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

Week Ending: August 20th, 2005

Alan Franciscus
Editor-in-Chief

To download pdf version click here


This Issue:

• CALIFORNIA: "Board Vote on Sales of Needles Delayed"

• Gilead and Achillion Announce Initiation of Phase I Clinical Trial Evaluating GS 9132 for the Treatment of Hepatitis C

• Economic Impact of MELD on Liver Transplant Centers

• Hepatitis B Virus DNA Integration in Hepatocellular Carcinoma after Interferon-Induced Disappearance of Hepatitis C Virus

• NEW JERSEY: "Appellate Panel Strikes Down Atlantic City Needle Exchange"

• HIV-Positive Patients Coinfected with HCV up to 80% More Likely to Die Even with HIV Treatment

• Rep. Souder Protests HHS Sponsorship of Conference on Meth Use, AIDS that Promotes 'Harm Reduction' Approach to Drug Use, USA

• Recipient of Liver Touts Blood Drive

• Viral Link to Liver Cancer Found

• Inova Warns Patients of Sterilization Error; Risk of Infection Very Low, Hospital Says

• Docs Reveal Possible Therapy for HCV Fatigue

• Weight Loss with Drug Treatment of Chronic Hep C

• Anadys Hits $10 million Novartis Milestone

• Vertex Stock Soars on Upgrade

• Tarvacin(TM) Phase I Hepatitis C Virus Trial, Peregrine Pharmaceuticals

• Nurse Shares Story of Hepatitis C, the 'Silent Epidemic'

On August 10, Sacramento's Board of Supervisors voted 3-2 to postpone a decision on whether to allow adults to purchase needles without a prescription. Some supervisors said they had been unaware that the proposal would govern areas other than unincorporated parts of the county and believed several cities need to be consulted before a vote is taken. County health officials, who approve of the measure, have not contacted city leaders in each city about the proposal.

"I contacted the two cities in my district - Folsom and Citrus Heights," said Sup. Roberta MacGlashin. "They are concerned that they don't have a voice." "There has been no conversation with the cities of Elk Grove, Galt and Isleton," said Sup. Don Nottoli, referring to cities in his district. Sups. MacGlashin, Nottoli, and Susan Peters voted to delay the decision.

However, the county often makes health decisions without consulting all the cities, said Sup. Roger Dickinson. "Each day we wait condemns more people unnecessarily to disease and death," he said. Sup. Illa Collin also supported the proposal and said the county bore ultimate responsibility for implementing it.

Nine counties have acted under the state law allowing pharmacies to sell up to 10 non-prescription needles at once to adults through 2010, said Tom Stopka, a research scientist in the California Department of Health Services' Office of AIDS. "Based on experience in other states, you can expect to see a reduction in HIV infection rates" if the measure is approved, he told the board.

Steven Fisk, president of the Sacramento County Deputy Sheriffs' Association, stated his opposition to pharmacy sales but his support for needle-exchange efforts and a bill that would make it easier for counties to operate such programs.

After contacting city leaders in the county about the measure, health officials will report to the board in October.

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August 15th, 2005


Gilead and Achillion Announce Initiation of Phase I Clinical Trial Evaluating GS 9132 for the Treatment of Hepatitis C
www.gilead.com

FOSTER CITY, Calif. and NEW HAVEN, Conn.--(BUSINESS WIRE)--Aug. 15, 2005--Gilead Sciences (Nasdaq:GILD) and Achillion Pharmaceuticals today announced that the companies have begun dosing patients in a Phase I study of GS 9132, also known as ACH-806. Gilead and Achillion are investigating GS 9132 for the treatment of hepatitis C.

The Phase I trial is a double-blind, randomized, placebo-controlled dose-escalation study. The goal of the trial is to evaluate the pharmacokinetics, tolerability and safety of single escalating doses of GS 9132 in healthy volunteers. The study will take place in the United States and will enroll approximately 20 subjects.

In November 2004, Gilead and Achillion established an agreement granting Gilead worldwide rights for the research, development and commercialization of certain Achillion compounds for the treatment of hepatitis C. GS 9132 is a small molecule inhibitor of hepatitis C virus (HCV) replication, which works through a novel mechanism of action involving HCV protease. GS 9132 was discovered by Achillion, and the company completed the initial work necessary to move the compound into clinical development.

"Gilead and Achillion share a commitment to advancing novel compounds with the potential to address the unmet medical need that exists for patients chronically infected with hepatitis C," said Norbert Bischofberger, PhD, Executive Vice President, Research and Development, Gilead Sciences. "Achillion's leadership in the early clinical development of this compound, and work to ensure rapid progress toward the Investigational New Drug application filing earlier this summer, has allowed us to advance this important clinical program. We look forward to our continued collaboration."

"We are excited about the novel mechanism of action of GS 9132 involving HCV protease, and we are looking forward to establishing the safety profile of this compound in humans," stated Milind Deshpande, PhD, Chief Scientific Officer of Achillion. "Gilead has been a tremendous partner through the early part of our agreement and we look forward to benefiting from their clinical experience and building upon our relationship as Achillion brings GS 9132 through proof of concept studies."

About Hepatitis C

Hepatitis C is a viral liver disease, caused by infection with the hepatitis C virus. Globally, more than 170 million people have chronic hepatitis C. About three million Americans are now estimated to be chronically infected with HCV. Chronic hepatitis C is a leading cause of cirrhosis, a common cause of hepatocellular carcinoma, and is the leading cause of liver transplantation in the United States.

About Gilead Sciences

Gilead Sciences is a biopharmaceutical company that discovers, develops and commercializes innovative therapeutics in areas of unmet medical need. The company's mission is to advance the care of patients suffering from life-threatening diseases worldwide. Headquartered in Foster City, California, Gilead has operations in North America, Europe and Australia.

About Achillion

Achillion is an innovative pharmaceutical company dedicated to bringing important new treatments to patients with infectious disease. The company's proven discovery and development teams have advanced multiple product candidates with novel mechanisms of action. Achillion is focused on solutions for the most challenging problems in infectious disease -- HIV, hepatitis and resistant bacterial infections.

As an investigational compound, GS 9132 has not yet been determined safe or efficacious in humans for its ultimate intended use.

This press release includes forward-looking statements, within the meaning of the Private Securities Litigation Reform Act of 1995, that are subject to risks, uncertainties and other factors, including risks related to Gilead's ability to develop and commercialize this product. For example, the data from this trial may not warrant further development of this compound and initiating and completing clinical trials may take longer or cost more than expected. These risks, uncertainties and other factors could cause actual results to differ materially from those referred to in the forward-looking statements. The reader is cautioned not to rely on these forward-looking statements. These and other risks are described in detail in the Gilead Annual Report on Form 10-K for the year ended December 31, 2004 and in the company's Quarterly Reports on Form 10-Q, which are on file with the U.S. Securities and Exchange Commission. All forward-looking statements are based on information currently available to Gilead, and neither company assumes any obligation to update any such forward-looking statements.

For more information on Gilead Sciences, please visit the company's web site at www.gilead.com or call the Gilead Public Affairs Department at 1-800-GILEAD-5 or 1-650-574-3000.

For more information on Achillion, please visit the company's web site at www.achillion.com or call Achillion at 1-203-624-7000.

CONTACT: Gilead Sciences
Erin Edgley, 650-522-5635 (Media)
Susan Hubbard, 650-522-5715 (Investors)

or

Achillion
Kari Lampka, 508-647-0209 (Media)
Mary Kay Fenton, 203-624-7000 (Investors)

SOURCE: Gilead Sciences

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August 16th, 2005


Economic Impact of MELD on Liver Transplant Centers
SourceURL:http://www.gastrohep.com

Contractual reimbursements not indexed by disease severity may not reflect increased costs resulting from the MELD system, and cause a net loss for the transplant center, reports the latest issue of the American Journal of Transplantation.

The adopted model for end stage liver (MELD) disease system prioritizes patients awaiting liver transplant by severity of illness.

The model for end stage liver disease included progressive renal dysfunction.

Unfortunately, current reimbursement for liver transplantation is not adjusted by severity of illness.

The model is also not adjusted for need of simultaneous liver-kidney transplantation.

Dr David Axelrod and colleagues examined hospital cost and reimbursement for liver transplantation and liver-kidney transplantation.

The researchers determined the effect of MELD on transplant center financial outcomes given current reimbursement practices and outlier threshold limits.

Liver transplantation was performed for 86 adults prior to and 127 following the implementation of MELD.

Liver-kidney transplants performed increased from 6% to 17% – American Journal of Transplantation

The research team found that between the eras, there was a substantial increase in the average laboratory MELD score from 17 to 21.

The team noted that the percentage of liver-kidney transplants performed increased from 6% to 17%.

The researchers observed that increasing MELD score was associated with higher costs of $4309 per MELD point.

An increased MELD score was associated with decreasing transplant centers net income at $1512 per MELD point.

In patients not achieving the Medicare outlier status, predicted net loss was $17,700 for high-MELD patients.

In addition, the team found that the predicted net loss for Medicare outlier patients and for those needing liver-kidney transplantation was $19,133.

Dr Axelrod's team commented, “Contractual reimbursement agreements that are not indexed by severity of disease may not reflect the increased costs resulting from the MELD system.”

“Even with outlier thresholds, Medicare reimbursement is inadequate resulting in a net loss for the transplant center.”

Am J Transplant 2005: 5(9): 2297

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Hepatitis B Virus DNA Integration in Hepatocellular Carcinoma after Interferon-Induced Disappearance of Hepatitis C Virus.
SourceURL:http://www.ncbi.nlm.nih.gov/

Tamori A, Nishiguchi S, Shiomi S, Hayashi T, Kobayashi S, Habu D, Takeda T, Seki S, Hirohashi K, Tanaka H, Kubo S.

Department of Hepatology, Osaka City University Graduate School of Medicine, Osaka, Japan.

OBJECTIVES: Hepatocellular carcinoma (HCC) has been reported in patients in whom hepatitis C virus (HCV) was eliminated by interferon (IFN) therapy. We examined the pathogenesis of HCC in patients with sustained viral response. METHODS: Operable HCC developed in 7 of 342 patients cured of HCV infection by IFN monotherapy. No patient abused alcohol or had diabetes mellitus or obesity. Resected specimens of HCC were histologically evaluated. DNA extracted from HCC was examined by polymerase chain reaction (PCR) to locate hepatitis B virus (HBV) DNA. HBV integration sites in human genome were identified by cassette-ligation-mediated PCR. RESULTS: HBV DNA was not amplified in serum samples from any of the seven patients with HCC and was found in liver in four patients. In the latter four patients, HBV DNA was integrated into the human genome of HCC. In two of these patients, covalently closed circular HBV (cccHBV) was also detected. The patients with HBV DNA integration were free of HCV for more than 3 yr. In two of the three patients without HBV DNA integration, the surrounding liver showed cirrhosis. The liver of HCC with HBV DNA integration had not progressed to cirrhosis. Three of the four tumors with HBV integration had one integration site each, located at chromosomes 11q12, 11q22-23, and 22q11, respectively. The other tumor had two integration sites, situated at chromosomes 11q13 and 14q32. At chromosome 11q12, HBV DNA was integrated into protein-coding genome, the function of which remains unclear. CONCLUSION: Integrated HBV DNA may play a role in hepatocarcinogenesis after the clearance of HCV by IFN treatment. (Am J Gastroenterol 2005;100:1-6).

Source: Am J Gastroenterol. 2005 Aug;100(8):1748-53.

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NEW JERSEY: "Appellate Panel Strikes Down Atlantic City Needle Exchange"
Associated Press
John Curran

Atlantic City cannot operate a needle exchange program without violating a law against distributing drug paraphernalia, an Appellate Division panel unanimously ruled on Tuesday. Both Atlantic City and Camden planned to operate needle-exchange programs; Camden's program has yet to begin operating, said Rob Tomasello, spokesperson for Camden County government, which was to oversee it through its health department.

The court recognized the objective of such programs is to reduce the spread of HIV and other blood-borne diseases among intravenous drug users. "However, Atlantic City and its employees are not exempt from the Code [of Criminal Justice] provisions prohibiting the possession, use and distribution of drugs and drug paraphernalia simply because they adopted a needle exchange program for beneficent reasons," Judge Stephen Skillman wrote for the tribunal.

In 2004, Atlantic City approved a municipal needle-exchange program. Atlantic County Prosecutor Jeffrey Blitz sued to stop the program and last September won in a ruling that said it would violate state drug laws if enacted. The city appealed, and Tuesday's decision upheld the ruling. Bob Sandman, the city's attorney in the case, said no decision has been made whether to appeal again.

On June 17, the Appellate Division stayed an executive order issued in October by then-Gov. James McGreevey authorizing needle-exchange pilot projects in three municipalities. That case revolves around whether he had overstepped his authority. Needle-exchange bills have failed in New Jersey's Legislature.

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August 17th, 2005


HIV-Positive Patients Coinfected with HCV up to 80% More Likely to Die Even with HIV Treatment
SourceURL:http://www.aidsmap.com
Michael Carter

Infection with hepatitis C virus increases the risk of death in HIV-positive individuals by between 30% - 80%, even after factors such as the use and success of anti-HIV treatment are controlled for, according to a US study published in the August 15th edition of the Journal of Acquired Immune Deficiency Syndromes. The investigators, from the US’s largest provider of HIV care, the Department of Veterans’ Affairs, question whether currently available treatment for hepatitis C, which has a lower response rate in HIV-positive individuals, would significantly reduce this level of excess mortality and suggest instead that efforts should be made to treat the high levels of mental illness and drug and alcohol abuse present in their coinfected patients, factors which they believe “contribute directly and indirectly to poor outcome in HIV and HCV coinfection.”

It is estimated that as many as 300,000 HIV-positive individuals (15% - 30% of all HIV cases) are coinfected with hepatitis C virus. Since effective anti-HIV therapy became available, liver disease caused by hepatitis C has emerged as a major cause of illness and death in HIV-positive patients.

Investigators wished to determine the impact of hepatitis C infection on mortality in HIV-positive patients receiving antiretroviral therapy. Their analysis controlled for potential confounding factors including virologic and immunologic response to anti-HIV treatment.

The study included a total of 12,216 individuals who were treated with their first potent anti-HIV treatment regimen at the Department of Veterans' Affairs between early 1997 and 2003. To be included in the study individuals also had to have been tested for hepatitis C and to have CD4 and viral load tests conducted prior to starting HIV therapy.

A total of 4,668 patients (38%) were coinfected with hepatitis C virus. Coinfected individuals were older than patients who tested negative for hepatitis C and were also more likely to be black or Hispanic, have a history of psychiatric illness (71% versus 60%, p < 0.001), abuse drugs (62% versus 20%, p <0.001), and have alcohol problems (63% versus 30%, p < 0.001). Prior to starting potent anti-HIV therapy, hepatitis C coinfected patients had higher viral loads than patients who were only infected with HIV (median 26,000 copies/ml versus 19,000 copies/ml, p < 0.001), but baseline CD4 cell counts were comparable between the two groups of patients (median 257 cell/mm3 versus 248 cells/mm3).

Hepatitis C-infected and hepatitis C-negative individuals had a similar virologic response to HAART with approximately 80% of both groups of patients achieving an undetectable viral load at least once. Nor was there any difference in the proportion of patients who maintained good control of HIV replication (37% hepatitis C-infected, versus 39% hepatitis C-negative). CD4 cell gain was, however, lower amongst the patients infected with hepatitis C (median peak gain 199 cells/mm3 versus 239 cells/mm3 for hepatitis C-uninfected patients, p < 0.001).

A total of 2087 deaths occurred during follow-up. There were proportionately more deaths amongst hepatitis C virus-infected patients than individuals who were not infected with hepatitis C (22% versus 14%, p < 0.001). The unadjusted risk of death was 6.4 per 100 patient years for coinfected patients and 4 per 100 patient years for patients who only had HIV. This difference was highly statistically significant (p < 0.001).

The investigators repeated their analysis, limiting their analysis to patients with controlled HIV replication on at least one occasion and still found that coinfected patients had a significantly higher risk of death (hazard ratio, 1.77, p < 0.001). The result was similar when analysis was restricted to individuals with well-controlled viral load - coinfected patients having a hazard ratio of death of 1.69, p < 0.001). The investigators then controlled for CD4 cell response to anti-HIV therapy and still found a significantly increased hazard ratio of death for coinfected patients (1.34, p < 0.001).

“Hepatitis C virus infection increases the risk of death in HIV patients who received HAART, controlling for numerous demographic and clinical factors, including exposure to HAART and response to HAART”, write the investigators. They add, “depending on the factors for which we controlled, we found that the risk of death among HAART-treated HIV patients was between 30% and 80% higher for those who were also infected with HCV.”

The investigators suggest that their study “raises the pressing question of whether HCV treatment can ameliorate the observed increase in the risk of death.” They note that the study was largely completed before pegylated interferon and ribavirin became the standard of treatment for hepatitis C virus. However, they emphasise that the response to hepatitis C therapy is poorer in patients who are coinfected with HIV. They therefore suggest that until better hepatitis C treatment becomes available efforts to treat the high rates of mental illness, and drug and alcohol abuse seen in their cohort may help lower mortality.

Reference

Backus LI et al. Effects of hepatitis

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Rep. Souder Protests HHS Sponsorship of Conference on Meth Use, AIDS that Promotes 'Harm Reduction' Approach to Drug Use, USA
SourceURL:http://www.medicalnewstoday.com

Rep Mark Souder (R-Ind) is protesting... HHS' sponsorship of a conference exploring the link between crystal methamphetamine and the spread of HIV/AIDS and hepatitis because the meeting's organizers promote a "harm reduction" approach to drug policy, the Washington Times reports. Harm reduction programs provide injection drug users with clean needles and syringes or methadone therapy to help reduce the risk of them becoming infected with bloodborne diseases. However, some Republicans view such programs as a cover for those who wish to decriminalize illegal drugs, according to the Times. The conference, which is scheduled for Aug. 19-20 in Salt Lake City, is organized by the Harm Reduction Project, and HHS is listed as the main sponsor of the conference because it awarded $3,000 in travel scholarships to participants. Souder on Friday sent "an angry letter" to HHS Secretary Mike Leavitt, saying the conference's support of harm reduction programs undermines federal policy, according to the Times. "That administration officials from your department are consulting with harm reduction advocates ... and sponsoring conferences controlled by the harm reduction network completely undermines the work of the president, the Congress, and the men and women who work in law enforcement across the nation who are trying desperately to fight the meth epidemic," Souder wrote. However, Drug Policy Alliance Executive Director Ethan Nadelmann, who is speaking at the conference, said harm reduction techniques are successfully used in other countries. Earlier this year, Sen. Orrin Hatch (R-Utah) and Rep. Jim Matheson (D-Utah) praised the conference. Other government agencies sponsoring the conference include the Utah Department of Health, the Utah State Division of Substance Abuse and Mental Health and the California Department of Health Services (Wetzstein, Washington Times, 8/16).

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Recipient of Liver Touts Blood Drive
SourceURL:http://www.suburbanchicagonews.com
By Tom Polansek
STAFF WRITER

Transplant patient understands need for donations

When Dave "Rocket" Wittrock of Elgin had a liver transplant three years ago, his surgery required 14 pints of blood. Now he holds a blood drive every year to ensure other people get the blood they need.

ELGIN – A little more than three years ago, Dave Wittrock did not have a lot to celebrate.

Suffering from hepatitis C, Wittrock had been on a national waiting list to receive a new liver for more than a year. Then, the Elgin resident was diagnosed with liver cancer and told he would have to drop off the list to begin chemotherapy.

"That is about what broke our hearts," his mother, Marie, said Tuesday.

But then Wittrock's luck changed. His name came up on the list just days before he was scheduled to begin cancer treatment.

He endured a long, complicated transplant operation, during which he received 14 pints of blood, and came out a new man. His liver problems were over, and the cancer was gone.

It took Wittrock, whose friends call him Rocket, about six months to recover, but since then he has not forgotten the blood donors who helped him survive.

For the past three years, he has held Rocket's Celebration of Life Blood Drive to give back to those who helped him when he was in need.

"You just never know who's going to need it," Wittrock, 54, said about blood donations. "It could be your loved ones. It could be you, yourself."

His next blood drive is scheduled for 10 a.m. to 3 p.m. Sunday, Aug. 21, at Heartland Blood Centers' mobile coach at 1600 Eagle Road, Elgin. Donors must bring photo IDs and will receive $25 gift certificates from diningdough.com, which can be redeemed for Omaha Steaks, Lobster Grams and products from Mrs. Fields, among other places.

Along with the restaurant rewards, the blood drive also is slated to feature food, drinks and music. Wittrock, a drummer, said he and his friends will have "a friendly jam" session beginning at noon and sell concessions to benefit people on the list for organ donations.

Blood donations typically dry up in the summer, as high school blood drives are suspended and people leave town on vacation, so Heartland hopes Wittrock's celebration event will be a success. Jill Bernard, director of mobile recruitment for Heartland, said people who personally have benefited from blood donations often make the best recruiters for new donors.

"I think usually they're more passionate about encouraging people to donate," Bernard said about blood recipients. "They understand the need. Therefore, they seem to be able to have more success."

Bernard said Heartland especially needs type B-negative blood now.

And, although Wittrock encourages others to donate, he cannot be a donor himself. According to the Centers for Disease Control and Prevention, anyone who has ever tested positive for hepatitis C is not eligible to donate blood, even if they were never sick from the infection.

According to the CDC, hepatitis C is spread primarily by direct contact with infected human blood, for example from mother to child during birth or between intravenous drug users.

"I contracted hepatitis C somewhere along the line," Wittrock said. "It had been in my body a long time."

There will not be a shortage of Wittrocks or their relatives on hand to donate, though. Marie Wittrock said the blood drive has become a big family affair, with relatives driving in from as far away as Wisconsin and Indiana to celebrate the event.

"It's just so important to our family," she said.

To donate blood

When:

10 a.m. to 3 p.m. Sunday.

Where:

Heartland Blood Centers' mobile coach at 1600 Eagle Road, Elgin.

For an appointment:

Call Dave "Rocket" Wittrock at (224) 402-1414. Walk-ins also are welcome.

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Viral Link to Liver Cancer Found
by John C. Martin
SourceURL:http://www.hepatitisneighborhood.com

It's well known that people with hepatitis B (HBV) face a higher risk of developing liver cancer.1 Now, doctors at the MD Anderson Cancer Center claim they've found how HBV can help mediate the development of liver cancer in people with the viral infection. For people with hepatitis B, this finding paves the way for a possible treatment, either to prevent liver cancer or for people who already have the disease, the researchers point out.

"This study identified a novel mechanism for how hepatitis B primes liver cells to turn cancerous," explained the study's chief investigator Mien-Chie Hung, PhD, a professor of Molecular and Cellular Oncology at the University of Texas and MD Anderson. "And what we found has potential relevance for other cancers, as well."

Cancer Can Occur in Chronic Infection

Hepatitis B affects an estimated 73,000 people a year in the United States. Of those, 5,000 die each year from illnesses related to the infection, according to the government. In contrast, an estimated 1.25 million people are chronically infected.

HBV is caused by a virus that attacks the liver, and can cause lifelong (chronic) infection, cirrhosis of the liver, liver cancer, liver failure, and death. Symptoms range from jaundice, to fatigue, to abdominal discomfort. But sometimes, people with the disease have no symptoms. HBV infection is spread primarily through sex with an infected person, sex with multiple partners, injecting drugs, living with someone who has chronic HBV infection or contact with infected blood.2

Infection with chronic hepatitis B can lead to liver inflammation, which in turn, may lead to cirrhosis, and eventually, cancer. Hepatocellular carcinoma is the most common form of liver cancer, accounting for 80% of all such cancers.3

"Individuals who carry the hepatitis B virus have a greater than 100-fold increased relative risk of developing hepatocellular carcinoma," explained Hung. "Many researchers have been working to understand how the virus causes this cancer so that potential treatments can be designed."

Hepatitis B Deactivates a Cancer Protector

Hung and his team found that the hepatitis B virus turns off an enzyme known as GSK-3 beta, which normally suppresses tumors and blocks the spread of cancer. Other cancers like those of the breast, colon, kidney and stomach use a similar process that leads to cancer development, the researchers speculated.

Additionally, liver cancer may arise from the activation of a process that involves a protein known as beta catenin. In healthy people, beta catenin sits on the outside surface of cells, helping them stick to other, similar cells in a particular tissue. However, when the protein is found at high levels inside a cell or its nucleus, it works to turn on genes involved in the development of cancer. In this study, up to 70% of all hepatocellular carcinoma tumors had abnormal accumulations of beta catenin within its cells.

The focus of this research was to find out how HBV causes the accumulation and activation of the protein in liver cancer. The research team zeroed in on a gene for the hepatitis B virus known as the hepatitis B 'X' gene (HBX). They found that HBX shuts off the GSK-3 beta enzyme, whose normal role is to "eat away" at beta catenin. As a result, beta catenin invades cells and goes to work promoting cancer. (Another enzyme called Erk also inactivates the GSK-3 beta enzyme, the study found.)

When GSK-3 beta becomes inactive, then beta catenin activity inside cells surges, Hung explained. "This is important because beta catenin [activity] is found in many cancer types," he said.

Blocking HBV's Insidious Work

This study wasn't just about discoveries, however. The team also found a way to rein in beta catenin. They developed a super-active, abnormal form of the gene for GSK-3 beta, and added it to liver cells. The abnormal gene blocked the beta catenin protein in the cells and stopped cancer from building, they reported. "We think it may be possible in the near future to develop novel therapeutic approaches for treatment of the aforementioned cancers, including development of gene therapy and a small molecule that will activate GSK-3 beta," said Hung.

1.Brechot C. Pathogenesis of hepatitis B virus-related hepatocellular carcinoma: old and new paradigms. Gastroenterology 2004 Nov;127(5 Suppl 1):S56-61.

2. Centers for Disease Control and Prevention. Hepatitis B Frequently Asked Questions. Available at: http://www.cdc.gov/ncidod/diseases/hepatitis
/b/faqb.htm#gen. Accessed August 11, 2005.

3. American Liver Foundation. Liver Cancer. Available at: http://www.liverfoundation.org/db/articles/1093. Accessed August 11, 2005.

John Martin is a long-time health journalist and an editor for Priority Healthcare. His credits include overseeing health news coverage for the website of Fox Television's The Health Network, and articles for the New York Post and other consumer and trade publications.

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Inova Warns Patients of Sterilization Error; Risk of Infection Very Low, Hospital Says
SourceURL:http://www.leesburg2day.com
Dan Telvock

Aug 17, 2005 -- Inova Loudoun Hospital sent 144 letters last week urging patients who had colonoscopy exams asking them for free blood testing after it was discovered that hospital technicians did not properly disinfect the scopes used for the exams over a 10-day period that started July 5. The hospital stressed that the risk to patients is remote, but offered the tests free of charge as a precautionary measure.

Patients, a number of whom contacted Leesburg Today, said they had been told they could contract HIV or hepatitis as a result of the error. While authorities say tests show it was unlikely that patients were exposed to any affected material, it may be six months before the 144 people know for sure.

Hospital spokesman Tony Raker said the hospital discovered the problem July 14 during an equipment examination. He provided a written statement from the hospital dated Monday, Aug. 15 and said the actual letters sent to patients could not be released because of patient confidentiality.

“As soon as the situation was discovered, we conducted a thorough review of the situation, consulting physicians who are experts in epidemiology and microbiology,” Raker said. “We conducted tests on the equipment to determine the effectiveness of the disinfectant process that was followed. We also worked to identify all patients who may have had a procedure with a scope that was disinfected in the new cleaning equipment during the time period in question.”

Raker said the testing showed that the scopes were not contaminated with bacteria.

“The experts we consulted believe that the cleaning and disinfectant process we used would likely have killed any viruses that may have been present on the scopes.”

The statement explains that during a review of a new piece of equipment used to clean scope devices at Inova Loudoun Hospital’s Endoscopy Suite, it was discovered that hospital staff did not follow the proper cleaning procedures. Health Department Director Dr. David Goodfriend said the health department was notified immediately, even though the hospital was not required to do so.

“The scopes were scrubbed, immersed in disinfectant and rinsed with alcohol,” the statement says. “However, the new piece of equipment was programmed so that the scopes were immersed in disinfectant for one minute instead of the recommended five minutes.”

The hospital says it decided to warn patients of the error and offer free testing because it cannot rule out all risk with 100 percent certainty.

‘We want our patients to know that we are going to work with them throughout this process, keeping them informed every step of the way,” said hospital CEO Rod Huebbers, who signed the letters, in a prepared statement. “We are working directly with our patients to answer any questions or concerns that they may have.’

One man who received the letter said although he is appreciative the hospital isn’t “trying to hide anything from us,” he was angry because it took the hospital about a month to notify patients. He asked not to be identified.

The man said he got a call from the hospital and the person told him “We need you to use a condom for the next six months.”

“I said ‘pardon me, I am married. I think it is a little late now, don’t you’ and there was no response on the other end of the line,” he said.

“Here is what bothered me about the letter – they were all mailing labels, they weren’t personally handwritten envelopes, which told me oh my gosh this must be lots of people that they are running off labels,” he said. “Something like this should have never happened.”

Raker said patients should get their test results within 10 days of the blood being drawn.

“We are confident we can have test results back to them within a 10-day window – sooner if at all possible,” he said. Raker added: “The initial blood draw is to establish a baseline. A second draw in six months will determine any infection. If there is any question of infection, barrier protection is always advised.”

Goodfriend said, depending on the virus, it could take anywhere from a week to six months before it can be detected. He said the hospital may have to conduct follow up blood work because HIV can take up to six months before it turns positive.

Raker said the incident resulted in the hospital providing additional monitoring of the disinfectant equipment to “prevent another occurrence.”

“We have conducted follow-up checks of the new protocols to be sure they are adequate,” he said.

He added that he is unaware of a similar incident at any other Inova hospital. In discussions he had with experts in the field, Raker said similar events have happened at other hospitals in the nation but no patient has ever been infected.

Reviewing published reports on the Internet, it is believed that there have been two incidents in the nation in which someone contracted hepatitis through a contaminated scope; there were no reports of a patient contracting HIV in this way.

More than 15 million people undergo such procedures every year. The exam requires the use of a small camera mounted on a thin, flexible scope that can help detect the early stages of colon cancer.

As recently as May 6, a Hospital in Holland asked 19 patients to return for HIV and hepatitis tests after being treated with a dirty endoscope in Leyenburg hospital.

On April 1, about 200 patients who had colonoscopies at Forbes Regional Hospital near Pittsburgh, PA, were asked to return to the hospital for blood testing. Forbes Regional Hospital learned that the scopes were not properly cleaned over a four-month period.

In June 2004, North Shore University Hospital in Manhasset, N.Y., had a similar problem after it discovered scopes might not have been properly disinfected. That hospital notified 177 patients.

In September 2004, Kaiser Permanente in Redwood City, CA, sent letters to more than 2,000 patients who had undergone endoscopies asking them to return for blood tests to ensure they were not exposed to any viruses after it discovered incidents of faulty or inadequate cleaning of medical equipment used to screen for gastrointestinal diseases.

Lawrence Muscarella, PhD, chief of infection control for Custom Ultrasonics Inc., told Infection Control Today magazine that he wasn’t surprised last year by the number of hospitals that alerted patients to come in for blood work after colonoscopies and similar scope procedures. He could not be reached for comment.

“Basically it goes back to funding, with hospitals using untrained medical staff to reprocess endoscopes,” he told the magazine. “Endoscopes are somewhat unique in the extent to which they can transmit disease to many patients in a short period of time”due to their use and their high cost. It’s an issue of funding.”

The Technology Committee of the American Society for Gastrointestinal Endoscopy estimates that the chance that a serious infection could be transmitted by endoscopy – similar to colonoscopies – is only 1 in 1.8 million. That report stated that from 1966 to 2002, 317 incidents of pathogen transmission were attributed to endoscopy.

The myriad of opinions on this issue doesn’t clearly reveal if cleansing scopes in hospitals is a much larger problem.

Dr. Robert Lafsky, a gastroenterologist who operates at Loudoun Hospital, said the chance that patients contracted viruses from the equipment that wasn't sterilized according to directions, is very rare. However, the hospital’s follow-up testing though may not be able to determine when someone contracted the virus, Lafsky said.

"It's very unlikely that anyone actually had this transmitted by their procedure," he said. "One of the problems here, if you take a large number of people and test them for these viruses, you're going to find some who didn't realize they had it already."

The HIV virus causes the most anxiety, Lafsky said, but it would be more likely that Hepatitis could be transmitted, although that risk is rare as well, he added.

"The [viruses] that are the most likely things are harmless to normal people. Bacteria that are harmless are the hardest things to eradicate in the process," he said.

Infectious Disease Dr. Antonio Pastor, like Lafsky, said the incident is extremely rare.

“All the appropriate measures have been taking by the hospital and the director of infectious control,” he said. “This is a very rare occurrence. I don’t know of any case of anybody picking up a viral infection from this type of instrumentation.”

Pastor said the most important issue is to make sure any patient who had this exam be offered a free blood test.

"The main thing here is the hospital identified a problem and has taken appropriate steps to resolve the problem and offer the testing to the exposed patients and explain to them exactly what is going on,” he said. “We’re a community hospital and we work very hard to do our best for our patients."”

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Docs Reveal Possible Therapy for HCV Fatigue
by John C. Martin
SourceURL:http://www.hepatitisneighborhood.com

A small study from France suggests that a drug prescribed for people with chronic fatigue syndrome may also help patients who have chronic fatigue related to hepatitis C infection.1 The drug, marketed as Zofran (ondansetron), falls in a class of medications known as serotonin receptor antagonists.

How is the Drug Currently Used?

Zofran, available in either oral form or as an injectable, is mainly prescribed to ease nausea and vomiting associated with chemotherapy. It was approved for this indication in 1991. Previous to that, it was believed that chemotherapy-related nausea and vomiting was unpredictable and unavoidable.2

The drug is also prescribed to reduce nausea and vomiting related to certain outpatient surgeries. These side effects are among the most common causes of unplanned hospital admission after outpatient surgery, affecting as many as 80 percent of patients.3

Zofran Versus SSRIs for Chronic Fatigue

People with a condition known as chronic fatigue syndrome, characterized by never-ending tiredness, may be prescribed medications known as selective serotonin reuptake inhibitors (SSRIs), which help treat the depression associated with this condition.4 These drugs work by boosting levels of a neurotransmitter in the brain known as serotonin. Serotonin helps neurons transmit impulses to each other in the brain, which in turn, improves mood, and has helped ease the fatigue associated with depression.5

Still, some medical researchers have tested Zofran and similar serotonin receptor antagonists, as a therapy for chronic fatigue syndrome, as well, which work in the opposite way as SSRIs by blocking the activity of serotonin in the central nervous system.6,7 Experts suggest that serotonin plays a key role in chronic fatigue.8

A 'Disabling' Hepatitis Symptom

In the wake of positive research testing drugs in the same class as Zofran for chronic fatigue,6 doctors at Hopital Archet in Nice, France enrolled 18 patients in their study to see if the drug would work for hepatitis C-related fatigue. Fatigue associated with the disease is not only common, but "disabling", the researchers pointed out.9 "Considering the high prevalence of fatigue, thus constituting a considerable burden for the health care system the development of effective therapies for its relief may be important goals for research in Hepatogastroenterology," they wrote.

This persistent fatigue, they write, is not only the most common symptom in primary care, but renders people who have it unable to perform daily routines, significantly reducing their quality of life. But, one of the main roadblocks to finding an effective therapy is the fact that relatively little is known about its origins, the researchers stress.

Testing Zofran Versus No Treatment

The French research team launched this small clinical trial in hopes of finding more answers. Each patient who enrolled was assigned at random to a group receiving 4 mg of Zofran twice each day, or a group receiving a placebo, an intervention used as a comparison in clinical trials that have no therapeutic effectiveness. Nearly all the patients considered fatigue their most significant symptom of the disease, and nearly two-thirds considered it their worst, the researchers noted. Neither the patients nor the clinicians in the study knew who was taking Zofran, and who was not, to eliminate any possible bias. One potential side effect of the medication is constipation, but patients were treated using a laxative, if necessary.

The trial lasted four weeks. During that time, levels of fatigue and depression were measured regularly using questionnaires completed by each patient. After one month of treatment, the patients then underwent observation four weeks afterwards.

Promising Findings

The investigators found that, based on the patients' questionnaires, fatigue was reduced by nearly a third in the group given Zofran compared to the patients taking a placebo. Those in the latter group saw their fatigue diminish, but no more than 30% for the entire study. At the follow-up 60 days after the study began, the patients in the placebo group reported their fatigue had dropped less than 6%, on average. In contrast, during this same follow-up, fatigue was reduced by about 31% in the treatment group, the French research team reported.

"Overall, the reduction in fatigue was significantly higher with ondansetron compared with placebo for the whole follow-up period or the treatment period only," the study team wrote. "Ondansetron also significantly reduced depression scores." By the time patients were examined one month after the study ended, depression had eased by nearly 42%, on average, in the group given Zofran, compared to just a 5.8% decline in the group that had received a placebo.

Despite about 38 percent of the patients experiencing constipation as a treatment side effect, the researchers concluded that Zofran provided "a positive effect", while stressing that larger trials of the drug should be performed.

Still Few Answers, but Therapy Appears Promising

In a commentary on the trial,10 Dr. Nicholas Barnes, a neuropharmacologist at the University of Birmingham in the UK, wrote that there are still many elusive answers about the nature and origins of chronic fatigue. "Despite a high prevalence with massive socioeconomic implications, fatigue per se, or as a symptom of a diagnosed condition, remains poorly understood," Barnes wrote. Further, since fatigue is a key symptom in people with clinical depression, "it would be pertinent" to determine whether medications like Zofran can ease both depression and the fatigue associated with it, he added.

In concurring with the French researchers who published this study, Barnes stresses that growing evidence of the benefit of serotonin receptor antagonists for chronic fatigue "requires support from large multicenter trials."

1. Piche T, Vanbiervliet G, Cherikh F et al. Effect of ondansetron, a 5-HT3 receptor antagonist, on fatigue in chronic hepatitis C: a randomized, double blind, placebo controlled study. Gut 2005 Aug;54(8):1169-73.

2. GlaxoSmithKline. Zofran can help you and your healthcare professional prevent nausea and vomiting. Available at: http://www.zofran.com. Accessed August 11, 2005.

3. GlaxoSmithKline. Nausea and vomiting caused by surgery are very common. Available at: http://www.zofran.com/surgery/surgerymain.html. Accessed August 11, 2005.

4. Mayo Foundation for Medical Education and Research. Chronic Fatigue Syndrome. Available at: http://www.mayoclinic.com/invoke.cfm?objectid
=A026FC79-096B-4920-AA54503DE4B22308&dsection=8. Accessed: August 11, 2005.

5. Mayo Foundation for Medical Education and Research. Selective serotonin reuptake inhibitors (SSRIs). Available at: http://www.mayoclinic.com/invoke.cfm?id
=MH00066. Accessed August 11, 2005.

6. The GK, Prins J, Bleijenberg G, van der Meer JW. The effect of granisetron, a 5-HT3 receptor antagonist, in the treatment of chronic fatigue syndrome patients - a pilot study. Neth J Med 2003 Sep;61(9):285-9.

7. National Cancer Institute. Nausea and Vomiting. Treatment of Acute/Delayed Emesis. Available at: http://www.nci.nih.gov/cancertopics/pdq
/supportivecare/ nausea/HealthProfessional/page6. Accessed August 17, 2005.

8. Sharpe M, Hawton K, Clements A, Cowen PJ. Increased brain serotonin function in men with chronic fatigue syndrome. BMJ 1997 Jul 19;315(7101):164-5.

9. Piche T, Huet PM, Tran A. Treatment of fatigue in Gastroenterology: fact or fiction? Gastroenterol Clin Biol 2005 May;29(5):561-3.

10. Barnes NM. 5-HT3 receptor antagonists ameliorate fatigue: so much potential, so little knowledge! Gut 2005 Aug;54(8):1056-7.

John Martin is a long-time health journalist and an editor for Priority Healthcare. His credits include overseeing health news coverage for the website of Fox Television's The Health Network, and articles for the New York Post and other consumer and trade publications

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August 18th, 2005


Weight Loss with Drug Treatment of Chronic Hep C
SourceURL:http://www.gastrohep.com

Patients experience weight loss during interferon with ribavirin therapy, and those with greater weight losses during therapy do not benefit from improved antiviral response, reports the most recent Journal of Viral Hepatitis.

Treatment of Hepatitis C virus infection with interferon-alpha, as monotherapy or in combination with ribavirin, is associated with side-effects including weight loss.

Dr Mutimer and colleagues from England described the evolution of body weight during combination antiviral treatment.

The researchers examined the possible determinants of weight loss.

The research team conducted the retrospective analysis of 126 patients.

Median weight values at 24 weeks were 94 vs 91 at 48 weeks - Journal of Viral Hepatitis

The patients received combination therapy of pegylated interferon-alpha-2b and ribavirin at our unit.

The team recorded body weight at each outpatient attendance during treatment and follow-up, and was expressed as a percentage of baseline value.

The researchers observed a decline of body weight during treatment.

The median weight values expressed as percentage of baseline weight at 4, and 12 weeks, were 98 and 95.

The team noted that the median weight values at 24, and 48 weeks were 94 and 91 respectively.

There was no significant association of increased weight loss with age, gender, pretreatment weight, ethnicity, or pretreatment histological stage.

The research team found no association of weight loss with cumulative interferon dose adjusted for body weight, Hepatitis C genotype or treatment outcome.

Median body weight returned to baseline within 6 months of stopping treatment.

Dr Mutimer's team concludes, "Patients experience significant weight loss during combination therapy."

"Those experiencing greater weight losses during therapy did not benefit from improved antiviral response."

J Viral Hepat 2005: 12(5): 531

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Anadys Hits $10 million Novartis Milestone
SourceURL:http://news.yahoo.com

San Diego-based Anadys Pharmaceuticals Inc. (Nasdaq: ANDS, News) announced Thursday that the Food and Drug Administration has accepted its investigational new drug application. The acceptance will trigger a $10 million milestone payment from Novartis.

The payment follows on the heels of the biotech firm's announcement of a $71.3 million public offering of 5.75 million shares on Aug. 11. On Aug. 2, Anadys announced a 6-month loss of $15.4 million.

The application is to evaluate its lead compound, ANA975, in the United States. Anadys has a joint development and commercialization collaboration with Novartis for ANA975, an oral Toll-Like Receptor 7 (TLR7) agonist.

"This is an important milestone for ANA975 and for our Toll-Like Receptor Programs," said Kleanthis G. Xanthopoulos, Ph.D., Anadys' president and CEO, in a statement.

Pretty much it is in line with what we have announced in the past, said Xanthopoulos. It could be worth up to 570 million. It makes sense in terms of our strategy. This is essentially an approval to start the clinical trials. We are still several years from producing a product.

On June 2, Anadys announced that it had entered into a global license and co-development agreement with Novartis for the development and potential commercialization of ANA975 and potentially additional Toll-Like Receptor 7 (TLR7) oral prodrugs for chronic HCV and HBV infections, as well as other potential infectious disease indications. Under the collaboration, Anadys is eligible to receive up to a total of $570 million in upfront and milestone payments from Novartis based on the successful development and commercialization of ANA975, including a $20 million upfront payment received in July and the $10 million milestone payment for the IND.

ANA975 is an oral prodrug of isatoribine, a small molecule TLR7 agonist that has been administered intravenously to 68 subjects in clinical trials. Results from a clinical trial in HCV-infected patients receiving intravenous isatoribine over a one week period indicated that isatoribine treatment resulted in an average decrease in plasma viral load of the hepatitis C virus of 0.76 log10 units, or 83 percent, after the one week of treatment.

Data from a recently completed Phase 1 clinical trial of ANA975 in 36 subjects indicate that the bioavailability of ANA975 is virtually complete and conversion to isatoribine in plasma is rapid and efficient, delivering levels of isatoribine that have been shown to be clinically relevant.

The Phase 1 clinical trial was conducted in the United Kingdom under a Clinical Trial Application filed with the Medicines and Healthcare products Regulatory Agency. Under the IND, Anadys plans to initiate a Phase 1 clinical trial in the United States.

ANDS shares were up 8 cents, or .65 percent, to $12.35 in midday trading.

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August 19th, 2005


Vertex Stock Soars on Upgrade
SourceURL:http://money.cnn.com
By Aaron Smith, CNN/Money staff writer

J.P. Morgan's 'outperform' rating sends Vertex stock up 17 percent.

NEW YORK (CNN/Money) - The stock price for Vertex Pharmaceuticals surged following an upgrade from J.P. Morgan on Friday, as the small drug maker moves ahead with testing on an experimental treatment for hepatitis C.

Vertex (up $2.43 to $18.80, Research) stock surged about 17 percent Friday on J.P. Morgan's upgrade to "outperform."

"Vertex is hot," said Andrew McDonald, analyst for ThinkEquity who initiated his coverage of the company with a "buy" rating on Aug. 10.

McDonald said he gave the company a favorable rating and a 52-week price target of $29 based "almost entirely on the prospects for VX-950."

"There's no question this is a potential blockbuster," said McDonald.

Vertex completed phase 1, the initial stage of testing, on VX-950, the experimental hepatitis C drug, and plans to begin phase 2, a wider stage of testing in humans, by the end of the year, said Vertex spokesman Zachry Barber.

Vertex CEO Joshua Boger said his company released "break-through" data on VX-950 in May, showing that during a two-week period the experimental drug lowered the presence of the virus in the blood by 25,000.

"It's an unprecedented result," said Boger. "Nothing else has been reported anywhere near this dramatic.

VX-950 is being tested as a protease inhibitor that kills proteins that allow viruses to reproduce.

If VX-950 successfully completes clinical trials and is approved by the Food and Drug Administration, McDonald projects the drug could reach sales of $700 million in 2010.

Schering-Plough is testing a hepatitis C treatment that could be a future competitor for VX-950. McDonald projects that Schering's (down $0.19 to $20.89, Research) hepatitis C product, if approved, would reach $1.6 billion in sales by 2010.

Based in Cambridge, Mass., Vertex is a relatively tiny drug maker with $32 million in second-quarter sales. The revenues come from two treatments for the HIV virus that the company is distributing with GlaxoSmithKline (down $0.08 to $48.21, Research).

McDonald does not own stock in the companies and ThinkEquity does not do business with them.

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Tarvacin(TM) Phase I Hepatitis C Virus Trial, Peregrine Pharmaceuticals
SourceURL:http://www.medicalnewstoday.com

Peregrine Pharmaceuticals, Inc. (Nasdaq: PPHM), announced today the initiation of a phase I anti-viral study of Tarvacin(TM), the Company's first Anti-Phospholipid Therapy candidate. The phase I study is an open-label, dose-escalation study in up to 32 adult patients with chronic hepatitis C virus (HCV) infection who either no longer respond to or failed standard therapy with pegylated interferon and ribavirin combination therapy.

The objectives of the trial are to evaluate safety, pharmacokinetics and viral load following a single intravenous infusion. The study is being conducted at Bach and Godofsky Infectious Diseases, the largest private infectious disease practice specializing in the treatment of viral hepatitis in the United States. Bach & Godofsky is located in Bradenton, FL.

"Tarvacin(TM) is truly a novel approach to treating HCV and we are eager to offer patients the opportunity to participate in this trial," stated Eliot W. Godofsky, M.D., Principal Investigator and clinical assistant professor of medicine at the University of South Florida in Tampa.

"This study is an important step for our Tarvacin(TM) antiviral program," said Joseph Shan, Peregrine's senior director of clinical and regulatory affairs. "Meanwhile, we are continuing our Tarvacin(TM) development efforts for other viral diseases."

About Peregrine Pharmaceuticals

Peregrine Pharmaceuticals, Inc. is a biopharmaceutical company with a broad portfolio of products under development directed towards the treatment of cancer, viruses and other diseases. The company has opened patient enrollment in two separate clinical trials using Tarvacin(TM) for the treatment of solid cancers and for the treatment of Hepatitis C virus infection. In addition, Peregrine is in the process of initiating patient enrollment in a Cotara(R) clinical trial for the treatment of brain cancer. Peregrine Pharmaceuticals is also developing Vascular Targeting Agents, Anti-Angiogenesis, and Vasopermeation Enhancement Agents (VEAs) for the treatment of cancer and other diseases.

Peregrine Pharmaceuticals also has in-house expertise to develop and manufacture antibodies and recombinant proteins through its wholly-owned subsidiary, Avid Bioservices, Inc., (http://www.avidbio.com). Avid is engaged in providing contract manufacturing services and development of biologics for biopharmaceutical and biotechnology companies, including Peregrine.

Copies of Peregrine Pharmaceuticals press releases, SEC filings, current price quotes and other valuable information for investors may be found at http://www.peregrineinc.com. Statements in this press release which are not purely historical, including statements regarding Peregrine Pharmaceutical's intentions, hopes, beliefs, expectations, representations, projections, plans or predictions of the future are forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. The forward-looking statements involve risks and uncertainties including, but not limited to, uncertainties like our ability to obtain, protect and enforce commercially valuable patents. It is important to note that the company's actual results could differ materially from those in any such forward-looking statements. Factors that could cause actual results to differ materially include, but are not limited to, the timing to enroll patients in this clinical study or any study the Company is conducting and the uncertainty of clinical trial results in this study or any clinical study. Our business could be affected by all of the foregoing and a number of other factors, including the risk factors listed from time to time in the Company's SEC reports including, but not limited to, the annual report on Form 10-K for the year ended April 30, 2005. The Company cautions investors not to place undue reliance on the forward looking statements contained in this press release. Peregrine Pharmaceuticals, Inc. disclaims any obligation, and does not undertake, to update or revise any forward-looking statements in this press release.

Investor Inquiries

Krista Mallory
Direct of Investor Relations Edelman
714-508-6000
info@peregrineinc.com
http://www.peregrineinc.com

Media Inquiries

Rachel Martin
(323) 202-1031 / (323) 893-9047
Rachel.Martin@edelman.com
http://www.edelman.com

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August 20th, 2005


Nurse Shares Story of Hepatitis C, the 'Silent Epidemic'
http://www.ksdk.com/news/
By Kay Quinn
Healthbeat Reporter

KSDK-A former nurse is sharing the story of her battle with Hepatitis C in the hopes of lowering the stigma attached to the disease.

Kathie Bryson is one of an estimated five million people in this country with the liver disease Hepatitis C, a viral illness five times more common than HIV-AIDS. It's called a silent epidemic because so many people have it and don't know it. Bryson hopes by breaking the silence, more people at high risk will get tested.

"It's like AIDS was in the 80's. People have the belief that if you got it, well somehow you deserved it," says Bryson.

This former nurses' story isn't unusual. Hepatitis C is considered an occupational hazard in the health care field, and Bryson got the disease from a needle stick. What is unusual is that her first symptom of the disease was not a gradual scarring of the liver as is typical, but liver cancer.

"Maybe that's the deal. Maybe that's what God intended to do. To give me this and try to get people to wake up and and look at it," she says.

"In my practice, 90 per cent of people don't have excess alcohol as a cause of their liver disease and a good large percentage of the people who have Hepatitis C have it unrelated to needle use," explains Dr. Bruce Bacon, a liver specialist at St. Louis University School of Medicine who helped cure country western star Naomi Judd of hepatitis C.

The treatment protocol uses two antiviral drugs, medicines that can cure 60 percent of patients.

He recommends the following people be screened for the disease: health care workers, anyone who recieved a blood transfusion or organ transplant before July of 1992, injected illegal drugs at any time in the past, used inhaled drugs like cocaine, has piercings or tattoos, or is overly promiscuous, although the risk of sexual transmission is low.

Bryson is undergoing treatment for her cancer. She says knowing you have Hepatitis C is key to surviving the disease. "If people don't stop the silence and don't start talking about it, more people are going to die and I don't think we should die of something doctors have a good cure rate for."

To help raise awareness about Hepatitis C, St. Louis University, and St. Louis University Hospital are sponsoring a two-evening gala, dubbed "Denim & Diamonds." On September 12, Willie Nelson will perform in a sold-out concert at the Pageant. Country singer Naomi Judd will speak at a black-tie event on September 13. Proceeds from both events go to the St. Louis University Liver Center.