October 28, 2010

CDC’s “Winnable Battles” Fails to Include Asian Health Issues

By Bill Picture– October 28, 2010
Posted in: Health, National

Last month, the Centers for Disease Control and Prevention announced its priority issues in a list of “six winnable battles,” including HIV/AIDS, obesity and nutrition, traffic accidents, and teen pregnancy.

Some Asian American community activists, however, are saying that the list will do more harm than good to Asian Pacific Americans.

“The Centers for Disease Control’s new prioritization of ‘six winnable battles’ once again demonstrates the CDC’s poor track record towards achieving health equity for all Americans,” said AsianWeek Foundation Director Ted Fang in a statement.

Cancer kills more Asian Americans than any other disease, and Asians are the only racial group in which cancer is the number one killer. Liver cancer and hepatitis B liver disease are the greatest health disparities for Asians.

Community groups on the frontline in the battle against hepatitis B and liver cancer, say that the CDC’s new priorities could stymie their efforts to increase public awareness of the diseases, as well as lessen their chances of securing the funding necessary to implement effective and comprehensive prevention programs.

Hepatitis B attacks the liver when active, and is one hundred times more infectious than HIV. Left untreated, the disease can cause cirrhosis, liver cancer and liver failure. 80% of liver cancer cases worldwide are caused by hepatitis B. One out of ten Asian/Pacific Islanders is infected.

“You need to get people to get tested, you treat those who have it and vaccinate those who haven’t been exposed. That’s how you bring that (infected) number way down,” explains Janet Zola, Health Prevention Specialist with the San Francisco Department of Public Health

“We have a vaccine that works and drugs to manage it. Talk about a winnable situation,” she says. “The problem is, more than half of the people who have it don’t even know it.”

Hepatitis B has been called a “silent killer” because infected individuals often exhibit no symptoms until the liver has been compromised, limiting the effectiveness of available treatments. Early detection is key, and the blood test used is both simple and inexpensive. However, few physicians routinely test patients for hepatitis B.

The CDC has yet to explain why hepatitis B and liver cancer were not included on the list of agency priorities. CDC representatives did not comment for this story despite repeated attempts by AsianWeek.com to contact the agency. A few theories have been posed by members of the public health community, however.

“They don’t have the resources necessary for it to be considered winnable,” says Dr. Samuel So, founder of the Asian Liver Center at Stanford University.

According to So, the CDC only has $17.3 million allocated to national hepatitis B and C prevention. Congressman Mike Honda (D-CA) has introduced a Liver Cancer Bill calling for $600 million to be allocated for national interventions. The bill has 75 co-sponsors. CDC studies estimate a $300 million price tag for a comprehensive national hepatitis B and C prevention and control effort.

Dr. So, Zola and Fang are co-founders of the Hep B Free campaign in San Francisco, a community-based model for hepatitis-B-prevention now being replicated by municipalities across the country.

“Dr. So is probably right,” says Michele Peterson, MPH, Project Manager for the California Hepatitis Alliance, which has been working with the state to draft a strategic plan for viral hepatitis prevention that can be paired with healthcare reform and a plan for viral hepatitis prevention at the national level drafted by the Trust for America’s Health.

“These documents give the CDC the tools to address the problem, and make it an even more winnable battle,” adds Peterson. “But, until we having the funding, these strategies can only be guides.”

“This is the height of idiocy,” says California Hepatitis Alliance Chair, Leslie Benson. “Hepatitis C is curable, and the other two forms are vaccine-preventable at low cost. Not only is viral hepatitis one of the most winnable battles, it’s also the bargain of the century.”

“In terms of hepatitis B, sickle cell anemia is the only other disease I know of with such a huge impact on a specific ethnic group,” Benson adds. “Ignoring it like this is a deadly form of racism, and should not be tolerated.”

Some also point to a possible breakdown in communications at the CDC. The agency has a department that deals specifically with viral hepatitis. In fact, just two years ago, that department’s director, Dr. John Ward, visited San Francisco to discuss the importance of prevention efforts and announce new guidelines for hepatitis B screening at a press conference organized by the SF Hep B Free campaign.

“It makes me wonder who [CDC] leadership talked to within the organization when they were making the list, if the viral hepatitis people didn’t get any input,” says Janet Zola.

“They probably didn’t have an oncologist or a hepatologist on the panel,” adds Dr. Robert Gish, Co-Director of the Center for Hepatobiliary Disease and Abdominal Transplantation at the University of California, San Diego School of Medicine. “Moving forward, we need to make sure there is.”

“For Version 2.0 of the list, we want liver cancer to be one of the top discussion points at that meeting, and we need to keep putting pressure on them.”

“We won’t stop, of course,” says Zola. “But it’s disappointing. The head of the CDC looked right over us. That’s very discouraging, to say the least.”

So went further, issuing a challenge to the community.

“To get more money from the government, the public needs to speak up, convince policymakers that it’s important to them, and demand that something be done,” So adds. “People took to the streets for HIV.”

The problem is, the public isn’t even aware that hepatitis B poses a significant risk to public health, even though it affects millions of Americans. Further lessening the chances of a big enough stink being raised to force politicians’ hands is the fact that half of those infected with hepatitis B are Asian & Pacific Islanders, whose cultures do not encourage activism. 1 in 4 APIs diagnosed with hepatitis B will die of liver cancer unless they receive treatment.

“So there’s no public outcry and, therefore, no political will to address it,” says So. “It’s a Catch 22.”


Also See:
-- CDC's 'Winnable Battles' Out of Step with Healthcare Reform and Achieving Health Equity for the American People, Says Ted Fang, Co-Founder, Hep B Free
-- NVHR: In Fighting for 'Six Winnable Battles,' CDC May Lose the Nation's Overall Public-Health War
-- CDC chief picks 6 'winnable battles' in health

Gene Variants Affect Hepatitis C Treatment, But Link Is Elusive

Science 29 October 2010:
Vol. 330. no. 6004, p. 579
DOI: 10.1126/science.330.6004.579

Jessica Wapner*

A year ago, three groups independently found that patients with a particular variant of a gene called IL28B tend to fare better than others in battling hepatitis C virus (HCV). The finding promised new insights into the complex interplay between the immune system and HCV, which is estimated to infect 4 million people in the United States and 170 million worldwide. A diagnostic test for the IL28B variants recently became available. It is helping to guide decisions on whether, and when, patients begin treatment with the current therapy, a combination of pegylated interferon- and the antiviral drug ribavirin. And there are hints that the IL28B polymorphisms may play a similar role in responses to treatment with two new drugs that are expected to be approved early in 2011. So far, however, research to determine why different versions of the gene provide different levels of protection against HCV and different responses to treatment has yet to yield any answers.

* Jessica Wapner is a science writer in New York City.

Read the Full Text


More Older Americans Living With HIV

Many have multiple conditions, posing new challenges for U.S. health care system

Posted: October 28, 2010
By Jenifer Goodwin
HealthDay Reporter

THURSDAY, Oct. 28 (HealthDay News) -- Better treatments are extending the lives of people with HIV, but aging with the AIDS-causing virus takes a toll that will challenge the health care system, a new report says.

A survey of about 1,000 HIV-positive men and women ages 50 and older living in New York City found more than half had symptoms of depression, a much higher rate than others their age without HIV.

And 91 percent also had other chronic medical conditions, such as arthritis (31 percent), hepatitis (31 percent), neuropathy (30 percent) and high blood pressure (27 percent). About 77 percent had two or more other conditions. About half had progressed to AIDS before they got the HIV diagnosis, the report found.

"The good news is antiretroviral therapies are working and people are living. If all goes well, they will have life expectancies similar to those without HIV," said Daniel Tietz, executive director of the AIDS Community Research Initiative of America.

"But a 55-year-old with HIV tends to look like a 70-year-old without HIV in terms of the other conditions they need treatment for," he said Wednesday at a meeting of the Office of National AIDS Policy at the White House in Washington, D.C.

The research included interviews with 640 men, 264 women and 10 transgender people. Dozens of experts on HIV and aging attended the meeting, which was intended to identify the needs of older adults with HIV and to explore ways to improve services to them.

Currently, about 27 percent of those with HIV are over 50. By 2015, more than half will be, said the report.

Because of their special needs, this poses challenges for public health systems and organizations that serve seniors and people with HIV, Tietz said.

HIV can be isolating, Tietz said. Seventy percent of older Americans with HIV live alone, more than twice the rate of others their age, while about 15 percent live with a partner, according to the report.

The survey found that loneliness was higher among HIV-positive adults than for other older Americans. One reason is that many men and women conceal the condition from friends and family for fear of stigma or rejection, both real and imagined, Tietz said.

Lack of social and family support increases the likelihood of needing costly health care, such as home health aides and nursing homes as they get older, Tietz said.

Dr. Amy Justice, an HIV researcher who also attended the meeting, spoke of the need for health care professionals to learn about specific issues facing HIV-positive seniors.

HIV organizations tend to gear messages toward younger people, and senior services organizations often don't know much about the needs of HIV-positive seniors, said Justice, principal investigator of the Veterans Aging Cohort Study. This ongoing study involves some 40,000 veterans with HIV and 80,000 without HIV from 10 Veterans Affairs medical centers nationwide.

"There are a lot of people with HIV who are 60 or 65 and even 80 or 85," Justice said. "Those individuals feel older than their stated age and may have some of the same problems people 10 or 15 years older would normally experience."

Many older Americans with HIV are still sexually active and should be encouraged to practice safe sex, Justice said. While 57 percent of older Americans with HIV said they disclosed their HIV status to sexual partners, about 16 percent didn't, the report found.

About half the survey participants were black, one-third were Hispanic and 14 percent were white. About 67 percent considered themselves heterosexual, 24 percent were gay and 9 percent bisexual.

Why people with HIV are more likely to have other chronic diseases is still unclear, Tietz said. The cause could be the HIV itself or long-term side effects from taking multiple medications, he said. Early HIV drugs were especially toxic, he added.

More information
AIDS.gov has more on aging and HIV.


Ten uses for your body after you die

J. Nathan Bazzel donated his hip bones, which had to be replaced a few years ago, to Mütter Museum

By Elizabeth Cohen, CNN Senior Medical Correspondent
October 28, 2010 -- Updated 1221 GMT (2021 HKT)

(CNN) -- Like many Americans, you probably think you're pretty charitable. Perhaps you donate money to the needy or ill, give away your old clothes, volunteer at your child's school or participate in holiday gift drives in December.

But you may be missing something. As you're charitable in life, you could also be charitable in death. This holiday season -- Halloween -- you could start thinking about a kind of ghoulish donation: your body.

J. Nathan Bazzel has already made his plans. In 2001, he signed all the necessary documents to donate his body parts to the Mütter Museum, a part of the College of Physicians of Philadelphia. A friend of his worked there, and he knew that researchers from around the world came to look at its vast collection of body parts.

Bazzel, 38, is HIV-positive, and he wants scientists to learn from his remains.

"If just one person can take a look at my skull and kidneys, which have suffered from HIV and the drugs used to treat it, and learn something from them -- what a magnificent gift," he said.

He's so impassioned that the same year he signed the forms for his postmortem donation, he donated his right hip, which had to be replaced because of damage from an HIV drug, and then three years later, he donated his left hip.

Bazzel, who became the college's communications director two years ago, has already seen the benefits of having real human body parts on display: When high school students come in and see his hips' deformities, his lecture to them on the importance of safe sex takes on a whole new meaning.

Of course, being on display in a museum isn't everyone's cup of tea. So in the spirit of the season, here are 10 ways you can put your body to use after you die. In many cases, you can do more than one.

1. Donate your organs

Nineteen people die every day waiting for an organ such as a kidney, heart, lung, liver or pancreas. Learn about organ donation, sign an organ donor card, tell your family your wishes, and don't be misled by myths about organ donation. If you like, you can donate some organs but not others.

2. Donate your tissue

Your bones, ligaments, heart valves and corneas might not be of use to you in the hereafter, but they can certainly help someone else. Learn about tissue donation, sign a card, and again, tell your family members you've done this so they won't be surprised when the time comes. As with organs, you can specify what types of tissues you'd like to donate.

3. Will your body to a university

Help a future doctor learn about the human body by becoming a cadaver dissected by first-year medical students. A state-by-state list of medical schools can get you started. Be sure to ask exactly what will happen to your body. While you might be used for dissection, you could be used for other purposes within the school, and you might not have much control.

Here's an interesting conversation about the respect shown by students to their cadavers.

4. Help doctors practice their skills

If you'd prefer to be worked on by folks with more experience, actual, not future, doctors can learn from your body. At the Medical Education and Research Institute in Memphis, Tennessee, doctors brush up on their skills and learn new techniques; it's the training facility for organizations such as the American Association of Neurological Surgeons, the North American Skull Base Society and the International Spinal Injection Society.

Doctors get to practice (and possibly make mistakes on) the dead rather than the living. In return, the institute provides for transportation for your body to Memphis, pays for cremation once the work is done and returns the ashes to your family (or, if you prefer, to an interment facility in Memphis).

If you like the idea, you can fill out a donor form. If you'd prefer to first see where your body's headed, the institute welcomes visitors.

5. Leave your body to "the body farm"

Did you ever wonder how, on TV shows, detectives know the time of death just by examining the body? Cops can thank the folks at the University of Tennessee's Forensic Anthropology Center for helping them figure it out. "The body farm," as it's known, has "650 skeletons and growing" scattered over 2.5 acres in Knoxville, according to its website. Researchers and students study bodies in varying stages of decay to help anthropologists and law enforcement officials answer important questions, such as body identification and time of death analysis. (For a fascinating account of a visit to the center, see Mary Roach's book "Stiff.")

If you want to become one of those skeletons after you die, you're in luck, as they make donation pretty easy at the Body Farm. Get their Body Donation Packet, fill out their Body Donation Document and complete the biological questionnaire. They'll want a photo of you to help them learn more about "facial reconstruction and photographic superimposition as a means for identifying unknown individuals," according to the center's website.

If you live in Tennessee and within 200 miles of Knoxville, you're really in luck, because they'll take care of all the costs. If not, your family will be responsible for arranging transportation to the center.

Once they're done with you at the Body Farm, your family doesn't get your remains back, so if that's important to you, this isn't your best option.

6. Become a crash test cadaver

Plastic crash test dummies are all well and good, but there's nothing like a real human body to simulate what happens in a car crash. You can will your body to the Wayne State University School of Medicine to become a crash test cadaver by filling out its Body Bequest Form. The form is for donation to the university, but "if a person specifically requests that their body be used in safety testing that is ongoing at the Bio-Mechanics lab, then we would honor that wish," according to an e-mail from Barbara Rosso-Norgan, the school's mortuary supervisor.

7. Give your body to a broker

We don't mean a stockbroker; we mean a body broker, who will take your parts and get them to scientists who will use them for research, training and education.

There are several groups in this business, including Science Care, Anatomy Gifts Registry and BioGift Anatomical.

Generally speaking, here's the upside of these groups: They pay to have your body transported to their facility, and with the parts that are not used in research, they pay for cremation and to have the ashes returned to your family (some will, if you prefer, distribute them at sea). This can save your family a lot of money.

The downside: You don't know where your parts will go. "We don't guarantee that we can use the body in any specific research program, and that's because our research is always changing," said Kristin Dorn, community relations manager at Science Care. "Your intent is to donate to science, not a specific research project."

Some brokers will allow you to say what areas you'd prefer your parts not go to. If this is important to you, find the broker who offers this option. "If someone is ready to donate their body to science, they will definitely need to do some research," Dorn said.

8. Send your body on tour

If you've been to the "Body Worlds" exhibit, you know what plastination is: a process of posing and hardening a body so it appears life-like.

You, too, could become one of these bodies on display by donating to the Institute for Plastination. If you live in the United States or Canada, your body will be embalmed on your own continent and then shipped to Germany, where technicians will perform the plastination process. They'll remove fat and water, "impregnate" your corpse with rubber silicone and position it into a frozen pose (you might be, say, running or sitting cross-legged or performing ballet or perhaps riding a horse). Your body is then hardened into that position with gas, light or heat. The entire process takes about a year, according to the group's website.

Your family pays to get your body to the embalming location, and the Institute for Plastination incurs the shipping costs to Germany.

There are rules about donation. You can be old, and you can be an organ donor, but if you died in a violent manner, it might not work out, as your body must be "largely intact" in order to donate, according to the institute's website.

Also, there's no guarantee your body will end up in one of the five exhibits. Some plastinated bodies are sent to medical schools and training programs, and you don't get to decide the destination of your corpse, according to Georgina Gomez, the institute's director of development.

If you're interested in going on tour and you live in North America, read the Guide to Donors and fill out the Donor Consent Form. There are also forms for European donors.

9. Become a skeleton

Researchers from around the world visit the extensive skeleton collection at the Maxwell Museum of Anthropology at the University of New Mexico.

Here's some information and the legal donor permission form and a donor information form.

The ground rules: Your family pays to get your body to the museum's facility in Albuquerque, and your remains (besides your bones, of course) get cremated and disposed of; they don't go back to your family. Researchers who want to work with the skeletons have to apply to the museum's Laboratory of Human Osteology; the skeletons are not put on display for anyone at the museum to see.

If you'd like to be put on display, see below.

10. Be on display at a museum

Like Bazzel, you can donate parts of your body to the Mutter Museum at the College of Physicians of Philadelphia.

If you do so, you'll be a part of a pretty rarified group. Anna Dhody, the museum's curator since 2004, has received only three inquiries about donation after death, including Bazzel's.

"One woman contacted me and said, 'I have a 120-degree curvature of my spine. Would you like it when I'm done with it?' and I said, 'Yes, please,' " Dhody recalled.

Although the museum is particularly interested in bodies with abnormalities, it'll also consider taking your remains even if there's nothing particularly pathological about them. Either way, your family will have to foot the bill to get you to Philly. To learn more, send an e-mail to info@collegeofphysicians.org.

CNN's John Bonifield and Renea Lyon contributed to this report.


Obese children experience later mortality post liver transplantation

Public release date: 28-Oct-2010

Contact: Dawn Peters

Lower survival rate for thin pediatric patients in first year after transplant

A new study from the University of Washington reported obese children are at increased mortality risk in later years following primary liver transplantation (LT). Pediatric patients who are thin or severely thin, experience an early mortality risk—within the first year post-LT. Details of the ten-year survival analysis are published in the November issue of Liver Transplantation, a peer-reviewed journal of the American Association for the Study of Liver Diseases (AASLD).

Childhood obesity is a serious public health concern worldwide. According to the World Health Organization (WHO), the prevalence of obesity has been increasing at an alarming rate, with 22 million children under the age of five worldwide who are overweight. In the U.S., the National Center for Health Statistics estimates that 17% of children between the ages of 2 and 19 years old are overweight or obese.

"Controversies exist regarding the mortality of patients undergoing liver transplantation at the extremes of body mass index (BMI), and in pediatric patients weight is typically the only factor considered in survival analysis," explained lead study author André Dick, M.D., from Seattle Children's Hospital and the University of Washington. "Our study is the largest thus far to report on the impact of pre-transplant BMI on post liver transplant survival in the pediatric population." Prior studies in adult populations have shown there to be a negative impact on post transplantation survival for LT patients with extreme BMIs.

For the present study, researchers reviewed data from the Organ Procurement and Transplantation Network (OPTN) and found that 7,942 patients less than 18 years of age (who had full BMI data) underwent primary liver transplantation between 1987 and 2007. Using the WHO BMI criteria, the authors categorized patients as severely thin, thin, normal weight, overweight, or obese. During the study period 61% of patients were at normal weight.

Results indicate that children who were thin or severely thin had a significantly lower survival (84%) at one year compared to the survival (89%) of children in the normal and overweight groups. Researchers found no significant difference in survival during the first year after transplantation for obese pediatric patients. However, by the twelfth year following LT, those in the obese group had significantly lower survival (72%) than the survival (77%) of normal weight or overweight pediatric patients.

The authors observed that obesity had a significantly negative impact on pediatric patient survival more than five years after LT. They speculate post metabolic syndrome (PTMS) could contribute to the late morbidity and mortality due to the time it takes to develop long-term obesity-related conditions such as diabetes, hypertension, and hyperlipidemia. Moreover, long-term use of immunosuppressive therapy following transplantation, which while improving patient survival, can exacerbate the effects of PTMS. "Further research is needed to determine the optimal immunosuppressive regimen that will lessen the effects of PTMS," concluded Dr. Dick. "Pre- and post-transplant identification of malnourished or obese pediatric patients, along with optimization of their modifiable risk factors will help to best use scarce donor organs and maximize patient survival."


This study is published in the October issue of the Liver Transplantation. Media wishing to receive a PDF of this article may contact healthnews@wiley.com.

Full citation: "The Impact of Obesity on Children Undergoing Liver Transplantation." André A.S. Dick, James D. Perkins, Austin L. Spitzer, Oliver B. Lao, Patrick J. Healey, Jorge D. Reyes. Liver Transplantation; Published Online: August 27, 2010 (DOI: 10.1002/lt.22162); Print Issue Date: November 2010. http://onlinelibrary.wiley.com/doi/10.1002/lt.22162/abstract

About the Journal

Liver Transplantation. is published by Wiley-Blackwell on behalf of the American Association for the Study of Liver Diseases and the International Liver Transplantation Society . Since the first application of liver transplantation in a clinical situation was reported more than twenty years ago, there has been a great deal of growth in this field and more is anticipated. As an official publication of the AALSD and the ILTS, Liver Transplantation. delivers current, peer-reviewed articles on surgical techniques, clinical investigations and drug research — the information necessary to keep abreast of this evolving specialty. For more information, please visit Liver Transplantation.

About Wiley-Blackwell

Wiley-Blackwell is the international scientific, technical, medical, and scholarly publishing business of John Wiley & Sons, with strengths in every major academic and professional field and partnerships with many of the world's leading societies. Wiley-Blackwell publishes nearly 1,500 peer-reviewed journals and 1,500+ new books annually in print and online, as well as databases, major reference works and laboratory protocols. For more information, please visit http://www.wileyblackwell.com/ or our new online platform, Wiley Online Library (wileyonlinelibrary.com), one of the world's most extensive multidisciplinary collections of online resources, covering life, health, social and physical sciences, and humanities.

Media Advisory

What: The 61st Annual Meeting of the American Association for the Study of Liver Diseases (AASLD)

Founded in 1950, AASLD is the leading organization of scientists and healthcare professionals committed to preventing and curing liver disease. AASLD has grown into an international society responsible for all aspects of hepatology, and the annual meeting attracts 8,500 physicians, surgeons, researchers, and allied health professionals from around the world.

The Liver Meeting® is the premier meeting in the science and practice of hepatology, including the latest findings on new drugs, novel treatments, and the results from pilot and multicenter studies.

When: October 30 – November 2, 2010
Where: Hynes Convention Center
900 Boylston Street
Boston, Massachusetts

Contact: Please contact Ann Haran at 703-299-9766 or aharan@aasld.org to obtain a press pass for this event


PRA International to Exhibit at Liver Diseases Conference

Available to Discuss Innovative Approaches to Hepatitis B & C Studies

RALEIGH, N.C., Oct. 28 /PRNewswire/ -- PRA International, a leading Clinical Research Organization, will exhibit at the 61st conference of the American Association for the Study of Liver Diseases, The Liver Meeting®, being held 30 October – 1 November 2010 in Boston, Massachusetts, USA.

Representatives from PRA's Infectious Diseases Research Center and other departments will be available at booth 300 to discuss our expertise in hepatitis B & C as well as other liver diseases.

Because infectious disease is one of PRA's core therapeutic areas, we have a proven record of accomplishment in hepatitis B & C study management and drug development from early phase through NDA submission. PRA also offers clients the benefit of centralized, coordinated activities through our Infectious Diseases Research Center. This cross-functional department is comprised of staff from Scientific Affairs, Project Management, Patient Recruitment, Corporate Development and Clinical Informatics.

For more information about the conference, navigate to http://www.praintl.com/ and click on "Events." The Liver Meeting® is a registered trademark of the American Association for the Study of Liver Diseases.

About PRA International

PRA International conducts clinical trials in more than 85 countries across 6 continents and provides services through all phases of clinical development. PRA performs studies in all therapeutic areas, with specialization in Infectious Diseases, Oncology, Neurosciences, Respiratory/Allergy and Cardiovascular. In the last five years, PRA has supported over 3000 clinical trials through its 38 global offices.

PRA's therapeutic expertise, global reach and project experience, combined with extensive local knowledge and our differentiating PERSONAL ELEMENT enable our project teams to deliver consistent and on time performance for our clients. This unique PRA philosophy - THE PERSONAL ELEMENT - recognizes that true client service comes only from trained, empowered and dedicated employees who are encouraged to use innovation and their personal commitment to accelerate the development lifecycle.

To learn more about PRA International, please visit http://www.prainternational.com/, email Endpoints@PRAintl.com or call our Global Headquarters at +1 (919) 786-8200.

SOURCE PRA International


GlobeImmune Expands GI-5005-02 Phase 2b Trial to Include Additional Treatment Naive IL28B T/T Subjects With Chronic Genotype 1 HCV

By: Marketwire
Oct. 28, 2010 08:00 AM

LOUISVILLE, CO -- (Marketwire) -- 10/28/10 -- GlobeImmune Inc. today announced the expansion of its Phase 2b clinical trial of GI-5005, an investigational Tarmogen product for the treatment of hepatitis C virus (HCV) infection. The Company previously reported data demonstrating a 60% improvement in sustained virologic response (SVR) in chronically infected HCV patients with the hardest-to-treat IL28B T/T genotype when GI-5005 was added to standard of care (SOC) versus SOC alone (60% vs. 0% SVR). The Company plans to enroll 40 additional subjects with the IL28B T/T genotype. Approximately 20% of chronically infected HCV patients have the IL28B T/T genotype, and those patients are least likely to respond to treatment with SOC. Data from the additional 40 subjects will allow for more precise powering of pivotal clinical trials.

"HCV patients with the IL28B T/T genotype have a very poor prognosis with current treatment options," said Timothy C. Rodell, M.D., President and CEO of GlobeImmune. "We believe that GI-5005 addresses a fundamental deficit in patients carrying the T allele of the IL28B gene by augmenting their deficient T cell immune response against HCV. Our phase 2 immunology data indicate that a limited T cell immune response is likely why the current standard of care, which acts primarily by inhibiting viral replication, has limited efficacy in this patient group."

"Patients with the IL28B T/T genotype have the lowest rates of sustained virologic response to today's standard of care and will very likely continue to have lower response rates and a high rate of anti-viral resistance with the addition of a protease inhibitor," said Mitchell L. Shiffman, M.D., Director of The Liver Institute of Virginia. "Preliminary data strongly suggest that GI-5005 enhances the ability of a patient with the IL28B T/T genotype to respond to HCV treatment. This represents the first significant advance in our ability to treat chronic HCV in patients who are genetically less sensitive to interferon. The expansion of the GlobeImmune program to specifically study patients with the IL28B T/T genotype is an important step for successful treatment of these patients in the future."

Additional data from the original 140 subjects enrolled in the trial will be presented this week at 61st Annual Meeting of the American Association for the Study of the Liver (AASLD) in Boston.
  • Paul J. Pockros, M.D. of Scripps Clinic will deliver an oral presentation of the results from the GI-5005-02 trial in patients previously treated with SOC in a late-breaker session Monday November 1, 2010 at 6 p.m. EDT in the Hynes Auditorium.
  • John M. Vierling, M.D. of Baylor College of Medicine will present immune response data in a poster on Tuesday November 2, 2010 Hynes Exhibit Hall C. 
The design of the clinical trial expansion is identical to the original GI-5005-02 trial, and will be conducted in approximately 30 of the participating U.S. sites. The primary endpoint of the randomized, open-label expansion study is sustained virologic response (SVR).

Tarmogens are whole, heat-killed recombinant S. cerevisiae yeast that are engineered to express one or more disease-related proteins. GlobeImmune's GI-5005 Tarmogen is a therapeutic vaccine product candidate that contains conserved HCV proteins and is designed to generate an HCV-specific T-cell response.

About GlobeImmune

GlobeImmune Inc. is a private company developing active immunotherapies called Tarmogens for the treatment of cancer and infectious diseases. Tarmogens generate activated killer T cells that are designed to locate and eliminate cancer cells and/or virally-infected cells. The Company's lead product candidate, GI-5005, is a Tarmogen being developed for the treatment of chronic hepatitis C infection (HCV). GI-5005 is designed to complement both the current standard of care and emerging novel therapies for HCV. The Company's lead oncology program, GI-4000, targets cancers caused by mutated versions of the Ras oncoprotein. GI-4000 is being investigated in clinical trials for the treatment of pancreas cancer as well as other cancers that contain mutated Ras, including non-small cell lung cancer and colorectal cancer. In May 2009, the Company announced a global partnership with Celgene focused on the discovery, development and commercialization of multiple product candidates for the treatment of cancer.

For additional information, please visit the company's Web site at http://www.globeimmune.com/.

This news release and the anticipated presentation contain forward-looking statements that involve risks and uncertainties, including statements relating to initiation and progress of the Company's clinical trial programs and the results from the clinical trials. Actual results could differ materially from those projected and the Company cautions readers not to place undue reliance on the forward-looking statements contained in the release and anticipated presentation.


Pharmasset Reports Positive Preliminary Antiviral Data with PSI-938 for the Treatment of Hepatitis C

-- PSI-938 achieves a median 3.94 to 4.64 log10 reduction in HCV RNA after 7 days of monotherapy
-- No early discontinuations or serious adverse events reported
-- Initiating nucleotide combination trial later this quarter
-- Conference call at 8:00 AM ET today

PRINCETON, N.J., Oct. 28 /PRNewswire-FirstCall/ -- Pharmasset, Inc. (Nasdaq: VRUS) reported positive preliminary results today from its phase I monotherapy trial of PSI-352938 ("PSI-938") for the treatment of chronic hepatitis C (HCV). PSI-938 is a guanosine nucleotide analog polymerase inhibitor in development for the treatment of chronic HCV infection.

PSI-938 Phase 1 Multiple Ascending Dose Study Overview

In August 2010, Pharmasset initiated a phase 1 multiple ascending dose study with PSI-938 administered once daily (QD) or twice daily (BID) for 7 days. The trial was conducted at two US centers as a blinded, randomized, and placebo-controlled study in 40 patients chronically infected with HCV genotype 1. The primary objective was to assess the safety, tolerability, and pharmacokinetics of PSI-938 administered over 7 days. The secondary objective was to assess antiviral activity by measuring the change in HCV RNA. Patients were randomized within each cohort to receive either PSI-938 (8 patients per cohort) or placebo (2 patients per cohort). Four dose cohorts of PSI-938 (100 mg QD, 200 mg QD, 300 mg QD and 100 mg BID) have been completed.

PSI-938 Antiviral Activity Summary

PSI-938 demonstrated potent antiviral activity with a mean HCV RNA change from baseline of 4.31 log10 IU/mL, 4.64 log10 IU/mL, 3.94 log10 IU/mL and 4.59 log10 IU/mL in patients receiving 100 mg QD, 200 mg QD, 300 mg QD and 100 mg BID for seven days, respectively. HCV RNA declined consistently throughout the 7-day dosing period, with no viral breakthrough. For the 16 subjects who received PSI-938 200 mg QD or 300 mg QD for 7 days, more than half (9 of 16) of the subjects on PSI-938 monotherapy achieved HCV RNA below the limit of detection (15 IU/mL) and 11 out of 16 patients achieved HCV RNA below the limit of quantification (43 IU/mL).

PSI-938 Pharmacokinetic and Safety Summary

Pharmacokinetics parameters were similar between healthy subjects in the single ascending dose study and HCV infected patients in the seven-day multiple ascending dose study. PSI-938 at all doses provided good systemic exposure and continue to support once-daily administration.

PSI-938 was generally safe and well tolerated across all doses studied to date with no serious adverse events and no discontinuations. There were no dose-related trends in adverse events through the dose escalations, no grade 4 treatment emergent laboratory changes, and no trends in clinical laboratory abnormalities.

PSI-938 SAD and preclinical data

The Phase 1a single ascending dose study conducted earlier this year assessed single doses of PSI-938 ranging from 100 mg to 1600 mg or matching placebo in healthy male and female volunteers. No dose-limiting toxicity was identified. Safety and pharmacokinetic data supported progression of PSI-938 to the 7-day monotherapy trial. Full data from the SAD trial will be presented at the upcoming AASLD Annual Liver Meeting in Boston, MA, October 29-November 3, 2010 (poster #1890).

Preclinically, both PSI-938 and Pharmasset's other guanosine analog, PSI-661, which is in late preclinical development, have demonstrated similar potency against wild-type HCV or HCV with the S282T mutation, which can be selected by RG7128 and PSI-7977 in vitro. Although the S282T has not been detected in treatment-naive individuals with HCV, nor selected in clinical trials with any of Pharmasset's nucleoside/tide analogs, the potential for interferon-sparing regimens may increase the focus on antivirals with complementary resistance profiles.

"We are very encouraged by the preliminary efficacy and safety data with PSI-938, our purine nucleotide analog for HCV," said Michelle Berrey, MD, MPH, Pharmasset's Chief Medical Officer. "These data provide the first confirmatory evidence that a nucleoside/tide analog can exhibit substantial early antiviral activity in monotherapy as has been observed with compounds in other DAA classes. Unlike other classes of DAAs to date, our nucleotide analogs also provide a higher barrier to resistance and clinically-validated antiviral activity across a broad range of HCV genotypes, characteristics not yet demonstrated with other classes of DAA. We continue to believe that nucleoside/tide analogs will become the backbone of HCV therapy. In addition, similar to HIV, the combination of two complementary nucleoside/tide analogs could provide a differentiated therapy for HCV patients in the future."

PSI-938 and PSI-7977 Combination Study

In this quarter, Pharmasset plans to initiate a short-term study to assess the combination of PSI-938 and PSI-7977. The trial will be conducted in the US, as a blinded, randomized, placebo-controlled study in approximately 50 patients chronically infected with HCV genotype 1. The primary objective will be to assess the safety, tolerability, and pharmacokinetics of PSI-938 and PSI-7977 alone and in combination. Preliminary results are expected in the first half of 2011.

Conference Call and Webcast

Members of Pharmasset's management team will host a conference call today, October 28, 2010, at 8:00 a.m. ET to discuss the preliminary results of the multiple ascending dose trial with PSI-938. Investors may listen to the webcast of the conference call live on the "Events & Presentations" section of Pharmasset's website, http://www.pharmasset.com/. Alternatively, investors may listen to the call by dialing 877-771-7028 from locations in the U.S. and 973-200-3092 from outside the U.S. The webcast replay will be available for at least 72 hours following the call.

About Pharmasset

Pharmasset is a clinical-stage pharmaceutical company committed to discovering, developing, and commercializing novel drugs to treat viral infections. Pharmasset's primary focus is on the development of oral therapeutics for the treatment of hepatitis C virus (HCV). Our research and development efforts focus on nucleoside/tide analogs, a class of compounds which act as alternative substrates for the viral polymerase, thus inhibiting viral replication. We currently have four clinical-stage product candidates. RG7128, a cytosine nucleoside analog for chronic HCV infection, is in two Phase 2b clinical studies in combination with Pegasys(R) plus Copegus(R) and is also in the INFORM studies, the first series of studies designed to assess the potential of combinations of small molecules without Pegasys(R) and Copegus(R) to treat chronic HCV. These clinical studies are being conducted through a strategic collaboration with Roche. Our other clinical stage HCV candidates include PSI-7977, an unpartnered uracil nucleotide analog presently in a Phase 2b study, and PSI-938, an unpartnered guanosine nucleotide analog in Phase 1. We also have in our pipeline an additional purine nucleotide analog, PSI-661, in advanced preclinical development. Racivir, for the treatment of HIV, has completed a Phase 2 clinical study.

Pegasys® and Copegus® are registered trademarks of Roche.

Richard E. T. Smith, Ph.D.
VP, Investor Relations and Corporate Communications
Office: +1 (609) 613-4181

Forward-Looking Statements

Pharmasset "Safe Harbor" Statement under the Private Securities Litigation Reform Act of 1995: Statements in this press release that are not historical facts are "forward-looking statements," that involve risks, uncertainties, and other important factors, including, without limitation, the risk of cessation or delay of any of the ongoing or planned clinical trials and/or our development of our product candidates, the risk that the results of previously conducted studies involving our product candidates will not be repeated or observed in ongoing or future studies involving our product candidates, the risk that our collaboration with Roche will not continue or will not be successful, and the risk that any one or more of our product candidates will not be successfully developed and commercialized. For a discussion of risks, uncertainties, and other important factors, any of which could cause our actual results to differ from those contained in the forward-looking statements, see the section entitled "Risk Factors" in our Annual Report on Form 10-K for the fiscal year ended September 30, 2009 and our Quarterly Reports on Form 10-Q for the periods ended December 31, 2009, March 31, 2010 and June 30, 2010 filed with the Securities and Exchange Commission and discussions of potential risks, uncertainties, and other important factors in our subsequent filings with the Securities and Exchange Commission.

SOURCE Pharmasset, Inc.



Also See: Pharmasset to Webcast an Investor Event from the AASLD Meeting

Biolex Announces Locteron® SVR12 Results and Safety/Tolerability Advantages in SELECT-2 Hepatitis C Trial

Oct 28, 2010 07:30 ET

Additional Tolerability Results From Two Phase 2b Trials of Locteron to Be Presented in Late-Breaker Session at AASLD Conference on November 1, 2010

PITTSBORO, NC--(Marketwire - October 28, 2010) - Biolex Therapeutics, Inc. announced positive efficacy, safety and tolerability results from its 72-week SELECT-2 Phase 2b dose-finding Phase 2b trial of Locteron®, the Company's lead product candidate for the treatment of hepatitis C. For each of the three Locteron doses tested in SELECT-2, the percentage of patients who maintained undetectable levels of virus at week 60 of the trial, 12 weeks after completion of 48 weeks of treatment (SVR12), were comparable with or exceeded the response rate for the PEG-Intron® control. As a result of its controlled-release mechanism, Locteron was dosed half as frequently as PEG-Intron. PEG-Intron is one of two currently marketed pegylated interferon products for the treatment of hepatitis C, a market that currently exceeds $2.5 billion in worldwide sales.

Additional results from SELECT-2 demonstrated the substantial tolerability advantages of Locteron. Patients treated with each of the three Locteron doses in SELECT-2 reported a statistically significant reduction in flu-like adverse events (p < 0.001) compared to the PEG-Intron group. Accordingly, Locteron patients in all three dose groups used less concomitant medications (analgesics and antipyretics) than the PEG-Intron patients during the study period. Lastly, patients receiving the two lower doses of Locteron experienced lower rates of depression and discontinuations due to adverse events than patients receiving PEG-Intron.

Response rates and tolerability results for SELECT-2 are outlined in the table below:
"The strong viral response of Locteron achieved with once-every-two-week dosing is an improvement over current interferons, and I am impressed by the consistency of the flu-like effect across trials and different reporting methodologies," said Nezam Afdhal, M.D., Chief of Hepatology at Beth Deaconess Medical Center, Harvard Medical School. "The reduction in symptoms of depression is quite promising and needs to be followed up in additional clinical evaluation. The Locteron safety and tolerability results are clearly important as recent clinical results demonstrate that interferon is likely to remain a core component of future treatment regimens that incorporate the new direct-acting anti-virals, highlighting the need for a more tolerable interferon to reduce the side-effect burden on patients from these multi-drug combinations and maximize their adherence to treatment."

SELECT-2 Depression Results

In SELECT-2, depression was measured in both patient-reported and clinic-reported methods and showed an advantage for Locteron for the dose groups encompassing the expected commercial dose range, the 320 and 480 µg doses. Throughout the 48 weeks of treatment in SELECT-2, patients self-reported their status using the Beck's Depression Inventory (BDI), one of the most widely used instruments for measuring the severity of depression. Results demonstrated that fewer patients reported scores greater than 16 using the BDI (the threshold for mild depression) in the 320 and 480 µg Locteron dose groups compared to the PEG-Intron group. The patient-reported BDI results were confirmed independently by adverse event assessments performed by the clinical sites as highlighted in the table below

These findings from SELECT-2 are of particular importance as a survey of hepatitis C patients published in the Journal of Viral Hepatitis in 2010, showed that depression and flu-like symptoms were cited as the two most important adverse events impacting patient adherence to treatment.

AASLD Presentation

Biolex also announced today that new tolerability data from two Phase 2b trials of Locteron have been accepted for a late-breaker presentation on November 1, 2010 at the 61st Annual Meeting of the American Association for the Study of Liver Diseases (AASLD) in Boston. These latest tolerability results include daily patient self-reporting of flu-like adverse events using an electronic patient reported outcome system (ePRO).

"We believe that the efficacy, safety and tolerability results from SELECT-2 support the profile of Locteron as the most combinable interferon for use with direct-acting anti-viral drugs in emerging combination regimens," said Mr. Jan Turek, Biolex's President and Chief Executive Officer. "We are pleased that the ePRO results, the newest data supporting the tolerability advantages of Locteron, have been accepted for presentation at the AASLD conference."

Locteron is an investigational therapeutic candidate and has not been approved for sale by the United States Food and Drug Administration or by any international regulatory agency.

About SELECT-2 Study

Biolex's SELECT-2 Phase 2b trial was designed to identify one or more doses of Locteron that demonstrated viral kinetics and response rates comparable to the PEG-Intron® control while also achieving at least a 50% reduction in flu-like adverse events. SELECT-2 is being conducted in the United States and Europe in 116 treatment-naïve, genotype-1, chronic hepatitis C patients. Patients were randomized into one of four dosing cohorts, the 320, 480 or 640 µg dose of Locteron (administered once every two weeks) or a control arm consisting of PEG-Intron (1.5 µg/kg, administered every week), with all patients receiving weight-based ribavirin. Patients were treated for 48 weeks and are being followed for an additional 24 weeks to determine the sustained virologic response (SVR) rate. All patients in the trial have reached at least the 60-week time point of the study, or 12 weeks of follow-up after completion of the scheduled 48 weeks treatment.

In SELECT-2, all adverse events were recorded during weekly clinic visits by the clinical site personnel. Flu-like adverse events were predefined to include arthralgia, chills, fever, headache, and myalgia. Under the statistical analysis plan for the trial, the reductions in flu-like adverse events were tested after four and 12 weeks of treatment and were statistically significant for all three Locteron doses (p < 0.001 at 12 weeks for each of the 320, 480 or 640 µg doses of Locteron). In addition to the weekly clinic reporting, flu-like adverse events were self reported daily by patients through an electronic patient reported outcome system (ePRO). The ePRO results will be reported at the upcoming AASLD meeting as detailed above.

Locteron Overview

Locteron, controlled-release interferon alpha 2b, is designed to offer key advantages compared to currently approved products, including reduced flu-like symptoms and rates of depression, and cutting in half the number of injections required. In contrast to Locteron, the currently approved products, Pegasys® and PEG-Intron, are immediate-release products that lack a controlled-release mechanism. The two-drug combination of interferon alpha and ribavirin serves as the current standard of care for the treatment of hepatitis C. The launch of the first direct-acting anti-viral (DAA) product, projected for 2011, will transform treatment of genotype-1 patients to a triple-drug therapy (interferon plus ribavirin plus DAA) and substantially raise cure rates. Other recent triple or quad drug combinations (including interferon plus ribavirin plus two DAA agents) have shown promise in early clinical testing, further solidifying the continued role of interferon in the treatment of hepatitis C. It is estimated that worldwide sales of interferon products for the treatment of hepatitis C will approach $6 billion by 2016.

Locteron incorporates an advanced controlled-release drug delivery technology that allows dosing once every two weeks, more convenient than Pegasys and PEG-Intron, each of which require dosing every week. More importantly, Locteron's controlled-release mechanism results in the gradual release of interferon alpha 2b to patients over the duration of two weeks and avoids the early peak plasma levels of the active interferon that characterize the pegylated interferons. This controlled-release mechanism is designed to reduce the frequency and severity of flu-like symptoms and depression commonly experienced by patients treated with pegylated interferons.

About Biolex Therapeutics

Biolex is a biopharmaceutical company that uses its patented LEX System(SM) to develop follow-on biologics, hard-to-make therapeutic proteins and to optimize monoclonal antibodies. The LEX System is a novel technology that genetically transforms the aquatic plant Lemna to enable the production of biologic product candidates. The company's product candidates are designed to provide best-in-class efficacy/tolerability profiles while incorporating proven mechanisms of action. Biolex's lead product candidate, Locteron®, is in Phase 2b clinical testing for the treatment of chronic hepatitis C. Biolex has also developed two other product candidates that capitalize on the benefits of the LEX System. BLX-155 is a direct-acting thrombolytic designed to dissolve blood clots in patients. BLX-301 is a humanized anti-CD20 antibody glyco-optimized for the treatment of non- Hodgkin's B-cell lymphoma and other diseases.


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