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News Review

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HCV ADVOCATE WEEKLY NEWS REVIEW: A Review of HCV, HBV and HIV/HCV Coinfection Related News and Highlights

Week Ending: July 24th, 2004

Alan Franciscus
Editor-in-Chief

To download pdf version click here


In This Issue:

Hepatitis C Linked to Lymphoma
New Doppler Ultrasound Signs Improve Diagnosis of Cirrhosis or Severe Liver Fibrosis
Hepatitis C Can Be Deceptive; One Does Not Appear to Be Ill
MBI-3253 (Celgosivir) Demonstrates Potent Activity against Hepatitis C Virus Surrogate
Gift of Life Michigan Announces State Senate Support of Organ Donation Cause by Passing Senate Bill 817, The 'Organ and Tissue Donation Education Fund'
No Trace of Infection Found Due to Faulty Dialysis Machines
Area Health Responds to the Need for the Machine
Infected Patient of Ex-Fremont Doctor Dies
Roche Molecular Systems Issues Nationwide Recall of Cobas Taqman Analyzers and Cobas Taqman 48 Analyzers
NEC Discovers New Peptide-Vaccine Candidates for Hepatitis C Virus
Together with Kochi Medical School

Roche Files SBLA for Pegasys
2,000 Cases of Hepatitis Misdiagnosis
Experts Lament Poor Awareness of HBV
Yale Scientists Visualize Details of How Hepatitis C Unwinds RNA
Columbus - Illegal Tattooing Investigation
Convict with Life Sentence Gets Medical Commutation
Decades in Music World Earn Escovedo Peer Admiration




July 19th, 2004

Hepatitis C Linked to Lymphoma
Source:Reuters Health

NEW YORK--- Infection with hepatitis C virus (HCV) nearly doubles the risk of developing non-Hodgkin’s lymphoma, a cancer involving the lymph nodes, new research suggests.
Dr. Eric A. Engels of the National Cancer Institute, Rockville, Maryland and colleagues note that studies have shown abnormally high rates of hepatitis C among lymphoma patients, suggesting that the infection raises the risk of lymphoma by chronically stimulating the immune system.

To investigate further, the researchers conducted a study involving almost 1500 subjects with and without lymphoma, according to a report in the International Journal of Cancer.

The rate of HCV infection among lymphoma patients was 3.9 percent, much higher than the 2.1 percent rate seen among people without lymphoma. Moreover, this near doubling of the risk held true even after accounting for patient age and injection drug use.

The researchers conclude that there is an association between HCV and non-Hodgkin’s lymphoma in the US and that “HCV infection may be cause of NHL.”

SOURCE: International Journal of Cancer, August 10, 2004.

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New Doppler Ultrasound Signs Improve Diagnosis of Cirrhosis or Severe Liver Fibrosis
Source: www.gastrohep.com

A high proportion of patients with compensated liver disease can be accurately diagnosed with cirrhosis using Doppler ultrasound signs, including the new hepatic vein spectrum, reports an article in the European Journal of Gastroenterology and Hepatology.

Christophe Aube and colleagues have determined whether ultrasound, and particularly, new Doppler signs, increase the diagnostic accuracy of the most accurate, currently available markers for the diagnosis of cirrhosis or severe fibrosis.

They studied a total of 32 clinical (n = 4), biochemical (n = 11) and Doppler ultrasound (n = 17) variables that were recorded in 106 patients with compensated chronic liver disease.

In order to evaluate diagnostic accuracy, discriminant analysis was used, first globally, and then using all variables by variable analysis.

For diagnosis of cirrhosis using Doppler ultrasound, diagnostic accuracy was 92% globally, and 89% with 3 variables (spleen length, hepatic vein spectrum and maximum portal vein velocity).

Based upon clinical signs, diagnostic accuracy was 86% globally, and 85% with one variable (firm liver).

When basing findings upon biochemical parameters these values fell to 80% globally, and 81% with two variables (hyaluronate and platelet count).

Based upon all parameters, diagnostic accuracy was 91% globally, and 91% with four variables (firm liver, hyaluronate, platelet and hepatic vein spectrum).

On an intention to diagnose basis, Doppler ultrasound provided a lower independent contribution due to missing data.

In the diagnosis of severe fibrosis, diagnostic accuracy was 83% globally, and 77% with one variable.

The researchers, who have published their study in the August issue of the journal, conclude that cirrhosis can be correctly diagnosed in approximately 90% of patients with compensated chronic liver disease using a few Doppler ultrasound signs including a new sign, the hepatic vein spectrum.

They add that Doppler ultrasound could be used for the first line diagnosis and biochemical markers, such as hyaluronate, in patients with missing Doppler ultrasound data.

Eur J Gastroenterol Hepatol 2004: 16 (8): 743 - 751

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Hepatitis C Can Be Deceptive; One Does Not Appear to Be Ill
Kay Rudderow
Source: www.nj.com

HOPEWELL TWP.—Grace Peterson is only a 12.

That’s not her age—she’s 58 -- but the number represents her standing in the ever-growing line of people needing liver transplants.

“(Medical professionals guided by MELD: Model for End Stage Liver Disease) rate us in need from 1 to 35. I was a 13, now I am a 12,” she said.

To see her, it is nearly impossible to tell she is not in good health. Then she tells her story.

She’s been waiting for more than seven years for the transplant that will restore her health, which began deteriorating eight years ago.
“Hepatitis C, or end-stage liver disease, doesn’t mean you look like it, or need a wheelchair,” she said.

Ironically, her son Jerry’s accidental death in 1994 helped others to live, after his heart, eyes, kidneys and liver were donated to others on waiting lists like his mother’s.

“I first realized I had a medical problem while being counseled for depression after my son died,” she said. “I was unusually tired, so they sent me for blood work, and it showed I had Hepatitis C,” she said.

She had received a blood transfusion after the birth of a daughter in 1975 and again after a hysterectomy in 1981, she said.

And there have been five members of her family who died or have been treated for the disease. A cousin had a transplant, but suffered a blood clot that ended her life a day later, Peterson said.

“I have a rare blood type, AB+, and if you have that you can only donate to someone else with that type,” she said.

Complicating her condition is a painful gallstone problem, one which she can only treat with medications at this point because surgery to remove it may leave scar tissue that would jeopardize a future liver transplant.

She takes 12 pills a day, and tires easily, experiences the development of large bruises for unknown reasons, and suffers from mouth bleeding. A small cut could be disastrous as the liver disease reduces dramatically the amount of platelets her blood needs for clotting.

A year ago, she received a call from Thomas Jefferson Hospital in Philadelphia, where her transplant will someday take place, that she was second in line for a transplant, if the person first in line was not found to be compatible.

Fortunately for that person, he or she was a match.

And Peterson was sent home to wait, unable to travel more than a few miles from home, hoping the cell phone she carries for that purpose will ring.

“I may have a couple of hours to get ready, and that’s it,” she said. “I’m not complaining. I’m prepared.”

She remains plucky and upbeat, determined to be strong while she waits for that fateful call. She fears her age will hamper the efforts for a transplant, but has been encouraged by her physicians who assure her she will have her new liver in time.

Peterson has even been able to speak to groups to personally encourage organ donations.

Having endured the loss of her son, she is buoyed by the realization that part of him is still alive, through the lives of people he never met.

“I will personally encourage anyone to sign their organ donor cards,” she vows.

To obtain a card, or to learn more about organ and tissue donations, call the Sharing Network at 1-800-SHARE-NJ (1-800-542-7365).

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July 20th, 2004



MBI-3253 (celgosivir) Demonstrates Potent Activity against Hepatitis C Virus Surrogate
Source: PRNewswire

Antiviral activity synergistic in combination with ribavirin or interferon-a

VANCOUVER,--- Micrologix Biotech Inc. (TSX: MBI - News; OTC: MGIXF - News) announces the publication of results demonstrating the potent efficacy of MBI-3253 (celgosivir) against the widely accepted surrogate model of the Hepatitis C Virus (“HCV”), bovine viral diarrhea virus (“BVDV”). BVDV is closely related to HCV and is an in-vitro predictor of the efficacy of anti- HCV drugs in humans. The studies were carried out by Kevin Whitby, Ph.D and colleagues. The paper, entitled: “Action of celgosivir (6 O-butanoyl castanospermine) against the pestivirus BVDV: implications for the treatment of hepatitis C” was published in a recent issue of the peer-reviewed journal, Antiviral Chemistry & Chemotherapy (Volume 15 Issue 3; Pages 141-151).

Jake Clement, Ph.D., Chief Science Officer for Micrologix, stated, “This research represents important scientific support in a well-recognized non- clinical model for MBI-3253 as a potential treatment for chronic HCV infections.” The data indicated the following:

• Potent antiviral activity in a BVDV culture system considered to be predictive of anti-HCV activity
• Clear additive and synergistic effects of MBI-3253 in combination with ribavirin alone or interferon-a (ribavirin and interferon-a are two of the most common HCV therapies in use today)
• Confirmation of the mechanism of viral replication inhibition
• Lack of cellular toxicity at high drug concentrations in a variety of cell lines

About MBI-3253 & HCV Infections
MBI-3253 (celgosivir) is an orally-administered, unique antiviral agent exerting its effects through the inhibition of the mammalian cell enzyme, a-glucosidase I. Alpha-glucosidase I inhibitors can inhibit the replication of a broad range of enveloped viruses (including HCV) by preventing the correct folding of their envelope glycoproteins. Micrologix plans to initiate a Phase II clinical study of MBI-3253 in HCV patients during the second half of calendar 2004.

Chronic hepatitis C virus (HCV) infection is a serious public health concern affecting approximately 4.5 million people in the United States. Worldwide, the disease affects as many as 185 million people. HCV causes inflammation of the liver, which may lead to fibrosis and cirrhosis, liver cancer, and ultimately, liver failure. Cirrhosis of the liver resulting from chronic HCV infection is the leading indication for liver transplantation in the U.S. Due to the asymptomatic nature of HCV infection, it often goes undetected for up to 20 years following initial infection. Each year, 8,000 to 10,000 people in the U.S. die from complications of HCV. Current therapies for HCV infection have only limited effectiveness, especially against genotype I, the most common strain of HCV in North America. It is predicted that deaths from HCV will surpass those of AIDS in the United States by 2010, at which time the global HCV market is forecasted to be approximately $6 billion.

About Micrologix
Micrologix Biotech Inc. is engaged in the research, development, and commercialization of drugs that advance therapy, improve health, and enrich lives. The Company has four product candidates in human clinical development, multiple product opportunities in preclinical development, and several early- stage technologies in various stages of research and evaluation. On April 15, 2004, Micrologix announced an agreement to acquire San Diego-based MitoKor, Inc., a biotechnology company focused on the research and development of products for degenerative diseases such as Alzheimer’s disease, arthritis, and glaucoma.

James DeMesa, MD
President & CEO

Investor & Media Relations Contacts:
Jonathan Burke Gino DeJesus/ Dian Griesel, Ph.D
Micrologix Biotech Inc. The Investor Relations Group
Telephone: 604-221-9666 Extension 241 Telephone: 212-825-3210
Toll Free: 1-800-665-1968
Email: theproteam@aol.com
Email: jburke@mbiotech.com

Certain statements in this news release constitute “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995, which involve known and unknown risks, uncertainties and other factors that may cause our actual results to be materially different from any future results, performance or achievements expressed or implied by such statements. Forward looking statements in this news release include, but are not limited to, Micrologix initiating a Phase II human clinical study with MBI-3253 in HCV patients in the second half of calendar 2004. These statements are only predictions and actual events or results may differ materially. Factors that could cause such actual events or results expressed or implied by such forward-looking statements to differ materially from any future results expressed or implied by such statements include, but are not limited to: government regulation, dependence on and management of current and future corporate collaborations, early stage of development; technology and product development; future capital needs; uncertainty of additional funding; no assurance of market acceptance; dependence on proprietary technology and uncertainty of patent protection; manufacturing and market uncertainties; and intense competition. These and other factors are described in detail in the Company’s Annual Information Form and Annual Report on Form 20-F, forthcoming news releases and other filings with the Canadian securities regulatory authorities and the U.S. Securities & Exchange Commission. Forward-looking statements are based on our current expectations and Micrologix is not obligated to update such information to reflect later events or developments.

The Toronto Stock Exchange has not reviewed and does not accept responsibility for the adequacy or accuracy of this release.

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July 21st, 2004



Gift of Life Michigan Announces State Senate Support of Organ Donation Cause by Passing Senate Bill 817, the 'Organ and Tissue Donation Education Fund'
Source: PRNewswire

Ann Arbor, Mich.-- Senate Bill 817 is the favorite of at least 2,674 Michigan residents who are awaiting an organ transplant. Unanimously passed by the Senate on July 1, 2004, the bill proposes a public education trust fund to help encourage people to become registered organ donors. The bill enables the Secretary of State to provide an opportunity for individuals to make a minimum donation of $1 to the Education Fund in conjunction with the issuance of a driver’s license.

Educating people about the critical shortage of organs and the importance of becoming a registered organ donor is paramount to the cause. While national market research indicates that over 85% of the general public approves of organ donation, a meager 7% of Michigan residents are actually registered donors. Sadly, this gap results in many needless deaths -- 70 people have died waiting for an organ transplant in Michigan so far this year.

Gift of Life Michigan, the state’s full-service organ and tissue recovery organization, believes public education is critical to increasing registered donors. The Gift of Life Organ, Tissue & Eye Donor Registry is a confidential, 24-hours-a-day, computerized database that documents residents’ wishes regarding organ, tissue and eye donation. Since Gift of Life is contacted upon every hospital death, signing the Donor Registry is the best way to ensure a person’s wishes are carried out. Unfortunately, most people are simply unaware of the Registry’s existence. Gift of Life Michigan is confident that an ongoing public awareness campaign showcasing organ donation would inspire Michigan residents to sign the Donor Registry.

“Michigan lags far behind in donor registrants and rate of organ donation,” explains Tom Beyersdorf, Executive Director for Gift of Life Michigan. “We are optimistic that this legislation will pass and permit the public education funding so desperately needed in Michigan to strengthen the Donor Registry and ultimately provide more people with the precious gift of life.”

If Senate Bill 817 gains approval by the House of Representatives and the Governor this fall, Michigan will join seventeen other states that have passed similar legislation. These states have raised hundreds of thousands of dollars every year for programs to encourage people to become registered organ donors, resulting in an average registration rate of 40%. More registered donors equals more saved lives, which is the battle cry for this vital social cause.

To become a registered donor, sign up online at http://giftoflifemichigan.org or request a donor registry card by contacting the Gift of Life Public Education Department at 800-482-4881.

Source: Gift of Life Michigan
Web Site: http://giftoflifemichigan.org

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No Trace of Infection Found Due To Faulty Dialysis Machines
Source: Vancouver Sun - www.canada.com

Blood tests on 300 people have turned up no evidence of transmission of blood-borne illnesses through dialysis machines in Victoria hospitals.

Tests were ordered after the Vancouver Island Health Authority became aware of internal leakage and potential cross-contamination.
A spokesman says the HIV and hepatitis C tests have all come back negative, although they will have to be repeated twice over the next six months.

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Area Health Responds to the Need for the Machine
Source: www.laurieton.yourguide.com.au

"People who use drugs come from all walks of life. From one time users and experimental users to regular users and recreational users. They don't always fit a stereotype. They are people who have jobs, people who have families, and people who contribute to our society.

"Injecting drug use is already something that occurs in your community. The Needle and Syringe program is a health response to try and minimise the harm that those people suffer," said Jana Van der Jagt, area coordinator of Hepatitis C and Harm Reduction Programs with the MNCAHS.

Ms Van der Jagt gave facts and figures to concerned residents at the public forum last Thursday on needle and syringe vending machines.

Some 430 needles have been dispensed by the Laurieton needle and syringe vending machine since its installation in April this year.

The needles come in a package, called a Fit Pack. This contains five needles, sterile water and equipment for safe, sterile injecting, various safety messages and health information and, importantly, a tamper-proof, one-way disposal unit for sharps.

"Needle and syringe programs save lives," said Ms Van der Jagt.

"They reduce the harm to people that inject drugs because we know that despite being aware of the risks some people will chose to inject illicit drugs. They need the knowledge and skills to make informed choices and the risk to the whole community from blood borne viruses is much greater than the risk of drug use itself."

Ms Van der Jagt also highlighted a startling fact that one person every 30 minutes contracts the blood-borne virus Hepatitis C and the Mid North Coast, along with Northern Rivers, has the highest rate of infection in NSW, with 90 per cent of transmissions through sharing injecting equipment.

There are currently a number of people in the Camden Haven receiving specialist treatment for Hepatitis C and HIV and AIDS, she said.

The aim with the needle vending machine is to reduce the spread of those viruses.
"There are 12 machines in operation from Woolgoolga to Forster," Ms Van der Jagt said.

"Each is trialled for 6 months and then an evaluation is done and a community meeting is held to discuss the findings of that evaluation. So far those evaluations have shown that these vending machines have been a positive strategy that has been really trouble-free."

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Infected Patient of Ex-Fremont Doctor Dies
Kamahria Hopkins
Souce: www.omaha.com

An 84-year-old woman infected with hepatitis C during treatment at a Fremont, Neb., cancer clinic has died.

Rachel Cordes of Scribner, Neb., died last month, said one of her sons, Randy Cordes. It's unclear if her death was caused by the liver disease.

Cordes said his mother, who had colon cancer, received chemotherapy at the clinic run by Dr. Tahir Javed during the spring of 2000. She stopped treatment for a short while and then resumed from June 2000 to September 2000.

Nebraska health officials have linked 99 cases of hepatitis C - believed to be the largest outbreak of its kind in the United States - to poor infection control practices at the clinic.

Cheryl Gentry died in March 2003 from liver complications after contracting hepatitis C at the clinic.

Rachel Cordes may have contracted hepatitis C during her treatment, her son said, or during regular cleanings of her port - used to administer the chemotherapy - after her treatment ended in September.

Randy Cordes said his mother, who had also suffered from breast cancer and most recently from cancer of the lower spine, was notified in October 2002 that she may have been infected. Her first test came back positive about a month later, and was confirmed with a second positive test in January 2003.

"Like all of us, she felt the medical professionals that you trust didn't follow sound medical practices," Randy Cordes said. "She was wronged just like the other 98 were wronged."

Rachel Cordes, who lived alone and died at home, was not receiving treatment for her hepatitis C, her son said. He said doctors decided to focus on her cancer treatment.

Rachel Cordes was one of 90 who filed medical malpractice lawsuits against Javed. The first of those trials will begin Jan. 10.

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July 22nd, 2004



Roche Molecular Systems Issues Nationwide Recall of Cobas Taqman Analyzers and Cobas Taqman 48 Analyzers
Source: Company Press Release

Pleasanton, CA --- Roche Molecular Systems, Inc. (RMS), Pleasanton, California, has initiated a nationwide recall of COBAS TaqMan Analyzers and COBAS TaqMan 48 Analyzers that are used by laboratories to run tests for hepatitis B and hepatitis C viruses and for other in-house diagnostic testing. A few Analyzers have been found to have an improperly seated fiber optic cable, which potentially could result in falsely elevated patient test results. Falsely elevated results would suggest that the patient is not responding to treatment and the physician may stop or change therapy. In some cases this could result in progression of the disease and, due to the disease progression, ultimately lead to death. In extreme cases, the misalignment of the fiber optic cable could result in a mismatch of patient test results. RMS will continue to monitor instruments in the field to assess that fiber optic cables are correctly seated.

Roche began this investigation upon the receipt of one customer complaint. Based on this complaint, no patient was inappropriately treated as a result of this situation.

Customers who have COBAS TaqMan Analyzers or COBAS TaqMan 48 Analyzers have been notified by Roche Diagnostics and have had their instruments inspected by a Roche Field Service Engineer to assure proper alignment of the fiber optic cable.

The firm voluntarily initiated this field correction after learning that false positive results generated in a laboratory were caused by a misalignment of the fiber optic cable to one of the thermal cycler blocks contained in the instrument. FDA has been apprised of this action.

Based on customer feedback and ongoing investigation, Roche Molecular Systems, Inc. has confirmed the possibility of falsely elevated control and patient values on the COBAS TaqMan and COBAS TaqMan 48 Analyzers. It has been determined that if a fiber optic cable is incorrectly seated in the emission module of a thermal cycler, the emission signals may overlap those of neighboring wells resulting in cross-talk that could lead to falsely elevated results. Extreme misalignment could result in a sample-to-result mismatch. Analyzers have been distributed to laboratories in the United States, Canada, and Europe. They can be identified by brand name COBAS TaqMan and COBAS TaqMan 48 Analyzer.

Roche Molecular Systems notified its distributors and customers by letter in May of this year. Field Service Engineers have inspected all Analyzers for correct seating of the cable.

Laboratories with questions may contact the company at 1-800-526-1247.

Roche Molecular Systems, Inc.
4300 Hacienda Drive
Pleasanton, CA, US
Communications & PR
www.roche-diagnostics.com

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NEC Discovers New Peptide-Vaccine Candidates for Hepatitis C Virus Together with Kochi Medical School
Source: www.japancorp.net

Tokyo, Japan, July 22, 2004 -- NEC Corporation (TSE: 6701) and Kochi Medical School today announced the discovery of new peptide-vaccine candidates for the Hepatitis C Virus (HCV). The discovery was enabled by a jointly developed system that predicts human antigen-presenting HLA (Human Leukocyte Antigen) molecule-binding peptides, which possess a high binding accuracy of 70 - 80%. These peptide-vaccine candidates are now being applied in verification experiments, such as in vitro immunological activation experiments and clinical trials in the near future. NEC expects that these candidates will contribute greatly to the recognition of genuine drugs exerting prevention and treatment effectiveness in HCV.

NEC, together with Kochi Medical School, has applied for a patent regarding the HCV-derived peptide vaccine candidates at the Japan Patent Office. It is presently being verified via experiments that these peptides actually induce immune system activation. After immunological activation and toxicological safety has been confirmed, clinical trials are planned at Ehime Medical School Hospital.

Through the combination with the research results of peptide-HLA molecule binding experiments at Kochi Medical School (Prof. Udaka, Department of Immunology), NEC initiated the development of a prediction system of human HLA molecule-binding peptides from last year. NEC succeeded in developing the prediction systems for HLA-A*2402 and HLA-A*0201 molecules, and future plans exist for developing the prediction system for other HLA subtypes.

In 2001, NEC developed a unique bio-informatics technique; “Active-learning method”(*1) for extremely high prediction accuracy of binding peptide to mouse antigen-presenting molecules MHC (Major Histocompatibility Complex). This technique can predict binding peptides for more than 500 billion variations of 9-amino acid sequences by only applying several hundred experimental binding data.

NEC subsequently succeeded to predict human HCV poly-protein originated 9-amino acid peptides, which bind to HLA-A*2402 molecules, a HLA subtype that over 50% of the Japanese population carry. These peptide-vaccine candidates have huge potential of being developed into new drugs that may contribute to the prevention and treatment of HCV.

NEC, together with Kochi Medical School, has applied for a patent regarding the HCV-derived peptide vaccine candidates at the Japan Patent Office. It is presently being verified via experiments that these peptides actually induce immune system activation. After immunological activation and toxicological safety has been confirmed, clinical trials are planned at Ehime Medical School Hospital.

NEC anticipates that this system will contribute vastly to the recognition of peptide-vaccines, and plans to collaborate with various pharmaceutical companies. NEC has also started prediction of HCV poly-protein originated HLA-A*0201-binding peptides, (this is a HLA molecule subtype that a large number of U.S. and European people have) and is focusing on selecting target representatives of infectious diseases, such as SARS (Severe Acute Respiratory Syndrome), influenza viruses, cancer antigens, and allergic diseases such as pollinosis (hay fever). In the near future, the development of prediction systems for other HLA-A subtypes is also planned. In due course, prediction systems will contribute to personalized medicine by selection of the most suitable peptide combinations based on pre-inspection of HLA-subtypes of individual patients.

Note:

*1: “Active-learning method”
This is one of the machine learning methods, which can select experimental data from a large amount of candidates. After this approach is carried out several hundred times, highly informative experimental data is gathered, and based on this highly accurate prediction is achieved.

About NEC Corporation
NEC Corporation (NASDAQ: NIPNY) (FTSE: 6701q.l) is one of the world’s leading providers of Internet, broadband network and enterprise business solutions dedicated to meeting the specialized needs of its diverse and global base of customers. Ranked as one of the world’s top patent-producing companies, NEC delivers tailored solutions in the key fields of computer, networking and electron devices, by integrating its technical strengths in IT and Networks, and by providing advanced semiconductor solutions through NEC Electronics Corporation. The NEC Group employs more than 140,000 people worldwide and had net sales of 4,906 billion yen (approx. $47 billion) in the fiscal year ended March 2004.

For further information, about NEC Corporation see their company profile here

Contact:
In Japan
Diane Foley
NEC Corporation
d-foley@ax.jp.nec.com
+81-3-3798-6511

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Roche Files SBLA for Pegasys
Source: www.pharmexec.com

F. Hoffman-La Roche Ltd. filed a supplemental Biologics License Application with the Food and Drug Administration for Pegasys (peginterferon alfa-2a), seeking an indication to treat chronic hepatitis B.

The SBLA was based on Pegasys data from a comprehensive clinical development program in hepatitis B. More than 1,500 patients with chronic hepatitis B were evaluated in three separate studies.

In a Phase II trial, Pegasys was compared with standard interferon in patients with HBeAg-positive disease. In addition, two Phase III studies compared Pegasys against GlaxoSmithKline Plc’s Epivir (lamivudine) in patients with HBeAg-positive disease and in patients with HBeAg-negative disease, respectively.

HBeAg-negative disease is a more difficult-to-treat mutation of the hepatitis B virus. Roche noted that both Phase III trials were the largest of their kind to examine patient populations with either variation of hepatitis B.

“Each year, an estimated 5,000 to 6,000 people die in the United States because of chronic hepatitis B liver disease,” said Alan Brownstein, chief executive of the American Liver Foundation in a Roche press release.
The Food and Drug Administration originally approved Pegasys in October 2002 for the treatment of chronic hepatitis C.

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2,000 Cases of Hepatitis Misdiagnosis
Kim Dong-seup, dskim dskim@chosun.com
Source: http://english.chosun.com/national/

Shock is following revelations that Korean Red Cross staff misdiagnosed about 2,000 cases of hepatitis in the last 10 years, and of those misdiagnosed, some who were hepatitis B or C positive were diagnosed negative and allowed to donate blood to hospitals. As this is the first time it has been revealed that the blood of hepatitis-infected individuals was used for transfusions or to make medical supplies due to Red Cross staff carelessness or mistakes, the fallout is expected to grow.

Accordingly, there will be mass reprimands of Red Cross staff and questions of responsibility with the Ministry of Human Welfare, which supervises the Red Cross. Moreover, controversy will likely surround the investigations and compensation to be given to those who received blood infected with hepatitis. According to the Health and Human Welfare Ministry on Thursday, a review of blood donation conditions since 1994 yielded seven blood donation centers nationwide where tainted blood was received.

The Human Welfare Ministry and Red Cross apologized to the citizens for using hepatitis-infected blood for transfusions due to diagnosis errors and promised measures to ensure it never happens again. Along with this, prosecutors are investigating the Korean Red Cross and National Institute of Health, and an announcement on their poor maintenance of blood supplies is expected soon. An expert on blood supply management said that Red Cross's conducting of its own investigation into misdiagnoses was an expression of the willingness to make this an opportunity to get everything out into the open and allow the body to be reborn as institution worthy of public trust.

The 2,000 misdiagnosis cases included both those in which those who were infected tested negative and those who were not tested positive, and it seems there were more than a few cases in which infected blood was sent to hospitals for use. The Welfare Ministry said at a certain blood bank in 2002, there were 13 cases in which hepatitis-positive blood was diagnosed as negative, and 16 in which hepatitis-negative blood was initially diagnosed as positive. If the ministry confirms that some of the blood was supplied to hospitals for use, it will track down who received the blood and provide compensation to those who were infected.

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July 23rd, 2004



Experts Lament Poor Awareness of HBV
Godwin Haruna- Lagos
Source: This Day (Lagos) News

As the world's attention shifted to the HIV/AIDS pandemic at the just concluded international summit in Bangkok, Thailand, experts have decried the neglect by Nigeria of hepatitis B virus (HBV), another deadly disease said to be more virulent and common among Nigerians than HIV.

Speaking at the opening ceremony of the national workshop on hepatitis B virus held last week by the Association for the Study of the Liver (ASLIN) in collaboration with GlaxoSmithKline recently, the President Prof. Segun Ojo lamented that awareness on HBV infection in the country has remained very poor despite the fact that disease is as deadly HIV.

According to him, the mode of transmission of HBV is similar to that of HIV as it is also transmitted through sexual contact, contact with the blood or body fluids of an infected person, unsafe injections and transfusion.

Ojo further disclosed that HBV is 50 to 100 times more infectious than HIV and can even be transmitted from child to child. The major difference between the two infections, according to him is that HBV can be easily transmitted.

In a keynote address, former Chief Medical Director of the Aminu Kano Teaching Hospital, Kano, Prof. Sadiq Wali disclosed that Hepatitis B virus is the 10th leading causes of adult death in the world , with over 33 per cent of the world population or about 350 million people around the world currently infected.

According to him, the virus also claims one to two million lives every year while over 90 per cent of infants are infected prematurely, stressing that the hepatitis B virus is spread through the same route just like HIV.

Wali listed the clinical features of hepatitis B. These included gastro-intestinal symptoms such as anorexia, flatulence, vomiting, fever, arthralgia, upper abdominal pain, dark urine, jaundice, pruritus, vascultic rash, cirrhosis, fulminate hepatic (liver) failure and liver cancer.

He reviewed the various management methods of liver diseases and concluded that various complicated procedures required, including liver transplantation, could be performed in Nigeria with adequate planning.

He however stressed the need for good prevention strategies as a way out of the problem posed by HBV in Nigeria. Such strategies include public education on the disease, screening of blood products and immunisation.

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Yale Scientists Visualize Details of How Hepatitis C Unwinds RNA
Source: Yale University

New Haven, Conn. -- Research led by Anna Marie Pyle, professor of molecular biophysics and biochemistry at Yale University reveals how a protein from Hepatitis C (HCV) unwinds RNA, potentially allowing it to be copied.

The work published in the journal Nature focuses on an enzyme, helicase NS3, that unwinds the RNA virus for replication inside cells. NS3 is one member of an extensive family of helicases and is used as a model for studying unwinding activities of motor proteins.

Their findings are particularly important because NS3 is a major drug target against HCV and understanding the helicase function will aid in the development of HCV inhibitors.

Pyle's results contradict the idea that helicases move smoothly with the continuous action of a snow plow. Instead, NS3 moves with a discontinuous stepping motion that alternates rapid translocation with pausing. "We observe that the helicase proceeds through discreet spatial and kinetic microstates," Pyle said. "We actually track the speed and processivity of the helicase as it passes through each base pair of its substrate."

"While this report is the first of its kind, and has produced highly significant results, it is only the beginning of a new understanding in HCV enzymology," said Pyle. "In the future, our approaches will be used to understand the composition of the HCV replication complex and the interplay between its constituent proteins. Comparative studies will be done on other viruses and in other systems where helicase function is critical."

These novel features were revealed using a new type of combinatorial enzymology that allows the behavior of helicase enzymes to be directly compared on a sequence panel. This is the first time that the behavior of a nucleic acid remodeling protein has been monitored at this high resolution, as it acts upon or passes each subunit of its target, according to Pyle. Since the work was conducted on RNA, it helps to bring RNA helicases to the forefront of motor research.

"By visualizing one of the key steps in how hepatitis C makes copies of itself, Dr. Pyle unexpectedly discovered that the molecular motor that unzips the virus' genetic material looks a lot like the motor that drives muscles," said Dr. Richard Ikeda, a chemist at the National Institute of General Medical Sciences, which funded the work. "This is a perfect example of how a basic investigation revealed surprise insights into the similarities among widely different organisms.'

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Columbus - Illegal Tattooing Investigation
Source: www.wishtv.com

Columbus police are searching for a second suspect in a series of illegal tattooing that is leaving several people sick.

Police say James Skaggs, 38, is spreading more than just his art. They fear that he is transmitting highly infectious hepatitis to customers. Skaggs is known for giving tattoos by using guitar wire.

"We have people developing hepatitis and other contagious diseases, so it's a danger to all the people in the city of Columbus ,” said Columbus City Prosecutor Bill Hedrick, "We're just hoping we shut him down. This is ridiculous."

Skaggs is scheduled to appear in court Friday on an unrelated charge. The officers who busted him previously could be tested for exposure to hepatitis.

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Convict with Life Sentence Gets Medical Commutation
Source: www.wishtv.com

(Jackson, Michigan) - Maurice Carter says he never gave up hope. The 60-year-old native of Gary, Indiana, is scheduled to be released from a Jackson prison on Saturday.

Carter has spent more than 28 years behind bars after receiving a life sentence. A jury convicted him in 1976 of shooting and wounding of an off-duty Benton Harbor police officer. Carter always has maintained his innocence.

He has hepatitis-C and his doctors say he needs a liver transplant. Governor Granholm granted Carter a medical commutation last month.

Carter told The Grand Rapids Press in an interview from the prison's hospital that after he gets healthier, he wants to start rebuilding relationships with his loved ones.

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July 24th, 2004



Decades in Music World Earn Escovedo Peer Admiration
Kelley Shammon
Source: Associated Press

AUSTIN - Musician Alejandro Escovedo has spent a lifetime doing what he loves.

"Just the joy of traveling and playing guitar, I mean, that's a beautiful thing, to see the world as a guitar player," the 53-year-old Austin music veteran said. "It's almost like in the tradition of being a troubadour ... you're spreading the news."

After three decades, though, those days are over for Escovedo - at least for now.

Sidelined with a life-threatening illness, Escovedo is on hiatus from performing. But a CD collection of his music, "Por Vida: A Tribute to the Songs of Alejandro Escovedo," is being released Tuesday to honor Escovedo and raise money to assist him as he battles hepatitis C.

Artists performing on the CD include Lucinda Williams, John Cale, Los Lonely Boys, Jennifer Warnes, Steve Earle, the Cowboy Junkies and Son Volt. Some of Escovedo's musician relatives, brothers Javier and Pete Escovedo and niece Sheila E., also recorded for the album.

"It's all people that I have so much respect for," Escovedo said. "To me, it sounds like there's a lot of love put into every track."

The CD includes one new song by Escovedo, called "Break This Time," a fast-paced tune with distinctive guitar passages, recorded before his latest severe bout with illness. "So whisper so softly, tell me you love me," Escovedo sings. "But I just might break this time."

Escovedo's music is an array of styles, from hard-driving rock to emotion-filled ballads that sometimes incorporate cellos and violins.

He got his start in music in the 1970s as a member of the quasi-punk band The Nuns. That was followed by his work in the bands Rank and File and the True Believers. In the 1990s, even though he played in the band Buick MacKane on the side, his critically acclaimed solo albums and his live performances dominated his career.

He credits his late father, Pedro, who died in February at 97, and his mother, Evita, with encouraging his and his siblings' love of music. His father's stories and life experiences as an immigrant from Saltillo, Mexico, also had a major impact on his songwriting, Escovedo said.

Over the past few years, Escovedo, who was born in San Antonio and later grew up in southern California, has explored his Mexican-American roots. He has brought traditional Latin music sounds into his songs, written lyrics about the plight of immigrants and created a play titled "By the Hand of the Father," which features Escovedo's music and tells a story of Mexican-Americans.

Along with generating money for Escovedo's living and medical expenses, "Por Vida" aims to call attention to hepatitis C and ultimately help other musicians who have the disease, said Heinz Geissler, Escovedo's manager and an executive producer of the CD.
Hepatitis C is a blood-borne virus that can be contracted through a contaminated needle or sexual intercourse, and can lead to cirrhosis or liver failure. An infected person may not know for years that he or she has the virus.

Escovedo speculates he may have gotten the virus in the 1970s, but doesn't know for sure and doesn't offer details. He acknowledges that drinking, drugs and women are some of the temptations of touring.

When he was diagnosed eight years ago, Escovedo maintained a grueling touring schedule and admittedly didn't take good care of himself; he even continued drinking alcohol. Then he fell seriously ill during a performance in Arizona and was hospitalized in April 2003.

He spent the next few weeks recuperating in Arizona with his companion Kim Christoff and their baby daughter Amala, who is now 20 months old, he said. Escovedo has six older children from previous relationships, ranging in age from 5 to 34 years old.

"Suddenly, I was faced with the kind of distant thought that I wouldn't see my children again," Escovedo said.

Back in Texas, he saw several doctors and settled on a specialist in Dallas. He recently finished a difficult period of taking the drug interferon, which caused weakness, mood swings and some hair loss.

With Escovedo unable to work, and no health insurance, Geissler stepped in, organizing benefit concerts and helping to lead the CD project.

"We went back to Alejandro. We said, 'OK, give us your dream list of who you'd like to see do your songs,' " Geissler said. The list was long, he said. As word spread, more artists wanted to take part.

Most of the musicians' arrangements of his songs came as a surprise to Escovedo, who typically wasn't involved in the recordings. He did produce the Los Lonely Boys' version of "Castanets," from Escovedo's 2001 album "Man Under the Influence."

Working with Escovedo was like working with a brother or cousin or uncle, said Los Lonely Boys singer and guitarist Henry Garza.

"We are proud to be able to play music in tribute to a man we admire and has been recognized by others as a true artist," Garza said, through a publicist.

Escovedo said he hopes the album keeps his work before the public. His plans remain indefinite.

"Whether I play music again really doesn't matter," he said. "What matters is that I survive this, number one. I told this doctor, I said, 'I don't care about touring. I care about watching my children grow up.' That's all I want."

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