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Week Ending: January 20th , 2007
Alan Franciscus
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January 13th , 2007
Hidden Hepatitis B Infection Still Promotes Cancer
http://paktribune.com
ISLAMABAD: Infection with hepatitis B virus (HBV) promotes liver cancer even when there is no evidence of the virus in the blood, findings from a new study suggest.
Unlike the usual situation with HBV infection when the virus can be detected in blood samples, hidden or "occult" infection occurs when HBV is only detectable in liver tissues. Previous studies have linked the usual HBV infection with liver cancer, but it was unclear if the same held true with occult infection.
To investigate, Dr. Teresa Pollicino, from the University of Messina in Italy, and colleagues tested for HBV in liver tissue obtained from 107 patients with liver cancer and 192 patients with other liver diseases. None of the patients had any evidence of HBV in their blood.
The researchers' findings are reported in the medical journal Gastroenterology.
Liver HBV was detected in 64 percent of liver cancer patients compared with just 33 percent of patients with other diseases. Moreover, the apparent link between liver HBV and cancer held true after accounting for age, sex, and co-infection with hepatitis C virus.
"Our study definitively shows that HBV also maintains its (cancer-promoting) role in the case of occult infection," the researchers state. Therefore, patients with worsening liver disease but no evidence of HBV in their blood should probably be tested for liver HBV to assess their risk of cancer.
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January 15th, 2007
Endoscopic Screening for Varices in Cirrhosis Has Increased
www.gastrohep.com
The latest Gastrointestinal Endoscopy reports that endoscopic screening for varices in patients with cirrhosis has increased.
The current guidelines for primary prophylaxis of variceal hemorrhage in cirrhotic patients recommend screening for varices with upper endoscopy.
Utilization and outcomes of screening in clinical practice are unknown.
Dr Atif Zaman and colleagues from Oregon determined the use of endoscopic variceal screening in diverse practice settings.
The team of doctors assessed factors associated with the finding of esophageal varices.
Varices were found in 52% of screened patients -- Gastrointestinal Endoscopy
Endoscopic reports generated by 68 Clinical Outcomes Research Initiative repository were analyzed.
From these reports, the doctors evaluated the use, changes over time, and findings of screening upper endoscopies between 2000 and 2003.
Upper endoscopy was performed in 1688 of 172,854 patients for the purpose of screening for varices.
Overall, the doctors found that there was a linear increase in annual proportion of screening for varices with upper endoscopy.
More upper endoscopy variceal screenings are performed in academic centers than in Veteran's Affairs Medical Centers and community practices.
The doctors found varices in 52% of screened patients.
The team observed varices more often in Child-Pugh class B/C compared with Child-Pugh class A patients.
The team noted that, of those patients with varices, patients with Child-Pugh class B/C were more likely to have large varices.
Dr Zaman's team comments, “Endoscopic screening for varices represents a small proportion of all upper endoscopies performed.”
“This proportion increased between 2000 and 2003.”
“Varices were found more frequently in patients with more severe liver disease.”
Gastrointest Endoscopy 2007: 65(1): 82-8
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Roche Diagnostics Submits Hepatitis C Viral Load Monitoring Test to FDA
http://www.redorbit.com
PLEASANTON, Calif., Jan. 15 /PRNewswire/ -- Roche Diagnostics announced today that it has submitted its automated test for Hepatitis C viral load monitoring to the U.S. Food & Drug Administration (FDA) for review. The FDA will review the application to determine whether the test can be marketed for diagnostic use in the United States. The test, called the COBAS(R) AmpliPrep/COBAS(R) TaqMan(R) HCV Test, is designed to provide highly accurate information about the quantity of Hepatitis C virus in a patient's blood, from very high to very low levels. This type of diagnostic, called "viral load testing," is a key measure of how well a patient infected with Hepatitis C is responding to drug therapy.
"This is an important milestone in the development of our automated virology portfolio for the US market," said Daniel O'Day, head of Roche Molecular Diagnostics, the business area of Roche Diagnostics that developed the test. "As the global leader in molecular diagnostics, our goal is to continue to increase system integration and automation, enabling labs to deliver reliable healthcare information with greater ease and efficiency."
Hepatitis C is an often silent (asymptomatic) blood-borne infection of the liver, yet one that can cause serious chronic disease, liver failure, in some cases, death. According to the U.S. Centers for Disease Control, an estimated 4.1 million Americans have been infected with Hepatitis C virus, 3.2 million of whom are chronically infected. Combination therapy with pegylated interferon and ribavirin drugs (currently the treatment of choice) can get rid of the virus in up to 5 out of 10 persons infected with genotype 1 of the Hepatitis C virus, and up to 8 out of 10 persons infected with genotypes 2 and 3.
About the Roche Molecular Diagnostics Virology Portfolio
Roche Molecular Diagnostics (RMD), the global leader in molecular diagnostics, develops a broad range of tests based on the company's Nobel Prize-winning PCR technology. RMD tests for HIV and Hepatitis B & C provide actionable health information designed to help improve disease management through diagnosis of active infections, quantification of the amount of virus in the blood (viral load monitoring), and identification of drug resistance and disease recurrence.
RMD's newest generation of automated real-time PCR tests -- the COBAS(R) AmpliPrep/COBAS(R) TaqMan(R) HIV-1, Hepatitis C, and Hepatitis B tests -- have been available for diagnostic use in the European Union since 2005. The COBAS(R) AmpliPrep/Cobas(R) TaqMan(R) HIV-1 and Hepatitis C tests are currently under review by the FDA. The tests are designed for improved workflow efficiency and test results integrity, including configuration options that enable fully automated "sample in, results out" processing.
The FDA is also currently reviewing the Roche Diagnostics COBAS(R) TaqMan(R) HBV Test, which is designed for use with High Pure sample preparation reagents and the COBAS(R) TaqMan(R) 48 analyzer for automated amplification and quantitation of Hepatitis B virus in human blood.
Not all tests are available in all countries. Tests under review by the FDA are not available for diagnostic use in the United States until the agency has approved the pre-market notification application for each test.
About Roche and the Roche Diagnostics Division
Headquartered in Basel, Switzerland, Roche is one of the world's leading research-focused healthcare groups in the fields of pharmaceuticals and diagnostics. As a supplier of innovative products and services for the early detection, prevention, diagnosis and treatment of disease, the Group contributes on a broad range of fronts to improving people's health and quality of life. Roche is a world leader in diagnostics, the leading supplier of medicines for cancer and transplantation and a market leader in virology. In 2005 sales by the Pharmaceuticals Division totaled 27.3 billion Swiss francs, and the Diagnostics Division posted sales of 8.2 billion Swiss francs. Roche employs roughly 70,000 people in 150 countries and has R&D agreements and strategic alliances with numerous partners, including majority ownership interests in Genentech and Chugai. Roche's Diagnostics Division offers a uniquely broad product portfolio and supplies a wide array of innovative testing products and services to researchers, physicians, patients, hospitals and laboratories world-wide. For further information, please visit our websites http://www.roche.com/ and http://www.roche-diagnostics.com/ .
NOTE: All trademarks used or mentioned in this release are legally protected by law.
For further information please contact: Melinda Baker Molecular Diagnostics Communications Phone: 925-730-8379
Roche Diagnostics
CONTACT: Melinda Baker, Molecular Diagnostics Communications, of Roche,+1-925-730-8379
Web site: http://www.roche.com/http://www.roche-diagnostics.com/
Source: PRNewswire
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Arrow Therapeutics Selects a Further Hepatitis C Clinical Candidate
http://biz.yahoo.com
LONDON, January 15 /PRNewswire/ -- Arrow Therapeutics, the London based antiviral drug discovery and development company, has announced that a further Hepatitis C compound, A-689, has entered full preclinical development.
A-689 is the second compound from Arrow's broad approach to the NS5a target to enter development. November 2006 saw Arrow's first Hepatitis C compound, A-831, enter Phase I trials. Both compounds target the novel NS5a protein but have completely different chemical structures and bind to the target at different sites.
Once again A-689 originates from Arrow's focused chemical library and was optimised in-house. The compound has shown highly potent activity in the replicon assay and has an excellent therapeutic index and good pharmacokinetic properties. Phase I trials on A-689 are planned for the second half of 2007.
The urgent need for novel Hepatitis C inhibitors has been well documented, with an estimated 170 million sufferers worldwide. The current Standard of Care treatment (Pegylated Interferon + ribavirin) has a poor side effect profile and is only effective in around 50% of patients. As with HIV/AIDS, multiple drugs in combination therapy are likely to be needed to overcome drug resistance. The value of the Hepatitis C market was approximately $2.2 billion in 2005 and is forecast to grow substantially to $4.4 billion in 2010 and $8.8 billion in 2015.
Arrow's CEO, Ken Powell, speaks of his delight at the recent advancements made within the programme, "Since the inception of Arrow, we have been committed to the Hepatitis C field. With A-831 already in Phase I trials and now A-689 entering preclinical development, we are beginning to realise our aims for a broad pipeline of Hepatitis C inhibitors. We regard both our compounds as ideal components of the multiple drug combinations likely to be required to successfully treat this virus with its tendency to mutate and to resist new agents".
Arrow Therapeutics
Arrow Therapeutics was founded in 1998, and is focused exclusively on novel antiviral drug discovery and development. Based in central London with around 55 employees, the product pipeline includes novel antiviral lead and clinical compounds. Arrow's lead programme to treat Respiratory Syncytial Virus (RSV) is in Phase ll clinical studies and is partnered with Novartis. The Hepatitis C programme consists of multiple series from different chemical classes. The most advanced compounds inhibit NS5a, a novel viral target. The lead compound, A-831, is currently in Phase I trials and A-689, a compound from the second NS5a series, has just entered preclinical development (see above). Arrow also has a Hepatitis C polymerase programme in lead optimisation.
Compounds will be licensed at stages between preclinical and Phase IIb depending on the therapeutic area.
Seed funding of GBP1.5 million was provided by Unibio of London who also invested in the first major funding round completed in July 2000 along with GIMV Belgium (lead), Alta Partners USA, 3i Group London, TVM Munich, and NVM Edinburgh which brought in GBP11.1 million. The same group provided a further GBP7 million in January 2002. The latest funding round was completed in early 2004 raising over GBP23 million from the USA, Japan and Europe. Atlas Venture is now the lead investor.
www.arrowt.co.uk
Arrow Therapeutics Ltd, Britannia House, 7 Trinity Street, London SE1 1DB
Source: Arrow Therapeutics Ltd
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January 16th, 2007
Nabi Biopharmaceuticals Announces Initiation of Civacir Phase II 'Proof-of-Concept' Clinical Trial
http://www.pharmalive.com
- First Therapy Being Developed Specifically for the Prevention of the Recurrence of Hepatitis C-Related Liver Disease in Liver Transplant Recipients-
BOCA RATON, Fla., January 16, 2007 /PRNewswire-FirstCall/ -- Nabi Biopharmaceuticals announced today that it has initiated its Phase II "proof-of-concept" clinical trial for Civacir(R) [Hepatitis C Immune Globulin (Human)]. Civacir, the company's plasma-derived, polyclonal antibody product candidate, when approved, would be the first therapy for the prevention of the recurrence of hepatitis C-related liver disease in hepatitis C virus (HCV) positive liver transplant recipients, or in patients who received an HCV-positive liver. Currently, there are no marketed therapies specifically indicated for prevention of re-infection post-liver transplant in HCV-positive patients. The trial marked another critical milestone being met by the company.
Nabi Biopharmaceuticals is co-developing Civacir with Kedrion S.p.A., a global biopharmaceutical company, located in Lucca, Italy. Kedrion is fully funding the costs of the clinical trials and is also funding some of the costs of manufacturing Civacir for use in the trial. The two companies will pursue a common strategy to develop and commercialize Civacir in Europe and the U.S., with Kedrion being Nabi Biopharmaceuticals' exclusive licensee to commercialize Civacir in Europe. In addition to assuming the majority of the funding for the clinical trials and clinical materials in Europe and the U.S., Kedrion will pay milestone and royalty payments to Nabi Biopharmaceuticals.
Thomas H. McLain, chairman, chief executive officer and president, Nabi Biopharmaceuticals, stated, "Civacir is uniquely positioned to fill a critical gap in the care of liver transplant patients by preventing re-infection with hepatitis C during a period after surgery when other therapies cannot be used. If we are successful, this product will become a very important part of our global transplant franchise and product portfolio. Certainly, initiating this Phase II 'proof-of-concept' trial is an important milestone for us and our partner, Kedrion. But this trial also represents an important milestone for advancing clinical knowledge in an area of significant, unmet medical need. We are pleased to be partnering with Kedrion, who is contributing important knowledge and resources to this program. Through our strategic partnership, we expect to conduct this and future clinical trials for Civacir in a way that is faster and at the same time much less costly for Nabi Biopharmaceuticals."
About Hepatitis C
Each year there are approximately 5,000 liver transplant procedures performed in the U.S. and of those approximately 2,000 are due to HCV(1). Considering the prevalence of hepatitis C in the U.S. and Europe, and the size of the medical need, Civacir could develop into a significant product in a global market estimated at $400 million(2). Available therapies have a poor efficacy and safety profile and re-infection of the transplanted liver is almost universal. These infections often result in complications, the most serious of which is the re-development of end-stage liver disease, which in turn can lead to the need for a re-transplant or death. Currently, none of these therapies are specifically indicated for prevention of re-infection post-liver transplant in HCV-positive patients.
Henrik S. Rasmussen, M.D., Ph.D., senior vice president, clinical, medical and regulatory affairs, Nabi Biopharmaceuticals, stated, "There is a significant medical need to prevent the recurrence of hepatitis C-related liver disease in HCV-positive liver transplant recipients. The polyclonal antibody approach of Civacir, either alone or in combination with new antiviral agents that may be developed in the future, has the potential to neutralize the numerous strains of hepatitis C virus that exist and the dire health consequences that they cause. Hence, we are very excited about the initiation of this 'proof-of-concept' study."
About the Phase II "proof-of-concept" Trial
The Civacir Phase II "proof-of-concept" trial is a randomized, controlled study involving 30 patients in a 2:1 randomization, with 20 patients allocated to Civacir at a dosage of 400mg/kg vs. 10 patients receiving standard-of-care. The primary endpoints are progression of liver fibrosis on biopsies as well as HCV levels in liver and serum. The secondary endpoints include liver enzymes as well as safety and tolerance. The company expects to complete enrollment in the second half of 2007, with the results being announced in the second half of 2008.
The protocol for the current trial was developed through consultation with regulators in the U.S. and Europe and work with an outside advisory panel. The trial design is based upon an understanding of what would be evaluated in a Phase III study. The current Phase II "proof-of-concept" trial was sized to allow the results to demonstrate the therapeutic benefit of the drug candidate prior to initiating a Phase III studies. Product used in the trial was manufactured in Nabi Biopharmaceutical's Boca Raton, Florida facility at commercial scale.
Next Steps: Civacir Development Program
Based on positive results from the Phase II trial, Nabi Biopharmaceuticals and Kedrion would then collaborate on the development of a pivotal Phase III trial for Civacir. The pivotal study is expected to be conducted in the U.S. and Europe. It is also expected that the results of a single Phase III trial, if positive, would be sufficient to obtain the regulatory approvals needed for Kedrion to market Civacir in Europe and for Nabi Biopharmaceuticals to obtain regulatory approval to market the product in the U.S.
About Civacir
Civacir is an investigational human polyclonal antibody product that contains antibodies to the hepatitis C virus (HCV). In February 2006, Nabi Biopharmaceuticals announced that Civacir had been granted Fast Track Designation by the U.S. Food and Drug Administration (FDA). This designation facilitates the development of products that treat serious diseases where an unmet medical need exists. Civacir also has Orphan Drug Status in the U.S. which for provides a seven-year period of market exclusivity in the U.S. when the product is approved. Civacir has also gained Orphan Medicinal Product (OMP) designation in Europe. If a product with OMP designation is the first to receive marketing authorization in Europe for its designated indication, the product will be entitled to 10-year market exclusivity, thereby preventing a similar drug from receiving authorization for the same indication during this period.
About Nabi Biopharmaceuticals
Nabi Biopharmaceuticals leverages its experience and knowledge in powering the immune system to develop and market products that fight serious medical conditions. The company has two products on the market today: Nabi-HB(R) [Hepatitis B Immune Globulin (Human)], and Aloprim(TM) (allopurinol sodium) for Injection. Nabi Biopharmaceuticals is focused on developing products that address unmet medical needs and offer commercial opportunities in our core business areas: Hepatitis and transplant, Gram-positive bacterial infections and nicotine addiction. For a complete list of pipeline products, please go to: http://www.nabi.com/pipeline/index.php. The company is headquartered in Boca Raton, Florida. For additional information about Nabi Biopharmaceuticals, please visit our Web site: http://www.nabi.com.
About Kedrion S.p.A.
Kedrion is a biotechnology company specializing in the development, production and distribution of plasmaderivatives. In Italy, Kedrion is the main reference point for the National Health Service as regards the production of plasma-derived drugs. Moreover, its skills are also put to use in strategic partnerships with overseas health services. The quality of its products, its continuous commitment to research and development, its consistent industrial capacity and its consolidated presence on the national and international market are the company's main areas of competitiveness. Kedrion SpA is the parent company of a group comprising: Hardis SpA, Haemopharm, Advanced Bioservices LLC. It is located in Castelvecchio Pascoli, in the province of Lucca, Tuscany, and has two production plants, Kedrion Bolognana, in the vicinity of Lucca and Hardis S. Antimo, in the vicinity of Naples. Kedrion is characterized by its focus on the international scene and its commitment to improving its local plants. The specific assets of the various companies allow Kedrion to offer partner companies and health institutes a complete and integrated approach within the field of plasmaderivatives. Thanks to these assets, Kedrion is able to manage the entire plasma processing cycle, from its acquisition to the distribution of plasma-derived products, including logistical support services. Kedrion's operations cover three different areas of business: production and distribution of plasma-derived products (it produces plasma-derived drugs and virus deactivated plasma and it also distributes flu vaccines), Contract Manufacturing (working with the National Health Service, Kedrion receives the plasma from the regions and transforms it into drugs that are redistributed to the regions in order to respond to the population's therapeutic requirements), transfer of technological know how (by means of international partnerships, it offers its technological know how concerning two main activities, the construction of plasma-derived product production plants and the transfer of technological production processes). Its Website is www.kedrion.com.
Forward-Looking Statements
Statements in this press release about the company that are not strictly historical are forward-looking statements and include statements related to our plans to explore strategic alternatives and prospects. You can identify these forward-looking statements because they involve our expectations, beliefs, intentions, plans, projections, or other characterizations of future events or circumstances. These forward-looking statements are not guarantees of future performance and are subject to risks and uncertainties that may cause actual results to differ materially from those in the forward-looking statements as a result of any number of factors. These factors include, but are not limited to, risks relating to the company's ability to advance the development of products currently in the pipeline or in clinical trials; maintain the human and financial resources to commercialize current products and bring to market products in development; obtain regulatory approval for its products in the U.S., Europe or other markets; successfully develop, manufacture and market its products; successfully partner with other companies; realize future sales growth for its biopharmaceutical products; maintain sufficient intellectual property protection or positions; raise additional capital on acceptable terms; re-pay its outstanding convertible senior notes when due; and identify and complete transactions that represent strategic alternatives and opportunities. Many of these factors are more fully discussed, as are other factors, in the company's Annual Report on Form 10-K for the fiscal year ended December 31, 2005 and Quarterly Report on Form 10-Q for the Quarter ended September 30, 2006 filed with the Securities and Exchange Commission.
(1) Schiano TD, Martin P. Management of HCV Infection and Liver Transplantation. Int J Med Sci 2006; 3:79-83. http://www.medsci.org/v03p0079.htm.
Brown RS. Hepatitis C and liver transplantation. Nature. 2005 436:973-8.
Davis GL, Albright JE, Cook SF, Rosenberg DM. Projecting future complications of chronic hepatitis C in the United States. Liver Transpl. 2003 9:331-8, El-Serag HB. Hepatocellular carcinoma: recent trends in the United States. Gastroenterology. 2004 127:S27-34.
(2) LEK Market Analysis 2005, commissioned by Nabi Biopharmaceuticals
CONTACT: Thomas E. Rathjen, Vice President, Investor Relations of NabiBiopharmaceuticals, +1-561-989-5800
Web sites:
http://www.nabi.com/
http://www.nabi.com/pipeline/index.php/
http://www.kedrion.com/
http://www.medsci.org/v03p0079.htm/
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Presidio Pharmaceuticals Receives Exclusive License to Novel Hepatitis C Technology
http://www.endonurse.com
SAN FRANCISCO -- Presidio Pharmaceuticals, Inc. announced today that it has licensed the exclusive worldwide rights to novel hepatitis C virus (HCV) technology from Stanford University. This technology, invented in the lab of Stanford scientist Jeffrey Glenn, targets a specific region found in the HCV proteins NS4B and NS5A, viral proteins that are absolutely required for virus replication. Disrupting the normal function of these two proteins provides for a new method of HCV treatment and should combat the emergence of drug resistance to new HCV polymerase and protease inhibitors that will be on the market in the near future.
"We are very pleased to have licensed the rights to this exciting new technology," said Omar K. Haffar, PhD, president and CEO of Presidio. "We expect to work closely with Glenn and other experts in the field to identify and test new small molecules that bind to NS4B and NS5A in order to interrupt the life cycle of the virus."
About the Hepatitis C Virus
Infections from the hepatitis C virus (HCV) have reached pandemic proportions, affecting almost 200 million people worldwide. According to the Centers for Disease Control (CDC), 3.9 million Americans have been exposed to HCV, resulting in 2.7 million cases of chronic infection, with up to 30,000 new infections occurring each year.
Source: Business Wire
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Day Defends Cutting Prison Tattoo Project Despite 'Demonstrated Potential'
http://www.news1130.com
By: JIM BRONSKILL
OTTAWA (CP) - Public Safety Minister Stockwell Day had some explaining to do Tuesday after an internal report had positive things to say about a prison tattoo parlour project he axed last month.
In terminating the safe-tattooing program for federal prisoners, Day said an analysis of the project showed it "has not been demonstrably effective."
"When you have taxpayer dollars going into something that does not work, then you shouldn't be supporting it," he told a December news conference.
Critics expressed concern the move would increase the spread of AIDS and hepatitis C by encouraging illicit tattooing behind bars.
Copies of the Correctional Service's draft evaluation report of the pilot project were not made public at the time.
The report, now available from the prison service, says the safe-tattooing project resulted in increased knowledge and awareness amongst staff and prisoners about preventing blood-borne infectious diseases.
"The initiative has demonstrated the potential to reduce harm, reduce exposure to health risk, and enhance the health and safety of staff members, inmates and the general public."
It also found that while the price-tag of the project was low respective to the potential benefits, a more cost-effective model could be put in place with similar or better results.
Tattoo parlours at six federal prisons across Canada have been sitting idle since the one-year pilot project ended Sept. 30.
The $960,000 project was aimed at controlling the spread of AIDS and hepatitis C by informing inmates about sanitary tattoo inking and how to avoid infectious diseases. Some prisoners were also taught to give tattoos to fellow inmates.
The draft evaluation found the cost of treating a prisoner with HIV, the virus that causes AIDS, was 50 times that of a tattoo session.
The Union of Canadian Correctional Officers applauded cancellation of the pilot project, saying a tougher policy on the drugs prisoners inject with dirty syringes was the real key to tackling infectious diseases.
In a letter sent Tuesday to newspapers, Day defended his decision to end the project, insisting the draft evaluation "failed to conclusively determine that the health and safety of staff members, inmates and the general public would be protected by maintaining this program."
Day also says Correctional Service Commissioner Keith Coulter recommended the six tattooing sites be closed.
Michele Pilon-Santilli, a prison service spokeswoman, confirmed that Coulter made the recommendation at the end of September.
"It's not a cost-free initiative," said Pilon-Santilli, adding that expanding the project to all 58 federal institutions would have been expensive, competing with other prison service priorities.
A briefing note prepared for Day indicates the minister raised the pilot project at his first meeting with Coulter on Feb. 9, 2006, shortly after the Tories took office.
In the note, obtained by The Canadian Press, Coulter says while the prison service has had to work hard to counter the image it is too accommodating to inmates, the public safety objective of the tattooing project "can be very logically explained."
Coulter says the service planned to await the final evaluation of the pilot effort, expected in March 2007.
"Unless you wish otherwise, it is my intention to seek your views at that point on the results of the evaluation, and the way ahead from there."
Inmates are up to 10 times more likely to contract HIV, the virus that leads to AIDS, than the general Canadian population. Their likelihood of contracting hepatitis C is about 30 times higher.
Day said in December the prison service, in partnership with Health Canada and outside organizations, would continue to run health and education programs to help reduce the transmission of infectious diseases.
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January 17th, 2007
'Thousands' May Have Hepatitis C
http://news.bbc.co.uk
The Department of Health is urging people who think they may be at risk of having hepatitis C to come forward and get tested.
It is thought that several thousand people in Northern Ireland are not aware they are infected with the virus.
Hepatitis C, which is contracted through infected blood, can cause cirrhosis, liver failure or cancer.
However, early treatment is usually effective at clearing it up.
An action plan launched on Wednesday contains 14 recommendations, including advice and information for the public and health professionals.
Dr Michael Callender - a consultant in liver diseases at the Royal Victoria Hospital - said hepatitis C was a "big problem".
"It's a virus that can cause a lot of damage to the liver, once there is cirrhosis it can cause tumours and serious complications in the liver.
"We have so far detected 900 cases in our regional virus laboratory in Northern Ireland.
"But we estimate there are probably about 4,000 or up to 6,800 patients in Northern Ireland who are infected with this virus, so the majority don't know it."
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HIV/Hepatitis C Coinfected Patients Have Lower IL-7 Levels, May Explain Blunted CD4 Response to HIV Therapy
www.aidsmap.com
Michael Carter
HIV-positive individuals who are coinfected with hepatitis C virus have lower plasmatic levels of interleukin-7 (IL-7), according to Spanish research published in the January 11th edition of AIDS. The investigators suggest that this may help explain why HIV/hepatitis C coinfected patients have a blunted CD4 cell response to anti-HIV therapy.
Their cross-sectional study involved both HIV-positive individuals who were naive to potent antiretroviral therapy and patients who were undergoing HIV therapy.
A total of 97 treatment-naive patients, 40 of whom were coinfected, were included in their analysis. Of these naive patients, data on thymic output were available for 20 coinfected patients and 25 HIV-monoinfected individuals. The treatment-experienced population consisted of 92 patients. All had an undetectable HIV viral load and 49 were coinfected. Of the treatment-experienced patients, 24 coinfected individuals had data on thymic function available for analysis, as did 29 patients who were only infected with HIV.
IL-7 levels were significantly lower in coinfected treatment-naive (p = 0.004) and coinfected treatment-experienced patients (p = < 0.001) compared to patients who were HIV-monoinfected. The investigators then performed analysis of both treatment-naive and treatment-experienced patients together and found that both CD4 cell count (p < 0.001) and hepatitis C coinfection (p < 0.001) were significantly associated with IL-7 levels.
When the investigators looked at the results of liver biopsies from coinfected patients, they found that patients with lower IL-7 tended to have higher fibrosis scores. “Increasing the number of patients would give significance to this difference”, they note.
“In our study, we found a correlation between IL-7 levels and the CD4 cell count in HIV-HCV co-infected patients on HAART, supporting the theory that HCV coinfection may alter IL-7 levels”, write the investigators.
Reference
Soriano-Sarabia N et al. HIV-hepatitis C virus co-infection is associated with decreased plasmatic IL-7 levels. AIDS 21: 253 - 255, 2007.
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Father Recovering after Life-Saving Liver Transplant Surgery
http://www.voicenews.com
by Jeri Packer
Voice staff writer
He turned 40 on Sept. 30 and, on his second birthday on Aug. 1, 2006, he received a second chance at life when a portion of his son Danny's liver was transplanted into his ailing body.
Grant and Danny Harris were admitted to the University of Pittsburgh Medical Center's Thomas E. Starzl Transplantation Institute for the life-saving liver transplant surgery on Aug. 1.
According to wife and mom, Crystal Harris, Danny's surgery lasted almost nine hours; her husband's about five hours.
The men both sport a "Mercedes cut" - like the Mercedes car emblem - on their stomachs, with dad's cut requiring 79 staples and son, Danny needing 76.
Five months later, both are recovering speedily and are in good health.
"My liver functions are all back to normal," said Grant Harris. "There are no signs of rejection."
Besides what appears to be a successful transplant, there is another result of the surgery for which Harris is thankful.
"I am cured of the hemophilia. I stopped taking the (medication for hemophilia) in August," he said.
Harris, 40, was born with a hereditary medical condition called hemophilia "B." The disease was treatable, but he contracted HIV and hepatitis "C" in the process. After undergoing a drug therapy regime that took care of the HIV, his liver became cirrhotic. The only hope at that stage was a liver transplant.
In November 2005, he was placed on the United Network for Organ Sharing as a candidate to receive a cadaver transplant. After several false starts at matching up with a compatible liver, Harris' son Danny, 18, insisted he be the donor.
The doctors had planned on removing 45 - 60 percent of Danny's liver, but only had to take 30 percent.
"Livers are usually about three to three-and-a-half pounds; mine was five pounds," said the 6'5," 244 pound teenager.
A pinched nerve in his right arm from the surgery has caused a few challenges for Danny Harris, but the feeling in his arm, hand and fingers is slowly returning, he reported.
The Wayne State University student is a fast healer. He was out of the hospital in seven days, back at home in Michigan in 12 days, and attending classes by Aug. 29. Two weeks later, he went back to work at VG's grocery store in Marine City and is gaining more strength every day.
His father was back home in a record 21 days, but had a few complications that required more hospital care later. After going back for treatment for an infection and more surgery due to a stone in his bile duct, Grant Harris began to lose heart.
"When I was hospitalized for the second time with the stone, I thought, 'It's not going to happen,'" he said.
Since then, though, Harris feels he has turned a corner, and is feeling "better and better every day." He was encouraged when he received the okay from General Motors on Dec. 18 to officially return to work on Jan 2.
Harris, an operations manager, will be returning to the same job he had before his health began to decline.
Harris has developed a typical, but surprising, side effect for liver recipients, he said, exhibiting characteristics of his liver donor.
"My hair has lightened and is starting to get curly," he said, explaining that his son's hair is lighter and curly. He also reported the hair on his legs and chest is growing thicker like his son's, and he has an uncharacteristic craving for chocolate milk.
"For the past four to six weeks, I'm drinking it like crazy," he said.
Son Danny Harris has always loved chocolate milk and drinks a lot of it, according to Crystal Harris, who always has a supply of the drink on hand at home.
Grant Harris plans on using his experience as a liver donor to help others by working as an advocate for the Michigan Hemophilia Foundation. He explained that many institutions hesitate to perform liver transplants on hemophiliacs because of the high risk of success. Harris said he was only the third hemophiliac to receive a live donor transplant at the University of Pittsburgh.
"When I was younger, they never expected us to live past 40, but with new medications available, it is now possible," he said.
Grant Harris is thankful for his new lease on life and grateful for all the support he received from family and friends throughout the ordeal.
"I want to thank everyone in the community for their support; the cards and well-wishes they gave me," he said. "This is a good end to a nice year."
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Battle with Virus Gets Boost
http://www.terracestandard.com
By DUSTIN QUEZADA
AWARENESS. IT’S a word hepatitis C educators repeat until they’re blue in the face.
That’s especially true for aboriginal communities, where hep C rates are eight times higher than the rest of the population, says a facilitator who was here last month.
SueAnn Phillips said factors, such as a lack of awareness and harm reduction, plus addictions and poverty issues are chiefly to blame for those inflated rates.
Phillips was here in December 2006 with colleague and educator Alison Stevens to instruct six locals to become trainers in Terrace and surrounding communities.
Phillips says there are misconceptions about the virus.
“There’s confusion regarding hep C transmission,” Phillips said. “A lot of people believe it can be transmitted through kissing and coughing and that’s not true.”
More contagious than HIV, hep C is caused by consuming contaminated water or food, using dirty needles or syringes or practising unsafe sex.
“Through breaking down the stigma, we can allow people with hep C to live in a safe, healthy way and advocate for access to treatment,” said Phillips at the conclusion of the weeklong training at Kermode Friendship Centre.
Treatment remains a major stumbling block for a staggering majority of the estimated 60,000 infected people in B.C. According to Phillips, fewer than 700 people are treated with Pegatron, a drug used in the treatment of chronic hep C.
Its use is prescribed under a strict criteria. Sufferers must have a stable home and must be addictions free and depression free – the latter for a minimum six months.
Because people engaging in high-risk activities, such as illicit drug use and unprotected sex, are most likely to be infected those criteria are almost impossible to adhere to.
And even when people can follow the treatment guidelines, the cost of Pegatron is not included in most health care coverage.
That’s why Phillips and Alison travel from Vancouver to give the workshops because without treatment, awareness is paramount.
“Awareness, risky behaviours that go with it and testing,” said Phillips, explaining the educational strategy they promote.
Of the people already affected, only an estimated 30 per cent are aware of it, leading Phillips to dub hep C “an invisible disease.”
People infected with hepatitis can experience effects ranging from mild illness to serious liver damage. Many recover completely from an infection, while others become carriers of the disease and can spread it to others unknowingly.
Up to 90 per cent of infected persons carry hep C indefinitely. Over the long term, they are at risk of such illnesses as profound fatigue, cirrhosis, and liver cancer.
Five staff members at Kermode and one from Northwest Addictions Services attended the workshops and can now provide answers to questions and any information about the virus to members of the community.
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January 19th, 2007
A 25-Year-Old Diagnosed with HIV and Treated with HIV Therapy Can Expect to Live to His 60s, Danes Show
www.aidsmap.com
Thomas Kristensen
In settings where there is easy and free access to HIV medication and care, a young adult diagnosed with HIV has an estimated median survival rate of more than 35 years. However, this median survival rate is significantly lower than that of an HIV-negative person, according to a Danish study published in Annals of Internal Medicine. The study also found that HIV-positive individuals who were coinfected with hepatitis C virus, and patients who were older at the time of HIV diagnosis could expect to have poorer survival than younger, hepatitis C-uninfected HIV-positive patients.
The objective of the study was to estimate survival time and age-specific mortality rates of HIV positive people and compare the estimates with that of the general population. The study included data from all HIV-positive individuals treated in Danish HIV clinics from January 1995 until May 2005.
A total of 3,990 HIV-positive individuals and 379,872 people from the general population of Denmark were included in the investigators’ analysis. The study sample was taken from the Danish HIV Cohort Study and the Danish Civil Registration System. The first includes all HIV-positive people treated in Danish HIV clinics from 1995 and the latter includes all people registered as living in Denmark.
Survival among HIV positive people increased significantly during the study period. In the five-year period from 2000 to 2005, the median survival rate for HIV positive people rose to 33 years. Survival was even better (39 years) when the investigators excluded the 16% of HIV-positive patients who were coinfected with hepatitis C virus.
According to the investigators’ estimates, an individual diagnosed with HIV aged 25 could expect to survive until they were 64, compared to 76 years of age for the HIV-negative control group.
However, the mortality rate was significantly higher amongst HIV-positive patients than their HIV-negative peers. Mortality amongst individuals with HIV was 43 per 1000 person years compared to 4.7 per 1000 years in the general population.
Mortality fell significantly amongst patients with HIV following the introduction of potent HIV therapy. A mortality rate of 124 per 1000 person years was observed in 1995-96, but this fell to 38 per 1000 person years between 1997 and 1999 and 25 per 1000 person years in the five years after 2000.
Individuals who were coinfected with HIV and hepatitis C had significantly higher mortality rates than patients who only had HIV (59 per 1000 versus 38 per 1000 person years between 1997 and 1999), and this difference became even more marked after 2000 (mortality rate 57 per 1000 person years versus 19 per 1000 person years).
The investigators also established that age was an important determinant of survival. Mortality amongst HIV-positive, but hepatitis C-uninfected individuals aged between 25 and 50 was 12 per 1000 person years between 2000 – 2005, increasing gradually to 54 per 1000 person years in individuals aged between 65 –70 years.
Changes in the cause of death were observed by the investigators. The proportion of deaths related to HIV fell from 76% between 1995 – 1996 to 57% between 1997 and 1999 and to 43% between 2000 and 2005.
“We estimate a median remaining lifetime of more than 35 years for a 25-year-old, HIV-positive person without HCV infection who receives care in the twenty-first century”, write the investigators.
However, “despite the encouraging survival expectations, the study shows large, age-dependent excess mortality in the HIV-infected cohort compared with the general population.”
Chronic HIV infection is often compared to diabetes, but when the investigators compared the mortality among patients with type 1 diabetes with mortality amongst HIV-positive individuals, they found higher mortality rates amongst people with HIV.
“Our study suggests that most young people with the HIV infection can expect to survive for more than 35 years, but an ongoing effort is still needed to further reduce mortality rates amongst infected people,” conclude the investigators.
Reference
Lohse N et al. Survival of persons with and without HIV infection in Denmark, 1995-2005. Annals of Internal Medicine:146: 87-95, 2007.
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Coroner Calls for Clean Jail Syringes
http://www.news.com.au
By Rosemary Desmond
CLEAN syringes should be available to Queensland prisoners, given the inability of Corrective Services to keep drugs out of the system, the state coroner says.
Speaking during an inquest into the death of a prisoner by overdose, Michael Barnes noted that the inmate also had hepatitis C, and the availability of clean syringes would at least help to control the spread of viral diseases.
Darren Michael Fitzgerald was found dead around 2am (AEST) on June 13, 2004, at the Woodford Correctional Centre, two days after a contact visit from his girlfriend.
He was serving a life sentence for murder.
Prison officers conducting a routine head count of the unit in which Fitzgerald was housed noticed him slumped at his desk.
A nurse was called and she and the correctional officers entered the cell and found him dead.
The officers saw an orange syringe cap lying on the desk close to where Fitzgerald's head had been and a small syringe and a needle on the floor under the desk.
Mr Barnes said an autopsy found Fitzgerald was found to be suffering from Hepatitis C and that he had a total morphine level at the high end of the fatal range, and that he had ingested heroin within 12 hours of death.
Delivering his findings in Brisbane Magistrates Court today, Mr Barnes said he did not believe any other prisoner or prison officer directly contributed to the death.
"I am satisfied that Mr Fitzgerald accidentally caused his own death by unintentionally injecting more heroin than his body could effectively metabolise," he said.
Mr Barnes said Fitzgerald had a history of drug abuse in prison and had returned positive drug tests on urine samples on 15 occasions.
There was no compelling reason why the Department of Corrective Services should not issue clean syringes to prisoners, he said.
"In view of the inability of the Department of Corrective Services to keep prisons drug-free, and in recognition of its obligation to minimise the spread of blood-borne viruses among the prison population and those prisoners will come in contact with after release, I recommend that prisoners be given access to clean syringes," Mr Barnes said.
He said evidence at the inquest indicated illicit drug abuse remains a significant problem at the Woodford jail and throughout Queensland jails generally although there had been an improvement in the past 10 years.
In other findings today, Mr Barnes recommended hanging points be removed from all prison cells after Leon Mark Carroll was found on December 1, 2003 by prison staff hanging in the cell in the Arthur Gorrie Correctional Centre near Brisbane.
He had used a white piece of cloth fashioned into a noose with the other end tied around bars in the louvre windows above the bunk.
It was noticed that Carroll had rolled up towels and clothing on his bed under the blanket fashioned in a manner to make it appear that someone was sleeping in the bed.
A suicide note was found nearby.
Although he had been assessed on entering the prison as "high risk", it raised the question of why the assessment was later reversed.
Mr Barnes said the Royal Commission into Aboriginal Deaths in Custody had recommended hanging points be eliminated from watch houses and prison cells.
"The state government accepted that recommendation and committed to implementing it," Mr Barnes said.
"Obviously this had not occurred at the Arthur Gorrie Correctional Centre at the time of Mr Carroll's death."
"I recommend that as a matter of urgency the Department of Corrective Services cause the cells at the Arthur Gorrie Correctional Centre to be modified to remove hanging points."
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Health Canada Approves Cangene's Anti-Hepatitis B Product
http://biz.yahoo.com
TORONTO and WINNIPEG, Jan. 19 /CNW/ - Cangene today announces that it has received a Notice of Compliance with conditions ("NOC/c") for its HepaGam B(TM) hyperimmune product from the Biologics and Genetic Therapies Directorate of Health Canada. The approved indication is for the prevention of Hepatitis B recurrence following liver transplantation in adult patients with Hepatitis B who have no or low levels of hepatitis B virus replication. This NOC/c confers marketing approval to the drug in Canada while requiring the Company to continue with a confirmatory clinical study. HepaGam B(TM) is Cangene's Hepatitis B Immune Globulin (human) Injection, which is a purified antibody or hyperimmune that is specific for the hepatitis B virus. It is the only intravenous product licensed in Canada for this indication. An NOC/c is granted to provide patients who are suffering from serious, life-threatening or severely debilitating illnesses or conditions, accelerated access to promising new therapies.
"There are currently no other products licensed in Canada to prevent hepatitis B recurrence following liver transplantation and we are pleased to be able to answer the unmet medical need faced by these patients," said Dr. John Langstaff, Cangene's president and chief executive officer.
Hepatitis B is a highly infectious virus that can be spread through contact with blood and other bodily fluids. Hepatitis B recurrence can occur after liver transplantation in patients who are hepatitis B surface antigen ("HBsAg")-positive at the time of transplant. Recurrence results from the infection of the liver graft with hepatitis B virus that had remained in circulation.
Cangene manufactures HepaGam B(TM) in its Winnipeg facility using a process similar to that of WinRho(R) SDF, vaccinia immune globulin and VariZIG(TM), the Company's other hyperimmune products that have been approved in Canada and/or the United States. HepaGam B(TM) was approved last year by the United States Food and Drug Administration for treatment following acute exposure to blood containing HBsAg, perinatal exposure of infants born to HBsAg-positive mothers, sexual exposure to HBsAG-positive persons and household exposure to persons with acute hepatitis B virus infection.
A vaccine for hepatitis B is available, yet the virus continues to cause significant disease worldwide and pose a significant public health problem. Hyperimmune products can be used in situations where a vaccine is not applicable. Approximately 60,000 new infections are seen annually. There are an estimated 1.25 million chronically infected Americans, 20-30% of whom were infected as children. Severe liver disease is seen in 15-25% of chronically infected people.
About Cangene
Cangene is one of Canada's largest biopharmaceutical companies. It was founded in 1984 and is headquartered in Winnipeg, Manitoba. Cangene carries out research and development in Mississauga, Ontario and in Winnipeg. It uses patented manufacturing processes to produce plasma-derived and recombinant therapeutic proteins. In addition to having four approved products, Cangene has two products that have been submitted for regulatory review and a significant clinical trial program. Cangene also provides contract research and manufacturing services using its drug-manufacturing expertise and the resources of Chesapeake Biological Laboratories, Inc. (a wholly owned subsidiary). The Company has manufacturing facilities in Winnipeg, Manitoba and Baltimore, Maryland. Cangene's website, www.cangene.com, includes product and investor information, including past news releases. Chesapeake's website is www.cblinc.com.
Forward-looking information
The reader should be aware that Cangene's businesses are subject to risks and uncertainties that cannot be predicted or quantified; consequently, actual results may differ materially from past results and those expressed or implied by any forward-looking statements. Factors that could cause or contribute to such risks or uncertainties include, but are not limited to: the regulatory environment including the difficulty of predicting regulatory outcomes; changes in the value of the Canadian dollar; the Company's reliance on a small number of customers including government organizations; the demand for new products and the impact of competitive products, service and pricing; cost of raw materials, especially the cost and antibody concentration in plasma; fluctuations in operating results; government policies or actions; progress and cost of clinical trials; reliance on key strategic relationships; costs and possible development delays resulting from use of legal, regulatory or legislative strategies by the Company's competitors; uncertainty related to intellectual property protection and potential cost associated with its defence; the Company's exposure to lawsuits, and uncertainties related to estimates and judgments used in preparation of financial statements in accordance with GAAP and related standards, and other matters beyond control of management.
Risks and uncertainties are discussed more extensively in the MD&A section of the Company's most recent annual report and annual information form, which are available on the Company's website or on SEDAR at www.sedar.com. Scientific information that relates to unapproved products or unapproved uses of products is preliminary and investigative. No conclusions can or should be drawn regarding the safety or efficacy of such products. Only regulatory authorities can determine whether products are safe and effective for the uses being investigated. Healthcare professionals are directed to refer to approved labelling for products and not rely on information presented in news releases.
The cautionary statements referred to above should be considered in connection with all written or oral statements, especially forward-looking statements, that are made by the Company or by persons acting on its behalf and in conjunction with its periodic filings with Securities Commissions, including those contained in the Company's news releases and most recently filed annual information form. Forward-looking statements can be identified by the use of words such as "expects", "plans", "will", "believes", "estimates", "intends", "may", "bodes" and other words of similar meaning (including negative and grammatical variations). Should known or unknown risks or uncertainties materialize, or should management's assumptions prove inaccurate, actual results could vary materially from those anticipated. The Company undertakes no obligation to publicly make or update any forward-looking statements, except as required by applicable law.
For further information
John McMillan, Vice President, Commercial Development at (204) 275-4310, or by email at jmcmillan@cangene.com.
Source: Cangene Corporation
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