006 Mendocino County Community Health Status Report.
"It shocked me when the health report came out," MCAVN Executive Director Cyril Colonius said, referring to the fact that Hep C is said to be the fastest growing infection in the county. "And it's preventable. And, of the estimated 4,000 people in the county who have it, half don't even know they do, and of the half that knows they do, less than half are in treatment. ... Treatment is available and the alternative to not being treated could lead to liver failure," he said.
Asked if people are simply in denial, he said: "Health behaviors are a very complex issue, especially when they involve pleasure, which could come from sexual activity or drug use. I often try to look at other health issues like smoking when talking about drug use and sexual behavior.
"I remember one time when someone told me, I don't understand why people don't just quit drugs' and I said, Have you ever tried to quit smoking?' Each and every one of us is wired very differently. What would motivate me to stop sharing needles is very different than what would motivate another person," Colonius said.
The answer?
Primary prevention, for one thing.
"People need to avoid sharing blood through needles," Colonius said, noting Hepatitis C is not thought of as a sexually transmitted disease and is primarily transmitted through blood.
If people do share needles, they should be tested for Hepatitis C, he said, noting the tests can be done at MCAVN for free and people can remain anonymous. Lastly, people who do have Hepatitis C need to seek medical care, he said.
"We can manage this disease; it doesn't have to end up in death," he said. For example, people with Hepatitis C should reduce -- or eliminate -- their alcohol consumption. Drinking alcohol when you have Hepatitis C is like throwing gasoline on a fire, Colonius said.
In addition to free HIV/HCV testing, MCAVN offers a variety of services, including counseling, referrals and education.
To contact MCAVN or to purchase tickets for the Event of the Heart, call 462-1932 or stop by the office at 148 Clara Ave., Ukiah. Tickets for the event are also available at the Mendocino Book Company and at Leaves of Grass in Willits.
Laura McCutcheon can be reached at udjlm@pacific.net.
Back to top
China OK's Worldwide's Hepatitis C Test
http://www.upi.com
XI'AN, China, Feb. 5 (UPI) -- Worldwide said Monday the Chinese Food and Drug Administration approved its hepatitis C diagnostic kit.
The company said the product, known as "diagnostic kit to hepatitis C antibody," is the only diagnostic test developed from intact HCV virus, which could improve accuracy and diagnostic window compared to other tests.
"This transition is a critical milestone of our growth strategy to become the leading figure in the research & development of HCV diagnostics and therapeutics," said Wenxia Guo, Worldwide's president and chief executive officer.
"Our ability to release a highly sensitive and accurate HCV diagnostic product based on the intact HCV virus, that we cultured, strongly enhances the leading position of our company in HCV research," Guo added.
Worldwide said it has already commenced the large-scale production and sale of its test.
Back to top
Cirrhosis Depletes CD4 Cells, Even in the Absence of HIV
Source: AIDS Clinical Care
Absolute CD4-cell counts might not be a reliable means of assessing immunosuppression in HIV-infected patients with advanced liver disease.
In patients coinfected with HIV and hepatitis C virus (HCV), clinicians have sometimes observed that CD4-cell counts are lower than would be expected, given an apparently good virologic response to treatment. Indeed, some studies have suggested that coinfection is a risk factor for impaired immunologic response. This study of CD4-cell counts among HIV-uninfected patients with advanced liver disease sheds further light on the subject.
Sixty HIV-negative patients with cirrhosis (as determined by biopsy or clinical criteria) were prospectively enrolled in this Boston-based study; 31 had HCV infection, and 1 had HBV. Based on Child-Turcotte-Pugh scores, 21 patients had class A cirrhosis, 24 had class B, and 15 had class C. Thirty-nine patients (65%) had abnormally low CD4 counts, defined as <550 cells/mm3; of these, 26 had CD4 counts <350 cells/mm3, and 4 had counts <200 cells/mm3. Notably, CD4 percentages were preserved in 95% of all patients with low CD4-cell counts. Factors significantly associated with abnormal CD4-cell counts were splenomegaly, overall leukopenia, thrombocytopenia, and other clinical markers of portal hypertension. Demographic characteristics and etiology of liver disease were not associated with lower CD4-cell count s.
Comment: This study is the first to report abnormal CD4-cell counts in HIV-negative patients with cirrhosis. Based on the strong association between low CD4-cell counts and both leukopenia and thrombocytopenia, the authors postulate that abnormal CD4 values are the result of T-cell sequestration related to portal hypertension and splenomegaly. The authors and the editorialist raise important points regarding how these results may affect our interpretation of previous studies on immunologic response to antiretroviral therapy in HIV/HCV-coinfected patients. In future encounters with HIV-positive patients with liver disease, researchers and clinicians need to account for the possible effect of liver disease on the absolute CD4-cell count. Perhaps more important, though, is that they account for the possible discordance between CD4- cell count and CD4 percentage and examine the clinical significance of this discordance, given that it could affect treatment decisions and the evaluation of disease progression.
— Rachel Baden, MD
Dr. Baden is an Instructor in Medicine at Harvard Medical School and an Attending Physician in the Infectious Diseases Division at Beth Israel Deaconess Medical Center in Boston.
Citation(s):
McGovern BH et al. The impact of cirrhosis on CD4+ T cell counts in HIV-seronegative patients. Clin Infect Dis 2007 Feb 1; 44:431-7.
[Medline abstract]
Gandhi RT. Cirrhosis is associated with low CD4+ T cell counts: Implications for HIV-infected patients with liver disease. Clin Infect Dis 2007 Feb 1; 44:438-40.
[Medline abstract]
Back to top
Internationally Renowned Expert in Artificial Liver Device Development Joins HepaLife
http://www.genengnews.com
Business Wire
HepaLife Technologies, Inc. (OTCBB:HPLF) (FWB:HL1) (WKN:500625), developing the first-of-its-kind artificial liver device, is pleased to announce the addition of Prof. Jorg C. Gerlach, MD, PhD, to the Company's Scientific Advisory Board.
With over 20 years of experience as a professor, bioengineer, experimental transplantation surgeon, and medical doctor, Dr. Gerlach is a widely-published, internationally recognized lecturer and leading expert in the development of bioreactor systems and artificial organs for patients suffering from liver failure.
"I'm honored to welcome Dr. Gerlach to the HepaLife team," stated Mr. Frank Menzler, President and CEO of HepaLife Technologies, Inc. "Dr. Gerlach brings us extensive American and European experience in liver-related medicine, surgery, and the engineering required in creating an artificial liver device - a goal that has eluded traditional researchers."
"It is widely understood in the scientific community, that the most vital component in an artificial liver device is not the mechanical hardware, but rather, it is the biological cells inside the device which are responsible for truly replicating and performing the functions of the human liver," continued Mr. Menzler.
"It is here that our patented PICM-19 cells have repeatedly performed exceptionally well. Even after continual splitting, culturing, and grueling room temperature exposure, our cells have repeatedly behaved and performed like liver cells. In contrast, cells used by others have developed cancers, lost their ability to function, or simply died."
In ongoing research, scientists have demonstrated that HepaLife's PICM-19 cells have unique characteristics distinct from other cells, and are able to mimic the human liver's response in several important ways. PICM-19 cells:
-- Do not develop tumors or become cancerous, despite years in continuous culture
-- Are the only cell line known to uniquely differentiate into hepatocytes (liver cells) and bile duct epithelium
-- Successfully express inducible P450 and GGT; important indicators of liver and bile duct functions, respectively
-- Are able to remain in continuous culture and undergo repeated passage while retaining hepatic function; these results demonstrate cell strength and function
-- Can grow at high cell density, potentially able to populate a liver device in high numbers and thus, increase its efficiency
-- Express proteins and mRNA that are unique to the liver
-- Successfully remove toxic ammonia and produce urea; both are significant functions of the human liver
-- Respond to acetaminophen (Tylenol) exposure, similar to the human liver
-- Survive human plasma exposure; a function vital to an artificial liver device
-- Can survive at room temperature for prolonged periods of time while retaining function; this makes PICM-19 cells ideally suited for shipping in the clinical application of an artificial liver device for human patients with liver failure.
Liver failure is frequently the consequence of cirrhosis, viral hepatitis, liver cancer, and chronic liver disease. This combined diagnosis now makes liver disease one of the 10 leading causes of death in the United States.
Twenty-five million Americans have, or have had liver disease, and according to the World Health Organization, 10% of the global population has chronic liver disease, accounting for an estimated half a million deaths in China alone. One in four Americans will suffer from a biliary or liver disease at some point in their lifetime, according to the National Institutes of Health (NIH).
In response, HepaLife, incorporating its PICM-19 cells, is developing the first-of-its-kind artificial liver device for patients with liver disease, a strategy endorsed by healthcare experts, clinicians, and the NIH, which recently reiterated the need, "to develop a hepatic assist device or bioartificial liver and demonstrate its efficacy in acute liver failure."
The NIH, backed by 250 liver disease experts, has issued a formal Action Plan for Liver Disease, stating: "In the area of acute liver failure, the primary goals of research should be in developing means to prevent acute liver failure and ameliorate its course.... Most helpful would be an artificial or bioartificial liver assist device that could be used to sustain patients and serve as a bridge to liver transplantation, which is the only effective treatment that is currently available for fulminant hepatic failure."
Prof. Jorg C. Gerlach, MD, PhD Joins HepaLife Scientific Advisory Board:
Liver Researcher, Surgeon, Bioengineer; Expert in Artificial Liver Device Development
Jorg C. Gerlach, MD, PhD is an internationally renowned authority in liver function, disease, and cutting-edge artificial liver support systems, with formal European training and extensive European and American experience as a medical doctor, specialist in experimental surgery, cell biology, hybrid organ development, bioengineering, and artificial liver devices.
Dr. Gerlach is a widely-published liver expert, with more than 100 research publications to his credit (90 first-authorships) in peer-reviewed scientific publications and industry journals, alongside 100-plus research abstracts, 15 book contributions, and over a dozen patents in Europe, Japan, and the United States covering cell biology, hybrid organs, and bioreactor systems.
At the University of Pittsburgh's McGowan Institute for Regenerative Medicine, Dr. Gerlach currently directs the Bioreactor Group, researching artificial organs, hybrid organs and bioartificial liver systems. The McGowan Institute is internationally recognized for regenerative medicine research and the clinical translation of emerging therapies. The Institute serves as a single base of operations for the university's leading scientists and clinical faculty working to develop tissue engineering, cellular therapies, and artificial and biohybrid organ devices.
Dr. Gerlach is also tenured as a Professor of Surgery (School of Medicine) and as Professor of Bioengineering (School of Engineering) at the University of Pittsburgh. He additionally serves as Professor of Experimental Surgery at Humboldt University, Berlin, Germany.
Dr. Jorg C. Gerlach received his MD and PhD degrees at Freie Universitaet, Berlin, completing a post-doctoral, Habilitation in Experimental Surgery at Humboldt University, Berlin, and subsequently earned his second PhD in Bioengineering at Strathclyde University, Glasgow, Scotland.
ABOUT HEPALIFE TECHNOLOGIES, INC.
HepaLife Technologies, Inc. (OTCBB:HPLF) (FWB:HL1) (WKN:500625) is a development stage biotechnology company focused on the identification, development and eventual commercialization of cell-based technologies and products.
Current cell-based technologies under development by HepaLife include 1) the first-of- its-kind artificial liver device, 2) proprietary in-vitro toxicology and pre-clinical drug testing platforms, and 3) cell-culture based vaccines to protect against the spread of influenza viruses among humans, including potentially the high pathogenicity H5N1 virus.
For additional information, please visit www.hepalife.com.
To receive future press releases via email, please visit: http://www.hepalife.com/alerts.php
To view the full HTML text of this release, please visit:
http://www.hepalife.com/20070205-1.html.php
Legal Notice Regarding Forward-Looking Statements
No statement herein should be considered an offer or a solicitation of an offer for the purchase or sale of any securities. This release contains forward-looking statements that are based upon current expectations or beliefs, as well as a number of assumptions about future events. Although the Company believes that the expectations reflected in the forward-looking statements and the assumptions upon which they are based are reasonable, it can give no assurance that such expectations and assumptions will prove to have been correct. Forward-looking statements, which involve assumptions and describe our future plans, strategies, and expectations, are generally identifiable by use of the words "may," "will," "should," "could," "expect," "anticipate," "estimate," "believe," "intend," or "project" or the negative of these words or other variations on these words or comparable terminology. The reader is cautioned not to put undue reliance on these forward-looking statements, as these statements are subject to numerous factors and uncertainties, including but not limited to adverse economic conditions, intense competition, lack of meaningful research results, entry of new competitors and products, adverse federal, state and local government regulation, inadequate capital, unexpected costs and operating deficits, increases in general and administrative costs, termination of contracts or agreements, technological obsolescence of the Company's products, technical problems with the Company's research and products, price increases for supplies and components, litigation and administrative proceedings involving the Company, the possible acquisition of new businesses or technologies that result in operating losses or that do not perform as anticipated, unanticipated losses, the possible fluctuation and volatility of the Company's operating results, financial condition and stock price, losses incurred in litigating and settling cases, dilution in the Company's ownership of its business, adverse publicity and news coverage, inability to carry out research, development and commercialization plans, loss or retirement of key executives and research scientists, changes in interest rates, inflationary factors, and other specific risks. We currently have no commercial products intended to diagnose, treat, prevent or cure any disease. The statements contained in this press release regarding our on going research and development and the results attained by us to-date have not been evaluated by the Food and Drug Administration. There can be no assurance that further research and development, and /or whether clinical trial results, if any, will validate and support the results of our preliminary research and studies. Further, there can be no assurance that the necessary regulatory approvals will be obtained or that HepaLife will be able to develop commercially viable products on the basis of its technologies. In addition, other factors that could cause actual results to differ materially are discussed in the Company's most recent Form 10-Q and Form 10-K filings with the Securities and Exchange Commission. These reports and filings may be inspected and copied at the Public Reference Room maintained by the U.S. Securities & Exchange Commission at 100 F Street, N.E., Washington, D.C. 20549. You can obtain information about operation of the Public Reference Room by calling the U.S. Securities & Exchange Commission at 1-800-SEC-0330. The U.S. Securities & Exchange Commission also maintains an Internet site that contains reports, proxy and information statements, and other information regarding issuers that file electronically with the U.S. Securities & Exchange Commission at http://www.sec.gov. The Company undertakes no obligation to publicly release the results of any revisions to these forward looking statements that may be made to reflect the events or circumstances after the date hereof or to reflect the occurrence of unanticipated events.
Back to top
February 6th, 2007
Lessons Learned from Liver Retransplantation
http://www.medicalnewstoday.com
A new study on liver retransplantation (re-LT) over a 15 year period at a clinic in Germany found that indications for the surgery had changed and there were fewer rejections, complications, and recurrence of disease during that time. The positive trend may be due to improvements in intensive care management and immunosuppressants, along with early decisions about when to retransplant despite the shortage of quality donor organs.
The results of this study appear in the February 2007 issue of Liver Transplantation, the official journal of the American Association for the Study of Liver Diseases (AASLD) and the International Liver Transplantation Society (ILTS). The journal is published on behalf of the societies by John Wiley & Sons, Inc. and is available online via Wiley InterScience.
While liver transplantation has become increasingly successful over the last two decades, liver retransplantation shows significantly inferior results. The reasons for this include infections following surgery, multiorgan failure, bleeding complications, recurrence of the underlying disease, and chronic rejections. In addition, it is more expensive than first-time transplants and presents the problem of claiming organs that might have otherwise been used by first-time recipients, who are more likely to have a better outcome. For these reasons, retransplantation is controversial, but for many patients it is the only alternative to death.
Led by Robert Pfitzmann, M.D. of Charité Virchow Clinic in Berlin, Germany, researchers conducted a study of 119 retransplant recipients in their clinic between 1989 and 2003 in order to find ways of improving treatment and results. Indications for retransplant included initial non-function of a transplanted liver, recurrence of the underlying disease, rejection, blood clots in the main artery that carries blood to the liver, and ischemic-type-biliary-lesions (ITBL), a complication of liver transplants. The mean follow-up was approximately 5 years; 65 percent of retransplants were performed within the first year of the initial transplant, the vast majority taking place within three months.
Analysis showed that coma, hemoglobin and the amount of plasma transfused during surgery were independent predictors of survival following retransplantation. In contrast to other studies, creatinine (a protein in the blood), the amount and time between the first and second transplant, donor and recipient age, ischemia time, bilirubin and hepatitis C status did not influence survival. "These results support our assumption that the recipients' clinical status immediately before re-LT plays a very important role on the outcome of our patients, whereas the donor status appears less important" the authors note. At the same time, they acknowledge that they used "high quality standard selection criteria and acceptance of donor organs," which may explain why donor status was not predictive of outcome.
Their findings led to several therapeutic measures, including lowering the dosage of immunosuppressants very early, administering medication to improve kidney function, early blood transfusions, and continuous improvements in intensive care management. They note that patient survival after retransplant very strongly depends on the reason for the transplant, with patients experiencing ITBL and rejection showing the best survival rates. They also observed that the major complications leading to death following retransplant were bacterial infections with septic complications, which indicates a variety of measures that can be undertaken to prevent infection from claiming lives. Although they achieved good results, they conclude that "further progress and improvement in the treatment of retransplanted patients is required to enchance survival after re-LT."
In an accompanying editorial in the same issue, R. Mark Ghobrial, M.D., Ph.D., F.R.C.S. of the David Geffen School of Medicine at University of California Los Angeles noted that retransplantation requires sophisticated decision-making but that accurate outcome predictors are lacking. The author suggests that the most important contribution of the current study is the determination of factors that predict outcomes in retransplants, noting that it is in agreement with previous reports stressing the influence of recipient status on retransplant outcome. However, he states that while the study minimizes the importance of donor status, these effects should not be underestimated. He questions why factors found to be independent predictors of death at other hospitals were not significant in the current study, noting that it may be due to the level of surgical expertise or the ability of the current study's authors to apply stringent selection criteria for donors and recipients. "The fruits of this selection effort are reflected in the good survival achieved in this series," he concludes. "The lessons for re-OLT may therefore be: selection, selection, selection."
###
Article: "Trends and Experiences in Liver Retransplantation Over 15 Years," Robert Pfitzmann, Birgit Benscheidt, Jan Michael Langrehr, Guido Schumacher, Ruth Neuhaus, Peter Neuhaus, Liver Transplantation; February 2007 (DOI: 10.1002/lt.20904).
Editorial: "Changing Faces of Liver Retransplantation: It is All About Selection," R. Mark Ghobrial, Liver Transplantation; February, 2007 (DOI: 10.1002/lt.21020).
Contact: David Greenberg
John Wiley & Sons, Inc.
Back to top
Conversation Piece: I Love My Wife with All My Liver
www.valleynewstoday.com
By Ken Knepper, Valley News Today Publisher
According to a friend, beginning this Valentine's Day I can no longer tell my wife that I love her with all my heart because he read somewhere that love isn't actually cardio - it's chemical.
That means, with about one week to go, I have to rethink my entire theme for this year's event.
For past Valentine's Days, I followed the mainstream approach to gifting, right down to poems with phrases rhyming with heart - she's smart; I was hit by Cupid's dart; my life was only a painting until she made it art; if love were a race track, she'd be the wheels on my go-cart; she's sweeter than all the candy in Wal-Mart...
You get the idea.
I've surprised her with heart-shaped candy boxes, heart-shaped balloons and once danced a little jig for her in heart boxer shorts.
But now I realize that was all for not.
My own research into the bodily function known as love uncovered some compelling evidence as well.
First, scientists say that infatuation is caused by brain chemistry and is actually a form of mental illness.
That means a person who is "madly in love" should seek professional help - not candy and a dozen roses.
And the enzymes we associate with a warm and fuzzy feeling or butterflies in the stomach when we're near our significant other are actually produced by secretions from our livers.
If that's true, we may need to completely change the body parts for Valentine's Day and make the color brownish-gray instead of red - just like a real liver served with onions.
We'll also have to change the icon associated with the holiday. A liver looks a lot like a chuck roast, so it should still be easy to find art for Valentine's Day in the meat section at your local grocery store.
Instead of having a "sweetheart," we'll have a "secretion of love" and I'll have to come up with a completely new set of poems for my wife...
"Those chemicals in my brain are only part of what my body delivers, because you also cause me to have a mighty quiver in my liver."
Or, "I'm attracted to you with an intense admiration; Scientists say I'm nuts, but I call it, Infatuation."
How about, "When I'm near you, my enzymes form a river, which explains why I love you with all my liver..."
All that's left is to find an appropriate pair of boxers...something gray or brown and adorned in liver spots.
I'll bet that gives her butterflies...
- Ken welcomes your views and comments at: Ken.Knepper@valleynewstoday.com
Back to top
Experts Explore Ways to Tackle Liver Diseases
http://www.gulfnews.com/
By Rania Habib, Staff Reporter
Abu Dhabi: One of the human body's vital organs and the diseases that affect it are the subject of the second International Conference at Al Noor Hospital, which was inaugurated by Shaikh Nahyan Bin Mub-arak Al Nahyan, Minister of Higher Education and Scientific Research, in Abu Dhabi yesterday.
The three-day event is hosting experts from the region as well as from Europe and Asia, and is discussing issues such as Hepatitis B and C, liver transplants and hepatobiliary diseases.
"The problem with diseases such as Hepatitis is that we have a big dilemma, because we have treatments but still no cure," said Dr Kassem Alom, Al Noor Hospital managing director and conference president.
Back to top
Chinese Scholars Call for Better Protection of Labor Rights of HBV Carriers
http://en.ce.cn/
Chinese scholars have called for better protection of the labor rights of hepatitis B carriers, most of whom are still unable to get jobs in local governments and companies.
Li Kungang, an associate professor with the law school of the Beijing-based Renmin University of China, said he had seen a number of reports on job discrimination against HBV carriers in recent years.
"This liver disease cannot be spread through casual contact. Barring the carriers from work for no good reason contravenes the labor law. Such practices also infringe HBV carriers' equal rights to employment," Monday's China Youth Daily quoted Li as saying.
Hepatitis B is mainly transmitted through the exchange of bodily fluids such as contaminated blood and semen, shared needles and infected mother-to-newborn contact.
China has an estimated 120 million chronic HBV carriers -- roughly 10 percent of the country's total population. Most of them show no symptoms and do not pose a threat to co-workers, but are locked out of jobs and suffer discrimination in social life.
"It's a huge waste of human resources and will exacerbate social tension if this massive group of people is not provided with proper jobs," Li said.
Ye Jingyi, a professor from Beijing University law school, said that under China's previous system, companies had to foot the bill for all medical expenditure for HBV carriers, who run a greater risk of developing liver cirrhosis and cancer.
But the old system has been replaced by the medical insurance system, under which companies only need to pay premiums for their employees. Fear of high medical costs can no longer be used as an excuse to refuse HBV carriers, Ye said.
She said that society should not ignore the plight of HBV carriers and the state should rapidly enact laws against job discrimination.
In April 2004, Zhao Xiaohua won a lawsuit against the personnel affairs bureau of the Wuhu government, in east China's Anhui Province, after being rejected for a job because he was an HBV carrier.
It was considered a landmark case since it gave HBV carriers a boost in their fight for equal employment opportunities.
While there are no national laws or regulations forbidding HBV carriers from joining the public service, many local governments and central government departments have issued their own regulations to bar them.
Some local administrations, including central Hunan Province and southwestern Guizhou Province, have lifted the ban on employing HBV carriers.
Source:Xinhuanet
Back to top
MIGENIX provides Update on License-Option Agreement with Schering-Plough for Celgosivir in Hepatitis C
http://biz.yahoo.com
VANCOUVER, BC, & San Diego, CA, Feb. 6 /CNW/ - MIGENIX Inc. (TSX: MGI - News; OTC: MGIFF - News), a clinical-stage developer of drugs for infectious and degenerative diseases, and Schering-Plough Corporation ("Schering") have agreed that the Schering limited period of exclusivity for data review of the celgosivir Phase II results announced November 6, 2006 has not yet commenced. This is the result of Schering having informed MIGENIX that approximately 50% of the original viral load samples from the study, which Schering tested under a Material Transfer and License Option Agreement between the companies, require retesting.
MIGENIX has just received results for approximately half of the required retests from Schering (this leaves approximately 25% of the original viral load samples from the study to be retested). Based on a preliminary review of these partial retest results by MIGENIX, it appears the overall conclusions drawn from the retest results will remain consistent with the conclusions of the original study analysis. However, as all retesting has not been completed, nor the results fully analyzed, at present it is unknown whether the retesting will result in any material changes - positive or negative - to the conclusions of the November 6, 2006 reported results.
A new data package of the results will be provided to Schering once the retesting is complete and the study results re-analyzed (see press releases of November 6, 2006 and December 13, 2006 for additional information on the original study results and the provision of the results to Schering). It is estimated that a period of approximately 8 weeks will be needed to finish the retesting and complete the new data package of the results, after which Schering's limited period of exclusivity for data review under the agreement between Schering and MIGENIX will commence.
Jim DeMesa, M.D., President & CEO of MIGENIX commented, "While the retesting represents a delay, we are encouraged by our preliminary analysis of the partial retesting results. We look forward to the retesting being completed, the study results re-analyzed and moving ahead with Schering in their evaluation of this novel, first-in-class product for treating Hepatitis C patients."
Additional Information: Impact of Retesting
Primary efficacy analysis for this study involves the determination of viral load changes from screening/baseline (prior to treatment) to study week 12 (on-treatment). Therefore, retest results from these study time points would have the greatest impact on the overall analysis. Based on our review of the samples scheduled for retesting, a significant number of patients in each of the 3 treatment groups will have their screening/baseline samples retested and a much smaller number will have their week 12 samples retested. From the sample retest data provided by Schering to date, approximately 90% of the results show a higher viral load than previously reported. As most of the retested samples are from screening/baseline (compared to week 12) and the retest results have shown higher reported viral loads, we expect to see greater viral load reductions from pre-treatment to study week 12 for most affected patients. This information together with the fact that there are a similar number of affected patients in each treatment group and study population, and other more detailed analyses, provides the basis for the current belief of MIGENIX that the overall conclusions with retest results will be consistent with the study results previously reported.
Material Transfer and License Option Agreement
Under the terms of the Agreement, Schering supplied PEGETRON(TM) (peginterferon alfa-2b powder for solution plus ribavirin 200 mg capsules) as well as certain technical and laboratory support and other services for MIGENIX's celgosivir Phase II combination study in chronic HCV patients. In addition, the Agreement granted Schering limited periods of exclusivity for data review of clinical trial results and for the negotiation of a license agreement.
About MIGENIX
MIGENIX is committed to advancing therapy, improving health, and enriching life by developing and commercializing drugs in the areas of infectious and degenerative diseases. The Company's clinical programs include drug candidates for the treatment of chronic hepatitis C infections (Phase II and preclinical), the prevention of catheter-related infections (Phase III), the treatment of neurodegenerative diseases (Phase I and preclinical) and the treatment of dermatological diseases (Phase II). MIGENIX is headquartered in Vancouver, British Columbia, Canada with US operations in San Diego, California. Additional information can be found at www.migenix.com.
"Jim DeMesa"
James M. DeMesa, M.D.
President & CEO
FORWARD-LOOKING STATEMENTS
This news release contains forward-looking statements within the meaning of the United States Private Securities Litigation Reform Act of 1995, and forward looking information within the meaning of applicable securities laws in Canada, (collectively referred to as "forward-looking statements"). Statements, other than statements of historical fact, are forward-looking statements and include, without limitation, statements regarding our strategy, future operations, timing and completion of clinical trials, prospects, plans and objectives of management. The words "anticipates", "believes", "budgets", "could", "estimates", "expects", "forecasts", "intends", "may", "might", "plans", "projects", "schedule", "should", "will", "would" and similar expressions are often intended to identify forward-looking statements, which include underlying assumptions, although not all forward-looking statements contain these identifying words. By their nature, forward-looking statements involve numerous assumptions, known and unknown risks and uncertainties, both general and specific, that contribute to the possibility that the predictions, forecasts, projections and other things contemplated by the forward-looking statements will not occur.
Although our management believes that the expectations represented by such forward-looking statements are reasonable, there is significant risk that the forward-looking statements may not be achieved, and the underlying assumptions thereto will not prove to be accurate. Forward-looking statements in this news release include, but are not limited to, statements concerning: our expectations regarding Schering's limited period of exclusivity for data review of the celgosivir Phase II results; our expectations regarding the conclusions of the retest results; our expectation that, once the retesting is complete and the study results re-analyzed, a new data package of the results will be provided to Schering; and our expectations regarding the time required to complete the new data package of the study results.
With respect to the forward-looking statements contained in this news release, we have made numerous assumptions regarding, among other things, the ability to successfully to complete the retests and re-analyze the celgosivir Phase II results within our expected timelines.
Actual results or events could differ materially from the plans, intentions and expectations expressed or implied in any forward-looking statements, including the underlying assumptions thereto, as a result of numerous risks, uncertainties and other factors including: dependence on corporate collaborations; uncertainties related to early stage of technology and product development; uncertainties as to the requirement that a drug be found to be safe and effective after extensive clinical trials and the possibility that the results of such trials, if completed, will not establish the safety or efficacy of our products; uncertainties as to future expense levels and the possibility of unanticipated costs or expenses or cost overruns; the possibility that opportunities will arise that require more cash than presently anticipated and other uncertainties related to predictions of future cash requirements; and other risks and uncertainties which may not be described herein. Certain of these factors and other factors are described in detail in the Company's Final Prospectus dated November 29, 2006, Annual Information Form and Annual Report on Form 20-F for the year ended April 30, 2006 and other filings with the Canadian securities regulatory authorities and the U.S. Securities & Exchange Commission.
Forward-looking statements are based on our current expectations and MIGENIX assumes no obligations to update such information to reflect later events or developments.
The Toronto Stock Exchange has not reviewed and does not accept responsibility for the adequacy or accuracy of this release.
For further information
Art Ayres, MIGENIX Inc., Tel: (604) 221-9666 Ext. 233, aayres@migenix.com
Dian Griesel, Ph.D., Investor Relations Group, Tel: (212) 825-3210, Theproteam@aol.com
Source: MIGENIX Inc.
Back to top
February 7th, 2007
Egypt: Five Million Infected with Hepatitis C
http://allafrica.com/
UN Integrated Regional Information Networks
Cairo
At least five million people in Egypt are infected with the hepatitis C virus (HCV), a new committee formed by the country's government to tackle the disease has said. It added that action must be taken now to combat rising mortality.
"The annual infection rate is more than 70,000 new cases, of which at least 35,000 would have chronic hepatitis C," said Dr Manal el-Sayed, Professor of Paediatrics at Cairo's Ain Shams University and member of the National Hepatitis Committee which is currently formulating an action plan to fight the disease.
Hepatitis C is a lethal virus which can cause liver cirrhosis and cancer. Egypt has one of the highest prevalence rates of the virus in the world, say specialists. An estimated 10-15 percent of the population, some 8-10 million people, are carrying hepatitis C antibodies, meaning that they either have or at one time had the virus. Five million of those are actively infected, according to government figures.
No vaccine is available for HCV although it can be treated with a combination of drugs if detected early enough.
Egypt's very high prevalence of HCV is largely the legacy of government campaigns prior to 1980 to treat rural populations for schistosomiasis (or bilharzia), a water-borne disease which at one time was endemic in Egypt. The treatment campaigns, which involved repeated injections, did not follow rigorous hygiene standards, and as such spread blood-borne HCV throughout the population.
As it may take up to 30 years for a patient to display symptoms of HCV or for the disease to become active, the full extent of the problem has only recently become known.
"The main risk factor [for HCV now], according to all the studies done in Egypt, is treatment in the past for schistosomiasis," said Dr Amr Kandeel, Director of the Communicable Disease Department at the Egyptian Ministry of Health and Population.
"At that time, the Ministry treated people in the villages without using disposable syringes," he added.
New infections
In addition to cases among the older population, new infections are still being recorded, due to poor medical practices and behavioural factors. Deaths from liver disease are, therefore, expected to increase in Egypt within the next 20 years.
"If we consider that by the year 2020 we are going to have so many patients who are having liver failure and liver cancer, treating them now is more effective than leaving them to that outcome," said el-Sayed.
Egypt's hepatitis committee is now making plans to prevent and treat hepatitis C. Treatment of HCV is usually done with a drug called Interferon. However, the most typical type of HCV in Egypt has about a 40 percent resistance to the drug. Although research is ongoing, no more effective treatment is yet available.
Nevertheless, the committee has succeeded in brokering a deal with the manufacturers of Interferon to supply the drug to Ministry of Health hospitals for one third of the usual price, and treatment under the committee's programme has begun in selected centres.
Even with the cost of Interferon reduced, the financial burden of Egypt's HCV problem is huge. The committee estimates that of the five million people actively infected with the virus, around one million currently need treatment. A year's treatment for a person with signs of liver damage from HCV costs around LE 25,000 (about US $4,500) - a sum few can afford.
In January this year, the committee began fundraising activities with the help of NGOs and international organisations including USAID, the World Health Organisation and UNICEF. The committee hopes to be able to provide free treatment to those most in need.
"We would also like to appeal to the international community to help with this campaign by whatever means possible," said el-Sayed.
Due to the cost and difficulty of treating chronic HCV patients, promoting awareness to prevent the disease, and detecting those infected before they develop liver damage are critical factors.
Screening the population
"We are going to promote screening for high-risk populations - including healthcare professionals who are at risk from needle injuries, and those who are undergoing repeated blood transfusion treatment," said el-Sayed.
The hepatitis committee has stressed the need for good infection control programmes in hospitals, and among healthcare professionals, to stem the transmission of the virus. The Egyptian Ministry of Health is co-operating through its National Infection Control Programme, which began in 2003.
Those at risk of new HCV infections in Egypt are not just those in medical contact with existing patients, however. The children and relatives of individuals affected during the schistosomiasis campaign are also a high-risk group, as widespread behavioural practices - such as the re-use of syringes, sharing of toothbrushes and even circumcision - all increase the risk of contracting blood-borne viruses such as HIV and Hepatitis C.
And although the circumcision of girls is officially banned in Egypt, the practice still continues, placing girls who are being circumcised at a very high risk of contracting HCV.
"Sometimes there is a sort of celebration for mass circumcision in certain communities. Girls are at a higher risk because it is a very bloody procedure. However, female circumcision has dramatically decreased, with more awareness and a ban by law," said el-Sayed.
As part of its Unite for Children, Unite Against Aids campaign, UNICEF Egypt has also been trying to raise awareness of the more common dangers of contracting HCV. Changing people's behaviour and attitudes toward blood safety is key, according to Wessam el-Beih, UNICEF's Unite Against Aids Egypt co-ordinator.
"Many people share razors and re-use syringes. They see no harm in just washing them and using them again. So there is a big behavioural component to the plan," she said.
[This report does not necessarily reflect the views of the United Nations ]
Back to top
Scottish Sexual HIV/HCV Transmission Trial Ends with Guilty Verdict
www.aidsmap.com
Edwin J. Bernard
A Glasgow High Court today found Italian national, Giovanni Mola, guilty of ‘reckless’ injury for sexually transmitting HIV and hepatitis C to a former girlfriend. It is the first time that anyone has been successfully prosecuted for the sexual transmission of hepatitis C, and the second successful Scottish prosecution for the sexual transmission of HIV.
Mr Mola, 38, was originally charged with “culpable and reckless conduct” in 2005. It was alleged that Mr Mola knew or believed that he had HIV and hepatitis C; that he knew or believed it could be transmitted through vaginal and oral sexual intercourse; that he did not disclose his infection to his former girlfriend – known as ‘Miss X’ – and repeatedly refused to wear a condom when they had sexual intercourse; that HIV and hepatitis C were transmitted as a result; and that this was to the permanent impairment of ‘Miss X’ and endangered her life and health.
During the trial Mr Mola admitted all but one of the charges. However, he denied repeatedly refusing to wear a condom. Thus, the outcome of the trial hinged on the credibility of Mr Mola and his former girlfriend. BBC online reported that whilst the former testified that he always used condoms during vaginal sex with ‘Miss X’ between September 2003 and February 2004, ‘Miss X’ testified that he “aggressively” refused to wear condoms.
However, BBC online also reported that ‘Miss X’ told the court that she had been a virgin before she met Mr Mola. Mr Mola’s defence lawyer, however, referred to evidence from Miss X’s sexual health clinic records that conflicted with her account.
The news reports make little mention of the scientific evidence presented in this case. However, since last August there is now a legal precedent showing the unreliabiltiy of phylogenetic analysis to conclusively prove that one person directly transmitted a virus to another.
It is also thought that there is an extremely low risk of heterosexual transmission of hepatitis C through unprotected vaginal and oral sex, even when exposed to someone who is coinfected with HIV.
Mr Mola’s conviction follows that of Stephen Kelly, who was the first person in Scotland – and in the UK – to be successfully prosecuted for the ‘reckless’ sexual transmission of HIV.
The first successful prosecution for ‘reckless’ sexual HIV transmission in England & Wales took place two years later, and there have been a further ten prosecutions, nine of which were successful. The most recent took place last month in Bournemouth.
Mr Mola is due to be sentenced on March 7th.
Back to top
February 8th, 2007
Gilead, Achillion Kill Hepatitis C Drug
http://www.businessweek.com
Biotechnology companies Gilead Sciences Inc. and Achillion Pharmaceuticals said late Thursday they are ending a collaboration on a developing hepatitis C treatment.
The companies said the drug candidate GS 9132, also called ACH-806, met its goal of antiviral activity in an early to middle-stage study. But the drug increased levels of serum creatinine, which indicates increasing loss of kidney function. Though the levels were reversible after the completion of dosing, the companies said, they have decided to end the study.
Both companies will now shift focus to collaborate on other similar compounds, called NS4A antagonists, citing the findings that the now-abandoned compound did work to fight hepatitis C.
Shares of Foster City, Calif.-based Gilead were down $1.16 to $71 in after-hours trading after closing down 8 cents to $72.16 on the Nasdaq. Shares of New Haven, Conn.-based Achillion fell 68 cents, or 3.6 percent, to close at $17.99 on the Nasdaq. That stock went public Nov. 9 and opened at $14 per share.
Back to top
MDS Nordion Establishes European Centers of Excellence for Innovative Liver Cancer Therapy
http://www.prnewswire.com
TheraSphere(R) expands treatment options for advanced tumors in patients
OTTAWA, Feb. 8 /PRNewswire-FirstCall/ - MDS Nordion, a leading global provider of medical isotopes and radiopharmaceuticals used to diagnose and treat disease, has established four Centers of Excellence in Europe for TheraSphere(R), its innovative liver cancer treatment. The Centers, located in Spain, France, Germany, and Italy will serve to train and educate oncology professionals on the use of the innovative technique. The Centres of Excellence are: BCLC Group Hospital Clinic, Barcelona, Spain; Centre Eugene Marquis, Rennes, France; University-Hospital Essen, Essen, Germany; and University of Pisa, Pisa, Italy.
TheraSphere(R) received the CE mark of approval for distribution and use in Europe in June 2006. TheraSphere(R) is a therapeutic medical device used in Europe for the treatment of liver cancer, including hepatocellular carcinoma (HCC), the most common form of primary liver cancer; or secondary liver cancer that has migrated to the liver from another location.
Comprised of tiny glass beads, TheraSphere(R) is injected by a physician into the main artery of the patient's liver using a catheter. The beads become lodged in the small blood vessels that feed the tumour and deliver a therapeutic dose of radiation directly to the cancer while minimizing impact on the patient's healthy tissue.
"Primary liver cancer can be difficult to treat as it is frequently accompanied by poor liver function resulting from other conditions such as hepatitis or cirrhosis. TheraSphere(R) is an option that is especially ideal for patients where surgery or transplantation is not possible," said Dr. Jordi Bruix, Director, BCLC Group Hospital Clinic in Spain.
"In this age of targeted therapies, TheraSphere(R) allows us to deliver a therapeutic dose of radiation directly to the cancerous tumour while minimizing the impact on a patient's healthy tissue," said Dr. Jean-Luc Raoul, Oncology Professor, Medical Oncology Department, Centre Eugene Marquis in France.
According to the National Cancer Institute, HCC is the fourth most common cancer in the world. Chronic hepatitis B and C and cirrhosis are known risk factors that increase the risk of HCC. Rates of HCC are higher in Europe than in North America. In North America the incident rate of liver cancer is about 2.1 per 100,000 people. In northern Europe the rate is approximately 5 per 100,000 population, while in southern Europe the rate ranges from 5-20 cases per 100,000 population.
"TheraSphere(R) complements and expands the treatment options for patients with primary liver cancer, particularly those with advanced tumors that were previously untreatable," said Dr. Philip Hilgard, Assistant Professor of Medicine with the University-Hospital Essen in Germany.
"The Centres of Excellence will greatly assist in increasing the awareness and understanding of the use and benefits of TheraSphere(R) among cancer treatment professionals in Europe," said Professor Riccardo Lencioni, Radiologist with the University of Pisa in Italy.
"The development of TheraSphere(R) Centers of Excellence is a significant step toward making this innovative cancer therapy more widely available to a greater number of patients in Europe," said Steve West, President of MDS Nordion. "We are excited to work with these prestigious institutions to gain valuable insight into the benefits of TheraSphere(R) for treating both primary and secondary liver cancer."
In September 2006, MDS Nordion announced it had received approval from the U.S. Food and Drug Administration to begin clinical trials on patients with secondary liver cancer. TheraSphere(R) has also been approved by the FDA for the treatment of patients with hepatocellular carcinoma (HCC), who have partial or branch portal vein thrombosis (PVT) and who have been identified as suitable candidates by their physicians. This expanded use extends the current approval of TheraSphere(R) as a Humanitarian Use Device for the treatment of HCC. In addition, MDS Nordion recently announced the first-time use of TheraSphere(R) at sites in India.
About TheraSphere(R)
TheraSphere(R) is a low toxicity, liver cancer therapy which consists of millions of micro-glass beads containing radioactive yttrium-90. The product is injected by physicians into the main artery of the patient's liver through a catheter which allows the treatment to be delivered directly to the tumor via blood vessels. Unlike chemotherapy, it has few side effects. Patients rarely experience nausea and vomiting usually associated with high-dose, systemic chemotherapies. TheraSphere(R) is approved in Europe for the treatment of primary and secondary liver cancer.
In the United States, the TheraSphere(R) treatment can generally be administered on an outpatient basis, does not usually require an overnight hospital stay and is 100% reimbursed by Medicare and many commercial health insurers. TheraSphere(R), is approved in the U.S. as a Humanitarian Device for the treatment of hepatocellular carcinoma, also referred to as primary liver cancer, and is now approved for patients who also have partial or branch portal vein thrombosis and who are identified as suitable candidates by their physicians. For more information on TheraSphere(R) go to http://www.therasphere.com or visit us at EASL 2007, April 11-15, 2007 in Barcelona, Spain, Booth # 2122.
About MDS Nordion
MDS Nordion (http://www.mds.nordion.com) is a world leader in medical isotopes, radiation and related technologies. It is a division of MDS Inc. (TSX:MDS)(NYSE:MDZ). MDS Inc. is a global life sciences company that provides market-leading products and services that our customers need for the development of drugs and diagnosis and treatment of disease. We are a leading global provider of pharmaceutical contract research, medical isotopes for molecular imaging, radiotherapeutics, and analytical instruments. MDS has more than 8,800 highly skilled people in 28 countries. Find out more at http://www.mdsinc.com or by calling 1-888-MDS-7222, 24 hours a day.
SOURCE MDS Nordion
Back to top
Tibotec Initiates Phase I Hepatitis Trial
http://www.pharmaceutical-business-review.com
By Victoria Harrison
Tibotec has initiated a phase I trial with a hepatitis C virus protease inhibitor, triggering a milestone payment of E2.5 million to its partner on the treatment, Medivir.
The phase Ia clinical trial is designed to assess the safety, tolerability, and pharmacokinetics in healthy volunteers. The study will be conducted in Europe.
Preclinical research conducted on the clinical candidate demonstrated favorable characteristics in potency, cross-resistance profiles and pharmacokinetic properties, supporting the exploration of oral dosing in the clinical trials.
"As there is a great need of new and effective treatment for chronic hepatitis C, we are extremely pleased that this project with joint resources and efforts now enters clinical trials," said Medivir's CEO Lars Adlersson.
The hepatitis C virus market is currently dominated by interferon-based treatments.
Back to top
Fears of HIV, Hepatitis Infections at Hospital
http://www.thewest.com.au/
The Canberra Hospital is searching for dozens of former infant patients who may have been infected with potentially deadly disease through inadequate sterilisation of equipment.
ACT Health says it has concerns that 97 babies may have been infected with Hepatitis B, Hepatitis C or HIV when they had a biopsy of the colon between February 1987 and mid-October last year.
About half have already been contacted and given blood tests but the results of the tests are not yet known.
The hospital is now trying to contact all of the others and their parents so they too can have tests to check if they have been infected.
Acting Chief Health Officer Dr Charles Guest says the chances of infection are slim, but the patients must be tested.
"The risks of disease transmission in this instance are remote, but it was important that the patients and their parents were informed that this breach had occurred and that their minds really be set at rest by offering them this testing," he said.
The problem was first noted in October last year when a staff member noticed the biopsy forceps had not been sterilised properly.
"These instruments have usually been cleaned with what's called an enzymatic cleaner and so they've looked clean all these years but on this one occasion late last year it was found that they looked dirty," Dr Guest told ABC Radio.
He said about half of the patients had already been contacted and the results from their tests should be back in a matter of hours or days.
"We're very aware that this process is likely to raise anxiety, we're very sorry for that, but we consider it a necessary step to ensure that people know what risks have occurred or haven't occurred."
Dr Guest said the patients and their parents had not been notified sooner as it was not considered a matter of emergency public safety.
ACT Health Minister Katy Gallagher said that was a wise decision as it was important to understand all the facts before the patients were notified.
"These are very sensitive issues - it would be much worse if we got only a handful of people that we knew about and rang them with only half of the information," the minister told ABC radio.
Ms Gallagher commended the hospital for informing the patients at all.
"I think it would've been must more distressing for the hospital to have found out and done nothing because the risk is so low and then have people find out perhaps down the track."
AAP
Back to top
Bands Play to Help Hepatitis C Patient
http://pittsburghlive.com
By Brian Bowling
TRIBUNE-REVIEW
A Penn Hills father of four has faced one surprise after another since he was diagnosed with hepatitis C in 2000, but the biggest surprise has been the support he's received from relatives, friends and neighbors.
"You don't know how many friends you have until something like this happens," said Tony Aleprete, 50.
Aleprete received a liver transplant in 2001, but needs a second one.
Some of his support comes from The Businessmen, a local rock band whose benefit concerts have raised more than $150,000 for local medical, anti-poverty, and literacy programs. The band has scheduled a benefit for Aleprete starting at 7 p.m. on Feb. 23 at Zanderz Sports Bar & Night Club, 951 Old Frankstown Road, Plum. James, another charity rock band, is scheduled to open for The Businessmen. The $10 admission will help defray Aleprete's medical costs.
Bob Lokar, manager for The Businessmen, said Aleprete is a lifelong friend to many of the band members, and is known in the community as someone who is always willing to help out.
"He's done so much for other people. It's just his turn," he said.
Aleprete's first surprise came in 2000 when he was diagnosed. A Navy veteran, the welder said he suspects he contracted the disease while he was in the service in the early 1970s.
The virus that causes hepatitis C wasn't discovered until 1989. It is mainly spread through contact with the blood of someone already infected. Aleprete said he could have gotten the virus during the assembly line-like vaccinations the military conducted on recruits, but some of his family members also suspect it could have happened in a Rhode Island bar.
"It was not the cleanest place," he said. "They were offering tattoos. I was 18, drunk, so I said, 'OK, put one on.' "
Regardless of where the virus came from, it nearly killed him before he received the first transplant. Aleprete said he was surprised how many people turned out to help his family after the operation. In particular, members of the Rosedale Beach Club took turns cooking dinners for his family for the first month.
"It was getting ridiculous after a while because we couldn't eat it all," he said. "I will never forget the kindness of everyone."
Aleprete's most recent surprise came in October when a routine checkup revealed he needed a new liver.
"I cleared (the virus) for six months, and then it came back," he said. "I was shocked when the doctor told me he was going to put me on the (transplant) list again. I thought that day would never come," he said.
Brian Bowling can be reached at bbowling@tribweb.com or (412) 320-7910.
Back to top
Back to News Review
|
