August 2002 News
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Thu Aug 1, 1:59 PM ET
By Richard Woodman LONDON (Reuters Health) - Hepatitis C spread by an "epidemic" of heroin use in Britain during the 1970s and 1980s appears to be resulting in a huge increase in the number of men dying from alcoholic liver disease, researchers said on Thursday.
Researchers at Imperial College and St. Mary's Hospital, London, said deaths from liver damage where the cause was unspecified shot up 259% in middle-aged men in England between 1993 and 1999. They said such a huge rise could not be explained by increased alcohol consumption alone and suggested that exposure to the liver-damaging virus hepatitis C, as a result of drug users sharing infected needles, was also to blame. The increase has not been seen in women, or in younger men. "Hepatitis C normally takes 20 or 30 years to lead to liver damage and so does alcohol, but if you are hepatitis C-positive and you also drink alcohol it races away," said Professor John Henry, of the academic department of accident and emergency medicine at St. Mary's. "That is what we think is happening. It is a sort of reaping effect," he told Reuters Health. Writing in the Journal of Clinical Pathology, the team said anyone infected with hepatitis C who also drank alcohol was 31 times more likely to suffer from liver cirrhosis. They said that a generation of men, now aged 40 to 59 years old, was involved in an "epidemic of illicit drug use which took hold in the 1970s and 1980s." They point out, "Significantly, this was before the introduction of needle exchange and other interventions to reduce the risk of HIV ( news - web sites) transmission in drug users." The report said hepatitis C infection--which had not even been recognized at the time--was now a worldwide health issue. In Britain alone, an estimated 300,000 people were infected though fewer than 5% had been diagnosed. The pathology of alcoholic liver disease and chronic hepatitis C were very similar. Clinicians and pathologists could fail to recognize hepatitis C infection as a cause of rapid progression of alcoholic liver disease unless they specifically tested for the virus. The scientists recommended more hepatitis C testing so that those found to be infected could be advised to cut down on their drinking and increase their chances of successful treatment and longer survival. SOURCE: Journal of Clinical Pathology 2002;55(9).
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Mon Jul 29, 5:43 PM ET
FRANKFURT (Reuters Health) - Germany's Paul Ehrlich Institute said on Monday it would investigate the case of a man reported to have contracted hepatitis A despite having been vaccinated.
The case was first reported in the journal Deutsche Medizinische Wochenschrift by a team of doctors in Bielefeld, led by Prof. Ulrich Junge. On Sunday, Germany's mass circulation Bild newspaper ran a story about the case, bringing it national attention. The 55-year-old German man was said to have received a full immunization with Twinrix Adult, marketed by GlaxoSmithKline, but some 47 days later became ill after eating shellfish. Junge and his team concluded that "combined hepatitis A/B vaccination according to the recommended schedule does not guarantee protection in elderly persons." Dr. Johannes Loewer, head of licensing and inspection at Paul Ehrlich Institute, said in a statement that the agency took Prof. Junge's data seriously and would conduct an investigation. However, he said he currently sees no reason to question the use of Twinrix. He noted that immunity in people over 40 years old can be less than in people younger than 40. Twinrix Adult was approved in 1996 by the European Agency for the Evaluation of Medicinal Products, and during the approval process it was found to be effective for older people, he said. Loewer suggested that any older people who have been vaccinated with Twinrix Adult and are nonetheless concerned could be tested to ensure they have effective levels of antibodies against hepatitis A virus. The Institute said it believed the vaccine to be safe and effective and saw no reason to question its use. "We are nearly certain that this was not a quality problem," said Susanne Stoecker, spokeswoman at the Institute.
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NEW YORK (Reuters Health) Jul 19 - In patients with transfusion-associated
hepatitis C, age at infection influences the likelihood of progression to
cirrhosis, according to Italian researchers.
Dr. Dario Conte of Ospidale Maggiore, Milan, and colleagues note that during the 1980s, before screening of donors was introduced, about 10% of patients receiving transfusions in Italy developed hepatitis C. In order to assess risks factors for progression to cirrhosis, the researchers eventually identified 268 patients with hepatitis C who recalled a single and precisely dated transfusion event and showed no other cause of chronic liver disease. All underwent ultrasound-guided liver biopsy. As reported in the June 15th issue of Blood, 54 of these patients (20.1%) were found to have cirrhosis, at a mean of 18.4 years after blood transfusion. Multivariate analysis showed that this was independently associated with serum levels of alanine aminotransferase and with age at biopsy, duration of followup and age at infection. The investigators calculate that over a period of 30 years, patients aged 21 to 30 years at the time of hepatitis C virus infection are 4.51 times more likely to develop cirrhosis than those aged 20 years or less. In those older than 31 years at infection, the corresponding risk ratio is 12.29. The researchers recommend that "an aggressive therapeutic approach should be adopted in patients infected by hepatitis C virus at an older age to prevent progression to end-stage liver disease." Blood 2002;99:4588-4591.
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Acupuncture increases risk of HCV infection
Repeated acupuncture and blood transfusion before 1992 both increase the
The team evaluated the prevalence of and the risk factors for hepatitis C
They published their results in the latest issue of the British Journal
of A total of 700 adults above the age of 40 years were studied. Seropositivity for hepatitis C virus antibody (11%) was found to be
higher Repeated acupuncture increases HCV risk by 2-fold. Anti-hepatitis C virus seropositivity was associated with a history of
It was also linked with blood transfusion (odds ratio = 5.5) before 1992,
The researchers found that hepatitis C virus 2a was the most prevalent
Hepatitis C virus risk attributable to acupuncture was 38% (9% for men
and The authors comment that safer acupuncture practice has become a priority
Br J Cancer 2002; 87: 314-8
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Hepatitis E Vaccine Recommended
For Patients With Chronic Liver Disease A DGReview of :"Hepatitis E virus superinfection in patients with chronic liver disease." Hepatology 08/05/2002 Superinfection from hepatitis E virus may lead to severe hepatic decompensation in adult patients with chronic liver disease. This vulnerability determines their suitability for vaccination against the infection. The majority of adult patients in endemic areas who have chronic liver disease caused by hepatitis C have been exposed to hepatitis A virus infection. Nevertheless, they may still be vulnerable to hepatitis E virus, which could lead to an increase in morbidity and mortality. Clinicians at the Aga Khan University in Karachi, Pakistan, had already documented hepatitis E virus superinfection in four patients with chronic liver disease (CLD) which had led to severe liver decompensation. Consequently, they designed a study to determine the seroprevalence of HAV and hepatitis E (HEV) among patients with stable CLD. Two hundred and thirty three patients fulfilling this criterion were enrolled to enable clinicians to determine which among them required protection against these viral infections. Ninety age and gender matched healthy blood donors served as controls and underwent tests for HAV and HEV antibodies IgG. HEV antibody immunoglobulin G positivity (HEV IgG) was identified in 41 patients (17.5 percent) from 233. However, the majority of patients, 228 (97.8 percent) were HAV IgG -positive. No differences were noted among the percentage of CLD patients and blood donors positive for HEV antibody IgG (17.7 vs 17.5 percent) or HAV IgG (97.8 percent vs 94). There were also no differences displayed in the severity of liver disease between patients who had previously been exposed to HEV and those who had not. Hepatology Aug 2002 Vol 36 No 2 pp 474-478. "Hepatitis E virus
superinfection in patients with chronic liver disease."
Hepatitis C May Cause Erectile Dysfunction NEW YORK (Reuters Health) - Infection with the hepatitis C virus may increase the risk of erectile dysfunction, the results of a new study suggest. The virus itself may play a direct role in causing erectile dysfunction, the findings suggest, since investigators took into account liver failure and treatment for hepatitis C, both of which are suspected of increasing the risk of erectile dysfunction in men with hepatitis C. Nearly 4 million American have hepatitis C, making it the most common chronic viral infection in the US. Chronic inflammation of the liver develops in many patients, and about 20% of people with hepatitis C will develop cirrhosis, a severe and sometimes fatal scarring of the liver. Cirrhosis increases the risk of liver cancer. Hepatitis is spread through contact with blood and other body fluids, but the route of transmission remains undetermined in a substantial percentage of infections. People who share needles to inject drugs have a high risk of contracting the disease. Cases of erectile dysfunction in men with hepatitis C have been reported, but it is unclear whether the blame should be placed on the virus itself or on poor liver function caused by the infection. A drug used to treat hepatitis C, interferon alfa, is another prime suspect. A team led by Dr. Clodoveo Ferri of the University of Pisa in Italy, compared the frequency of erectile dysfunction in 207 men with hepatitis C and 207 healthy men. Among men with hepatitis C, 39% had erectile dysfunction, compared with 14% of healthy men, according to a report in the August 14th issue of the Journal of the American Medical Association ( news - web sites). But neither the presence of liver failure nor interferon alfa therapy seemed to affect a man's odds of having erectile dysfunction, according to the researchers. "Nonetheless, both liver failure and interferon alfa may also contribute to erectile dysfunction, and treatment should be individualized," Ferri's team writes. Suggesting that antiviral treatment may relieve erectile dysfunction, the researchers recommend that this approach be studied in clinical trials. They also advise physicians to consider hepatitis C infection when diagnosing erectile dysfunction. SOURCE: Journal of the American Medical Association 2002;288:698-699
Update of Progress on New Drugs
- Including Albuferon for HCV
Human Genome Sciences, Inc., (HGSI) recently told financial analysts in
New York that the company expects to file four investigational new drug (IND)
applications in 2002, seeking clearance from the U.S. Food and Drug
Administration (FDA) to begin clinical trials of its new drugs. William A. Haseltine, PhD, chairman and CEO, said, "TRAIL-R1 mAb is an exciting new drug with a novel mechanism of action. It may eventually offer a promising therapeutic option for the treatment of certain solid tumors and cancers of hematopoietic origin. It is one of two IND applications we have filed so far in 2002. The other IND application, which is currently pending review at FDA, is for another novel anticancer compound, LymphoRad. We are seeking clearance to investigate LymphoRad(131) for use in treating multiple myeloma and other B-cell tumors. We hope to file two additional IND applications this year for new Human Genome Sciences drugs." During the meeting, Human Genome Sciences executives highlighted the following key points: * Encouraging preliminary interim clinical data were presented from ongoing phase I clinical studies of Albutropin (albumin-human growth hormone) and Albuferon-alpha (albumin-interferon alpha-2b). * Human Genome Sciences' pipeline includes seven drugs in clinical development, one drug that is currently pending FDA clearance to begin clinical trials, and many drugs in preclinical development. Each of these drugs is intended for use in meeting significant unmet medical needs. * Human Genome Sciences' current pipeline comprises roughly two thirds novel human protein drugs and antibody drugs arising from genomics-based research, and one third new improved long-acting versions of existing protein drugs. * The success of Human Genome Sciences' drug discovery efforts rests firmly on the company's expertise in genomics, the systematic collection and understanding of human genes and their functions, as well as its exclusive focus on developing human protein and antibody drugs. * Human Genome Sciences now has more than 1000 highly skilled employees, with a concentration on protein and antibody drug development and manufacturing. * Human Genome Sciences has protein and antibody manufacturing capabilities in bacteria, yeast and mammalian cells, and is constructing a commercial-scale protein and antibody drug manufacturing facility that will enable the company to produce several different protein and antibody drugs simultaneously. * With $1.6 billion in cash and equivalents, Human Genome Sciences has the financial strength necessary to advance that objective. Preliminary interim results of the open-label phase I dose-escalating safety trials of Albutropin and Albuferon-alpha were discussed. As expected, both Albutropin and Albuferon-Alpha demonstrated substantially longer half- life in serum than did the parental compounds. Surrogate marker data were also presented for both drugs. The significance of the surrogate marker data must be tempered by the very preliminary and interim nature of the results. These results were obtained at intermediate dose levels in the dose-escalation safety trials. Nonetheless, the results were encouraging. The level of insulin-like growth factor-1 (IGF-1) in serum is a robust surrogate marker for the biological activity of human growth hormone. Higher single doses of Albutropin were found to be capable of inducing prolonged elevations in the level of IGF-1 in some patients. Phase 1 studies of Albutropin continue. Dose-escalation studies are in progress using single doses. Repeat dosing is now planned since biological responses are being observed. Phase 1 studies of Albuferon-alpha are in progress with patients who have failed interferon treatment for hepatitis-C (HCV) and continue to test positive for active serum hepatitis-C virus. Levels of the enzyme, 2', 5'- oligoadenylate synthetase (OAS), provide a surrogate marker for interferon- alpha activity. A single dose of Albuferon-alpha has been demonstrated to be capable of inducing elevated OAS levels for up to 28 days. More remarkably, the HCV viral load was reduced by half a log in some patients treated with a single dose. Along with continued escalation of single-dose exposure, repeat dosing has been initiated to further assess safety and the durability of biological activity. Once again, it is important to stress the relatively small number of patients studied and the preliminary nature of the data. Craig A. Rosen, PhD, executive vice president, research and development, and David C. Stump, MD, senior vice president, drug development, reported on the progress of a number of Human Genome Sciences' drugs in clinical and preclinical development. Rosen said, "We have an exceptionally rich product pipeline of clinical and advanced preclinical compounds. Seven of our drug candidates are now in clinical development. These include two therapeutic proteins, two human monoclonal antibodies, and three improved long-acting versions of existing therapeutic proteins. We expect soon to receive FDA clearance to begin human clinical study of a radiolabeled protein. I am not aware of another biotechnology company with the depth and breadth of quality new drug candidates that we have developed at Human Genome Sciences." Autoimmunity and Immunology Many chronic diseases result from misregulation of the immune system, including autoimmune diseases as well as immunodeficiencies. Additionally, the immune system may be mobilized to fight chronic infections. Human Genome Sciences is developing four drugs in this therapeutic area. LymphoStat-B is the human monoclonal antibody that inactivates B- Lymphocyte Stimulator (BLyS), a protein discovered by Human Genome Sciences that stimulates the production of antibodies. The company's scientists, along with others, have reported in the scientific literature that some patients with systemic lupus erythematosus and severe arthritis have elevated levels of BLyS in their circulation. Excessive amounts of the protein induce lupus in laboratory studies. Overproduction of autoimmune-inducing antibodies may be counteracted by reducing BLyS levels with LymphoStat-B. Human Genome Sciences has initiated a phase 1 clinical trial of LymphoStat-B in systemic lupus erythematosus and will be enrolling patients into the study throughout the year. Stump said, "LymphoStat-B has generated considerable enthusiasm in the lupus clinical community. Enrollment in our initial phase I study is going very well. This drug has the potential to treat a family of serious autoimmune diseases. If the initial phase I trials are successful, we hope to be able to add new indications for additional trials for patients with rheumatoid arthritis and other autoimmune diseases." B-Lymphocyte Stimulator is a human protein discovered by Human Genome Sciences that stimulates the production of increased levels of antibodies. The drug acts to increase the number and activity of antibody-producing plasma cells. We currently are conducting phase I clinical studies of BLyS in patients with antibody deficiency diseases, including common variable immunodeficiency disease (CVID) and deficiencies in one specific type of antibody, immunoglobulin-A. We have been granted orphan drug status for treatment of CVID patients with BLyS. Enrollment for these studies should proceed throughout 2002. Albuferon-alpha and Albuferon-beta are new long-acting forms of interferon-alpha and interferon-beta, respectively. The drugs were created by fusing the genes for the parent drug to that for human albumin. Preclinical studies show that both drugs are active and have longer half-lives than do the original compounds. Human Genome Sciences has initiated human trials for Albuferon-alpha for the treatment of patients with hepatitis C. Interferon-alpha alone has been shown to be an effective antiviral drug. We hope that Albuferon-alpha will be more effective and perhaps better tolerated than interferon-alpha. Albuferon-alpha is also the subject of clinical study for use in treating chronic myelogenous leukemia Diabetes and Metabolism Diabetes, obesity, and other metabolic disorders pose serious and growing threats to health. Human Genome Sciences recently initiated systematic efforts to discover new human proteins and antibodies that could be used to treat these diseases. The company now has five new drug candidates in this therapeutic area. GMAD-1 is a novel human protein that emerged from Human Genome Sciences' screening programs designed to find new proteins and antibodies to treat diabetes and obesity. It affects multiple metabolic pathways involved in diabetes and obesity. GMAD-2 is a monoclonal antibody active in the same pathway as GMAD-1. Human Genome Sciences continues to explore the fundamental biology of GMAD-1 and GMAD-2 and to conduct additional preclinical experiments designed to enable the company to translate this exciting discovery into new compounds that may be used to treat both diabetes and obesity. There is a recognized need to establish and maintain a low basal level of insulin activity in patients with Type 1 and Type 2 diabetes. Albulin is a novel long-acting form of insulin. The drug was created by fusing the gene for human insulin to that for human albumin. In preclinical studies, Albulin is active in reducing blood glucose levels for a prolonged period. Additional preclinical studies are in progress to support an IND application for this drug candidate for the t This article was prepared by AIDS Weekly editors from staff and other reports. Copyright 2002, AIDS Weekly via NewsRx.com & NewsRx.net If you have any questions, problems or suggestions regarding this site,
Clinical Trials of Monoclonal Antibody for HCV Print this page XTL Biopharmaceuticals Initiates Multiple Dose Clinical Trials Of Therapeutic Monoclonal Antibody to Treat Hepatitis C-- Study to Test Multiple Escalating Doses Of Xtl-002 in Chronically Infected Patients CAMBRIDGE, Mass. and REHOVOT, Israel, Jun 11, 2002 /PRNewswire-FirstCall via COMTEX/ -- XTL Biopharmaceuticals Ltd. (LSE: XTL) today announces the commencement of a Phase 1B clinical study with XTL-002, its human monoclonal antibody ("hMAb") being developed for hepatitis C virus (HCV) infections. The study is expected to enroll 20 patients and is designed to test safety, tolerability and changes in viral levels following multiple escalating doses of XTL-002 in chronic HCV patients. This is the first time an hMAb has been progressed to multiple dose studies for HCV in humans. The study is being conducted under the regulation of the United States Food and Drug Administration (FDA) and Ministry of Health, Israel. XTL-002 is a fully human, high-affinity monoclonal antibody, which has been shown to reduce viral levels of the HCV virus in XTL's proprietary in vivo model, the Trimera System. Earlier this year, XTL announced positive Phase 1A clinical trials results in a group of 15 HCV patients receiving a single dose of XTL-002. In over half the patients, viral load reductions were seen with no serious adverse events reported. Norah A. Terrault, M.D., M.P.H., Assistant Professor of Medicine, Division of Gastroenterology, The University of California, San Francisco, and a principal investigator of XTL-002, commented: "As a monoclonal antibody therapeutic designed to fight Hepatitis C, XTL-002 is a promising new treatment for the industry and patients alike. Monoclonal antibodies have the distinctive ability both to reduce viral levels by directly acting on the virus and may be able to prevent re-infection of new liver cells. This offers the potential for XTL-002 to work in conjunction with other HCV drugs to create a more effective therapy. This next phase of multiple dose studies will look to further demonstrate its safety and efficacy in treating one of the world's most troublesome infectious diseases." The World Health Organization estimates that 170 million people worldwide are chronic carriers of the hepatitis C virus, with 4 million carriers in the United States alone. It is estimated that 25-35% of these chronic patients will develop progressive liver disease including cirrhosis and liver cancer. Hepatitis C is the leading cause of liver transplantation. The Centers for Disease Control and Prevention estimate that in the year 2000, about 10,000 people died in the US as a result of HCV. It is predicted that by the end of this decade, the number of deaths as a result of HCV will surpass the number of deaths from AIDS. About XTL Biopharmaceuticals XTL Biopharmaceuticals (LSE: XTL) develops novel therapeutics to treat life-threatening infectious diseases using fully human monoclonal antibodies and small molecule drugs. XTL's competitive advantage lies in its ability to leverage both its proprietary human tissue-based in vivo disease models and fully human monoclonal antibodies to validate and develop promising drug candidates. The Company's growing pipeline of therapies, designed to combat chronic viral infections, drug-resistant bacteria and serious systemic fungal infections, comprises internally developed products as well as those being co-developed with a number of biopharmaceutical partners. XTL has expanded its business development operations in the United States with the recent opening of offices in Cambridge, MA. For more information about XTL, visit the Company's Web site at http://www.xtlbio.com CONTACT: Mitchell Benus of XTL Biopharmaceuticals Ltd., 617-621-1570 or
ÈQ894-05134, ext 237; U.S. - James Forte, 858-566-9307,
jforte@keatingpr.com or Linda
Jasper, 973-376-9300,
ljasper@keatingpr.com, both of KeatingPR; UK - David Yates or Sarah
Mehanna, both of Financial Dynamics, 20-7831-3113, all for XTL
Biopharmaceuticals Ltd. Copyright (C) 2002 PR Newswire. All Rights Reserved. |
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