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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 2nd, 2005

Alan Franciscus
Editor-in-Chief

To download pdf version click here


This Issue:

• Living Life as a Gift

• NEW JERSEY: "Court Order Stops New Jersey Needle Exchange Programs"

• SciClone Announces Zadaxin Hepatitis C Triple Therapy Poster Presentation

• State Eliminates Funds to Treat Hepatitis in Prisons

• Rudolph Coenen Works Tirelessly to Raise Awareness for Organ Donation

• New Hepatitis B Law Lacks Teeth

• From the Red Cross, An Apology

• Study Shows 12 Weeks of Peginterferon Alfa-2b and Ribavirin Combination Therapy as Effective as 24 Weeks in Certain Hepatitis C Patients with Genotype 2 or 3 Virus

• Nabi Biopharmaceuticals Gains Orphan Medicinal Product Designation for Civacir(TM) in Europe

• Peregrine Pharmaceuticals Presents Data Supporting Broad Spectrum Anti-Viral Potential of Tarvacin(TM) at BIO 2005

• The Death of a Soldier

• Dynavax Initiates Pivotal Phase 3 Trial for Hepatitis B Vaccine

• Hepatitis C Case 'Likely' Work Related

• Hepatitis C: Hope on the Distant Horizon

June 19th, 2005

Living Life as a Gift
SourceURL:http://www.desertdispatch.com
By JAMES CRISWELL/Staff Writer

Illness shines new light onto Fathers Day for Hesperia family

For David Viayra and his children Kyle, Kia and Kaleb, Fathers Day holds a particularly special place in their hearts.

Because of a disease that looms over David's life, they're never sure when it might be his last.

Ten years ago, he first got sick and went into the hospital. There he was given the information that would change his life forever -- his liver was being destroyed by the Hepatitis C virus.

Doctors told him the cirrhosis had taken over 70 percent of his liver.

"We were shocked," said David's wife Tina Viayra. "We were always active and exercising. We never expected anything like that."

Doctors described the disease as in its advanced stages, and that he'd likely had it for 20 years and had probably contracted it in a blood transfusion he had received.

"Now each day is special," said 54-year-old David Viayra.

But it hasn't always been that way.

"I was very bitter at first," Viayra said. "I blamed everyone but myself. I blamed my wife, my children, my in-laws, but not me."

He told his wife that he wanted to leave, that the family would be better off without him. But they endured, battling to love him even as he tried to isolate himself and push them away.

"We just kept trying to tell him: You don't have to do this alone. We won't let you," Tina Viayra said.

Somehow, the family grew stronger -- and so did Viayra.

He has outlived the early expectations of doctors, but he says his health's improvement is bittersweet. Improvement moves him down the list for a liver transplant.

So together, David and Tina make the most of every day they have as a family.

The couple coach their children's sports including Kia's volleyball.

"He loves it, but it will just wipe him out," Tina Viayra said.

Their big plans for Father's Day -- to simply to spend it together, sharing in smiles and laughter to create memories that will last them a lifetime.

"I just try to live every day like it's a gift," Viayra said.

James Criswell may be reached at 951-6242 or jcriswell@vvdailypress.com.

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June 20th, 2005

NEW JERSEY: "Court Order Stops New Jersey Needle Exchange Programs"
Associated Press:
Angela Delli Santi

New Jersey's first needle-exchange programs, set to begin July 1 in Camden and Atlantic City, were halted by an appeals court pending arguments about their legality. The temporary injunction, issued by the Mercer County Superior Court Appellate Division on Thursday but not made public until Monday, stays an executive order issued last October by outgoing Gov. James E. McGreevey that permitted up to three cities to establish experimental needle-exchange programs.

"It's definitely a setback," said Roseanne Scotti, director of the Drug Policy Alliance of New Jersey. "Now we are in the situation where at least two people a day will get infected from sharing dirty needles."

For years, advocates have pushed for New Jersey to create needle exchanges for IV drug users, arguing that such access helps control the spread of blood-borne diseases like HIV. But efforts to legalize exchanges in the state have died in the Legislature, where some equate the programs to condoning illegal drug use.

Led by Sen. Tom Kean Jr. (R-Union), seven lawmakers challenged McGreevey's order declaring a public health emergency and allowing the programs, which would be monitored by the state Health Department. Kean said McGreevey "overstepped the bounds of his office" in issuing the order and accused the former governor of trying an "end run around the Senate" after failing to get the needle-exchange bill passed.

The Attorney General's office, which argued the case for the state, is "reviewing the court's order and considering our appellate options," said office spokesperson Lee Moore.

Scotti said the injunction is a "tragedy" for the two communities. "Both these cities have support from the grass roots to the top. We're not forcing anyone to do these needle exchanges. Now these communities have someone from the outside saying, 'No, we're not going to let you save lives in your city.'"

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June 21st, 2005

SciClone Announces Zadaxin Hepatitis C Triple Therapy Poster Presentation
SourceURL:http://www.marketwire.com

SAN MATEO, CA -- (MARKET WIRE) -- 06/21/2005 -- SciClone Pharmaceuticals, Inc. (NASDAQ: SCLN) today announced the poster presentation of additional data evaluating its lead product candidate ZADAXIN® (thymosin alpha 1), in combination with pegylated interferon alpha and ribavirin, as a potential treatment for the hepatitis C virus (HCV) at the Congress of the Mexican Association of Hepatology annual conference. Data reported in this presentation includes a full 72-week analysis of 30 HCV non-responder patients enrolled in this pilot trial and builds on the results reported on 25 of these patients in November 2004 at the American Association for the Study of Liver Disease (AASLD).

Of the thirty patients evaluated at week 72, at which point patients have completed 48 weeks of triple therapy of ZADAXIN, pegylated interferon alpha and low-dose ribavirin and 24 weeks of follow-up observation, 20% (6/30) achieved a sustained viral response (SVR). SVR is defined as the absence of HCV RNA in the bloodstream, measured by PCR test, at 72 weeks. Of the twenty six patients in this group infected with the difficult-to-treat genotype 1 strain of HCV, 23% (6/26) achieved an SVR. By comparison, a separate, unrelated trial reported only 9% of genotype 1 patients achieved SVR after retreatment with pegylated interferon alpha and a similar dose of ribavirin.

"We are pleased to report that the response rate observed in this additional data is consistent with the response we previously reported from the 25 patient cohort in this small pilot trial. While these data are encouraging, data from the large, ongoing phase 3 triple therapy clinical trial, being conducted by our European partner Sigma-Tau, should be more predictive of ZADAXIN's use as part of triple therapy," said Ira D. Lawrence, M.D., President and Chief Executive Officer of SciClone Pharmaceuticals, Inc. "Importantly, we look forward to reporting results in the early part of 2006 from our U.S. phase 3 HCV trials using ZADAXIN in combination with pegylated interferon alpha, currently considered to be the cornerstone of therapy."

All patients enrolled in this pilot trial were non-responders to prior HCV therapy and are Hispanic, a population that is suggested to be less likely to respond to therapy independent of genotype. In addition, most of the patients enrolled were infected with the genotype 1, widely considered to be the most difficult-to-treat strain of HCV in the general population. Genotype 1 infected carriers account for 70% of the 2.7 million chronic carriers of HCV in the United States.

About the Triple Therapy Pilot Trial

The triple therapy pilot trial evaluating ZADAXIN in combination with pegylated interferon alpha and low-dose ribavirin is being conducted by a team led by Dr. Jorge L. Poo, Chief Scientific Officer of CIF-Biotech at the Medica Sur Hospital in Mexico City. This trial is being funded by Laboratorios Columbia, SciClone's licensee in Mexico, a market where ZADAXIN is approved for the treatment of HCV. The following table summarizes the response rates at the end of the follow-up observation period:

Summary of Results
Week 72(1)
SVR

(1) HCV RNA negative by PCR test

Using an intent-to-treat analysis, 20% (6/30) of all patients and 23% (6/26) of the genotype 1 patients achieved an SVR. Using a per protocol analysis, which excludes the 2 patients who dropped therapy by week 24 due to adverse side effects from pegylated interferon, 21% (6/28) of all patients and 25% (6/24) of genotype 1 patients achieved an SVR. All of the patients who achieved an SVR were infected with genotype 1 and had failed previous combination therapy of interferon plus ribavirin.

This small, open label, single-arm pilot trial enrolled 40 patients infected with HCV, none of whom had responded to previous treatment with standard therapy. All patients are Hispanic, 39 were non-responders to prior therapy of interferon plus ribavirin and the other non-responder had previously been treated with interferon alone. Thirty patients have completed the treatment and follow-up period, eight have completed the treatment but not the follow-up period, and an additional two patients are still undergoing treatment.

Patients received 48 weeks of therapy of a standard dose of ZADAXIN (1.6 mg/twice-weekly), a standard dose of pegylated interferon alfa-2a (180 mcg/week), and a low dose of weight-based ribavirin (800 - 1,000 mg/day). At the end of 48 weeks of therapy, patients were observed for 24 weeks to determine SVR at week 72, the trial endpoint. During the course of therapy, 24% (9/38) of patients required a dose reduction of pegylated interferon, 18% (7/38) required a dose reduction of ribavirin and none required a dose reduction of ZADAXIN. As in all previous ZADAXIN studies, the safety profile was excellent without any reports of significant ZADAXIN related side effects or toxicities.

About SciClone's Ongoing Hepatitis C Trials

Non-responders to previous hepatitis C therapy are the subjects of SciClone's two U.S. phase 3 clinical trials for ZADAXIN in combination therapy with pegylated interferon. These trials enrolled over 1,000 patients and SciClone expects to report data in the early part of 2006. As previously announced, SciClone's European partner Sigma-Tau is enrolling non-responders in a 550-patient phase 3 HCV triple therapy trial using the current standard dose of ribavirin (1,000 - 1,200 mg/day), which is about 20% higher than the dose of ribavirin used in this pilot trial. SciClone's objective for the European trial is to generate data on ZADAXIN's use as part of a triple therapy combination for hepatitis C patients.

About SciClone

SciClone Pharmaceuticals is a biopharmaceutical company engaged in the development of therapeutics to treat life-threatening diseases. SciClone's lead product ZADAXIN is currently being evaluated in two phase 3 hepatitis C clinical trials in the United States and one phase 3 hepatitis C trial in Europe. ZADAXIN is also being evaluated in other late-stage clinical trials for the treatment of hepatitis B and certain cancers. The company's other drug development candidate is SCV-07, a potential IND candidate that is currently being evaluated in pre-clinical studies for the treatment of viral and other infectious diseases. For more information about SciClone, visit www.sciclone.com.

The information in this press release contains forward-looking statements including our expectations and beliefs regarding the progress of the triple therapy hepatitis C clinical trial and other clinical trials, and the fact that the experimental or clinical data described may imply certain actual results in larger patient populations. Words such as "expects," "plans," "believe," "may," "will," "anticipated," "intended" and variations of these words or similar expressions are intended to identify forward-looking statements. In addition, any statements that refer to expectations, projections or other characterizations of future events or circumstances, including any underlying assumptions, are forward-looking statements. These statements are not guarantees of future performance and are subject to risks, uncertainties and assumptions that are difficult to predict. Therefore, our actual results could differ materially and adversely from those expressed in any forward-looking statements as a result of various factors, including the fact that experimental data and clinical results derived from studies with a limited group of patients may not be predictive of the results of larger studies, interim data may not be predictive of clinical trial results, the progress or failure of the triple therapy hepatitis C clinical trial and other clinical trials, competition for enrollment of patients meeting a particular patient profile, maintenance of the sufficiency and eligibility of the enrolled patient population and unexpected adverse results to patients, as well as other risks and uncertainties described in SciClone's filings with the Securities and Exchange Commission.

Corporate contact:

Becky Horner
Investor Relations
SciClone Pharmaceuticals, Inc.
650-358-3437

SOURCE: SciClone Pharmaceuticals, Inc.

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June 22nd, 2005

State Eliminates Funds to Treat Hepatitis in Prisons
SourceURL:http://www.lansingstatejournal.com
By Stacey Range
Lansing State Journal

A hepatitis C testing and treatment program for Michigan prisoners that began last year has been eliminated in the 2005-06 state budget.

Spending plans passed by both chambers of the Legislature cut $1.15 million in funding to test and treat prisoners with the potentially fatal liver disease.

Democratic efforts to restore the money failed.

Mel Grieshaber, executive director of the Michigan Corrections Organization, which represents prison officers, criticized the funding cut.

"Hepatitis C is such a tremendous problem in our prisons," he said. "We can't ignore it and keep people safe."

The 2004-05 corrections budget included $1.2 million to start the program aimed at eradicating the disease festering inside Michigan's 42 prisons.

Gov. Jennifer Granholm pushed for the program after a 2003 Lansing State Journal investigative report found that up to 18,000 of Michigan's 48,000 prisoners are believed to harbor the deadly virus. About 55 were being treated.

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Rudolph Coenen Works Tirelessly to Raise Awareness for Organ Donation
SourceURL:http://www.nctimes.com/
By: DEIRDRE NEWMAN - Staff Writer

TEMECULA -- Rudolph Coenen is not one to sit around and wait.

While hepatitis C has ravaged his body and sapped his energy, it hasn't deterred Coenen from his crusade.

As he waits for a liver transplant, the Temecula resident cruises around Southern California in a donated recreational vehicle spreading awareness about an organization he created to promote organ donation -- A Gift of Life.

The RV was donated in April. Since then, Coenen has been traveling to health fairs around Southern California to let people know about Donate Life California Registry, a Web site that started in April. Since Coenen has been on his mission, he has signed up about 4,500 people for the registry, he said recently.

"Your body is just a vessel and if you can give life at the time of death, that's the noblest thing you can do," he said.

His plight and his tireless promotion of organ donation recently earned him attention on two fronts, including one that could save his life. One is from the Pechanga Band of Luiseno Indians, which signed on as a corporate sponsor to his organization, Coenen said.

The other is from Transplant Recipients International Organization, a Washington DC-based nonprofit agency that works to enhance the quality of life of transplant candidates, recipients, their families and the families of organ and tissue donors.

The president of the Transplant Recipient chapter in Ventura County, Ron Taubman, was impressed with Coenen's passion in promoting organ donation, Coenen's wife, Maribel, said.

Taubman connected Rudolph Coenen with the director of transplants at the Mayo Clinic in Florida, Jeffrey Steers. Coenen said Steers told him the wait for a liver in Florida for someone in Coenen's medical state was less than two months. He said Steers thought it would be to Coenen's advantage to come to Florida in the hopes of getting a liver.

In California, it could take 1 1/2 years for Coenen to get a liver transplant, Maribel Coenen said. Taubman said the difference is because demand in Florida is considered less than in California.

"There are more livers, more hearts, more lungs, more everything (in Florida)," Taubman said.

The family, which includes four daughters and two dogs, will be heading to Florida any day now. They anticipate staying there until a match is found, Coenen said.

Rudolph Coenen, 40, was diagnosed with hepatitis C in October and learned he was in need of a liver transplant. After a slew of tests, he went on a waiting list in the middle of February. He is now in the final stage of liver disease; the next level is being in a critical coma, he said.

The stage he is in now is the optimal one for a liver transplant because the hepatitis C has done its damage and is not in his body any longer. Thus, the disease wouldn't infect a transplanted liver, he said. He may also need to get his kidney and spleen removed, he said.

The Pechanga tribe will be paying for the family's travel to Florida and for other expenses, public relations manager Ciara Coyle said. It is also trying to set up lodging for the family with members of an Indian tribe in Florida, Coyle said.

The tribe is inundated for requests for contributions, but this one struck a chord, said Patrick Murphy, president of Pechanga Development Corp., in a release issued Monday.

"He is a father, a veteran and a member of our community and we're glad that we could help Rudy in this way," Murphy said in the release. "Our thoughts and prayers are with him and his family."

All this support has touched the Coenens and affirmed their faith in humanity, Maribel Coenen said.

"It's really hard to go through something like this; your whole life changes," she said. "But whoever's going through the same thing or something similar, they should have a lot of hope in humanity, because there's still good people that are willing to help if you knock on their door and ask."

Her husband remains optimistic that he will find a match and continue his quest of spreading awareness to the masses.

"I truly believe the Lord has given me an opportunity to make a change in society and I believe I'm going to come back with a new liver and healthier kidney and my spleen in place, and I'm going to explode like a nova and really make a positive change on the West Coast," he said. "The change is very important."

Contact staff writer Deirdre Newman at (951) 676-4315, Ext. 2623, or dnewman@californian.com.

GIFT OF LIFE

For more information on A Gift of Life, the organization founded by Rudolph Coenen to promote organ donation awareness, call (951) 775-5790 or e-mail rcoenen@adelphia.net. Register to be a donor through Donate Life California Organ and Tissue Donor Registry at www.donatelifecalifornia.org or, in Spanish, at www.donevidacalifornia.org.

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New Hepatitis B Law Lacks Teeth
SourceURL:http://www.southbendtribune.com
By DAVID RUMBACH
Tribune Staff Writer

The hepatitis B virus can cause serious liver disease and even death for those who develop chronic infections.

But the consequences for ignoring a new Indiana law "requiring'' hepatitis B shots for incoming high school freshmen and seniors are not nearly so dire.

The new law, which goes into effect this summer, says schools cannot prevent freshmen or seniors from enrolling in school, attending school or graduating from school just because they're not vaccinated against hepatitis B.

By contrast, schools are allowed to suspend students entering kindergarten and first grade for not having the hepatitis B vaccination and other shots.

"There's nothing the schools can do to enforce this,'' said Melinda Konrath, director of nursing for the St. Joseph County Health Department. "The law has no teeth.''

Konrath said a hepatitis B vaccination is a good idea for high school students, even if the lack of teeth in the law makes it essentially voluntary for this particular age group.

Chronic infection with hepatitis B can lead to liver failure, liver cancer or cirrhosis. An estimated 1.25 million people are chronically infected, and about 5,000 people die annually, according to the U.S. Centers for Disease Control and Prevention.

Because the virus is spread through blood and other body fluids, sexual activity with an infected partner and sharing an intravenous needle are behaviors that carry a high risk of transmission.

"Children get older and they become sexually active, and although that's something parents don't like to talk about or think about, it is a possibility,'' Konrath said. "This is a way to protect them.''

The virus is not spread through food or water, sharing cups or utensils, kissing, sneezing or coughing, according to the CDC.

Older laws have required hepatitis vaccination for younger students and even infants for several years. The new law is an attempt to "catch'' a group of students not covered by the previous rule before they leave school, said Dr. Charlene Graves, medical director of immunization programs for the Indiana State Department of Health. The law automatically expires in 2008.

The hepatitis B vaccination involves three shots given over a period of about six months, Konrath said. It is impossible to begin the series now and complete it by the beginning of the school year.

Long-term studies have proved that the protection conferred by the series of vaccines continues for at least 15 years, according to the CDC.

Konrath said the County Health Department provides hepatitis B vaccinations for adults and children. The cost is $8 per shot for children younger than 18 and $34 per shot for those who have turned 18.

Vaccinations are available at the health department's South Bend immunization clinic on the ninth floor of the County-City Building. It's open from 8 a.m. to noon and 1 to 4 p.m. on weekdays.

Shots also are given at the department's Mishawaka office clinic, 219 Lincoln Way W., which has slightly different hours: 8 a.m. to 12:30 p.m. and 1:30 to 4 p.m. weekdays.

Konrath said the department prefers that people make appointments for shots by calling (574) 235-9750. But you can walk in without an appointment as well, if you don't mind waiting in line.

Staff writer David Rumbach:
drumbach@sbtinfo.com
(574) 235-6358

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From the Red Cross, An Apology
SourceURL:http://www.arktimes.com
Leslie Newell Peacock

From Arkansas: Prison never proven as source of tainted blood.

INMATE BLOOD: Too risky to use.

In June 1983, a company that bought blood from Arkansas’s prison inmates discovered it had drawn 38 units from four inmates who previously had tested positive for hepatitis B. They had not tested positive at the time their blood was taken. (A fifth inmate who’d also tested positive in the past and had sold blood in 1982 was later identified.)

Within days, the company, Health Management Associates, notified the Food and Drug Administration and the buyer of the plasma, Continental Pharma, but said there was no need to recall the plasma because chances were – very remote – that it posed a health risk.

But during the same time period, health professionals were finding a link between hepatitis B and AIDS, a fatal disease: Most AIDS patients, they now knew, had at one time been infected with hepatitis B. It was already known that AIDS had been transmitted to people via transfusions.

In the years following, more than 1,000 Canadians who received blood products manufactured from pools containing the inmates’ blood were infected with the AIDS-causing virus HIV, and 20,000 with hepatitis C. Some 3,000 deaths had been reported by 1997.

Two weeks ago, on May 30, the Canadian Red Cross – which itself had quit collecting blood from Canadian inmates in 1971 because of the prevalence of hepatitis B in the prison population – pleaded guilty in Ontario Superior Court for its role in the public health disaster. Its CEO publicly apologized. “We could have and should have done more,” Dr. Pierre Duplessis said.

A report issued in 1997 by Canadian Justice Horace Krever noted that Australia, Japan and the United Kingdom provided financial assistance to infected persons – mostly the families of hemophiliacs – and Japan has made a formal and public apology. Of the governments that found fault with their blood product oversight, only the United States has not apologized or made restitution, Krever wrote.

Arkansas has never apologized for its role in the tainted blood distribution either, said Arkansas Department of Correction spokesman Dina Tyler. The Department of Correction has admitted it was possible the inmate blood taken there was to blame for the thousands of infections and deaths that ensued, and “if we’re responsible for anything, we’re sorry,” Tyler said. But, she added, “there were a lot of allegations, but nobody ever tracked anything to us.”

And while a group of Canadians vowed to sue the state Department of Correction, no suit ever materialized.

Arkansas’s prison blood ended up in Canada because the United States had, in 1982, stopped using blood taken from inmates. In 1982, the first cases of transfusion-caused AIDS infections turned up, triggering a public health debate on ways to make the blood supply safer. High risk providers were identified: Homosexuals, Haitians and intravenous drug users.

But prisons in Arkansas, Florida, Mississippi and Louisiana – filled with high-risk individuals – continued inmate blood sales.

Health Management Associates discovered the Arkansas inmates’ health histories in June. In August, it decided blood products that included plasma from Arkansas inmates should be withdrawn after all.

But by then, four units of plasma had been shipped to Canadian plasma processor Connaught, mixed with blood products from other sources, and delivered to the Canadian Red Cross.

Of 2,409 vials fractionated into blood products by Connaught, only 417 were retrieved. Later in August, Connaught learned of a fifth inmate whose blood was sold by HMA to Connaught. Only 27 of 1,968 vials containing plasma factor from that inmate could be withdrawn.

Then-DOC director Art Lockhart reportedly contributed to a 1984 prison association bulletin raising questions of quality control associated with the plasma program. As time went on, plasma centers began to shut down since, ironically, their plasma providers largely came from high-risk groups. What would be described as a public health “calamity” in Canada was erupting.

Why, then, did Arkansas continue to sell blood until 1994, until the last vein ran dry, when the market for inmate blood was finally reduced to zero? “It gave inmates spending money,” Tyler said. She said they were paid $5 to $7 a unit of blood.

She noted that the prison ended its practice of allowing inmates to handle medical records when the problems surfaced in 1983, and in 1985 began checking blood for HIV.

The Canadian Red Cross will pay a $5,000 fine for violating a regulatory charge and will also donate $750,000 to the University of Ottawa for a scholarship fund for families of persons harmed by transfusions of the tainted blood and another $750,000 to establish a National Medical Error Project.

A criminal suit against four Canadian doctors, the former director of blood transfusions for the Red Cross, and a New Jersey plasma broker is pending.

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Study Shows 12 Weeks of Peginterferon Alfa-2b and Ribavirin Combination Therapy as Effective as 24 Weeks in Certain Hepatitis C Patients with Genotype 2 or 3 Virus
SourceURL:http://biz.yahoo.com
Press Release Source: Alessandra Mangia, M.D.

Results Published in New England Journal of Medicine Support Shorter Course of Therapy Based on Predictability of Response at Week 4 of Treatment

SAN GIOVANNI ROTONDO, Italy, June 22 /PRNewswire-FirstCall/ -- Results of a new study published in the current issue of the New England Journal of Medicine show that a shorter, 12-week course of therapy with peginterferon alfa-2b and ribavirin combination therapy was as effective as a 24-week course for patients with hepatitis C virus (HCV) genotype 2 or 3 who had an early response to treatment, defined as HCV RNA negative at 4 weeks.

The shorter regimen was not only highly effective in these patients, with 85 percent achieving a sustained virological response, but it also was associated with fewer side effects and, consequently, less frequent withdrawals from therapy. Moreover, patients assigned to 12 weeks of treatment were less likely to require a dose reduction. Maintaining the therapeutic dose is important for achieving an sustained virological response.

"Our findings suggest that patients with chronic hepatitis C genotype 2 or 3 infection who have undetectable virus after 4 weeks of treatment with peginterferon alfa-2b and ribavirin achieve high response rates with only 12 weeks of therapy and do not require 24 weeks of treatment," said Alessandra Mangia, M.D., Gastroenterology Unit, IRCCS Casa Sollievo della Sofferenza Hospital, San Giovanni Rotondo. "Tailoring treatment so that those with an early response are given a shorter course may make therapy more appealing to patients, sparing the expense and inconvenience of extended treatment, without adversely affecting outcomes."

Most patients treated today for chronic HCV genotype 2 or 3 receive 24 or 48 weeks of therapy. Although these schedules are effective, side effects increase with the length of treatment.

Study and Results

This open-label clinical trial was conducted in 14 centers in Italy as an investigator-sponsored study without financial support from industry. Patients were randomly assigned to receive weight-based peginterferon alfa-2b (PegIntron, Schering-Plough) at a dose of 1.0 mcg per kilogram of body weight weekly plus oral ribavirin (Rebetol, Schering-Plough) at a dose of 1000 mg (for those with a weight of less than 75 kg) or 1200 mg (for those with a weight of greater than or equal to 75 kg) daily, administered either for the standard period of 24 weeks (in the control standard-duration group of 70 patients) or for a variable duration of 12 or 24 weeks (in the variable duration group of 213 patients), depending on whether tests for HCV RNA were negative or positive at week 4. The primary measure of efficacy was sustained virological response (SVR), defined as HCV RNA that was undetectable in the serum 24 weeks after treatment was stopped. Patients in the two treatment arms were well matched for baseline characteristics.

Peginterferon alfa-2b and ribavirin combination therapy was shown to be effective in eliciting an early response, with 64 percent of patients in the standard-duration group and 62 percent in the variable-duration group having undetectable virus (HCV RNA negative) at week 4. Early response was highly predictive of sustained virological response, with 91 percent and 85 percent of patients, respectively, achieving SVR. Overall, 76 percent of patients in the standard-duration group and 77 percent in the variable-duration group achieved SVR. Fewer patients receiving the 12-week regimen had adverse events and withdrew from treatment than in the group receiving the 24-week regimen (P=0.049).

Among patients with HCV genotype 2, the overall rate of sustained virological response was 80 percent compared to 66 percent among those with genotype 3 (P less than 0.001). The study findings suggest that stopping therapy after 12 weeks in patients with a response at 4 weeks is appropriate for patients with either genotype, because the rates of sustained virological response were similar in patients with genotype 2 or 3 who had an early response and who were treated for 12 or 24 weeks.

Importantly, the rate of relapse (defined as undetectable HCV at the end of treatment but detectable at the end of follow-up) in the group treated for 12 weeks was not different from that among patients in the standard-duration group with an early response (P=0.19). Patients in the 12-week group who did relapse were offered re-treatment with the same dose of peginterferon alfa-2b and ribavirin for an additional 12 weeks. Nine of 10 of these patients achieved an SVR. Therefore, even taking into consideration the rate of relapse, treatment for 12 weeks rather than 24 weeks appears to be appropriate for patients with an early response.

Source: Alessandra Mangia, M.D.

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Nabi Biopharmaceuticals Gains Orphan Medicinal Product Designation for Civacir(TM) in Europe
SourceURL:http://biz.yahoo.com

BRAY, Ireland, June 22 /PRNewswire-FirstCall/ -- Nabi Biopharmaceuticals (Nasdaq: NABI - News) today announced that, following the favorable opinion of the European Medicines Agency or EMEA (adopted by the Committee of Orphan Medicinal Products), the European Commission has granted Orphan Medicinal Product (OMP) designation to Civacir(TM) [Hepatitis C Immune Globulin (Human)], Nabi Biopharmaceuticals' product candidate for the prevention of recurrent hepatitis C virus-induced liver disease in liver transplant recipients.

The OMP designation will result in reduced Marketing Authorization Application (MAA) fees, free access to scientific advice from the EMEA and other potential research and development incentives. Furthermore, if a product with OMP designation is the first to receive marketing authorization in Europe for its designated indication, the product will be entitled to 10- year market exclusivity, which means that a similar drug is prevented from receiving authorization for the same indication during this period. Civacir has already been granted Orphan Drug designation from the U.S. Food and Drug Administration (FDA).

"The Orphan Drug designation and today's OMP status promises to accelerate Civacir's development and reduce our development costs. We are particularly pleased by getting this designation in Europe because of the pioneering role European investigators have played in demonstrating the utility of hepatitis B immune globulins in liver transplant patients," said Henrik S. Rasmussen, M.D., Ph.D., senior vice president, clinical, medical and regulatory affairs, Nabi Biopharmaceuticals.

Dr. Rasmussen continued, "Nabi Biopharmaceuticals is building a growing commercial hepatitis franchise in Europe. HEBIG(TM), our hepatitis B immune globulin that was recently submitted for registration in Europe, along with Civacir, represents a comprehensive approach to addressing post-liver transplant consequences of viral hepatitis. We look forward to advancing both of these products to the marketplace, in line with our strategy to provide the best solutions for patients, while reducing the financial burden on healthcare systems."

About Civacir

Civacir is an investigational human polyclonal antibody product that contains antibodies to the hepatitis C virus (HCV). Civacir is being developed for the prevention of recurrent hepatitis C virus-induced liver disease in liver transplant recipients. Civacir is also being evaluated for the treatment of chronic hepatitis C virus infections.

The National Institutes of Health (NIH) has funded and conducted a Phase I/II clinical trial of Civacir in HCV-positive liver transplant patients at four study sites in the U.S. This randomized, controlled study evaluated the safety of dosing patients with Civacir during and after transplant surgery, the level of HCV-specific antibodies in trial subjects following dosing, liver enzyme levels (a measure of liver damage) and HCV levels in the transplanted livers. Data from the trial were reported in February 2004 and revealed that Civacir was well tolerated in liver transplant patients and produced a trend towards a reduction in ALT (serum alanine aminotransferase, an important liver enzyme that measures liver function) levels. Based on the results from this trial, the company expects to now be able to define the continued development strategy for this agent following discussions with the FDA and the EMEA.

About Hepatitis C in Europe

HCV can be transmitted through blood transfusions, organ transplants, intravenous drug use, kidney dialysis and sexual contact. Chronic HCV infection is a frequent cause of end-stage liver disease in North America and Europe and is present in approximately one-third of patients undergoing liver transplants. HCV re-infection of a transplanted liver can occur within days of transplantation and is almost inevitable within weeks to months after surgery. HCV infections in transplant patients can contribute to failure of the transplanted liver and frequent hospitalizations.

HCV is the most common cause of end-stage liver failure in Europe, responsible for approximately 30-40 percent of all liver failure transplants within the European Union (EU). The World Health Organization (WHO) estimates 170 million individuals worldwide are infected with HCV. HCV is the most common blood-borne infection in the U.S. and is a leading cause of liver failure and liver cancer. The U.S. Centers for Disease Control and Prevention (CDC) estimates that approximately three million individuals in the U.S. are chronically infected with HCV.

In June 2004, Nabi Biopharmaceuticals announced that it had filed its first MAA in Europe for its intravenous formula of Nabi-HB® Intravenous [Hepatitis B Immune Globulin (Human) Intravenous], under the trade name HEBIG(TM). A Biologics License Application (BLA) has been filed in the U.S. for Nabi-HB Intravenous and is currently under review by the FDA. Together, Civacir and HEBIG represent a comprehensive approach in helping to address post-liver transplant consequences of the hepatitis B and C virus.

About Nabi Biopharmaceuticals

Nabi Biopharmaceuticals leverages its experience and knowledge in powering the immune system to develop and market products that fight serious medical conditions. We are poised to capture large, commercial opportunities in our four core business areas: Gram-positive bacterial infections, hepatitis, kidney disease (nephrology), and nicotine addiction. We have three products on the market today: PhosLo® (calcium acetate), Nabi-HB® [Hepatitis B Immune Globulin (Human)], and Aloprim(TM) [Allopurinol sodium (for injection)] and a number of products in various stages of clinical and preclinical development. The company filed its Marketing Authorization Application in Europe for its product candidate, StaphVAX® [Staphylococcus aureus Polysaccharide Conjugate Vaccine], in December 2004. The application was accepted for review in January 2005. StaphVAX is currently in a confirmatory Phase III clinical trial in the U.S. StaphVAX is designed to prevent the most dangerous and prevalent strains of Staphylococcus aureus bacterial infections. S. aureus bacteria are a major cause of hospital-acquired infections and are becoming increasingly resistant to antibiotics. The company's other products in development include Altastaph(TM) [Staphylococcus aureus Immune Globulin Intravenous (Human)], an antibody for prevention and treatment of S. aureus infections, NicVAX(TM) [Nicotine Conjugate Vaccine], a vaccine to treat nicotine addiction, and Civacir(TM) [Hepatitis C Immune Globulin (Human)], an antibody for preventing hepatitis C virus re-infection in liver transplant patients. For additional information on Nabi Biopharmaceuticals, please visit our website at: http://www.nabi.com.

This press release contains forward-looking statements that reflect the company's current expectations regarding future events. Any such forward- looking statements are not guarantees of future performance and involve significant risks and uncertainties. Actual results may differ significantly from those in the forward-looking statements as a result of any number of factors, including, but not limited to, risks relating to the possibility that our confirmatory Phase III clinical trial for StaphVAX or our plans to commercialize StaphVAX in the European Union and United States may not be successful; the possibility that we may not realize the value of our acquisition of PhosLo; the company's ability to raise additional capital on acceptable terms; the company's dependence upon third parties to manufacture its products; the company's ability to utilize the full capacity of its manufacturing facility; the impact on sales of Nabi-HB from patient treatment protocols and the number of liver transplants performed in HBV-positive patients; reliance on a small number of customers; the future sales growth prospects for the company's biopharmaceutical products; and the company's ability to obtain regulatory approval for its products in the United States or abroad or to successfully develop, manufacture and market its products. These factors are more fully discussed in the company's Annual Report on Form 10-K for the fiscal year ended December 25, 2004 filed with the Securities and Exchange Commission.

Source: Nabi Biopharmaceuticals

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Peregrine Pharmaceuticals Presents Data Supporting Broad Spectrum Anti-Viral Potential of Tarvacin(TM) at BIO 2005
SourceURL:http://biz.yahoo.com

Data Presented Shows That Tarvacin(TM) Binds to Viruses Belonging to Six Different Virus Families; Inhibits Replication of Multiple Virus Types; and Protects Against Lethal Viral Infections in Pre-Clinical Animal Models of Two Different Viruses

TUSTIN, Calif., June 22 /PRNewswire-FirstCall/ -- Peregrine Pharmaceuticals, Inc. (Nasdaq: PPHM - News), today presented new data at the Biotechnology Industry Organization 2005 (BIO 2005) annual meeting in Philadelphia, PA. supporting the broad anti-viral potential of Tarvacin(TM). The data presented at BIO 2005 showed that Tarvacin(TM) binds to enveloped virus particles representing 6 different virus families, binds to virally infected cells and inhibits viral replication in multiple virus systems. The data also indicated that Tarvacin(TM) provided significant protection against Cytomegalovirus (CMV) and Pichinde virus (an in vivo Lassa fever model) infections.

Data presented at the conference demonstrated:

* Tarvacin(TM) binds to viruses from six different enveloped virus families, including specific binding to HIV 1 and 2, Influenza A and B, Measles, Respiratory Syncitial Virus (RSV), Bovine Viral Diarrhea (a surrogate in vitro Hepatitis C virus model), and Pichinde virus.

* Tarvacin(TM) binds to cells infected with Influenza, Vaccinia (a model for Smallpox) and Pichinde viruses.

* Anti-Phosphatidylserine antibodies inhibited replication of RSV, Vesicular Stomatitis Virus and Pichinde viruses.

* Anti-Phosphatidylserine antibodies provided significant protection in animals infected with cytomegalovirus (CMV) with 100% of the Anti-Phosphatidylserine antibodies treated animals surviving and only 20% of animals receiving control treatment surviving.

* Tarvacin(TM) provided significant protection in animals administered lethal viral loads of Pichinde virus (a model of Lassa fever) with 50% of the Tarvacin(TM) treated animals surviving and none of the animals receiving control treatment surviving.

* Animals lethally infected with Pichinde virus that survived following Tarvacin(TM) therapy had long term immunity to reinfection.

"These data further illustrate why we are excited about the Tarvacin(TM) anti-viral program," stated Steven King, president and CEO of Peregrine. "We are looking forward to initiating the Tarvacin(TM) Hepatitis C clinical trial, continuing our collaboration with National Institute of Allergy and Infectious Diseases (NIAID) and expanding into other collaborations to further explore the potential of the program for the treatment of viral infections."

Peregrine received FDA approval to begin a Tarvacin(TM) phase I clinical trial in Hepatitis C infected patients in late May 2005. In April of 2005, Peregrine and the National Institute of Allergy and Infectious Diseases (NIAID) entered into a collaborative effort to screen Tarvacin(TM) for activity both in vitro and in vivo against a wide variety of enveloped viruses of health and bioterrorism concern including Hepatitis C, influenza and SARS. Peregrine is continuing to evaluate Tarvacin(TM) for the treatment of a variety of viral infections that could lead to additional therapeutic indications in this area. In addition, Peregrine is currently recruiting patients in a Tarvacin(TM) phase I clinical trial that is open to patients with advanced solid tumor cancer.

About Tarvacin(TM)

Anti-Phospholipid Therapy is Peregrine's novel approach to treating cancer, viral infections and certain other diseases. It is based on the finding that aminophospholipids, which are basic components of the inner surface of the cellular membrane, become exposed in certain disease states. Tarvacin(TM) is a chimeric monoclonal antibody that binds to the phospholipid, phosphatidylserine, and is part of Peregrine's Anti-Phospholipid Therapy platform. Tarvacin(TM) binds directly to tumor blood vessels to inhibit growth and development of solid tumors. Tarvacin(TM) has also shown promise in the treatment of viral infections and is expected to recognize a broad spectrum of enveloped viral types. Tarvacin(TM) is currently being evaluated for the treatment of both cancer and viral diseases. Peregrine has received FDA approval to initiate two separate Phase 1 clinical trials in advanced solid cancer and chronic Hepatitis C virus indications.

About Enveloped Viruses

A large number of viruses significant to global health and security possess an "envelope" derived from their host cell membrane. The outer shell of the virus is known as the viral envelope. Since viruses lack the means to maintain structural organization of the envelope, amino-phospholipids such as phosphatidylserine (PS) and phosphatidylethanolamine (PE) become exposed on the surface of these viruses, making them a potential therapeutic target. Peregrine Pharmaceuticals, together with its collaborators, has developed a series of monoclonal antibodies, including Tarvacin(TM), directed against aminophospholipids to take advantage of this property.

About Peregrine Pharmaceuticals, Inc.

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 a Tarvacin(TM) clinical trial for the treatment of all solid cancers and has received clearance from the FDA to initiate a Tarvacin(TM) Phase I clinical trial for the treatment of Hepatitis C virus infection, its first viral indication. In addition, Peregrine is in the process of initiating patient enrollment in a Cotara® 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, the uncertainties that pre-clinical binding studies of Tarvacin(TM) against various enveloped viruses may prove to be ineffective during clinical testing. 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, uncertainties associated with completing pre-clinical and clinical trials for our technologies; the early stage of product development; the significant costs to develop our products as all of our products are currently in development, pre-clinical studies or clinical trials; obtaining additional financing to support our operations and the development of our products; obtaining regulatory approval for our technologies; anticipated timing of regulatory filings and the potential success in gaining regulatory approval and complying with governmental regulations applicable to our business. 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, 2004, and the quarterly report on Form 10-Q for the quarter ended January 31, 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

Hawk Associates, Inc.
Frank Hawkins and Ken AuYeung
(800) 987-8256
info@hawkassociates.com

Media Inquiries

Edelman
(323) 202-1031/(323) 893-9047
Rachel.Martin@edelman.com

Source: Peregrine Pharmaceuticals, Inc.

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June 23rd, 2005

The Death of a Soldier
SourceURL:http://icteesside.icnetwork.co.uk/
Joanne Emmerson, Evening Gazette

A former soldier could have been infected with Hepatitis C after being given army injections with a used needle, an inquest was told yesterday.

William Douglas, 69, of Roman Road, Middlesbrough died on November 26 of liver cancer which spread to his lungs.

An inquest into his death heard it was possible the Hepatitis C which could have led to his cancer was caused by an infected needle used to vaccinate him in the army.

The hearing was told multiple use of needles was common during the 1950s when less was known about the risk of cross-contamination of serious infections.

Today Mr Douglas' son Andrew, of Parkside, Middlesbrough, told of his fear his father's case was just the "tip of the iceberg".

He said: "Personally I believe it was caused through the vaccinations when he was in the army."

He told how at his father's funeral a friend told him how his dad had stood up at an army reunion and told them all that he had Hepatitis C and cancer and he thought it was caused when he had injection in the army.

"He said you could have heard a pin drop. The room went silent because they were all in the same boat. This could be the tip of the iceberg for all we know."

Yesterday's inquest at Teesside Coroner's Court inquest was told Mr Douglas joined the forces in 1952 when he was just 17 and travelled to places such as Malaya, Kenya and Aden in the 1950s.

Later in his career he served in Northern Ireland and Germany until his German wife Ingrid died in 1971.

The court heard how during his military career Mr Douglas had 32 "vaccinations, immunisations and inoculations" between 1952 and 1974.

Mr Douglas' consultant Derek Manus told the hearing that it was possible Mr Douglas had contracted hepatitis after being given a vaccination with a shared needle.

He said that is quite possible that this was done "especially back in the 50s" when this disease was not known about.

Pathologist Dr Ursula Earl, who carried out a post mortem following Mr Douglas' death told the hearing damage to his liver was so severe she could not determine what had caused the problem.

She said: "There are two possibilities for liver damage, one being extensive alcohol abuse and the other being infections such as Hepatitis C.

"In this case it was more likely an infection."

Andrew Douglas, 39, told the hearing his dad was a social drinker who drank with friends and family perhaps twice a week, but was not a heavy drinker.

Deputy Teesside Coroner Gordon Hetherington concluded that there was not enough evidence to say for definite how the cancer was caused and recorded an open verdict.

Speaking afterwards, Mr Douglas' son said that although he and his dad thought the Hepatitis was contracted while he was in the army he understood that that was "the way things were done in those days" and doesn't feel anyone is to blame.

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Dynavax Initiates Pivotal Phase 3 Trial for Hepatitis B Vaccine
SourceURL:http://biz.yahoo.com

BERKELEY, Calif., June 23 /PRNewswire-FirstCall/ -- Dynavax Technologies Corporation (Nasdaq: DVAX - News) announced the initiation of a pivotal Phase 3 clinical trial of its hepatitis B (HBV) vaccine. The pivotal Phase 3 trial is designed to compare the effectiveness of Dynavax's HBV vaccine to GlaxoSmithKline's Engerix-B® HBV vaccine in an older adult population that is more difficult to immunize with conventional vaccine. A second pivotal Phase 3 trial in a younger adult population to be conducted in Europe and Canada is anticipated to begin in early 2006. Assuming positive data from these trials, Dynavax could potentially file a BLA for its HBV vaccine in 2007.

Dynavax's HBV vaccine is based on its proprietary immunostimulatory sequence (ISS) that specifically targets Toll-Like Receptor 9 (TLR-9) to stimulate an innate immune response. Dynavax's HBV vaccine combines ISS with HBV surface antigen (HBsAg) and is designed to significantly enhance the level, speed and longevity of protection.

"The initiation of Phase 3 testing of our ISS-based HBV vaccine is a major milestone for Dynavax," said Dino Dina, MD, president and chief executive officer. "We believe our vaccine is the first TLR-9 agonist-based product to reach late-stage development, and represents an important corporate as well as technological achievement."

Continued Dr. Dina: "Our HBV vaccine has consistently demonstrated superior effectiveness over the industry standard vaccine in earlier clinical trials. Our registration and commercialization strategy focuses on target populations where the clinical need for an enhanced vaccine is greatest and where we believe we can achieve a significant commercial return. These populations include hemodialysis patients, healthcare and emergency response personnel, people infected with HIV or hepatitis C, and people who receive multiple transfusions. These populations represent high value, underserved markets, as their needs for enhanced efficacy, faster response and shorter vaccination regimens are clear."

The Phase 3 trial will enroll more than 400 seronegative adults (with no detectable HBV antibodies), aged 40-70, and will take place at study sites in Singapore, Taiwan, Korea and the Philippines. The trial will be one-to-one randomized and double-blinded. One group will receive three doses of Dynavax's HBV vaccine, administered at a dose of 20 micrograms HBsAg plus 3 milligrams of ISS, by intramuscular injection at zero, two months and six months. The other group will receive three doses of Engerix-B administered at a dose of 20 micrograms HBsAg by intramuscular injection at zero, one and six months. The primary endpoint is seroprotection four weeks after the third vaccination (at month seven). Study subjects will also be followed for an additional five months. The trial is anticipated to be completed in the second half of 2006.

Dynavax also plans to conduct additional trials in selected high-risk populations, such as dialysis patients, in targeted markets in Europe, Canada and potentially in the United States.

Dynavax has previously reported that the primary endpoint analysis of a randomized, double-blind Phase 2/3 trial in older adults showed statistically significant superiority in protective antibody response and robustness of protective effect after three vaccinations compared to Engerix-B. Results from a double-blind Phase 2 clinical trial conducted in young adults (18-28 years) also showed protective antibody responses were achieved faster (two vaccinations over two months compared to three over six months) and were maintained longer with Dynavax's HBV vaccine than with Engerix-B.

Dynavax is currently evaluating global commercialization and distribution strategies for its HBV vaccine. Dynavax has a long-term supply contract with Switzerland-based Berna Biotech that includes a commercialization option. The companies are at the early stages of discussing this option.

The Public Health Challenge of Hepatitis B

Hepatitis B is a highly contagious, chronic infectious disease. It is estimated that one out of three people in the world is infected with HBV, and that 10-30 million people in the world become infected with HBV every year. Chronic HBV infections cause 80% of all primary liver cancers, and are the leading cause of liver transplantation.

Vaccination is central to managing the spread of the disease, particularly in regions of the world with large numbers of chronically infected individuals. While many countries have instituted infant vaccination programs, compliance is not optimal. There are large numbers of individuals born prior to the implementation of these programs who are unvaccinated and are at risk for the disease. Not all individuals respond to currently approved vaccines.

Compliance with the immunization regimen of currently approved HBV vaccines is a significant challenge, as many patients fail to receive all three doses. According to a survey of U.S. adolescents and adults published by the Centers for Disease Control and Prevention, only 53% of those who received the first dose of vaccine received the second dose of vaccine and only 30% received the third. Dynavax believes that compliance rates in other countries are similar, if not lower.

HBV vaccination represents today approximately $1 billion in sales worldwide. In many parts of the world such as China, Southeast Asia and India, and Eastern Europe, vaccination is managed through public health organizations and the price of vaccines used on a mass scale is very low. In other areas such as the US, Western Europe and high-value markets in Asia and the rest of the world, the private vaccine market is robust and differentiated products have the potential to command premium pricing. Dynavax's HBV commercial strategy targets these high value markets worldwide.

About Dynavax

Dynavax Technologies Corporation discovers, develops, and intends to commercialize innovative products to treat and prevent allergies, infectious diseases, and chronic inflammatory diseases using versatile, proprietary approaches that alter immune system responses in highly specific ways. Our clinical development programs are based on immunostimulatory sequences, or ISS, which are short DNA sequences that enhance the ability of the immune system to fight disease and control chronic inflammation. Dynavax's pipeline includes: a ragweed allergy immunotherapeutic, currently in a large-scale Phase 2/3 clinical trial, and in a supportive clinical trial in ragweed allergic children; a hepatitis B vaccine that is currently in a pivotal Phase 3 clinical trial; a cancer therapy currently in a Phase 2 clinical trial; and an asthma immunotherapeutic that has shown preliminary safety and pharmacology in a Phase 2a clinical trial.

Dynavax cautions you that statements included in this press release that are not a description of historical facts are forward-looking statements, including without limitation all statements related to the therapeutic and commercial potential of its HBV vaccine; statements concerning the company's other clinical programs and its ability to demonstrate the potential of its ISS technology. Words such as "believes," "anticipates," "plans," "expects," "intend," "will," "slated," "goal" and similar expressions are intended to identify forward-looking statements. The inclusion of forward-looking statements should not be regarded as a representation by Dynavax that any of its plans will be achieved. Actual results may differ materially from those set forth in this release due to the risks and uncertainties inherent in Dynavax's business including, without limitation, risks relating to: the ability of the company to demonstrate safety and effectiveness of its HBV vaccine in Phase 3 clinical trials; the progress and timing of implementing its Phase 3 clinical program in HBV; the ability of the company to develop and implement effective commercial strategies for its HBV vaccine; the progress and timing of clinical trials for the company's other products in development; difficulties or delays in developing, testing, obtaining regulatory approval of, producing and marketing its HBV and other products; the scope and validity of patent protection for its products; competition from other pharmaceutical or biotechnology companies; its ability to obtain additional financing to support its operations; its ability to maintain effective financial planning and internal controls; and other risks detailed in the "Risk Factors" sections of Dynavax's Annual Report on Form 10-K filed on March 18, 2005, and Dynavax's quarterly report on Form 10-Q filed on May 9, 2005. You are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof. All forward-looking statements are qualified in their entirety by this cautionary statement and Dynavax undertakes no obligation to revise or update this news release to reflect events or circumstances after the date hereof.

Source: Dynavax Technologies Corporation

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Hepatitis C Case 'Likely' Work Related
SourceURL:http://www.employmentlawtoday.com

Health-care worker awarded WCB benefits after contracting disease, suffering mental breakdown despite lack of concrete evidence he got it at work

An appeals tribunal of the Ontario Workplace Safety and Insurance Board has awarded benefits to a worker who was diagnosed with hepatitis C and later had an emotional breakdown.

The unnamed worker was a counsellor for mentally disabled adults from 1980 until 1995. In November 1994 he donated blood and the Red Cross sent him a letter stating it had found evidence of hepatitis C and that he should see his doctor.

The diagnosis was confirmed by a specialist in December 1994. Although the specialist made an immediate association between the worker’s condition and possible risk factors from working in an institutional setting, no claim was made at that time.

On Jan. 27, 1995, the worker’s father died. In March 1995 the worker was transferred to another facility because the residential group home where he had been working was closing.

On March 22, 1995, his first day of work at the new facility, he suffered an emotional breakdown. He never returned to work with the employer and filed a claim for hepatitis C and for mental distress in March 1995.

Entitlement for hepatitis C

There were several medical reports that addressed the question of this worker’s risk factors for hepatitis C.

A report by Dr. W. Depew, his specialist, addressed to the worker’s family doctor, confirmed the diagnosis and stated:

“This man’s only risk factor for the acquisition of hepatitis at least on historical grounds is his involvement with mentally retarded children (sic) in an institution. Although he has not sustained needle sticks he has been scratched many times and he has been bitten on at least one occasion.”

The employer obtained a report from Dr. M. Sherman, a specialist in hepatology at the Toronto General Hospital. He reviewed the medical records of the six residents at the home where the employee worked from 1991 until 1995. Some had tested positive for hepatitis B but few had been tested for hepatitis C.

“The exposure described (between the worker and the residents) is most unlikely to have resulted in transmission of disease,” said Dr. Sherman. “Hepatitis C is actually quite hard to catch.”

Dr. Sherman compared the incidents in question to the medical records of the residents in coming to the conclusion that the likelihood of the worker getting hepatitis C at work was low.

The appeals tribunal wanted more information about the six residents Dr. Sherman reviewed and information about other clients the employee had cared for from 1990 until 1994, given that the worker had tested negative for hepatitis C in 1990.

The tribunal referred questions to Dr. George Sweeney, the tribunal’s medical assessor. He looked at the records of a total of 16 residents that the worker had cared from 1990 to 1994. And while it was impossible to know if any of them had hepatitis C because they hadn’t been tested for it, the fact that nine of the 16 had hepatitis B made it ‘likely’ that some had it because there are similar risk factors for both diseases.

“According to the worker, his duties included cleaning up after residents and this could involve vomit and feces,” said Dr. Sweeney. “In the course of his duties he was subjected to biting and scratching and there was one well-documented exposure to blood on the worker’s skin. These are situation that involve increased risk of contracting (hepatitis C.)”

Dr. Sweeney said it was impossible to say for certain whether the worker contracted hepatitis C at work.

“But it would seem on the basis of the facts that (the worker) is much more likely to have contracted hepatitis C in the workplace,” he said.

The appeals tribunal conceded that one could not be certain where the worker contracted hepatitis C. But it said its role in this case was merely to decide whether it was more probable than not that he acquired his infection during his duties at work. It concluded it was likely work-related.

“While we would prefer more definitive medical or scientific evidence, we consider the evidence sufficient to support a conclusion in favour of the worker,” it said.

Entitlement for mental stress

The appeals tribunal then turned it attention to the worker’s claim for mental stress.

It focused on the March 22, 1995, emotional breakdown and his subsequent treatment for severe depression. Medical reports said there were a number of factors that impacted on his emotional condition, including his father’s death and his emotional reaction to his job re-assignment. It dismissed those two factors.

“The death of the worker’s father was a personal factor,” the appeals tribunal said. “(And) tribunal decisions have not generally granted entitlement to emotional reactions arising out of job changes or even job terminations.”

But the appeals tribunal said it was satisfied the medical evidence supported the notion that the diagnosis with hepatitis C was a “material or significant contributing factor” to his emotional breakdown.

“It is not necessary that the work-related factors be the sole cause of the condition,” it said.

The appeals tribunal ruled the worker was entitled to benefits for hepatitis C and for mental distress as the result of his exposures at work.

The appeals tribunal said the worker has since found another job and is currently working as a real estate agent.

For more information see:

– Decision No. 1386/03 , 2004 CarswellOnt 6365, 71 W.S.I.A.T.R. 95, 2004 ONWSIAT 2516 (Ont. W.S.I.A.T.)

Editor's note: The above case was heard in July 2003 and decided in August 2004. Though not a "recent" decision, as most cases covered by Canadian Employment Law Today are, it is still of interest and provides an example of when a worker is given the benefit of the doubt when it's not completely clear the injury or disease was work related.

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June 24th, 2005

Hepatitis C: Hope on the Distant Horizon
SourceURL:http://www.pharmaceutical-business-review.com

24 Jun 2005, 17:24 GMT - While progress in the hepatitis C virus market is expected to be slow until 2011, the launch of polymerase and protease inhibitors thereafter is expected to fuel rapid growth. The market is expected to exceed $4 billion by 2012 and this growth may even result in a new treatment paradigm.

Driven by a favorable epidemiology and high unmet medical need, the hepatitis C pipeline is both rich and varied. The chronic hepatitis C (CHC) treatment market is currently dominated by market leaders Roche and Schering-Plough, which market both components of the CHC standard of care - a combination of pegylated interferon (Peg-IFN) alfa and ribavirin (RBV).

Historical growth in the hepatitis C market has been high, with a compound annual growth rate (CAGR) of 28.5% experienced between 1999 and 2003. This was mainly fuelled by the launch of RBV in 1998 and the second-generation interferons, Peg-IFN alfa-2b and -2a in 2000 and 2002, respectively - both of which significantly improved the efficacy of therapy.

However, treatment outcomes following Peg-IFN plus RBV combination therapy are highly heterogeneous and depend on the viral genotype with which a patient is infected. Indeed, sustained viral response (SVR) rates in the 'easy-to-treat' genotypes 2 and 3 can be up to 88% of cases. In contrast, less than half of those who harbor hepatitis C virus (HCV) genotype 1 successfully respond to therapy. Significantly, genotype 1 accounts for between 70 to 75% of the patient pool in the West and, therefore, current therapy meets less than 50% of the CHC medical need.

This has led to the accumulation of patients that have failed first-line therapy with the current standard of care, known as non-responders, and patients who responded to therapy but subsequently relapsed. Moreover, as a result of the slow rate of HCV disease progression, the wave of patients seeking treatment is still gaining momentum and expected to peak from 2014 onwards.

Incremental improvements in short term

The combination of high patient potential and significant medical unmet need have attracted big pharma and small biotech alike, creating a pipeline consisting of 28 drugs in clinical development and a range of potential drug candidates at the preclinical stage. However only 14% of these molecules are currently in phase III, with none of these specifically targeting the HCV particle per se. Instead, they act by enhancing the host antiviral response and therefore, no major paradigm changes are expected to occur in HCV therapy for at least the next five years.

Research by Datamonitor found that among the three drugs that are closest to market, only Valeant's RBV follow-up drug viramidine is perceived as a key addition to HCV therapy. The drug has similar efficacy to its predecessor but differentiates itself based on its more favorable toxicity profile.

The highest hopes for effective future HCV therapy are being pegged on the small molecules able to specifically interfere with HCV replication, in particular the NS3 protease inhibitors. This new paradigm was first highlighted as a realistic goal by Boehringer Ingelheim (BI), whose protease inhibitor BILN 2061 demonstrated an unprecedented drop in viral load after only two days of therapy. However, the enthusiasm was largely dampened when BI was forced to suspend further development of the drug due to cardiac toxicity in animals.

With the most developed protease inhibitor - Vertex/Mitsubishi's VX-950 - still at least seven years from reaching the market, hopes are now centered on the polymerase inhibitors, most notably Idenix/Novartis's NS5B polymerase inhibitor valopicitabine (NM283). However clinical development has also led to general disappointment when early-stage trials showed only moderate reductions in viral load with NM283 monotherapy. This led to subsequent clinical trials being designed for combination therapy with Peg-IFN, with the end goal of potentially replacing RBV with NM283.

Is future therapy without an interferon backbone realistic?

Early results from the NM283 clinical trials raise the question about the future role of Peg-IFN in HCV therapy: will it remain the backbone for several years to come or eventually fade from use? Some people believe that future HCV therapy is more likely to consist of combination therapy, based on Peg-IFN plus one or more specific antivirals. Others take a more optimistic view nurtured by faith in that antivirals could be capable of curing HCV infection on their own.

Given the consequences of untreated HCV infection, which include liver cirrhosis, hepatocellular carcinoma, liver transplant and death, many physicians will require convincing data before replacing a proven therapeutic option with antiviral monotherapy. As such, Peg-IFN is expected to retain a relatively strong market presence, despite the plethora of drugs in the pipeline, resulting in a CAGR of 9.9% for the interferon class between 2004 and 2013.

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