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Week Ending: December 17th, 2005
Alan Franciscus
Editor-in-Chief
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This Issue:
• Heroin Mothers: An Intimate View
• ViRexx to Present Hepatitis C Vaccine Data at HepDART 2005
• China Releases Guidelines on Hepatitis B Treatment
• UC Berkeley Researchers Probe Details of How Hepatitis C Hijacks Cells
• Hepatitis C Patients to Burden NHS
• Legal Blow in Fight for Hepatitis C Inquiry
• 200 Proteins Which Detect Diseases of the Liver
• Common Alternative Treatment for Liver Disease Is Found to Be Ineffective
• SciClone Reports Results from First ZADAXIN Phase 3 Hepatitis C Trial
• Mothers Pass Hepatitis C More Often to Infant Girls
• Novel Recombinant Protein Shows Early Promise in Refractory Hepatitis C Patients: Presented at HEP DART
• Viramidine May Reduce Anemia Complications of Hepatitis C Treatment: Presented at HEP DART
• German Study Finds Hepatitis C Care Generally Meets Current Recommendations
• Call for Global Plan on Fighting Hepatitis
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December 11th, 2005
Heroin Mothers: An Intimate View
SourceURL:http://uninews.unimelb.edu.au
Women who inject drugs are likely to take their first hit to become closer to their partner and to change the way they see themselves, a University of Melbourne researcher has found.
Fiona Martin, who has been working with Dr. Kevin McDonald in the Sociology Program and Associate Professor John Fitzgerald in the University’s School of Population Health during her PhD study, followed twenty-one Melbourne women who were either pregnant or young mothers and had a history of heavy drug use.
The study followed the women through the final stage of their pregnancy and into early motherhood, qualitatively assessing their battle with addiction and exploring the reasons they started using, as well as their attempt to overcome addiction.
Ms Martin said the study was important because previous research has shown that around 50 per cent of drug injecting women have a partner, and over 70 per cent of these women's partners are also users.
Women are also much more likely than men to receive their first hit from a partner or lover and to continue to depend on them to administer injections.
"Although many stereotypical views of junkies are that of a depressed loner, research actually showed the opposite, that intimate relationships are central to the first experience of drug injecting, especially for women,"she said.
"The strength of the intimate relationships for the users I followed was remarkably strong " most of the women I interviewed recalled the memory of their first hit in detail; for most women these memories were shared with a lover, husband or partner.
"In many ways we live in a very isolating society. For some of the women I looked at, becoming closer to someone was more important than the risk of Hepatitis C, HIV or other damage which might ensue."
With Hepatitis C rates for women now starting to rise at a higher rate than men, Ms Martin says it is especially important to consider how drug users themselves see drug use, as well as what the statistics tell us.
"Public health research shows time and again that simply saying 'don't do it' is not an effective strategy. Knowing that something is risky does not necessarily mean that people won't do it," she said.
"With many injecting heroin users the closeness of connection during the experience is the key, and they might not worry about other things such as risks and damages."
"If we can start to understand what leads people to desire that closeness, or why people want to take risks, then we can start to address those issues and reduce the harms associated with injecting."
During her study Ms Martin found that the women she came in contact with, especially first-time mothers, wanted to stop using drugs through pregnancy, and that the support available for women at this time can assist them with this process.
But what happens during the first six months after becoming a mother was seen as the key to addressing the long-term nature of addiction.
"After six months lots of women go back to using, because the systems of support often fall away," she said.
"Most people I interviewed saw being a pregnant user as a moral issue rather than a health issue, and were painfully aware that they couldn't sustain being a mother and a heavy drug user at the same time."
"The main theme I then came across was a mothers' desire to have a relationship with her child and to remember the child's younger years --something not possible if she remained a heavy user."
For more information:
Fiona Martin
Sociology Program,
University of Melbourne
Tel: +61 3 8344 9496
Email: f.martin2@pgrad.unimelb.edu.au
More information about this article:
Matthew Johnston
Media Officer
matthewj@unimelb.edu.au
Tel: 8344 0561
Mob: 0437 367 490\n
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December 12th, 2005
ViRexx to Present Hepatitis C Vaccine Data at HepDART 2005
SourceURL:http://www.genengnews.com
ViRexx Medical Corp. (TSX:VIR) a company focused on immunotherapy treatments for certain cancers, chronic hepatitis B & C and embolotherapy treatments for tumors, announced that an abstract relating to pre-clinical data from a hepatitis C Chimigen(TM) vaccine candidate will be presented at the HepDART 2005: Frontiers in Drug Development for Viral Hepatitis in Hawaii.
The conference is being held from December 11 to December 15 in the Kohala Coast, Hawaii at the Fairmont Orchid Hotel. Dr. Lorne Tyrrell, Chief Executive Officer and Dr. Rajan George, Vice President, Research and Development, Infectious Diseases at ViRexx Medical Corp. will be presenting an abstract entitled "A Novel Dendritic Cell-Targeted Chimeric Therapeutic Vaccine for the Treatment of Chronic C Infection".
"The Chimigen(TM) technology targets patients with chronic hepatitis B or hepatitis C. It is estimated that 170 million people worldwide suffer from chronic hepatitis C. The poster presentation reviews pre-clinical data from a hepatitis C vaccine," said Dr. Lorne Tyrrell, Chief Executive Officer of ViRexx. "As part of our ongoing clinical development program, we recently filed a Clinical Trial Application to initiate a Phase I hepatitis B Chimigen(TM) vaccine trial and intend to select a vaccine candidate for clinical development for hepatitis C."
About ViRexx Medical Corp
ViRexx is an Edmonton, Alberta based biotechnology company focused on the development of novel therapeutic products for the treatment of certain cancers and specified chronic viral infections. ViRexx's most advanced programs include drug candidates for the treatment of ovarian cancer, chronic hepatitis B and C and solid tumors.
ViRexx's lead product, OvaRex(R) MAb, a therapy for the treatment of late-stage ovarian cancer, is currently the subject of two Phase III clinical trials being funded by ViRexx's licensing partner Unither Pharmaceuticals, Inc., a subsidiary of United Therapeutics Corporation. For additional information about ViRexx, please see www.virexx.com.
This news release contains certain forward-looking statements that reflect the current views and/or expectations of the Company with respect to its performance, business and future events. Such statements are subject to a number of risks, uncertainties and assumptions. Actual results and events may vary significantly.
The TSX has not approved or disapproved of the information contain ed herein.
ViRexx Medical Corp. (TSX:VIR)
CONTACT:
ViRexx Medical Corp. Marc Canton President & Chief Operating Officer
(780) 433-4411
Fax: (780) 436-0068
Email: mcanton@virexx.com
Website: www.virexx.com
OR
Fyre Marketing
Chris Marcus Investor Relations
(512) 963-5063
Email: Chris@FyreInvestor.com
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China Releases Guidelines on Hepatitis B Treatment
SourceURL:http://www.bernama.com
BEIJING, Dec 12 (Bernama) -- China has published its first professional guidelines on how to prevent and treat hepatitis B virus, Xinhua said Monday.
The current arrival of more and more anti-viral drugs onto the medical market has brought feelings of both hope and chaos due to the relatively limited knowledge Chinese doctors have on the treatment of hepatitis B, the Chinese news agency quoted a report in Monday's China Daily.
Irregular treatment is inflicting heavy economic burdens on patients, hepatitis experts said.
Zhuang Hui, academician of the Chinese Academy of Engineering from Peking University and director of the Society of Hepatitis Diseases, attached to the Chinese Medical Association, was quoted by the newspaper as saying that a professional treatment guideline is very important for both medical workers and patients.
More than 80 medical experts from the Society of Hepatitis Disease and the Infectious Diseases Society under the Chinese Medical Association have spent a year working on the guidelines, with the help of advice from more than 1,000 clinical hepatitis doctors around the country.
The guidelines detail the effects of major anti-viral drugs with recommendations of the most appropriate treatments.
"However, it should be noted that the guidelines only offer advise to doctors in order to aid them when treating hepatitis B. They are not an obligatory clinical rule.
They should work out the best forms of treatment based on their own clinical observations of individual cases," said Zhuang.
The consistency and success of treatment provided to hepatitis B patients by expert practitioners in this field are worrying, according to Weng Xinhua, director of the Society of Infectious and Parasitic Diseases attached to the Chinese Medical Association.
Recent surveys conducted by China Foundation of Hepatitis Prevention and Control and No 302 Hospital of PLA showed that 45 percent of anti-viral specialists were not fully aware of standard anti-viral treatment procedures.
In addition, only 19 percent of hepatitis B patients were sticking to their prescribed long-term anti-viral treatments.
Currently many doctors are treating hepatitis B carriers with anti-viral drugs that can lead to viral variations, thus failing to successfully treat patients.
Inconsistent treatment often brings unfavourable effects to patients, who fail to receive successful treatment at a high cost both economically and in terms of health, Went said.
At present, hepatitis B is among the top five infectious diseases and the top five killer diseases, according to the Ministry of Health.
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UC Berkeley Researchers Probe Details of How Hepatitis C Hijacks Cells
SourceURL:http://www.berkeley.edu
By Robert Sanders, Media Relations
BERKELEY -- The hepatitis C virus has found a clever way to hijack the body's cells and even make an end-run around defenses that cells throw up to stop its spread, according to new research by University of California, Berkeley, scientists.
While revealing the inventiveness of viruses, the finding also is leading the researchers to probe ever finer details of the process so they eventually can develop drugs to prevent the virus from taking over and establishing an infection.
Jennifer Doudna, Bunpote Siridechadilok and Eva Nogales used [a] cryo electron microscope to create a 3-D model of the protein complex eIF3 that shed new light on protein synthesis and Hepatitis C viral infections.
"The goal of this work is to get enough detail on the mechanisms involved to design a drug to prevent the disease," said biochemist Jennifer Doudna, professor of chemistry and of molecular and cell biology at UC Berkeley and a Howard Hughes Medical Institute investigator.
"This is basic research, telling us how hepatitis C acts," added biophysicist Eva Nogales, associate professor of molecular and cell biology and also a Howard Hughes Medical Institute investigator. "The more we learn about how it does things, the easier it will be to block it without interfering otherwise with the normal mechanism of the cell."
The work by Doudna and Nogales, both faculty scientists at Lawrence Berkeley National Laboratory (LBNL), appeared in the Dec. 2 issue of Science.
Scientists have known that the blood-borne virus hepatitis C and numerous other viruses - including the flu virus, polio, hepatitis A and the human immunodeficiency virus (HIV) - take over the machinery inside the cell that produces proteins and use it to make copies of themselves. Specifically, these viruses hijack the ribosome, a huge molecular complex that manufactures proteins based on a blueprint called messenger RNA (mRNA). The viruses not only force the ribosomes to manufacture viral proteins, they also suppress production of the cell's own proteins.
Moreover, hepatitis C does this in a way that circumvents the normal protein production process, so that even when the cell tries to shut down protein manufacturing by the ribosomes to fight the virus, the virus is able to hot-wire the ribosomes.
Doudna, Nogales and their colleagues found out how this happens, using a technique called cryo-electron microscopy to provide detailed pictures of the RNA and protein complexes involved.
[A] 3-D model shows how the eIF3 complex (pink) interacts with the binding protein complex (purple) to load a strand of mRNA (red) into the small subunit of a ribosome (yellow) for proper translation of its genetic message into a protein. Hepatitis C, on the other hand, hijacks the ribosome by binding directly to eIF3 without the binding protein and sending its mRNAs to the front of the line. (Eva Nogales & Jennifer Doudna/UC Berkeley)
The ribosome is composed of two pieces that must clamp together around a strand of mRNA in order to begin their work. In normal cells, a protein called eIF3 (eukaryotic translation initiation factor 3) latches onto one half of the ribosome, and together they scour the cell interior for an mRNA with a tag indicating it's legitimate. Only after this complex finds an mRNA with the proper tag, called a binding cap, does the other half of the ribosome come in to complete the ribosomal machine and start translating the mRNA into protein.
When hepatitis C invades a cell, however, a large piece of viral RNA called IRES (internal ribosome entry site) gloms onto eIF3 in imitation of the mRNA binding cap, essentially convincing the ribosome that it is one of the cell's own mRNAs. The viral mRNA, which lacks the binding cap of a cell's normal mRNA, is then able to feed through the machine to create its own proteins. The virus is thus able to get around the need for many other control proteins that are part of the well-regulated transcription process in the cell. For example, the binding cap protein that recognizes the binding cap tag on mRNA is no longer needed; the viral IRES substitutes for both the binding cap and the binding cap protein.
"It was known that the hepatitis C virus uses this IRES RNA in order to overcome the normal requirement for a very large number of cellular factors," Nogales said. "What was not known is how it did it and how it is able to overcome this requirement. What we have seen is that, basically, it does this by displacing the cap binding protein that normally selects the cellular mRNAs. That is the way it competes with the normal cellular mechanism and kidnaps the basic machinery for its own purpose."
This explains how, even when the cell tries to use these regulatory proteins to shut down the ribosome to stop infection, the hepatitis C virus is able to hijack the ribosomes anyway. Though other RNA viruses that target the ribosome may use this same technique, Doudna suspects that "nature has probably found a number of ways to skin the cat."
Nogales and Doudna revealed these details through cryo-electron microscopy, or cryo-EM, a technique Nogales has perfected that allows her to get images of large molecules in a liquid environment like that inside the cell. This contrasts with X-ray crystallography, where it is necessary to make a molecule condense into a hard crystal before it can be imaged.
"Cryo-EM is good because we don't have to crystallize the molecule, so we can deal with conformational flexibility, which is very important," Nogales said. "All these protein machines are moving, they have moving parts. Because we are not limited by having to crystallize our complexes, which really paralyzes them, we are able, with some ingenuity, to detect and describe the flex inherent to the complexes of the components. It is looking at complexes as they are in the cell."
The newly discovered details of how viral IRES latches onto the cell's normal eIF3 could lead to ways to foil this masquerade. Doudna, who has worked on RNA enzymes for most of her career and has collaborated with Nogales for nearly three years on this ribosome research, noted that small, single-nucleotide changes in the viral IRES RNA are known to inhibit binding to eIF3.
"Knowing how effective a small change in sequence can be means that it may be easy to find a small molecule that has a similar effect," Doudna said. "It's reasonable to think we might be able to come up with a small-molecule drug to inhibit IRES binding to the ribosome on eIF3."
At the moment, the team doesn't have sufficient detail about the viral-ribosome interactions, but it is working to improve the resolution of its cryo-EM models from 30 Angstroms to about 10 Angstroms. This would allow the researchers to see secondary protein structures which would give them a better understanding of the chemistry behind eIF3's interactions with other proteins and with RNA.
Co-authors with Doudna and Nogales are graduate student Bunpote Siridechadilok and post-doctoral researcher Christopher Fraser of UC Berkeley, and post-doc Richard Hall of LBNL. The work was supported by the Howard Hughes Medical Institute.
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December 13th, 2005
Hepatitis C Patients to Burden NHS
SourceURL:http://www.dailymail.co.uk
Rising numbers of people suffering severe liver disease caused by hepatitis C infection in the next five years will place a huge burden on the NHS, health experts have warned.
The Health Protection Agency (HPA) said that more conservative estimates suggested that the number living with cirrhosis, liver failure and liver cancer could rise from 4,500 now to 7,000 in England and Wales by 2010.
But in a worst case scenario as many as 13,200 people could have some form of severe liver damage caused by hepatitis C in five years' time.
The HPA used hospital admissions, diagnoses and liver transplant data to make their estimates, but said it was difficult to gauge the exact extend of the problem now and in the future.
In their report, Hepatitis C in England, experts said that around 200,000 people in England are estimated to be infected with hepatitis C, with as many as five out of six unaware of their infection.
But The Hepatitis C Trust has claimed that over 400,000 people in the UK with the virus are completely unaware they have been infected.
The charity also said that untreated hepatitis C is set to cost the NHS £156 million in 2006 alone.
In most cases people can be successfully treated and cleared of the infection.
But because it can have no symptoms for many years, those who are infected are at risk of suffering severe liver by the time they are diagnosed.
Dr Helen Harris, a hepatitis C expert at the HPA, said: "Most individuals with chronic hepatitis C infection can be successfully treated, but the success of treatment relies on people coming forward for testing."
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Legal Blow in Fight for Hepatitis C Inquiry
SourceURL:http://news.scotsman.com
John Robertson Law Correspondent
CAMPAIGNERS were dealt a blow yesterday in their fight for a public inquiry into why hundreds of people contracted hepatitis C through contaminated blood transfusions in the 1980s.
A judge refused to break Scottish legal ground by protecting relatives of three victims against expenses of about £10,000 each should their court action against the Executive fail.
Lord Glennie ruled at the Court of Session that no financial case had been made for sparing the relatives from the risk of having to pay, even if their litigation was in the public interest.
Jean Black lost her husband, the Rev David Black, in 2003. A haemophiliac, he received blood products and transfusions in the 1980s. He was later diagnosed as suffering from hepatitis C and had a liver transplant in 1996. He died of liver cancer caused by hepatitis C.
Mary McArthur's husband, Alexander, 69, died in 2000 from liver disease, a known complication of hepatitis C infection. He received blood transfusions when he had a kidney transplant in 1984.
Roseleen Kennedy, said her mother, Eileen O'Hara, who died aged 72 in 2003, underwent heart surgery in 1985, received contaminated blood in transfusions and developed hepatitis C.
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200 Proteins Which Detect Diseases of the Liver
SourceURL:http://www.medicalnewstoday.com
The biochemist Enrique Santamaría Martínez , a researcher in the area of Genetic Therapy and Hepatology at the CIMA of the University of Navarra, has identified more than 200 proteins which can be considered as indicators of the progression of steatohepatitis and liver hepatitis. In addition, these proteins provide a basis for new lines of research which can develop clinical application strategies for improving the diagnosis and treatment of this cancer. This research forms part of his doctoral thesis, which was presented at the School of Sciences.
As Dr. Santamaría explains, the study of liver diseases is one of the primary objectives of biomedicine today, given the growing prevalence of these pathologies among the population. Although the risk factors are well known, such as genetic factors and excessive consumption of alcohol, the mechanisms which participate in the development of the disease are not so well known.
When he concluded his research, he noted that "one of the biomarkers, in particular the oxidized form of the apolipoprotein A1, has been detected in the blood serum of liver cancer patients. For this reason it is especially relevant in the area of diagnosis".
Proteomics: new technologies for studying proteins
The work of Dr. Enrique Santamaría allows clinical practitioners to discover "the alteration of proteins in the liver and, as a result, to discern the biological malfunctions associated with them, at a much earlier stage than permitted by conventional diagnostic methods alone". This is the case with prohibitin, a protein involved in the generation of energy for the maintenance of cellular activity, or with regucalcin, a protein involved in the control of cellular aging, among others.
For the research he performed at the CIMA of the University of Navarra, he used new technologies, such as proteomics. "This technique allows the study of hundreds of proteins simultaneously, and in this way we can define the natural history of diseases at the molecular level, and can identify markers which facilitate the diagnosis and treatment of these sicknesses".
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December 14th, 2005
Common Alternative Treatment for Liver Disease Is Found to Be Ineffective
www.blackwellpublishing.com/ajg
COPENHAGEN, Denmark – Dec. 14, 2005 – Results of high-quality randomized clinical trials have determined that milk thistle extract, a widely used alternative medication, may not have any significant influence on the course of patients with alcoholic liver disease or hepatitis B or C liver disease. These findings are published in The American Journal of Gastroenterology.
According to the previous studies, milk thistle extracts have been shown to possess properties that protect against various hepatotoxins, including the prevention of lipid perioxidation, which is frequent in all stages of liver damage in alcoholic and non-alcoholic liver disease.
“The ironic fact is,” notes Christian Gluud of the Copenhagen Trial Unit, Center for Clinical Intervention Research at the Copenhagen University Hospital, “that even though milk thistle and milk thistle extracts have been widely examined, we are still not in a situation where we can exclude a potential beneficial or harmful effect.”
In this study, researchers aimed to determine the exact benefits or harm in using milk thistle to treat affected patients. Over 900 patients with the aforementioned types of liver disease were studied in these trials over a period of six months, in groups treated with milk thistle versus placebo treatment. No significant effects were observed on mortality or complication of the disease. Further, milk thistle was not associated with any significant risk of adverse events.
“It would be logical to stop the use of milk thistle products, not to reimburse any use, to stop the information that milk thistle products may be used, and to support further trials,” adds Gluud.
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SciClone Reports Results from First ZADAXIN Phase 3 Hepatitis C Trial
SourceURL:http://www.pharmalive.com
SAN MATEO, Calif. -- December 14, 2005 -- SciClone Pharmaceuticals, Inc. (NASDAQ: SCLN) today announced top-line results from the first of its two phase 3 clinical trials using ZADAXIN(r) (thymalfasin) in combination with pegylated interferon alpha to treat patients with hepatitis C virus (HCV) who have failed previous interferon-based therapy. Treatment with ZADAXIN and pegylated interferon alpha did not demonstrate a statistically significant benefit compared to treatment with pegylated interferon alone in sustained viral response (SVR) or histologic improvement, the trial's co-primary endpoints. In this protocol, SVR was defined as the disappearance or absence of detectable HCV RNA in the bloodstream as measured by qualitative PCR test at the completion of a 48-week course of treatment and at week 72 the end of a 24-week observation period following completion of treatment. ZADAXIN was well tolerated with no treatment-related toxicities or side effects. SciClone will host a conference call at 9:00 a.m. ET today to review these clinical data.
Although not statistically significant, a positive ZADAXIN treatment-related trend was observed in SVR. In addition, patients who received ZADAXIN therapy were less likely to relapse, an occurrence where the virus reappears after previously being undetectable at the end of 48 weeks of treatment.
"While all of us at SciClone are disappointed that this trial did not achieve statistical significance, there are several other important trials ongoing for ZADAXIN including the ongoing triple therapy HCV clinical trial as well as a phase 2 malignant melanoma trial, both trials being conducted in Europe," said Ira D. Lawrence, M.D., President and Chief Executive Officer of SciClone Pharmaceuticals, Inc. "We will evaluate the data from our HCV trial in greater detail as well as the second phase 3 trial results to determine and coordinate with Sigma-Tau, our European collaborator, the next steps regarding the development of ZADAXIN in hepatitis C therapy. Importantly, we expect the ongoing European HCV clinical trial evaluating the triple therapy combination of ZADAXIN, pegylated interferon alpha and ribavirin run by Sigma-Tau to provide further insight into ZADAXIN's potential in augmenting the current standard of care for hepatitis C patients."
SciClone expects that data from the second phase 3 clinical trial using ZADAXIN in combination with pegylated interferon alpha to treat non-responder HCV patients with early cirrhosis of the liver will be reported in May 2006.
About the U.S Hepatitis C Virus Phase 3 Trial
HCV patients in the first of two phase 3 clinical trials received a 48-week course of therapy of either ZADAXIN (1.6 mg, twice a week) and pegylated interferon alpha (180 mcg, once a week) or placebo and pegylated interferon alpha followed by a 24-week observation period. The primary endpoints of each U.S. HCV trial run by SciClone are the achievement of SVR and an improvement in the liver histological activity index assessed by liver biopsy at week 72.
Although not statistically significant, 4% (10/269) of patients treated with ZADAXIN plus pegylated interferon alpha achieved an SVR compared with only 2% (5/265) of patients treated with pegylated interferon alpha alone. No significant difference in histological improvement was observed between the patients treated with ZADAXIN plus pegylated interferon alpha and those patients treated with pegylated interferon alone.
All patients included in the trial had failed prior interferon-based treatment for hepatitis C virus, and had no cirrhosis of the liver. More than 75% of the patients enrolled in the trial were non-responders to the combination of interferon alpha (either regular or pegylated) and ribavirin, and were infected with the genotype 1 strain of the virus. Additionally, most patients in this trial had a high viral load, or greater than 850,000 copies per ml (or 5.93 log10) of the hepatitis C virus.
About the HCV Triple Therapy Trial
SciClone's European partner Sigma-Tau is enrolling non-responder HCV patients in a 550-patient phase 3 HCV triple therapy trial evaluating the triple combination of ZADAXIN, pegylated interferon alpha and ribavirin. This trial is different from the two U.S. phase 3 hepatitis C trials in two important ways. First, patients in this trial will be treated with the anti-viral agent, ribavirin, in addition to ZADAXIN and pegylated interferon alpha, whereas patients enrolled in the two U.S. phase 3 trials were only treated with ZADAXIN plus pegylated interferon alpha. Second, patients enrolled in this trial are previous non-responders to the combination of pegylated interferon alpha plus ribavirin, whereas patients enrolled in the U.S. phase 3 trials were previous non-responders to any interferon-based therapy. SciClone and Sigma-Tau's objective for the European trial is to generate data on ZADAXIN's use as part of a triple therapy combination for hepatitis C patients.
About ZADAXIN
ZADAXIN is a novel compound with immunomodulatory effects that facilitates the body's immune response to fight viruses and certain cancers. The compound is a synthetic version of the naturally occurring peptide thymosin alpha 1, generically referred to as thymalfasin. ZADAXIN promotes T-cell maturation as well as increases the response of the immune system, with both functions playing an important role in eradicating virally infected and cancer cells. ZADAXIN appears to be well tolerated, with few reports of significant side-effects or toxicities associated with its use.
About SciClone
SciClone Pharmaceuticals is a biopharmaceutical company engaged in the development of therapeutics to treat life-threatening diseases. SciClone's lead product ZADAXIN is currently being evaluated in two phase 3 hepatitis C clinical trials in the United States and one hepatitis C triple therapy clinical trial in Europe. ZADAXIN also is being evaluated in other late-stage clinical trials for the treatment of hepatitis B and certain cancers. The company's other principal drug development candidate is SCV-07, currently in phase 1 development, which is being evaluated for the treatment of viral and other infectious diseases. For more information about SciClone, visit www.sciclone.com.
The information in this press release contains forward-looking statements including our expectations and beliefs regarding the progress and timing of clinical trial events. Words such as "expects," "plans," "believe," "may," "will," "anticipated," "intended" and variations of these words or similar expressions are intended to identify forward-looking statements. In addition, any statements that refer to expectations, goals, projections or other characterizations of future events or circumstances, including any underlying assumptions, are forward-looking statements. These statements are not guarantees of future performance and are subject to risks, uncertainties and assumptions that are difficult to predict. Therefore, actual results could differ materially and adversely from those expressed in any forward-looking statements as a result of various factors, including the progress of patients during the ongoing clinical trials for Zadaxin, maintenance of the sufficiency and eligibility of the enrolled patient population, future actions of our collaborative partner, unexpected adverse results to patients, as well as other risks and uncertainties described in SciClone's filings with the Securities and Exchange Commission.
Corporate information contact:
Becky Horner
investorrelations@sciclone.com
650-358-3437
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December 15th, 2005
Mothers Pass Hepatitis C More Often to Infant Girls
SourceURL:http://today.reuters.com
NEW YORK (Reuters Health) - The results of a large European study suggest that mother-to-child transmission of hepatitis C virus (HCV) occurs significantly more often among girls than among boys.
The study findings, based on 1,787 HCV-infected pregnant women and their infants seen at 33 centers, also "strongly suggest" that women should not be encouraged to undergo elective cesarean section or discouraged from breast feeding solely in the hopes of preventing mother-to-child HCV transmission, the researchers add.
The overall mother-to-child HCV transmission rate for the study group was low (6.2 percent), Dr. Pier-Angelo Tovo from the University of Turin in Italy and colleagues report in The Journal of Infectious Diseases.
According to the team, elective cesarean section did not protect against HCV transmission. Maternal history of injection drug use, prematurity, and breast-feeding were also not significantly associated with mother-to-child HCV transmission. HCV transmission occurred more often in women with detectable levels of virus in their blood, but it also occurred in a few women without detectable virus.
As mentioned, Tovo and colleagues found that girls were twice as likely to be infected with HCV as were boys. To their knowledge, this is the first report of a significant association between sex and HCV vertical transmission.
The sex association is "an intriguing finding" that probably reflects hormonal or genetic differences in susceptibility or response to infection between males and females, they suggest.
In a related editorial, Dr. R. Palmer Beasley from the University of Texas in Houston says the higher HCV infection rates in female infants of HCV-infected mothers is "interesting, provocative, and worth further investigation."
This finding, the author further notes, is in accord with recent observations of similar excesses of HIV infections in infant girls of HIV-infected mothers.
SOURCE: The Journal of Infectious Disease, December 1, 2005.
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Novel Recombinant Protein Shows Early Promise in Refractory Hepatitis C Patients: Presented at HEP DART
http://www.docguide.com/
By Bonnie Darves
KOHALA COAST, HI -- December 15, 2005 -- The novel recombinant protein albuferon, in combination with ribavirin, may be effective in hepatitis C (HCV) patients who have failed traditional antiviral therapy, researchers reported here at the Frontiers in Drug Development for Viral Hepatitis HEP DART 2005 meeting.
Results of the 24-week phase 2 trial showed that 30% of patients were RNA negative at week 24 and that the drug's long-term safety profile appears favorable at this stage.
In addition, albuferon was fairly well tolerated by most of the patients and no one discontinued because of adverse events (AEs), said lead author Vijayan Balan, MD, Hepatologist and Associate Professor of Medicine, Mayo Clinic, Scottsdale, Arizona, United States.
Dr. Balan noted that hematologic reductions, maximal at week 8, were managed well with reductions of the albuferon dose. "We also saw no major increase in AE severity as treatment progressed" between week 12 and week 24, he said.
The study included 71 patients with chronic HCV who had not responded to previous interferon-containing regimens. Over the 24-week study, patients were randomized equally to receive 900 mcg or 1200 mcg of albuferon (ABF) every 2 weeks (Q2w) or 1200 mcg every 4 weeks (Q4W), with dose escalations up to 1500 and 1800 mcg as tolerated.
Dr. Balan noted that the inclusion criteria were very stringent, and that only patients who had received sufficient, full-dose therapy with PEG-IFN and had not undergone efficacy-limiting dose reductions were allowed to enroll.
Virologic response at week 12 was 52.2% in the 900 mcg cohort, 41.7% in the 1200 Q2W patients and also 41.7% in the 1200 Q4W group. RNA clearance at week 24 was highest, at 34.8%, in the 900 mcg cohort, compared to 25% in patients on the Q4W dosing schedule.
Dr. Balan noted that the drug's half-life was 6 days and that researchers found "no significant drug accumulations between week 12 and week 24."
The most common AEs were fatigue, which affected more than 80% of patients at all doses, and headache, which developed in 70.4% of patients. Three cases of thrombocytopenia were resolved adequately with dose reductions. Overall, 10 patients (14%) underwent dose reduction during the study. Neutropenia affected 32% of patients in the Q2W cohort and 8% in the Q4W group.
The study is ongoing, Dr. Balan said, and will next focus on evaluating safety and efficacy of the 1500 and 1800 mcg doses.
[Presentation title: A Phase 2 Study of Albuferon in Combination with Ribavirin in Non-responders to Prior Interferon Therapy for Chronic Hepatitis C. Abstract 27]
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December 16th, 2005
Viramidine May Reduce Anemia Complications of Hepatitis C Treatment: Presented at HEP DART
http://www.docguide.com
By Bonnie Darves
KOHALA COAST, HI -- December 16, 2005 -- The novel pro-drug viramidine could result in lower incidence of anemia than ribavirin with comparable efficacy in patients with hepatitis C, when used in interferon-combination regimens, according to a phase 2 study.
Anemia is a common adverse effect of ribavirin-interferon therapy that emerges as a dose-limiting toxicity in approximately one quarter of patients, according to researchers who presented the findings here on December 13th at the Frontiers in Drug Development for Viral Hepatitis HEP DART 2005 meeting.
The open-label study of 180 treatment-naïve HCV patients randomized participants equally to receive viramidine in doses of 400, 600 or 800 mg twice daily with pegylated interferon or ribavirin with interferon 1000-1200 mg twice daily for 12 weeks.
Overall hemoglobin levels were comparable among all four groups, ranging from 15.2 g/dL to 15.6 g/dL. Patients with decompensated liver disease, or with hepatitis B HIV-positive status were excluded from the study.
The researchers, led by Rajender Reddy, MD Professor of Medicine and Surgery Director of Hepatology Medical Director of Liver Transplantation University of Pennsylvania Medical Center, Philadelphia, Pennsylvania, United States, found that after 12 weeks of treatment, fewer patients on viramidine developed anemia than those taking ribavirin.
Among men participants on viramidine, 27 had hemoglobin levels of <12 g/dL, compared to the 19 men on ribavirin. One patient taking viramidine had an Hemoglobin level <10 g/dL, compared to seven on ribavirin.
A larger number of women experienced an Hemoglobin decline to <12 g/dL (25 out of 51 on viramidine and 10 out of 13 on ribavirin), yet progression to anemia was similar to that seen in the men.
These preliminary results indicate a slightly better safety profile for viramidine than ribavirin, the researchers concluded. Full data from this study will be available in the first quarter of 2006, they said.
A phase 3 trial of viramidine is planned, one researcher noted.
[Presentation title: Hemoglobin Decline and Anemia During HCV Therapy with Pegylated Interferon Alfa-2a with Either Viramidine or Ribavirin. Abstract 108]
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German Study Finds Hepatitis C Care Generally Meets Current Recommendations, Produces Good Outcomes: Presented at HEP DART
http://www.docguide.com/
By Bonnie Darves
KOHALA COAST, HI -- December 16, 2005 -- Patients with hepatitis C who are treated with combination ribavirin and pegylated interferon (PEG-IFN) according to current recommendations under community-practice conditions have good outcomes, with rates of sustained virologic response (SVR) of approximately 66%, according to results of a large German study.
The study's co-author Elmar Zehnter, MD, Gastroenterologist and Hepatologist, and Researcher in the BNG Hepatitis Group, Dortmund, Germany, presented the findings here on December 13th at the Frontiers in Drug Development for Viral Hepatitis HEP DART 2005 meeting.
"If patients are treated to recommendations, they have a good chance of cure, but what we know is that every week counts and patients must sometimes be encouraged to remain on therapy despite side effects," Dr. Zehnter said. "These 'real-life' results are very similar to those we've seen in the clinical trials, a fact that is very encouraging and shows that HCV treatment in Germany is at a high level."
Dr. Zehnter and colleagues presented data on the 2203 patients they have evaluated to date, who were treated in a total of 213 clinical office practices throughout Germany between September 2003 and October 2005. The patients had an average age was 40.3 years. They received 800-1200 mg/daily of ribavirin and 1.5 mcg/kg weekly of PEG-IFN for periods of 24 or 48 weeks, depending on their genotype.
Of the patients studied, 83.5% were Caucasian and 56.4% had genotype A. Fully 90% were treatment naïve at study inclusion, and 57 patients were HIV-coinfected, Dr. Zehnter noted. Nearly 20% were on narcotic-substitution during treatment.
Results show that 75% of the 1058 treatment-naïve patients had normalized alanine aminotransferase (ALT) levels at study end, compared to 57% of the 111 treatment-relapsed participants. The overall rate of SVR was 66%; it was 17% and 14%, respectively, in relapsed patients and non-responders. SVR for the 61 patients who underwent dose reduction was 55.7%.
The researchers hope to enroll a total of 2541 patients into this ongoing study, Dr. Zehnter noted, and will be replicated in the Canadian setting.
[Presentation title: Individualized Weight Adjusted Peginterferon Alfa-2b + Ribavirin in the Clinical Setting: the German Experience. Abstract 111]
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Call for Global Plan on Fighting Hepatitis
http://www.thepeninsulaqatar.com
DOHA: Dr Ghalia bint Mohammed Al Thani, chairperson of the National Health Authority has called for a global strategy to combat hepatitis, "en epidemic which paused serious threat to human life," and lamented the lack of any international or regional conventions that would help fight the disease.
She was inaugurating the First Qatar International Hepatitis Symposium at the Four Seasons hotel yesterday. The two-day conference is being attended by delegates from various parts of the world.
Sheikha Ghalia said, the idea of this forum had been roaming in her mind for quite a while due to her daily contacts with children who were infected by this viral epidemic.
“To my surprise, I have not found any international or regional conventions or protocols among scientists that would help combat this disease among children and adults alike," she added.
One of the most significant goals of this forum, Sheikha Ghalia said, was to create more awareness among the public to enable them to protect themselves against this disease, and among those who engaged in the health sector to carry out early detection and diagnosis as well as preventive and curative methods.
She noted that the burden that this disease imposes on the world and the national health care system calls for strategies and plans " that would help reduce its spread and bring about efficacious remedies without using up human and material resources particularly in the countries where this disease spreads."
She urged all international and regional organizations and all bodies concerned with public health, media and education to double their efforts in this field.
Dr Nazeeh Al Dweik, chairman of the Hepatitis Committee at HMC said, the committee was set up with the purpose of creating public awareness about the disease and implementing remedies for screening hepatitis patients. He stressed the importance of early detection, which, he said, would help prevent fatalities and complications being caused by this chronic disease.
Prof Dino Hazic from the UK gave a presentation on "management of chronic hepatitis among children," at the opening session. The symposium features a series of sessions focusing on various aspects of hepatitis being attended by expert speakers from Canada, the US, UK, Austria, Germany, Saudi Arabia, the UAE, Egypt and Turkey, apart from Qatar.
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