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Week Ending: February 4th, 2006
Alan Franciscus
Editor-in-Chief
To download pdf version click here
This Issue:
• Tattooed Donors No Longer Have to Wait
• Hope of Liver Cancer Blood Test
• Long-Term Lamivudine Therapy for Children with Hep B
• Schering-Plough Reports FDA Grants Fast Track Designation to Oral HCV Protease Inhibitor SCH 503034
• Woman Gets Hepatitis C After Blood Transfusions
• U.S. FDA Approves Cangene's Anti-Hepatitis B Product
• Intercell's Hepatitis C Vaccine Meets Success Criteria for Further Development - Route and Frequency of Administration Optimized
• Hospitals Face Hepatitis C Mix-Up Probe
• UAB Liver Center Ramps Up Programs Against Viral Hepatitis
• Sharing Blood Lancing Devices Could Result in Transmission of Blood-Borne Diseases
• Hepatitis B Genotype Linked to Degree of Liver Damage in HIV-Positive Patients
• Antifungal Prophylaxis in Low-Risk Liver Transplant Patients
• Nabi Biopharmaceuticals Announces U.S. Fast Track Designation for Civacir to Prevent Hepatitis C Re-infection in Liver Transplants
• Kerr Again Rejects Inquiry Into Transfusion Hepatitis Infection
• Preventive Treatment Helps Avoid Hepatitis B Relapse During Chemotherapy
• Wissinoming Man Proves You Can Battle and Survive Hepatitis C
• Hepatitis C Recurs Rapidly After Liver Transplant
• Vertex, Human Genome Sciences Seen Posting More Losses
• Noninvasive Alternative to Upper Endoscopy for Esophageal Varices
• Method for Estimating Deaths on Liver Transplant Waiting List
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January 29th, 2006
Tattooed Donors No Longer Have to Wait
SourceURL:http://www.phillyburbs.com/
By JO CIAVAGLIA
Bucks County Courier Times
Hoping it will attract more, younger people, a New Jersey blood bank last week eliminated waiting periods for many potential donors with new tattoos, an emerging experiment to pump up the sagging U.S. blood supplies.
On this side of the Delaware River, though, the Penn-Jersey branch of the American Red Cross has no plans to change its policy, one that most blood suppliers impose on the newly tattooed.
Last week, The Community Blood Council of New Jersey started immediately accepting as potential donors people with new tattoos, as long as the tattoos were done at a state-regulated parlor using a single-use needle and ink. Previously, the Ewing-based agency followed the industry standard of a one-year ban on blood donations from those with newly applied tattoos. The council also holds blood drives in Bucks County.
The procedural change was made in response to a directive issued last year by the American Association of Blood Banks, which accredits blood agencies, allowing blood banks to accept donors with new tattoos under those limited circumstances, said Charmaine Weldon, the council's director of quality assurance.
In New Jersey, potential donors are supposed to prove that the tattoo was done at a state-licensed parlor, but they don't need to bring paperwork to blood drives, Weldon said. It's one of the series of health and behavior questions that blood donors are asked as part of the evaluation process.
"We're relying on [them] to tell the truth," she said.
Donated blood products will continue to be screened and processed under state health and safety standards, council spokeswoman Sue Robbins added.
The American Association of Blood Banks restricts donors from giving blood for one year after getting a tattoo if the state does not regulate tattoo shops. In states with regulations, the waiting period is 30 days, according to its Web site. Waiting periods are imposed because tattoo equipment that isn't sterile can transmit hepatitis and other infectious diseases.
Pennsylvania has no licensing regulations for the parlors, though a few municipalities, including Philadelphia, require those located within their borders to obtain operating licenses, according to Richard McGarvey, a state health spokesman.
Since the new law went into effect in March, the Penn-Jersey chapter has noticed a less than 2 percent difference in blood donations there, Kane said.
Community Blood Council officials, though, believe that removing the one-year ban will help them better promote blood donation among people under age 30, an age group where tattooing is popular.
"We got into high schools and colleges and a lot of kids want to donate but couldn't," Robbins said.
In a 2002 survey, America's Blood Centers member agencies found perhaps as many as 114,000 people are rejected as potential blood donors annually because of body art. These are primarily young donors being deferred, at a time of the falling incidence of viral hepatitis and increased application of body art in the country, according to the center.
Jo Ciavaglia can be reached at 215-949-4181 or jciavaglia@phillyBurbs.com
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Hope of Liver Cancer Blood Test
SourceURL:http://news.bbc.co.uk
Scientists have measured protein levels
Scientists hope new technology will help them develop a blood test to improve early diagnosis of liver cancer in high risk groups.
A team at the University of Birmingham used sophisticated protein measurement and computer analysis to detect changes characteristic of early liver cancer.
The discovery could potentially save lives as liver cancer treatment is more effective if started early.
Details are published in the British Journal of Cancer.
LIVER CANCER
About 2,500 people are diagnosed with primary liver cancer in the UK each year
The major risk factors are infection with hepatitis B and C and consumption of foods contaminated with aflatoxin
Hepatitis B is more common and the distribution of this infection worldwide largely explains differences in rates of liver cancer
Cancer which first arises in the liver, or hepatocellular carcinoma, is the sixth most common cancer in the world, being especially widespread in East Asia.
High-risk groups, such as people with cirrhosis of the liver, are monitored currently - but tests are not sensitive enough to detect the disease early.
'First step'
Lead researcher Professor Philip Johnson said: "We have shown that the right combination of technology and computer analysis can 'break the code' of liver cancer and distinguish people with early liver cancer from those without the disease.
"Our method was more accurate than the existing liver cancer blood test.
"However, this is only the first step on a long road towards a test that can be reliably used for the many people at risk of developing primary liver cancer.
"We want to improve the technology to make the test even more accurate."
Liver diseases, including cirrhosis and hepatitis from the hepatitis B and C viruses, greatly increase the risk of hepatocellular carcinoma.
Although vaccinations against the hepatitis B virus are now administered to children in most countries of the world, there are millions of people already infected for whom vaccination would be too late.
And as there is no effective vaccination for hepatitis C, the global incidence of liver cancer is going to remain high for several decades.
The current methods used to monitor such high-risk groups include ultrasound scans and a test for the presence of a single protein in the blood called alpha-fetoprotein.
It is a good indicator of advanced liver cancer, but less able to detect early disease.
Professor John Toy, of Cancer Research UK, said: "More work is needed to prove that patterns of protein levels associated with liver cancer can be used as a reliable test for monitoring high-risk groups."
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January 30th, 2006
Long-Term Lamivudine Therapy for Children with Hep B
SourceURL:http://www.gastrohep.com
The latest Hepatology issue reports further clinical response in Hep B e antigen-positive children who did not achieve a virological response after 1 year of lamivudine.
A year of lamivudine treatment results in increased Hepatitis B e antigen seroconversion
It also leads to serum Hepatitis B virus DNA negativity in children with chronic Hepatitis B and high serum alanine aminotransferase concentrations.
Dr Etienne Sokal and colleagues from Belgium conducted a 1-year randomized, placebo-controlled study of lamivudine in 276 children.
The patients were stratified into 2 groups based on Hepatitis B e antigen status at week 48 of the previous study.
The investigative team entered 213 Hepatitis B e antigen-positive children into a treatment arm.
A further 63 Hepatitis B e antigen-negative children were entered into an observation arm to evaluate durability of Hepatitis B e antigen loss.
The team's primary endpoint included virological response, or Hepatitis B e antigen loss and Hepatitis B virus DNA negativity, at month 24.
In the treatment arm, 21 % of children previously treated with lamivudine achieved the primary endpoint.
21% previously treated achieved virological response vs 30% with placebo – Hepatology
Of the children who previously received placebo, 30% achieved virological response.
The investigators assessed the incidence of YMDD - tyrosine, methionine, aspartate, aspartate - mutations at month 24.
In the children previously treated with lamivudine, the incidence of YMDD mutations at month 24 was 64% vs 49% in those treated with placebo.
The incidence of virological response at month 24 was 5% for patients with YMDD mutant Hepatitis B virus and 54% for patients without.
In addition, the investigators found that the durability of response in the observation arm was 89% at month 24.
Dr Sokal's team concluded, "Further clinical response was seen over the 24-month open-label study period in children who had not initially achieved a virological response after 12 months of lamivudine treatment."
"However, the incidence of YMMD mutations increased over time and resulted in lower response rates."
"Virological response was maintained in most patients who had initially responded to lamivudine in the first 12 months."
Hepatol 2006: 43(2): 225-32
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Schering-Plough Reports FDA Grants Fast Track Designation to Oral HCV Protease Inhibitor SCH 503034
SourceURL:http://biz.yahoo.com
Press Release Source: Schering-Plough
KENILWORTH, N.J., Jan. 30 /PRNewswire-FirstCall/ -- Schering-Plough today reported that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation to its investigational oral hepatitis C protease inhibitor (SCH 503034), currently in Phase II clinical development for the treatment of chronic hepatitis C virus (HCV) infection.
The FDA granted Fast Track designation for the following reasons:
The proposed first indication for SCH 503034 is for treatment of HCV in patients with HCV genotype 1 virus who have not responded to combination therapy with pegylated interferon and ribavirin, the current standard of care, thus representing an unmet medical need.
SCH 503034 is an orally active inhibitor of the hepatitis C virus serine protease that inhibits HCV replication. This mechanism is distinct from those of current therapies, thus SCH 503034 represents a novel class of HCV inhibitor.
Fast Track designation allows FDA to expedite review of drugs and biologics for serious or life-threatening conditions and which demonstrate the potential to address unmet medical needs. An important feature of Fast Track designation is that it emphasizes the critical nature of close, early communication between the FDA and the sponsor company to improve the efficiency of product development.
Status of SCH 503034 Clinical Development
SCH 503034 has demonstrated potent antiviral activity and was well- tolerated, both as monotherapy(1) and in combination with PEG-INTRON® (peginterferon alfa-2b),(2) in Phase I clinical studies in patients chronically infected with HCV genotype 1 who were nonresponders to previous therapy, including peginterferon and ribavirin combination therapy. Results of Phase I clinical studies with SCH 503034, including in healthy subjects,(3) were presented at the 56th Annual Meeting of the American Association for the Study of Liver Diseases (AASLD) in November 2005. HCV genotype 1 is the most common form of the virus worldwide and is considered the most difficult to treat successfully.
Phase II Study Ongoing
Based on the results of the Phase I clinical program and extensive preclinical safety and pharmacology studies, Schering-Plough is conducting a large, randomized Phase II dose-finding study involving 300 patients worldwide. This study evaluates the safety and efficacy of SCH 503034 in combination with PEG-INTRON, with and without added ribavirin, for 24 or 48 weeks in patients with chronic HCV genotype 1 who were nonresponders to previous peginterferon and ribavirin combination therapy. The primary objective of this study is to determine the safe and effective dose range of SCH 503034 in combination with PEG-INTRON in this patient population. A secondary objective is to explore whether or not ribavirin provides an additional benefit when combined with SCH 503034 plus PEG-INTRON.
Additionally, an extensive preclinical and Phase I clinical development program is ongoing to support the potential broad utility of SCH 503034 in treating chronic hepatitis C.
About PEG-INTRON
PEG-INTRON is approved in the United States as monotherapy and for use in combination therapy with REBETOL® (ribavirin, USP) for the treatment of chronic hepatitis C in patients with compensated liver disease who are at least 18 years of age, and is not approved for treatment of patients who are nonresponders to previous therapy.
Important Safety Information Regarding U.S. Labeling for PEG-INTRON and REBETOL
WARNING
Alpha interferons, including PEG-INTRON, cause or aggravate fatal or life- threatening neuropsychiatric, autoimmune, ischemic, and infectious disorders. Patients should be monitored closely with periodic clinical and laboratory evaluations. Patients with persistently severe or worsening signs or symptoms of these conditions should be withdrawn from therapy. In many but not all cases these disorders resolve after stopping PEG-INTRON therapy.
Ribavirin causes hemolytic anemia. Anemia associated with REBETOL therapy may exacerbate cardiac disease that has led to fatal and nonfatal myocardial infarctions. Patients with a history of significant or unstable cardiac disease should not be treated with REBETOL. It is advised that complete blood counts (CBC) be obtained at baseline and at weeks 2 and 4 of therapy or more frequently if clinically indicated.
REBETOL and combination REBETOL/PEG-INTRON therapy must not be used by women, or male partners of women, who are or may become pregnant during therapy and during the 6 months after stopping therapy. REBETOL and combination REBETOL/PEG-INTRON therapy should not be initiated until a report of a negative pregnancy test has been obtained immediately prior to initiation of therapy. Women of childbearing potential and men must use effective contraception (at least two reliable forms) during treatment and during the 6- month post-treatment follow-up period. Significant teratogenic and/or embryocidal effects have been demonstrated for ribavirin in all animal species in which adequate studies have been conducted. These effects occurred at doses as low as one twentieth of the recommended human dose of REBETOL. If pregnancy occurs in a patient or partner of a patient during treatment or during the 6 months after treatment stops, physicians are encouraged to report such cases by calling (800) 727-7064.
PEG-INTRON
There are no new adverse events specific to PEG-INTRON as compared to INTRON® A (interferon alfa-2b, recombinant) for Injection, however, the incidence of some (e.g., injection site reactions, fever, rigors, nausea) were higher. The most common adverse events associated with PEG-INTRON were "flu-like" symptoms, occurring in approximately 50% of patients, which may decrease in severity as treatment continues. Application site disorders were common (47%), but all were mild (44%) or moderate (4%) and no patient discontinued, and included injection site inflammation and reaction (i.e., bruise, itchiness, irritation). Injection site pain was reported in 2% of patients receiving PEG-INTRON. Alopecia (thinning of the hair) is also often associated with alpha interferons including PEG-INTRON.
Psychiatric adverse events, which include insomnia, were common (57%) with PEG-INTRON, but similar to INTRON A (58%). Depression was most common at 29%. Suicidal behavior including ideation, suicidal attempts, and completed suicides occurred in 1% of patients during or shortly after completing treatment with PEG-INTRON.
PEG-INTRON/REBETOL is contraindicated in patients with autoimmune hepatitis, decompensated liver disease, and in patients with hemoglobinopathies (e.g., thalassemia major, sickle-cell anemia).
The following serious or clinically significant adverse events have been reported at a frequency less than or equal to 1% with PEG-INTRON or interferon alpha: Severe decreases in neutrophil or platelet counts, hypothyroidism, hyperglycemia, hypotension, arrhythmia, ulcerative and hemorrhagic colitis, development or exacerbation of autoimmune disorders including thyroiditis, RA, systemic lupus erythematosus, psoriasis, pulmonary disorders (dyspnea, pulmonary infiltrates, pneumonitis and pneumonia, some resulting in patient deaths), urticaria, angioedema, bronchoconstriction, anaphylaxis, retinal hemorrhages, and cotton wool spots.
In the PEG-INTRON/REBETOL combination trial the incidence of serious adverse events was 17% in the PEG-INTRON/REBETOL groups compared to 14% in the INTRON A/REBETOL group. The incidence of severe adverse events in the PEG- INTRON/REBETOL combination therapy trial was 23% in the INTRON A/REBETOL group and 31-34% in the PEG-INTRON/REBETOL groups. Dose reductions due to adverse reactions occurred in 42% of patients receiving PEG-INTRON (1.5 mcg/kg)/ REBETOL and in 34% of those receiving INTRON A/REBETOL.
REBETOL should not be used in patients with creatinine clearance less than 50 mL/min.
Schering-Plough Corporation is a global science-based health care company with leading prescription, consumer and animal health products. Through internal research and collaborations with partners, Schering-Plough discovers, develops, manufactures and markets advanced drug therapies to meet important medical needs. Schering-Plough's vision is to earn the trust of the physicians, patients and customers served by its more than 30,000 people around the world. The company is based in Kenilworth, N.J., USA, and its Web site is http://www.schering-plough.com.
SCHERING-PLOUGH DISCLOSURE NOTICE: The information in this press release includes certain "forward-looking statements" within the meaning of the Securities Litigation Reform Act of 1995, including statements relating to SCH 503034, PEG-INTRON and the potential market for these drugs. Forward-looking statements relate to expectations or forecasts of future events. Schering- Plough does not assume the obligation to update any forward-looking statement. Many factors could cause actual results to differ materially from Schering- Plough's forward-looking statements, including market forces, economic factors, product availability, current and future branded, generic or over-the-counter competition and the regulatory process, among other uncertainties. For further details about these and other factors that may impact the forward-looking statements, see Schering-Plough's Securities and Exchange Commission filings, including the company's third quarter 2005 10-Q.
References:
1. Zeuzem S et al. Antiviral Activity of SCH 503034, a HCV Protease Inhibitor, Administered as Monotherapy in Hepatitis C Genotype-1 (HCV-1) Patients Refractory to Pegylated Interferon (Peg-IFN-a), Abstract 67484, AASLD 2005.
2. Zeuzem S et al. Combination therapy with the HCV Protease Inhibitor, SCH 503034, Plus PEG-INTRON in Hepatitis C Genotype-1 PEG-INTRON Nonresponders: Phase Ib Results, Abstract 67627, AASLD 2005.
3. Zhang J et al. Single Dose Pharmacokinetics of a Novel Hepatitis C Protease Inhibitor, SCH 503034, in an Oral Capsule Formulation, Abstract 66787, AASLD 2005.
Source: Schering-Plough
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Woman Gets Hepatitis C After Blood Transfusions
SourceURL:http://www.irishexaminer.com
By Catherine Shanahan
THE Irish Blood Transfusion Service (IBTS) has been unable to establish how a woman who received three blood transfusions subsequently developed hepatitis C.
Eileen Kelly, 76, of Hampton House, Mill Road, Killarney, tested positive for the virus in June last year, approximately four months after receiving the last of three blood transfusions. She received her first blood transfusion shortly after contracting the MRSA superbug in hospital.
After testing positive, she was referred to the IBTS as "a possible case of transfusion-transmitted Hepatitis C-- according to regional director of the IBTS, Dr Joan Power in a letter to Ms Kelly" son, Dennis.
Ms Kelly received two transfusions in February 2005, on the 18th and 19th, while she was an inpatient at Kerry General Hospital (KGH). Previously, she received a blood transfusion on September 2, 2004, while attending St Mary's Orthopaedic Hospital in Cork for corrective surgery to a bone in her foot.
The procedure was meant to be straightforward, but Ms Kelly went on to develop an infection in her foot and subsequently contracted the MRSA superbug.
She spent 11 weeks in hospital and during that time received the first of the three blood transfusions.
The blood cells of five donors were transfused to Ms Kelly. Mr Kelly says it took six months before he was told that all five donors had been traced and retested negative for hep C.
Dr Power said Ms Kelly's strain of Hep C - HCV type 1 - was "more commonly transmitted in the distant past" and was specifically associated with the BTSB (former name of IBTS) anti-D immunoglobin contaminated with Hep C. However, Dennis Kelly said his mother never received Anti-D injections.
He also expressed concern that Dr Power was confusing his mother with another patient because of her reference to Ms Kelly as a former public health nurse. In a letter to Mr Kelly, she wrote: "In the circumstances of your mother having worked as a public health nurse, I believe we should rule out any inadvertent exposure to BTSB anti-D immunoglobin."
Mr Kelly says he does not know how she came to this understanding, as his mother was never a public health nurse.
Another letter written from Dr Power to Dr Barry Moynihan at KGH on August 25 referred to "a possible history of transfusion at CUH in November 2004". Dennis Kelly says his mother did not receive a transfusion at CUH at that time.
The most recent communication Dennis received from the IBTS was to say a sample would be sent to the University of Edinburgh "where we will compare your mother's viral strain to that of hepatitis C associated with BTSB anti-D immunoglobin". It also suggested Ms Kelly may have been exposed to hep C infection during obstetrical and surgical treatments in the US, where she lived from 1950 to 1967.
The IBTS denies transfusion-transmitted infection in the case of Ms Kelly. "All cases referred to us in the recent past have been investigated and transmission through blood transfusion has been ruled out," a statement said.
Mr Kelly has received no communication from the IBTS since December 13 and has not been informed of the results of the Edinburgh test. He remains in the dark as to how his mother contracted hep C.
Fine Gael health spokesperson Dr Liam Twomey was critical of what he said was ongoing lack of transparency in the IBTS. He said it was disgraceful Mr Kelly had to continually seek information about what was being done to trace the source of his mother's infection.
He also criticised the delay in tracking the fifth donor. "It wasn't that long ago we had the issue of donors not being informed that they had contracted hep C and the majority were in the Cork region. "
"There should have been no stone left unturned to track down and check these donors and for Dennis Kelly to have to make inquiries about whether they had been tracked down is a worry for the donors themselves and for those who received transfusions," he said.
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U.S. FDA Approves Cangene's Anti-Hepatitis B Product
SourceURL:http://www.finanznachrichten.de
TORONTO and WINNIPEG, Jan. 30 /PRNewswire-FirstCall/ -- Cangene (Nachrichten) today announces that the U.S. Food and Drug Administration (FDA) has approved Cangene's HepaGam B(TM) for treatment following acute exposure to hepatitis B virus. HepaGam B(TM) is Cangene's hepatitis B immune globulin (human), a purified antibody or hyperimmune that is specific for the hepatitis B virus. Hepatitis B is a highly infectious virus that can be spread through contact with blood and other bodily fluids from an infected person or can be transmitted from an infected mother to a newborn during birth.
"This is Cangene's fourth approved drug and the third drug to receive FDA approval-a significant accomplishment for a biopharmaceutical company. The depth of our hyperimmune program keeps growing, as does our international reputation," said Dr. John Langstaff, Cangene's president and chief executive officer.
Cangene manufactures HepaGam B(TM) in its Winnipeg facility using a process similar to that of WinRho(R) SDF and Vaccinia immune globulin, the Company's earlier FDA-approved drugs. The Company anticipates that the drug will be distributed in the U.S. by Apotex Corp., a member of the Apotex Group, Cangene's majority shareholder. The companies expect to launch the product within the next few months.
Specifically, HepaGam B(TM) has been approved for treatment of acute exposure to blood containing hepatitis B surface antigen (HbsAg), perinatal exposure of infants born to HbsAg-positive mothers, sexual exposure to HbsAg-positive persons and household exposure to persons with acute HBV infection.
Hepatitis B is a major disease worldwide and a significant public health problem. Approximately two billion people worldwide have been infected with the virus; more than 350 million of these have chronic infections. Approximately 8,500 new cases are reported annually in the U.S.
About Cangene
Cangene is one of Canada's largest biotechnology companies. It was founded in 1984 and is headquartered in Winnipeg, Manitoba. Cangene carries out research and development in Mississauga, Ontario and Winnipeg. It uses proprietary manufacturing processes to produce plasma-derived and recombinant therapeutic proteins. In addition to its four approved products, Cangene has another product that has been submitted for regulatory review and a significant drug development program. Cangene is also expanding its contract research and manufacturing business 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, http://www.cangene.com/, includes product and investor information, including past news releases. Chesapeake's website is http://www.cblinc.com/.
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 http://www.sedar.com/.
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 the Ontario Securities Commission, 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. 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.
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January 31st, 2006
Intercell's Hepatitis C Vaccine Meets Success Criteria for Further Development - Route and Frequency of Administration Optimized
SourceURL:http://www.presseportal.de
Intercell (VSE; "ICLL") today announced initial data from a clinical trial aiming at the optimization of its therapeutic Hepatitis C vaccine IC41. Results indicate that IC41, given in optimized route and schedule, is considerably more immunogenic than it has been shown previously.
These results will make it possible for Intercell to expand its leading position in Hepatitis C therapeutic vaccination through a clearly structured development plan that will include additional trials in Hepatitis C patients. In the current trial, 50 healthy adults were vaccinated with IC41 in alternative regimes. In order to increase T-cell response, which plays an essential role in the natural defense against the Hepatitis C virus, various intervals, numbers and routes of vaccination were tested. In an IC41 Phase II trial that has already been completed, the strongest T-cell responses were associated with a clinically meaningful decline of HCV-RNA.
The optimization study shows that the T-cell responses were stronger and significantly more frequent than seen up to now. This was true for both CD4- and CD8- positive T-cells. Compared to the previous regime, the improvements were positive and meet the success criteria for further development. The favourable safety profile and local tolerability seen in previous trials involving approximately 300 healthy volunteers and Hepatitis C-patients was maintained. The final results of the study will be presented at the European Association for the Study of the Liver (EASL) congress April 26-30, 2006, in Vienna.
Based on these results, Intercell is now planning to test IC41 with this optimized schedule in a further Phase II trial in patients with chronic Hepatitis C. This study aims to show sustained reductions of HCV-RNA through IC41 stand-alone therapy in a substantial subset of patients. Intercell plans to start the trial in mid-2006, with first results expected in mid-2007. The estimated date for market launch is currently 2011.
Furthermore, results from an ongoing Phase II study in combination with Interferon/Ribavirin standard therapy are expected for mid-2006. The primary objectives of this study are safety and the pharmacodynamic interactions of IC41 with standard therapy. Intercell hopes the study will further support the development of IC41 in a combination therapy setting using the new and improved administration scheme of IC41.
"The significant improvement in critical T-cell responses in connection with the new optimized schedule and the viral load reductions that were observed in previous clinical trials with chronic Hepatitis C patients give encouraging support towards a further clinical Phase II trial to demonstrate the therapeutic effect of IC41", states Prof. Michael P. Manns from Hanover Medical School, key investigator in Intercell’s past and upcoming patient trials.
"We are following a very straightforward development strategy. The results of the optimization trial are encouraging and confirm our scientific and clinical approach in the development of a therapeutic Hepatitis C vaccine to meet a substantial medical need", states Gerd Zettlmeissl, CEO of Intercell.
About Hepatitis C
HCV is a major cause of chronic liver disease, including cirrhosis and liver cancer. According to the World Health Organization (WHO), worldwide, approximately 170 million people are chronic HCV carriers (3% of the world’s population), including about 10 Million Europeans, 3.9 Million Americans and 2 Million Japanese. 35.000 new infections occur in the United States alone each year. The substantial unmet medical need is underscored by the fact that each year 8.000 to 10.000 deaths and 1.000 liver transplantations in the United States are due to HCV.
Currently, there is no vaccine or immunotherapy against Hepatitis C and the infection can only be treated with a combination of Interferon and Ribavirin - a long-term therapy with limited efficacy and substantial side effects. It also gives rise to high treatment costs for patients. In 2002, worldwide sales of HCV drugs totaled at around EUR2.8bn, and demand has since grown significantly. The market is seen to be expanding to EUR3.5bn by 2006.
This communication expressly or implicitly contains certain forward-looking statements concerning Intercell AG and its business. Such statements involve certain known and unknown risks, uncertainties and other factors which could cause the actual results, financial condition, performance or achievements of Intercell AG to be materially different from any future results, performance or achievements expressed or implied by such forward-looking statements. Intercell AG is providing this communication as of this date and does not undertake to update any forward-looking statements contained herein as a result of new information, future events or otherwise.
Further inquiry note:
Intercell AG
Mag. Katharina Wieser
Head of Corporate Communications
Tel. +43 1 20620-303
kwieser@intercell.com
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Hospitals Face Hepatitis C Mix-Up Probe
SourceURL:http://news.scotsman.com
HOSPITALS face public inquiries into how patients contracted hepatitis C during blood transfusions.
MSPs were today set to consider the case for an independent inquiry into patients infected through NHS blood products.
The Scottish Parliament's cross-party health committee was set to hear from several campaign groups who claim enough new evidence has recently come to light to warrant an investigation.
The committee will take evidence from several haemophilia groups as well as non-haemophiliac hepatitis sufferers.
Solicitor advocate Frank Maguire, who is pressing for a separate public inquiry into the deaths of three people who caught hepatitis C through blood transfusions or infected blood products, will also appear before MSPs.
However Health Minister Andy Kerr, who will also appear before the committee, said he remained to be convinced that a public inquiry would be useful.
He added: "It would be difficult to conduct an inquiry at this distance in time."
"We are not convinced either that there is anything significant to be learned from an inquiry that has not already been implemented in the interests of patient safety or that it would be helpful in establishing responsibility."
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UAB Liver Center Ramps Up Programs Against Viral Hepatitis
http://main.uab.edu/
Media Contact:
Hank Black
(205) 934-8938
E-mail: hblack@uab.edu
BIRMINGHAM, AL — The UAB Liver Center has announced plans to launch a broad campaign against viral hepatitis, the leading cause of liver disease in Alabama. The initiative will kick off with a fundraising dinner February 16 at the Wynfrey Hotel at the Riverchase Galleria featuring former New Jersey Governor Thomas Kean, who chaired the 9/11 Commission. Kean, retired as president of Drew University, now chairs the board of trustees of the Robert Wood Johnson Foundation, whose philanthropic priorities include the improvement of health care for all Americans.
Information and tickets to the dinner, which will benefit the UAB Viral Hepatitis Support Fund, are available by calling (205) 975-5602.
Joseph Bloomer, M.D., professor of medicine and director of the UAB Liver Center, said that one form of the viral disease, Hepatitis C, afflicts 80,000 in this state alone. “We have seen inroads against some other types of viral hepatitis, but Hepatitis C is expected to remain a major health care problem for another 20 years,” Bloomer said. “Many people from all walks of life have Hepatitis C due to receiving blood donations prior to 1992, when blood banks started screening for this disease.”
He pointed out that Hepatitis C is the leading cause of liver transplantation, accounting for nearly one-third of all liver transplants; and that, for unknown reasons, African-Americans are particularly susceptible to this disease, being twice as likely as Caucasians to become infected.
“But this is a battle against all viral hepatitis, an attempt to raise public awareness of the need to be vaccinated against A and B, and to continue to work toward a prevention and better treatments for Hepatitis C,” he said.
Backers of the Viral Hepatitis Support Fund include Hepatitis B patient Rosie Butler of Hoover, who said, “We thank UAB’s Liver Center for taking the leadership in filling the great need for public education and services in Alabama about viral hepatitis and liver disease. We are excited about the opportunity to marshal Alabama resources and keep them here in Alabama, where the resources will support UAB liver specialists and scientists and — most importantly — the patients and their families.
”Bloomer said priorities of the Viral Hepatitis Support Fund include:
•a nurse to manage patients in clinical trials of a “promising new treatment;”
•a stipend to support a Fellow in the UAB Liver Center;
•an education program for newly diagnosed patients and their families;
•outreach aimed a preventing the spread of viral hepatitis in children and teens;
•Acquisition of new technologies to assist laboratory researchers.
The UAB Liver Center was established 10 years ago, according to Michael Fallon, M.D., professor and chief of the hepatology section. “Increased use of vaccines, improved blood donation screening and other preventive measures have helped decrease the incidence of acute viral hepatitis by half in the past 25 years,” he said. “However, the number of Americans who die from chronic viral hepatitis is expected to double to 30,000 in 20 years largely due to the bubble of people who received contaminated blood products before Hepatitis C was included in screening.
”An effective treatment for Hepatitis C is available, “but these patients require constant counseling and medical management to help them cope with its very severe side effects,” according to Aasim Sheikh, M.D., assistant professor, who directs UAB’s large clinic for people with the disease. “We have become much like cancer doctors, who must pay very close attention to the side effects of chemotherapy and encourage patients to complete the treatment if possible.
”Sheikh’s clinical research program involves eight industry-sponsored trials of therapy for Hepatitis C, including collaborations with UAB kidney and transplant specialists.
The Liver Center faculty also includes Brendan M. McGuire, M.D., Miguel R. Arguedas, M.D., and Gary Abrams, M.D., associate professors of medicine; and Steven J. King, M.D., assistant professor.
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Sharing Blood Lancing Devices Could Result in Transmission of Blood-Borne Diseases
SourceURL:http://news.gc.ca
OTTAWA - Health Canada is advising Canadians that blood lancing devices labelled for personal use should not be shared due to the risk of transmitting blood-borne viruses, including hepatitis B and hepatitis C.
Lancing devices are used to obtain blood samples for such purposes as blood sugar monitoring. They consist of a hand-held tube into which a small surgical knife known as a lancet is loaded. The device is held against the skin and a button is pressed to release the lancet. An endcap controls the penetration depth of the lancet.
Lancets used for blood sampling should not be shared and should be disposed of in an appropriate safety container. In addition, the labelling of lancing devices should be read carefully to determine their intended use. Some are intended for single use and others are intended for multiple use by one patient only. Finally, some devices can be used on multiple patients only if the endcap is properly disinfected or replaced, according to the manufacturer's directions.
There have been several cases in Canada and abroad where blood lancing devices were inappropriately used by health care workers to obtain samples from multiple patients. Health Canada recently issued a Notice to Hospitals to remind health care workers of the safety measures that should be observed to minimize the risk of transmission of blood-borne diseases when using these devices.
Individual users of blood-lancing devices who have questions about the safety measures to be observed when handling these products are urged to communicate with the manufacturer of the device they use and with a physician.
Media Enquiries:
Nathalie Lalonde
Health Canada
(613) 957-1803
Public Enquiries:
(613) 957-2991
1-866 225-0709
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Hepatitis B Genotype Linked to Degree of Liver Damage in HIV-Positive Patients
SourceURL:http://www.aidsmap.com
Chris Gadd
A French study has found that the degree of liver damage in patients infected with both hepatitis B and HIV is affected by the strain or 'genotype' of hepatitis B virus. This leads the investigators to call for testing of hepatitis B genotypes in patients co-infected with HIV. The study's findings are published in the 14th February edition of AIDS.
There are seven known genotypes of the hepatitis B virus, which are given the letters A to G. Previous studies have shown that genotype can affect the speed of liver disease progression in HIV-negative patients. However, its effects in patients who also have HIV have not been analysed before.
To gain more information on the role of hepatitis B virus genotypes in liver disease, investigators from seven French HIV clinics examined the risk factors for liver damage or 'fibrosis' in 104 HIV-positive patients, as part of a larger prospective study.
The investigators compared the patients' risk factors for liver damage to the degree of fibrosis detected in liver biopsies. Risk factors included hepatitis B genotype, duration of HIV and hepatitis B infection and treatments for both viruses, as well as infection with hepatitis C or D, alcohol intake and body mass index.
Seventy (67%) of the patients had "extensive" fibrosis, with a score of two or greater on the METAVIR scale, which runs from zero to four.
After adjusting the data for the known risk factors for fibrosis, the researchers found that the odds of a patient having a METAVIR score of two or more were 12.6 times greater when they were infected with genotype G than the more common genotype A (p < 0.009).
"Hepatitis B virus genotype G is a determinant of liver fibrosis in HIV / hepatitis B virus-co-infected patients," they conclude. "Hepatitis B virus genotyping should be considered as part of the management of patients with multiple risk factors for rapid profession of liver fibrosis."
Although usually rare, genotype G was found in 13% of the patients included in this study. "Genotype G is thought to occur mainly in Western countries and to be transmitted by men having sex with men," the investigators explain. "The relatively high frequency of this genotype in our study population may, therefore, reflect the predominance of male homosexuals and supports previous data."
Other factors that were independently linked to fibrosis were exposure to efavirenz (Sustiva; odds ratio: 3.6, p < 0.03) and length of HIV infection (odds ratio: 3.9, p < 0.01). However, there was no significant association between fibrosis and the use of anti-hepatitis B drugs, resistance to lamivudine (3TC, Zeffix / Epivir) or mutations in the hepatitis B virus.
The study was limited by only including patients who had had liver biopsies as part of their medical care. Compared to co-infected patients who had not had liver biopsies taken, the patients included in the study had markers of more severe hepatitis B disease, including higher levels of hepatitis B virus in the blood, antibodies against hepatitis B and higher levels of the liver enzyme alanine aminotransferase (ALT). They were also more likely to have received interferon therapy.
The investigators also stop short of directly linking efavirenz use to liver damage. "The observed association between efavirenz exposure and the degree of liver fibrosis may not be a causal one," they write. "Other non-nucleoside reverse transcriptase inhibitors, such as nevirapine, have been linked to a higher risk of hepatotoxicity in HIV-infected patients with hepatitis C virus or hepatitis B virus co-infection."
"Prospective studies are needed to draw firm conclusions on the impact of nevirapine and efavirenz on liver fibrosis," they add.
Reference
Lacombe K et al. Major role of hepatitis B genotypes in liver fibrosis during coinfection with HIV. AIDS 20: 419-427, 2006.
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February 1st, 2006
Antifungal Prophylaxis in Low-Risk Liver Transplant Patients
SourceURL:http://www.gastrohep.com
Liver transplant recipients at low risk for invasive fungal infections can be identified with pre-determined criteria, and post-transplantation antifungal prophylaxis may be routinely withheld, finds the latest American Journal of Transplantation.
Fluconazole prevents invasive fungal infections in orthotopic liver transplant recipients utilizing postoperative systemic antifungal prophylaxis.
Fluconazole, is justified among those at high risk for invasive fungal infections.
The use of postoperative antifungal prophylaxis for low-risk ortohotopic liver transplant recipients is widely practiced.
However, this is not universally accepted nor supported by data.
Dr Pappasa and colleagues conducted a prospective observational study among 200 orthotopic liver transplant recipients.
The transplant recipients were at low risk for invasive fungal infections, and did not receive postoperative antifungal prophylaxis.
2% of invasive fungal infections were due to Candida spp., and preventable by fluconazole – American Journal of Transplantation
Patients were considered low risk if they had 1 or more of various conditions, including choledochojejunostomy, anastomosis, or retransplantation.
Intra-operative administration of 40 blood products or more, or return to the operating room for intra-abdominal bleeding was considered low risk.
The team considered patients returning to the operating room for anastomotic leak or vascular insufficiency as low risk.
In addition, using preoperative serum creatinine of 2 mg/dL or more, and perioperative Candida colonization was considered low risk.
The researchers followed 193 patients for 100 days post-transplantation for evidence of invasive fungal infections.
Of 193 eligible patients, 4% developed an invasive fungal infection.
The researchers found that 2% of invasive fungal infections were due to Candida spp. and potentially preventable by standard fluconazole prophylaxis.
The team noted that a further 2% developed invasive aspergillosis; and 1 patient developed late onset disseminated cryptococcosis.
Dr Pappasa's team concludes, "Liver transplant recipients at low risk for invasive fungal infections can be identified utilizing pre-determined criteria."
"Post-transplantation antifungal prophylaxis can be routinely withheld in these patients."
Am J Transplant 2006: 6(2): 386
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Nabi Biopharmaceuticals Announces U.S. Fast Track Designation for Civacir to Prevent Hepatitis C Re-infection in Liver Transplants
SourceURL:http://www.finanznachrichten.de
ROCKVILLE, Md., Feb. 1 /PRNewswire-FirstCall/ -- Nabi Biopharmaceuticals (Nachrichten) today announced important regulatory and clinical advancements for its product candidate Civacir(TM) [Hepatitis C Immune Globulin (Human)], an antibody for preventing Hepatitis C virus re-infection in liver transplants. Civacir has been granted Fast Track Designation by the U.S. Food and Drug Administration (FDA). Under the FDA Modernization Act of 1997, Fast Track regulations facilitate the development of products that treat serious diseases where an unmet medical need exists. Fast Track regulations are also designed to expedite the review process for designated products, including the potential for companies to ask for priority review.
The company also announced today that recent discussions with regulators in the U.S. and EU have been very productive with respect to advancing the development program for Civacir. Based on this important input, Nabi Biopharmaceuticals believes that a proof-of-concept Phase II trial, followed by a single pivotal Phase III study, would be adequate for licensure in the U.S. and Europe, assuming that prospectively defined endpoints are met. The Phase II proof-of-concept study will be designed to add to the knowledge of how Civacir works and the levels of antibodies needed to protect the transplanted liver from re-infection with the Hepatitis C virus.
In addition, Nabi Biopharmaceuticals announced today that consistent with its overall approach to product development, it is establishing an outside scientific and clinical advisory panel to work with the company on the Civacir development program. The company believes that the input and guidance it receives from the panel, combined with input from regulatory bodies in the U.S. and Europe, will be valuable in advancing the regulatory, clinical and commercial development path for Civacir and lead to the design of an optimal Phase III pivotal trial for this first-of-its-kind product.
The Fast Track Designation is the latest in a number of regulatory milestones achieved with Civacir by Nabi Biopharmaceuticals. In June 2005, the company announced that it had gained Orphan Medicinal Product (OMP) designation for Civacir 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. OMP designation in the EU was an important milestone for Nabi Biopharmaceuticals, as it represents further validation for the need for new treatment approaches in the care of HCV-positive liver transplant patients. Civacir received orphan drug status in the U.S. in 2002. Among other benefits of orphan drug designation, Civacir will be entitled to seven years of market exclusivity in the U.S., post-launch, thereby preventing a similar drug from receiving authorization for the same indication during this period.
About Civacir
Designed to be the first therapy approved specifically for the prevention of recurrence of Hepatitis C-related liver disease in HCV-positive liver transplant recipients, or in patients who receive a HCV-positive liver, Civacir has the potential to fill a critical void in treatment options for this vulnerable patient population. Most notably, market research completed by the company in 2005 supports growing physician awareness and support for this potential new treatment alternative for HCV. This increased awareness is due, in part, to the following factors:
* Currently, there are no products that can be dosed safely at the time of transplant or immediately after transplant in hepatitis C-positive liver transplant recipients; and as a result, transplanted livers universally become re-infected;
* Current products and products under development for maintenance tend to convey a poor risk-benefit ratio in liver transplant recipients; and
* Due to the variations in strains of the Hepatitis C virus, it is well recognized that a polyclonal antibody approach is needed; a monoclonal antibody is unlikely to be effective.
HCV is the most common chronic blood-borne infection in the U.S. and a leading cause of end-stage liver disease resulting in liver transplantation. Interferon and ribavirin, currently available treatments, have demonstrated limited efficacy in chronically infected HCV patients. Furthermore, these therapies cannot be used to protect liver transplant patients from HCV re-infection after surgery and are considered too toxic for immune-suppressed liver transplant patients. As a result, among chronic HCV patients who undergo liver transplantation, HCV recurrence in the transplanted liver is nearly universal(1). In addition, associated severe side effects often lead to dose reductions and discontinuation of treatment.
Henrik S. Rasmussen, M.D., Ph.D., senior vice president clinical, medical and regulatory affairs, Nabi Biopharmaceuticals, stated, "The Fast Track Designation provided by the FDA not only acknowledges Civacir as a viable potential treatment option for HCV patients, but it also recognizes that current therapies are inadequate. Nabi Biopharmaceuticals has engaged in extensive and productive discussions with the FDA and the European Medicines Agency regarding the optimal development path for Civacir. The guidance we have received from these organizations and other third parties will be critical factors in the future development of Civacir. Based on input received so far, we plan to initiate a larger dose-ranging proof-of-concept Phase II study later this year."
Next Steps: Civacir Development Program (Phase II Proof-of-Concept Study)
Nabi Biopharmaceuticals plans to initiate a Phase II proof-of-concept study for Civacir in the second half of 2006. This timing is aligned with our goal to have the clinical lot of Civacir manufactured by October 2006, a critical and required step before trial initiation. It is also important to note that Nabi Biopharmaceuticals has developed important technical know-how through a unique and safe production process for Civacir that allows for the separation of high-quality antibodies from patients infected with Hepatitis C.
We believe this timing and product development approach will support our goals of completing enrollment within twelve months, and, subsequently, having data available in the second half of 2008.
The trial will be designed as a double-blinded, placebo-controlled study in approximately 100 HCV-positive patients, post-liver transplant (3 active dose levels, 100, 200 and 400mg/kg, 25 patients per group). The endpoints of the trial are: progression of liver fibrosis; liver enzyme levels; and safety and tolerance. Nabi Biopharmaceuticals plans to conduct the trial in the U.S. and EU.
Thomas H. McLain, chairman, chief executive officer and president, Nabi Biopharmaceuticals, stated, "Civacir is an important and strategic part of Nabi Biopharmaceuticals' product portfolio and our global hepatitis franchise. Civacir leverages assets and competencies within Nabi Biopharmaceuticals today, including our expertise in plasma collection, manufacturing, clinical and regulatory, and sales and marketing, and it builds upon our commercial success with Nabi-HB(R) [Hepatitis B Immune Globulin (Human)] the current gold standard for Hepatitis B. Combined, Civacir and our Nabi-HB product, currently marketed for the prevention of HBV infections following acute exposure, could represent better medical care for patients and a reduction in healthcare dollars spent on additional transplants. Nabi Biopharmaceuticals remains committed to advancing this clinically and commercially important global franchise."
About Liver Transplants and Hepatitis C
There are approximately 6,000 liver transplants conducted yearly in U.S. and 4,000 in the EU, the majority of which are due to Hepatitis C. Furthermore, the proportion of transplants due to Hepatitis C is expected to increase as other causes of end-stage liver disease decrease (i.e., Hepatitis B).
Hepatitis C is the most common cause of end-stage liver disease in the developed world. Most transplant patients, because of their immunocompromised status, suffer immediate re-infection of the liver, which in many cases will progress to liver cirrhosis and can eventually result in death or the need for a re-transplantation. The U.S. Centers for Disease Control and Prevention (CDC) estimates that approximately three million individuals in the U.S. are chronically infected with HCV, and the World Health Organization (WHO) estimates that 170 million individuals worldwide are infected with HCV. The virus can be transmitted through blood transfusion, organ transplants, intravenous drug use, kidney dialysis and sexual contact.
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. We are focusing on developing products addressing commercial opportunities in our core business areas: Gram-positive bacterial infections, hepatitis, kidney disease (nephrology), and nicotine addiction. We have three products on the market today: PhosLo(R) (calcium acetate), Nabi-HB(R) [Hepatitis B Immune Globulin (Human)], and Aloprim(TM) [Allopurinol sodium (for injection)] and a number of products in various stages of clinical and pre-clinical development. The company also filed Marketing Authorization Applications (MAA) in Europe to market Nabi-HB(R) Intravenous [Hepatitis B Immune Globulin (Human) Intravenous] under the trade name HEBIG(TM) for the prevention of hepatitis B disease in HBV-positive liver transplant patients; and for PhosLo, which is already marketed in the United States. The company's products in development include NicVAX(TM) (Nicotine Conjugate Vaccine), a vaccine to treat nicotine addiction, and Civacir(TM) [Hepatitis C Immune Globulin (Human)], an antibody for preventing hepatitis C virus re-infection in liver transplant patients. For additional information on Nabi Biopharmaceuticals, please visit our website: http://www.nabi.com/.
This press release contains forward-looking statements that reflect the company's current expectations regarding future events. Any such forward- looking statements are not guarantees of future performance and involve significant risks and uncertainties. Actual results may differ significantly from those in the forward-looking statements as a result of any number of factors, including, but not limited to risks relating to the company's ability to: advance the development of products currently in the pipeline or in clinical trials; complete the assessment of the StaphVAX Phase III clinical trials during the first half of 2006; 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. or other markets; successfully develop manufacture and market its products; utilize the full capacity of its manufacturing facility; realize the value of its acquisition of PhosLo; realize sales from Nabi-HB due to patient treatment protocols and the number of liver transplants performed in HBV-positive patients; realize the value from its vaccine manufacturing facility; realize future sales growth for its biopharmaceutical products; prevail in patent litigation; raise additional capital on acceptable terms; re-pay its outstanding convertible senior notes when due; and the company's dependence upon: third parties to manufacture its products and a small number of customers. 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 25, 2004 filed with the Securities and Exchange Commission.
(1) U.S. Department of Health and Human Services. Management of Hepatitis C: 2002. NIH Consensus State Sci Statements. National Institutes of Health, 2002 Jun 10-12; 19 (3) 1-46
First Call Analyst:
FCMN Contact: njohnson@nabi.com
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Kerr Again Rejects Inquiry Into Transfusion Hepatitis Infection
ROBBIE DINWOODIE
SourceURL:http://www.theherald.co.uk
MSPs expressed astonishment yesterday that more had not been done to track down patients who may have received transfusions of blood infected with hepatitis C during the 1970s and 1980s.
The Holyrood health committee was considering demands from campaigners, many of them haemophiliacs, seeking a full public inquiry into the saga, which only began to be brought under control in September 1991 when a blood test for the condition became available.
By that time up to 3500 patients were believed to have received infected blood. There are now about 37,000 people with the virus. Many will have contracted it through sharing needles or via sex, but an unknown number may be relatives of those early patients who received blood.
The committee heard from sufferers of HIV, hepatitis C and a leading lawyer fighting cases through the courts, all stressing that what they wanted from an inquiry was the truth about the circumstances of the time.
Andy Kerr, the health minister, responded by continuing to resist such an inquiry as costly and pointless, insisting that after this length of time it would never bring out the full story or help the victims find closure.
Responding to questions from MSPs, Mr Kerr said some tracking back had been done, but only involving regular blood donors who had been found to be infected.
Mr Kerr said that whether it was possible to trace every patient was something he would look into.
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February 2nd, 2006
Preventive Treatment Helps Avoid Hepatitis B Relapse During Chemotherapy
SourceURL:http://www.eurekalert.org
A new study on treating hepatitis B patients who have cancer with an antiviral drug at the same time as they undergo chemotherapy found that the treatment helped prevent relapse of hepatitis B.
The results of this study appear in the February 2006 issue of Hepatology, the official journal of the American Association for the Study of Liver Diseases (AASLD). Published by John Wiley & Sons, Inc., Hepatology is available online via Wiley InterScience at http://www.interscience.wiley.com
/journal/hepatology.
Patients who develop hepatocellular carcinoma (HCC), a type of liver cancer caused by the hepatitis B virus, have up to a 55 percent chance of having the virus reactivated during chemotherapy. The idea of preemptively treating these patients with the antiviral drug lamivudine in order to prevent hepatitis B relapse and it varying complications is promising but has never been investigated in patients with HCC.
Researchers led by Jeong Won Jang of the Department of Internal Medicine at the Catholic University of Korea in Seoul, conducted a prospective randomized study on pretreating HCC patients undergoing chemotherapy with lamivudine between January 2004 and February 2005. The study involved 36 patients with HCC who were given the drug while undergoing transarterial chemo-lipiodolization (TACL) chemotherapy and a control group of 37 patients who underwent the chemotherapy without receiving lamivudine. The chemotherapy was continued every month without any limit on the number of cycles until the tumors disappeared, while treatment with lamivudine began with the chemotherapy and continued for 12 months following its completion.
In total, 43 percent of the patients in the control group developed overall clinical hepatitis during the follow-up period, compared to 17 percent of the patients who took lamivudine. In addition, there was a significantly higher incidence of severe hepatitis in the control group and the researchers established the level of viral load (>104 copies/ml) that predicted whether a patient would have a relapse of hepatitis B.
In addition to demonstrating that treatment with lamivudine significantly reduced hepatitis B reactivation, allowing chemotherapy to continue in these cancer patients, the study suggests that lamivudine therapy decreases the severity of clinical hepatitis if it develops during chemotherapy. "The beneficial effects of preemptive therapy on the severity of hepatitis most probably result from an elimination of any potential risk arising from viral reactivation," the authors state.
While previous studies have shown a higher viral load as a predictor of hepatitis B reactivation, the lower cutoff in the current study was identified as a better predictor and the authors urge the use of a highly sensitive test to detect and measure viral load in order to identify patients at the greatest risk of hepatitis B reactivation. In those patients with lower viral loads, it would still be beneficial to closely monitor virological and biochemical changes when they are undergoing repeated courses of chemotherapy, since the study demonstrated that even lower viral loads are associated with an approximately 30 percent risk of viral reactivation.
Although the study did not examine long-term survival in the patients who took lamivudine, the authors conclude: "Given that preemptive antiviral therapy ameliorates the hepatic morbidity seen during transarterial chemotherapy and facilitates further chemotherapy without disruptions in the treatment schedules, the expectation would be for an increased chance of survival with this approach."
Article: "A Randomized Controlled Study of Preemptive Lamivudine in Patients Receiving Transarterial Chemo-Lipiodolization," Jeong Won Jang, Jong Young Choi, Si Hyun Bae, Seung Kew Yoon, U Im Chang, Chang Wook Kim, Se Hyun Cho, Jun Yeol Han, Young Sok Lee, Hepatology; February 2006 (DOI: 10.1002.hep.21024).
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Wissinoming Man Proves You Can Battle and Survive Hepatitis C
SourceURL:http://www.newsgleaner.com/
Six years ago, Wissinoming resident John Waddell gave hope to Philadelphia firefighters who had just learned they were infected with the Hepatitis C virus. He discovered in 1994, after 20 years of unknowingly donating contaminated blood to the Red Cross, that he had contracted the liver damaging virus from a 1970 blood transfusion.
Waddell, now 76, is a proven survivor; he has lived the past five years with a new liver.
"Here's somebody who has waited for quite a while, wore a beeper, got a liver and here he is now," Waddell said of his accomplishment.
Waddell was diagnosed with Hepatitis C at a time when few people knew what the virus was. According to the Centers for Disease Control and Prevention, about 30,000 Americans are infected with the virus each year. It can cause cancer, cirrhosis of the liver, even death. Those infected must either receive a liver transplant or take medication the rest of their lives. There is no cure.
Perhaps Hepatitis C's worst feature, however, is that it can go undetected for years after a person contracts it. It was 20 years before Waddell felt its effects, including fatigue, nausea and weight loss. A severely damaged liver can also release toxins into the body that cause hepatic encephalopathy, severe mental confusion and hallucinations, which Waddell also experienced.
"It was a whole new ball game," said Waddell's wife, Doris, a retired nurse. "I inquired, I asked and I read about it. It was a learning experience as we went on."
Waddell in 1998 was placed on a liver transplant list through Temple University Hospital's Living Donor Program. He wore a beeper that sounds when an organ becomes available. It beeped several times until the program was discontinued and Waddell was forced to seek help at the University of Pennsylvania Hospital. Doris knew that time was not on their side; as many as five percent of infected persons die from the disease's complications.
When he visited U of Penn., Waddell, then 71, received devastating news - the hospital did not perform liver transplants for people over age 70. But after learning that Waddell had not abused his body, doctors agreed to put him on their transplant list. He wore a beeper that sounded twice before he got the call he had been waiting for in 2001. They had a liver for him.
Doctors prepped him for the six to eight hour operation, which turned out to be an overwhelming success for Waddell. He returned home just days before his 72nd birthday in March.
"I had a good recovery," Waddell said. "I felt wonderful. The tiredness left me, the appetite came back."
Waddell went to doctor's appointments every week for three months after his transplant. He will take medication for Hepatitis C for the rest of his life and undergo liver biopsies each year. A new liver doesn't force the virus from the body. Waddell's new liver is already being attacked.
Waddell, who is both a father and grandfather, credits Doris, his doctor at Temple and God for helping him through his struggle.
"When they told me there was nothing they could give me [to cure the disease], I just turned it over to the Lord," Waddell said, "because I couldn't handle it in my own strength."
His message is still one of optimism. He offers the contact information of his doctor to anyone he meets with the virus.
"Don't give up hope," he said. "You have to have a positive attitude."
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Hepatitis C Recurs Rapidly After Liver Transplant
SourceURL:http://www.eurekalert.org
Extrahepatic sites may account for some viral replication
When a diseased liver is removed from a patient with Hepatitis C (HCV), serum viral levels plummet. However, after receiving a healthy liver transplant, virus levels rebound and can surpass pre-transplant levels within a few days, according to a new study published in the February 2006 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 (http://www.interscience.wiley.com/journal
/livertransplantation).
Hepatitis C is the number one reason for liver transplantation, however, the virus always recurs in the new liver. Since mathematical models have been useful in the study of the viral dynamics of HIV and hepatitis B, researchers, led by Kimberly A. Powers and Ruy M. Ribeiro of the Los Alamos National Laboratory in New Mexico, sought to use a mathematical model to quantify the liver reinfection dynamics of HCV.
The researchers, in collaboration with a surgical team lead by John McHutchison now at Duke University Medical Center, followed six HCV-infected patients who received cadaveric liver transplants. They collected blood samples before, during and after transplantation to assess changing levels of HCV RNA which was measured using reverse transcription polymerase chain reaction assay. They then plugged the data into a mathematical model, correcting for fluid balance, and analyzed the results using linear regression.
"In most patients," the authors report, "HCV RNA levels decreased rapidly during and after transplantation and subsequently began to increase – reaching above pre-transplant levels in all but one patient – within a few days of the procedure." They found that when the diseased liver was removed, virus levels dropped with an average half-life of 48 minutes. After the new liver was implanted, they found that virus levels continued to drop for up to 23 hours, then began to rise, doubling every 2 days.
Notably, in three patients, the virus levels plateaued before rising, suggesting, say the authors "that a non-hepatic source supplied virions and balanced their intrinsic clearance." The authors estimate, however, that non-hepatic sources can only account for 4 percent of total viral production. Ninety-six percent of it occurs in the liver.
The patterns of viremia decline and increase seen in this study are consistent with previous studies, although this study indicates a much faster virion half-life than previously suggested. The findings also support the notion that HCV can replicate rapidly in the post-transplant immunosuppressed patient, leading the authors to suggest that early antiviral therapy may delay or prevent reinfection.
The study was limited by the small number of patients and the single compartment model, which did not separately account for liver and extrahepatic sites of viral replication. "Nevertheless," report the authors, "the rapid HCV RNA decline in the anhepatic phase, followed by the postoperative increase observed in several patients suggest that the liver is the primary site of viral replication, with at most small contributions from extrahepatic sites."
In conclusion, the authors write, "Continued work towards elucidating extrahepatic replication, the time-course of reinfection, the effects of immunosuppressive therapy, and the relationships among viremia, infection and liver damage will be beneficial in optimizing treatment for HCV patients undergoing liver transplantation."
###
Article: "Kinetics of Hepatitis C Virus Reinfection After Liver Transplantation," Kimberly A. Powers, Ruy M. Ribeiro, Keyur Patel, Stephen Pianko, Lisa Nyberg, Paul Pockros, Andrew Conrad, John McHutchison, and Alan S. Perelson, Liver Transplantation; February 2006; (DOI: 10.1002/lt.20572).
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Vertex, Human Genome Sciences Seen Posting More Losses
http://www.iii.co.uk/
BOSTON (AFX) -- Vertex Pharmaceuticals and Human Genome Sciences head the list of biotech groups slated to report quarterly results next week, with both expected to report narrowed losses.
Vertex Pharmaceuticals , a component of the Amex Biotechnology Index, is slated to roll out its fourth-quarter report after the closing bell Tuesday.
The Cambridge, Mass.-based developer of HIV and hepatitis-C drugs is expected to post a loss of 23 cents a share, compared with a loss of 38 cents a share last year, according to a survey by Thomson First Call.
The same poll sees Vertex showing that revenues will have grown about 45% to $58 million over the year.
Vertex derives most of its revenue through research collaborations and royalties on the sales of two HIV drugs marketed via partner GlaxoSmithKline .
In its most recent forecast, Vertex projected a 2005 adjusted loss of $140 million to $150 million.
Human Genome Sciences , also part of the Amex Biotech Index, will report next Thursday.
The company is expected to report a loss of 48 cents a share, on revenue of $3 million, compared with a loss of 50 cents a share last year, according to First Call.
Human Genome Sciences, which has been developing drugs to treat illnesses such as cancer and lupus, currently doesn't have any drugs on the market.
This story was supplied by MarketWatch. For further information see www.marketwatch.com.
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February 3rd, 2006
Noninvasive Alternative to Upper Endoscopy for Esophageal Varices
SourceURL:http://www.gastrohep.com
PillCam ESO may represent an accurate noninvasive alternative to conventional upper endoscopy for the detection of esophageal varices and portal hypertensive gastropathy, finds this month's Endoscopy.
Variceal bleeding is a major complication of cirrhosis, and is associated with a 20% mortality at 6 weeks.
Current international guidelines recommend that patients with cirrhosis are screened by conventional upper endoscopy in order to detect esophageal varices.
The PillCam ESO esophageal capsule endoscope has been shown to be an accurate diagnostic tool for gastroesophageal reflux and Barrett's esophagus.
Dr Eisen and colleagues from Italy compared the PillCam ESO capsule endoscope with conventional upper endoscopy.
The researchers assessed whether this technique detects esophagogastric varices and portal hypertensive gastropathy in patients with cirrhosis.
The research team conducted a pilot trial at 3 sites.
The team included patients with cirrhosis undergoing clinically indicated conventional endoscopy for screening or surveillance for esophageal varices.
The patients underwent a PillCam ESO study followed by conventional upper endoscopy within 48 hours.
The overall concordance between the methods was 97% for the diagnosis of esophageal varices – Endoscopy
Capsule videos were assessed by an investigator who was blinded to the patient's medical history and endoscopy findings.
A total of 23 of the 32 enrolled patients were found to have esophageal varices using both endoscopy techniques.
In 1 patient, PillCam ESO detected small varices that were not seen at conventional endoscopy.
The team noted that the overall concordance between PillCam ESO and conventional endoscopy was 97% for the diagnosis of esophageal varices.
The researchers observed a 91% concordance between PillCam ESO and conventional endoscopy for the diagnosis of portal hypertensive gastropathy.
There were no adverse events related to PillCam ESO endoscopy.
Dr Eisen's team commented, "In a high-prevalence population, PillCam ESO may represent an accurate noninvasive alternative to conventional upper endoscopy for the detection of esophageal varices and portal hypertensive gastropathy."
"A large-scale trial is underway to validate and expand these findings."
Endoscopy 2006: 38: 31-5
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Method for Estimating Deaths on Liver Transplant Waiting List
SourceURL:http://www.gastrohep.com
The competing risk analysis method is useful in estimating the risk of death among patients awaiting liver transplantation, and allows evaluating end points individually, reports the most recent issue of Hepatology.
The usual method of estimating survival probabilities, namely the Kaplan-Meier method, is suboptimal in the analysis of deaths on the transplant waiting list.
Death, transplantation, and withdrawal from list must all be considered.
Dr Ray Kim and colleagues from Rochester applied the competing risk analysis method.
This method allows evaluating these end points individually and simultaneously.
It also enables the comparison of the risk of waiting list death across era, blood types, liver disease diagnosis, and severity.
The researchers assessed 861 patients registered on the waiting list at Mayo Clinic Rochester between 1990 and 1999.
Of these patients, 76% underwent transplantation, 10% died while waiting, 5% withdrew from the list, and 9% patients were still waiting as of 2002.
The research team noted that the risk of death at 3 years was 10% by the competing risk analysis.
The risk of death was increased in those with higher MELD scores – Hepatology
During the study period, the median time to transplantation increased from 45 to 517 days.
In univariate analyses, the team found no significant difference in the risk of death by era of listing or blood type.
However, the team observed that the risk of death was significantly higher in patients with alcohol-induced liver disease.
The risk of death was also increased in those with higher Model for End-stage Liver Disease (MELD) scores.
A multivariable analysis showed that after adjusting for MELD, blood type, and diagnosis, patients listed in the latter era had higher mortality.
Dr Ray Kim's team concludes, "The competing risk analysis method is useful in estimating the risk of death among patients awaiting liver transplantation."
Hepatol 2006: 43(2): 345-51
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