Blog of M.D. King

Intercell Starts A Phase I Clinical Trial For A New Vaccine To Prevent Clostridium Difficile Infections

admin — Wed, 22 Feb 2012 18:21:00 +0000

Intercell AG (VSE: ICLL) today announced that a Phase I clinical trial with the company’s vaccine candidate IC84 to prevent disease caused by the bacterium Clostridium difficile (C. difficile) has started. The pathogen is one of the main causes of nosocomial diarrhea.

Intercell’s vaccine candidate is a recombinant protein vaccine consisting of two truncated toxins A and B from Clostridium difficile. The toxins are known to be disease-causing and anti-toxin immunity can be protective. The vaccine candidate will be tested with or without the adjuvant aluminum hydroxide.
This Phase I trial is a first-in-man study to obtain safety and immunogenicity data in a small population of healthy adults aged 18-65 years in the first part of the study as well as from healthy elderly subjects above 65 years of age in a second part of the study, the latter age group representing the main target population for a Clostridium difficile vaccine. 60 healthy adults and up to 100 elderly subjects will be enrolled in this open-label study. Three different alum-adjuvanted vaccine concentrations will be tested; two of the three vaccine concentrations will also be tested without adjuvant.

“The initiation of this clinical Phase I trial is an important step to further strengthen Intercell’s leading position in the development of vaccines against hospital-acquired infections”, commented Intercell’s COO, Thomas Lingelbach.

There is no vaccine available against Clostridium difficile, which represents the leading cause of nosocomial diarrhea in the U.S. and EU and is an increasing burden to the health care system. The disease affects in particular elderly patients with prolonged antibiotic treatment and patients with underlying co-morbidities or immunocompromising conditions. Antibiotic treatment is the current standard of care of Clostridium difficile-associated disease but has its limitations due to increasing treatment failures attributable to antibiotic resistance and disease relapse in up to 30% of patients after discontinuation of the treatment.

Potential indications for a Clostridium difficile vaccine include community prophylaxis for the elderly, prophylaxis in hospitalized patients with particular risk factors for Clostridium difficile-associated disease and the prevention of relapsing disease.

* Intercell starts a Phase I clinical trial for a new vaccine to prevent Clostridium difficile infections (.pdf, 204kB)

Source:
Intercell

USA Today Examines Cost, Coverage Issues For Retirees

admin — Tue, 21 Feb 2012 18:17:00 +0000

USA Today on Monday examined how as “Americans live longer and health care costs surge, underestimating the impact of medical costs could dash … plans for a comfortable retirement.” According to estimates from Fidelity Investments, couples who retire at age 65 will require — in addition to Medicare coverage — about $200,000 to cover 20 years of health care costs, which excludes the cost of over-the-counter medications, dental services and long-term care. Individuals who retire before age 65 and do not receive health insurance through their former employers should try to obtain coverage unless they “can afford a serious illness, which could run $100,000 to $200,000,” Gary Claxton, a Kaiser Family Foundation vice president and director of its Health Care Marketplace Project, said. Gail Shearer of Consumers Union, which publishes Consumer Reports, said health insurance options for early retirees are “very bleak.” Some options include health insurance though the employers of spouses, coverage through COBRA and coverage through individual plans, USA Today reports. In addition, early retirees should expect that health insurance premiums will increase annually and that those with histories of significant medical problems “might not be able to get coverage at any price,” according to USA Today. Some states have high-risk insurance pools for individuals who cannot obtain health insurance because of histories of significant medical problems, although some of those have long waiting lists. Shearer said, “It’s … a reason that Congress should do something to extend Medicare coverage to younger age groups, even if people have to pay the full premium themselves.” Even retirees ages 65 and older are not “home free” because Medicare requires beneficiaries to pay “significant costs” for some medical procedures and does not cover others, USA Today reports (USA Today, 6/26).

“Reprinted with permission from kaisernetwork. You can view the entire Kaiser Daily Health Policy Report, search the archives, or sign up for email delivery at kaisernetwork/dailyreports/healthpolicy. The Kaiser Daily Health Policy Report is published for kaisernetwork, a free service of The Henry J. Kaiser Family Foundation . © 2005 Advisory Board Company and Kaiser Family Foundation. All rights reserved.

Baltimore Sun Examines HIV/AIDS-Related Literature, Art in South Africa

admin — Mon, 20 Feb 2012 18:13:00 +0000

The Baltimore Sun on Sunday examined the “new genre” of AIDS-related art and literature in South Africa, which “is unabashed in its effort to raise consciousness about the virus, in the same way that 20th century anti-apartheid writing was often explicit in its efforts to show the evils of that racially repressive system.” Writers and artists recently have created HIV-positive characters who are “recognizable and surprising, different from one another and believable,” including businesswomen, commercial sex workers and truckers, according to the Sun. Some of the pieces are “subtle” in their attempts to increase awareness about HIV/AIDS, while others “treat the virus as a powerful, but beatable, enemy,” the Sun reports. The genre can “sometimes seem repetitive and unremitting,” challenging the writers and artists to be original and at the same time “reflect the mass devastation crippling South Africa,” according to the Sun (Hanes, Baltimore Sun, 10/23).

New Technology Aims To Repair The After-Effects Of Gum Disease

admin — Sun, 19 Feb 2012 18:09:00 +0000

Advances in tissue engineering are offering the promise of being able to restore lost bone and gum tissue following periodontal disease.

About a third of the population are affected by chronic inflammatory gum disease which can result in loss of the bone and other tissues that support our teeth.

Professor Saso Ivanovski, Listerine Chair in Periodontology at Griffith’s School of Dentistry and Oral Health, said even when the infection or inflammation was brought under control, people can be left with an unsightly appearance and poor function.

The colloquial expression ‘long in the tooth’ is often used to describe people and things of a significant age, however the unsightly effects of severe gum disease and gum retraction leading to wobbly teeth are not confined to the elderly.

“Smoking, uncontrolled diabetes, stress and genetic susceptibility are some of the risk factors for gum disease, which affects people of all ages,” he said.

Advanced disease affects about 10 per cent of the population.

Over recent years, Professor Ivanovski’s research at the Griffith Institute for Health and Medical Research has been focussed on growing layers of cells such as stem cells and gingival (gum) fibroblasts for restoring damaged smiles.

“Previous work was involved in looking at the growth factors and optimal cell types for regenerating destroyed tissue.”

“Now we are using new technology to harvest sheets of these cell cultures and transfer them safely to the surface of the tooth root,” he said.

Laboratory studies indicate that the cells can be successfully grafted with periodontal repair taking about six months.

Professor Ivanovski said the technique had already been shown to be useful in other applications such as harvesting cells for skin grafts and other injured tissues.

His research has recently been given a significant boost with funding from a National Health and Medical Research Council Project Grant.

The research is conducted in collaboration with Professor Dietmar Hutmacher and Associate Professor Yin Xiao from the Queensland Institute for Technology.

Source:
Mardi Chapman
Research Australia

Pharmaceutical, Biotechnology Industries Hesitant To Make Large Investments In AIDS Vaccine Research, IAVI Says

admin — Sat, 18 Feb 2012 18:05:00 +0000

Many pharmaceutical manufacturers and biotechnology companies have hesitated to make large investments with their own funds in AIDS vaccine research because of scientific and financial risks, according to the International AIDS Vaccine Initiative, the Newark Star-Ledger reports. IAVI said pharmaceutical and biotechnology firms in 2005 spent about 10% of the estimated $759 million on AIDS vaccine development, and three of the 30 companies involved in AIDS vaccine research invested more than $5 million of their own money. Robert Hecht, vice president of IAVI, said pharmaceutical firms are concerned that they might not be able to recover their long-term investments in drug research, in part because HIV prevalence is highest in developing countries that cannot afford to pay for treatment. Worldwide funding for vaccine research has doubled over the last five years in large part because of increases in U.S. government funding which totaled $574 million in 2005. However, as federal and philanthropic funding — such as commitments of $287 million by the Bill & Melinda Gates Foundation — have increased, the estimated private sector investment has decreased. IAVI said private sector funding dropped from $99 million in 2002 to $75 million in 2005. “We need industry to be more involved in this search for an AIDS vaccine because they bring unique skills and resources to challenge that no one else can,” Hecht said, adding, “They bring a very disciplined approach to project management and conducting clinical trials. They know about the bioengineering and manufacturing possibilities.” Ken Johnson, senior vice president of the Pharmaceutical Research and Manufacturers of America, said that drug and biotechnology firms “have remained key players in the search for a vaccine, despite the difficulty of vaccine research and the fact their researchers have spent hundreds of millions of dollars on this important scientific effort so far” (Cohen, Newark Star-Ledger, 9/24).

Washington Post Examines Topics Discussed At XVI International AIDS Conference

admin — Fri, 17 Feb 2012 18:01:00 +0000

Although advocates, health care workers and scientists “long ago gave up the idea” that they could end the HIV/AIDS pandemic “with a single blow,” participants at the XVI International AIDS Conference — which ended on Friday in Toronto — discussed the idea that it “might be possible to bleed it to death with a thousand cuts,” the Washington Post reports. Various prevention strategies were discussed at the conference — including microbicides, male circumcision, herpes treatment, single doses of antiretroviral drugs taken before sex and providing universal access to HIV tests. In addition, several studies presented at the conference “provided yet more evidence” that increased access to antiretroviral drugs is a “great strategy for prevention,” the Post reports. In one of the “more provocative presentations,” Julio Montaner, director of British Columbia Centre for Excellence in HIV/AIDS, presented a mathematical model that predicted the outcome of treating all reported HIV cases worldwide. According to the model, global HIV prevalence decreased to “basically” zero by 2050, and treatment costs “took a clear downward turn” beginning in 2015 as the number of new HIV cases decreased, the Post reports. Mark Wainberg, co-chair of the conference and head of the McGill University AIDS Centre, said, “Treated people just simply become less infectious. This is win-win. This is not a subject that requires debate.” According to the Post, the “real power of treatment’s preventive effect is that it would synergize” with other prevention methods that might be made widely available over the next five to eight years. Although researchers and advocates are “hesitant to announce the dawning of an era of [HIV] prevention that could eventually lead to the epidemic’s end,” there was “little doubt the meeting ended on a note of optimism and anticipation,” the Post reports (Brown, Washington Post, 8/19).

Kaisernetwork served as the official webcaster of the conference. View the guide to coverage and all webcasts, interviews and a daily video round up of conference highlights at kaisernetwork/aids2006.

AP/Long Island Newsday Profiles Effort To Address HIV/AIDS Through Community Development In Kenya

admin — Thu, 16 Feb 2012 17:57:00 +0000

The AP/Long Island Newsday on Sunday examined the efforts of a mother-daughter team to reduce HIV/AIDS through community development in Kenya. Rosemell Ong’udi and her daughter, Loyce Mbewa-Ong’udi — who runs the Rabuor Village Project — have developed “community-owned” programs in which residents rather than donors set the priorities. According to the AP/Newsday, the project’s work “embodies what experts consider the most effective approach to development.”

In 10 years, the village of Rabuor has founded a nursery school and feeding program, a pharmacy, a youth group and income-generating projects with little international aid. Youth involved in the project also teach school and adult groups about HIV prevention, testing and treatment. The work has affected more than 10,000 people in 10 villages and continues to grow, according to the AP/Newsday. District Commissioner Godfrey Kigochi, a senior government official for Kisumu West, said he wishes he had a project similar to Rabuor’s in every village in the district. Organizations that provide funding or expertise to the Rabuor project also say it is “unique for its pragmatism and deep community roots,” the AP/Newsday reports. The Rev. Charles Ong’injo, who has been involved in the project since its launch, is helping other congregations launch similar projects.

Because residents were not prepared to discuss HIV/AIDS directly at the beginning of the program, it initially focused on increasing crop production, followed by projects aimed at earning incomes, keeping children in school and training adults in agriculture, nutrition and vocational skills. Although Loyce Mbewa-Ong’udi does not own land in Rabuor or live there — the project is based in Seattle — she said she recognizes the project can only work if villagers are involved.

According to the AP/Newsday, the village “is not utopia,” and residents often disagree over how the project should operate. However, “competing views are a sign of subsistence farmers becoming active citizens, of women speaking up,” the AP/Newsday reports. In addition, such disagreements are part of the reason why some people believe the project will work in the village in the long-term, compared with other projects that collapse when donors leave, the AP/Newsday reports (Borst, AP/Long Island Newsday, 8/17).

Reprinted with kind permission from kaisernetwork. You can view the entire Kaiser Daily Health Policy Report, search the archives, or sign up for email delivery at kaisernetwork/dailyreports/healthpolicy. The Kaiser Daily Health Policy Report is published for kaisernetwork, a free service of The Henry J. Kaiser Family Foundation.

Vaginal Bacteria Vary Among Healthy Women

admin — Wed, 15 Feb 2012 17:53:00 +0000

Silence may impact women’s health since few women or their doctors are comfortable talking about vaginal health openly. This hesitation, combined with a limited understanding of the differences between women, can lead to misinformation, misdiagnosis and potentially ineffective treatments. Research at the University of Idaho is helping to increase understanding about normal vaginal biology so that physicians can better identify conditions that make women prone to infections and other diseases, and avoid the development of health problems.

“Women suffer from insidious health problems, including bacterial vaginosis and yeast infections, and those problems send them in droves to seek medical treatment,” said Larry Forney, a professor of biology at the University of Idaho. “Unfortunately, prescribed treatments aren’t necessarily effective because doctors don’t understand distinctive differences in the microbial composition of the vagina among women.”

Forney’s interdisciplinary team of researchers found that the microbial ecosystem of the human vagina varies greatly among women. Those differences can lead to conditions that, if not diagnosed and treated correctly, may leave some women susceptible to a range of infections, including sexually transmitted diseases such as HIV.

His research team compared the type of vaginal bacteria in a representative group of Caucasian and black women in North America. Three major findings emerged from the study: there are at least eight kinds of normal vaginal bacterial communities, each community is different, and, among the eight kinds of communities, some bacterial communities are unique to one or the other racial group.

“Understanding the differences between these normal vaginal communities is the key to developing effective treatment and keeping women healthy,” Forney said. “For example, with this new insight into the vaginal ecosystem, we will be able to better understand a woman’s risk to disease and individual health care needs, and assist doctors and women to make more informed decisions about health issues and treatment plans.”

“It’s important for us to understand that the bacterial landscape in vaginas is different in different women and that’s normal,” Forney said. “Every speck of the human body has bacteria and those bacteria, including bacteria in the vagina, play a role in maintaining the body’s health.”

A healthy vagina is populated with lactic acid-producing bacteria, explained Forney. The environment maintains a low pH balance that inhibits the growth of pathogens. “The vagina is elegant in its simplicity,” he said. “A healthy vagina maintains itself and is able to self-correct when minor imbalances occur.”

When conditions in the vagina change the pH balance dramatically, harmful bacteria can invade and cause infections. When the pH is imbalanced, a condition known as bacterial vaginosis can develop; the condition is not well understood and is marked by several indicators including elevated pH levels and vaginal discharge. If left untreated or if treatment fails, the condition can predispose a woman to harm from sexually transmitted disease, including HIV.

Forney stressed the importance of the research team’s findings because they may:

– shed light on why some women have recurrent vaginal yeast infections, while others have never had one;

– partly explain differences in susceptibility to infection in the two racial groups, based upon the relative frequency of different kinds of bacterial communities in women.

Forney also said differences in the kinds of bacteria normally present in the vagina might mean that vaginal odor is normal for some women and not an indication of an underlying health problem.

The research has personal meaning for Forney as well. “I am vitally concerned about women’s health issues because I’ve got two daughters and I know that these issues will affect them.”

Forney’s team includes Xia Zhou, Celeste Brown and James Foster, from the department of biological sciences, University of Idaho; and Zaid Abdo and Paul Joyce, from the departments of mathematics and statistics department, University of Idaho.

About the University of Idaho

Founded in 1889, the University of Idaho is the state’s flagship higher-education institution and its principal graduate education and research university, bringing insight and innovation to the state, the nation and the world. University researchers attract nearly $100 million in research grants and contracts each year; the University of Idaho is the only institution in the state to earn the prestigious Carnegie Foundation ranking for high research activity. The university’s student population includes first-generation college students and ethnically diverse scholars. Its high academic performers include 42 National Merit Scholars and a 2006-07 freshman class with an average high school grade point average of 3.42. Offering more than 150 degree options in 10 colleges, the university combines the strengths of a large university with the intimacy of small learning communities. For information, visit uidaho.edu.

University of Idaho
PO Box 443221
Moscow, ID 83843
United States
uidaho.edu

Reducing the Risk of West Nile Virus, Public Health Agency of Canada

admin — Tue, 14 Feb 2012 17:49:00 +0000

With the onset of mosquito season, Public Health Agency of Canada is reminding Canadians to take preventative measures to
protect themselves from West Nile Virus.

Despite a significant decrease in human cases in 2004 – possibly due in part to unseasonably cool and wet conditions much of
Canada saw in the spring and summer months – Canadians are still at risk for contracting West Nile Virus.

“Prevention is the best medicine when it comes to protecting yourself from West Nile Virus,” said Dr. David Butler-Jones,
Canada’s Chief Public Health Officer. “We know that the virus is here to stay. Canadians can reduce the risk of becoming ill
by taking appropriate measures to avoid becoming infected,” he said.

West Nile Virus is spread by mosquitoes that have fed on the blood of infected birds. The virus can cause health
complications for people of any age and health status, but the extent and severity of symptoms varies from person to person.
Most people who contract West Nile Virus show no symptoms or have a mild flu-like illness with fever, headache and body
aches. Others – particularly older people and those with chronic disease and weakened immune systems – may experience more
serious health complications such as encephalitis, meningitis and other kinds of neurological illness. Some of these
complications can cause long-term health issues.

The greater risk of infection from West Nile Virus starts in Canada as early as mid-April and lasts until the first hard
frost in late October. At this time, there is no specific treatment or vaccine for the infection, so the best protection is
to reduce the risk of mosquito bites.

Canadians are advised again this year to eliminate sources of standing water on their properties to reduce potential mosquito
breeding places. Standing water should be drained regularly. For example eaves troughs and bird baths should be drained twice
a week, and unused items such as old tires, where water may collect should be removed from the property.

Once West Nile Virus has been reported in an area, the Public Health Agency recommends taking the following steps to reduce
the risk of infection:

– If you are going to be outside when mosquitoes are active, take appropriate precautions to protect yourself.
Contact your local public health authority to find out when you are more at risk.

– Make sure your door and window screens have no holes and fit tightly.

– Wear protective clothing such as long-sleeved shirts, long pants and a hat. Light coloured clothing is
best because mosquitoes tend to be attracted to dark colours.

– Choose an insect repellant that contains DEET or other approved ingredients, and follow the product
directions carefully to maximize protection. Personal insect repellants containing DEET are safe if used according to
manufacturers instructions.

There were 26 reported cases of West Nile Virus in 2004, with cases reported in Quebec, Ontario, Manitoba, Saskatchewan and a
single travel related case in Alberta. This represents a decline from 1,494 cases reported in 2003. The level of West Nile
Virus activity is influenced by many factors including weather conditions and by the number of infected birds and mosquitoes
in a region.

The Public Health Agency of Canada collaborates with its partners to co-ordinate national surveillance to detect the presence
of the virus as early as possible in any given area so that communities and individuals can take steps to reduce the risk.
Canadians can access more information on West Nile Virus by calling the toll-free line 1 800-816-7292 or by visiting the
Public Health Agency of Canada’s Web site at: westnilevirus.gc.

Media Inquiries:
Jean-Mathieu Dion
Public Health Agency of Canada
(613) 948-7970

Health Canada

Mother’s Immune System May Block Fetal Treatments For Blood Diseases

admin — Mon, 13 Feb 2012 17:45:00 +0000

Pediatric researchers have resolved an apparent contradiction in the field of prenatal cell transplantation — a medical approach that holds future promise in correcting sickle cell disease and other serious congenital blood disorders. In a new study in animals, the researchers showed that the mother’s immune response interferes with the offspring’s earlier ability to tolerate transplanted donor cells.

The study team concludes that focusing on transplant techniques that avoid the maternal immune response may allow scientists to take advantage of fetal tolerance to achieve a long-sought goal of treating blood diseases prenatally.

While cautioning that much work must be done to understand how these animal findings apply to humans, the current findings are “surprising but reassuring,” said study leader Alan W. Flake, M.D., of the Children’s Center for Clinical Research at The Children’s Hospital of Philadelphia.

The study appeared online August 3 in the Journal of Clinical Investigation.

For over 50 years, explained Flake, it has been a fundamental precept of immunology that a fetus tolerates foreign antigens in a window-of-opportunity period before its immune system fully develops the capacity to mount an immune response. Scientists assumed that by carefully introducing donor cells and stimulating a fetus to develop tolerance to those cells, one could set the stage for a later organ or cellular transplant that would not be rejected by a more mature immune system.

As prenatal diagnosis has continued to become available for a greater number of congenital diseases, scientists have considered the possibility of correcting blood disorders such as sickle cell disease or thalassemia. After first transplanting a small number of healthy cells in an early-stage fetus to establish tolerance, a second dose of transplanted cells later in gestation would proliferate, and treat the blood disorder before birth. Researchers use hematopoietic cells — stem cells that that develop into blood cells — in this technique, in utero hematopoietic cell transplantation (IUHCT).

However, over the years, Flake’s team and other research groups found that IUHCT studies in animal models yielded inconsistent results, ranging from no tolerance to transplants to full tolerance and every degree of tolerance in between. Contrary to the concept of fetal tolerance, an immune barrier seemed to be acting against transplanted cells.

The current study, done in mice, solves the puzzle of an apparent immune barrier. Newborn mice (pups) that received cell transplants in utero were divided into two groups. Mice nursed by their biological mothers lost the transplanted donor cells, while mice nursed by foster mothers retained those donor cells.

The mothers whose fetuses received the donor cells transplants had developed antibodies against those cells, and subsequently transmitted those antibodies to their pups through breast milk. “Those antibodies in the breast milk triggered rejection of the transplanted blood cells in the pups,” said Flake. “But in the absence of a maternal immune response, we confirmed that immune tolerance does occur in the early-gestation fetus 100 percent of the time.”

Of course, mouse biology is not the same as human biology, and Flake added, “Mouse time is not the same as human time.” Because mice have such a brief gestational period, the mother’s immune response didn’t develop until after the birth of her pups, and was therefore transferred by breastfeeding. In large animals and humans, said Flake, the more likely route of maternal-to-fetal transmission would be through the placenta late in pregnancy, and not through postnatal breastfeeding.

However, it remains an open question whether the mouse findings are applicable to larger mammals and especially to humans. Flake’s study team is continuing their investigations in larger animal models.

Looking forward to techniques to avoid maternal immune reactions to prenatal cell transplants, Flake proposed two possibilities. One would be use the mother as a source of donor cells, which would not stimulate an unwanted immune response. Another strategy could involve inducing the generation of increased numbers of T regulatory cells; those cells normally act to prevent the fetus from inappropriately reacting against maternal cells.

The ultimate goal, said Flake, is to develop IUHCT as a prenatal treatment for any congenital blood disorder that may currently be treated with postnatal bone marrow transplants. That would include sickle cell disease, thalassemia, and some inherited immunodeficiency diseases. Currently such postnatal transplants are risky and relatively rare.

“Our current finding is not a clinical breakthrough,” added Flake. “But it does offer new potential to the field of cellular transplantation.”

Funds from the National Institutes of Health, the Ruth and Tristram C. Colket Jr. Chair of Pediatric Surgery at The Children’s Hospital of Philadelphia and the Albert M. Greenfield Foundation supported this study.

About The Children’s Hospital of Philadelphia: The Children’s Hospital of Philadelphia was founded in 1855 as the nation’s first pediatric hospital. Through its long-standing commitment to providing exceptional patient care, training new generations of pediatric healthcare professionals and pioneering major research initiatives, Children’s Hospital has fostered many discoveries that have benefited children worldwide. Its pediatric research program is among the largest in the country, ranking second in National Institutes of Health funding. In addition, its unique family-centered care and public service programs have brought the 430-bed hospital recognition as a leading advocate for children and adolescents.

Source: The Children’s Hospital of Philadelphia