Target Health Will Be at DIA Again this Year

 

Target Health will again be exhibiting at DIA, in Boston this year (June 24-27).  We will be in Booth #226. In addition, Dr. Mitchel will be presenting in an eSource Symposium on Thursday between 9:00-10:30am. His talk is entitled “Time to Change the Clinical Trial Monitoring Paradigm.  Results From Clinical Trials Using eSource and Risk-based Monitoring.”

 

For more information about Target Health contact Warren Pearlson (212-681-2100 ext. 104). For additional information about software tools for paperless clinical trials, please also feel free to contact Dr. Jules T. Mitchel or Ms. Joyce Hays. The Target Health software tools are designed to partner with both CROs and Sponsors. Please visit the Target Health Website.

Quest for Edible Malarial Vaccine Leads to Other Potential Medical Uses for Algae

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The edible algae Chlamydomonas, seen here at UC San Diego, can be grown in ponds anywhere in the world. (Credit: SD-CAB)

 

Malaria afflicts 225 million people worldwide, primarily in the tropics.

 

Can scientists rid malaria from the Third World by simply feeding algae genetically engineered with a vaccine? That’s the question biologists at UC San Diego sought to answer after they demonstrated last May that algae can be engineered to produce a vaccine that blocks 1) ___ transmission. In a follow up study, published online in Applied and Environmental Microbiology (19 April 2013), results showed that the same method may work as a vaccine against a wide variety of viral and bacterial infections. In their most recent study, the authors fused a protein that elicits an antibody response in mice against the organism that causes malaria, Plasmodium falciparum, with a protein produced by the bacterium responsible for cholera, Vibrio cholera, that binds to intestinal epithelial cells. They then 2) ___ engineered algae to produce this two-protein combination, or “fusion protein,” freeze dried the algae and later fed the resulting green powder to mice. The researchers hypothesized that together these proteins might be an effective oral vaccine candidate when delivered using algae.

 

Results showed that mice developed Immunoglobulin A (IgA) antibodies to both the malarial parasite protein and to a toxin produced by the cholera bacteria. Because IgA antibodies are produced in the gut and mucosal linings, they don’t protect against the malarial parasites, which are injected directly into the bloodstream by mosquitoes. But their study suggests that similar fusion proteins might protect against infectious diseases that affect mucosal linings using their edible freeze-dried 3) ___.

 

“Many bacterial and viral infections are caused by eating tainted food or water,” says Stephen Mayfield, a professor of biology at UC San Diego who headed the study. “So what this study shows is that you can get a really good immune response from a recombinant protein in algae that you feed to a mammal. In this case, it happens to be a mouse, but presumably it would also work in a 4) ___. That’s really encouraging for the potential for algae-based vaccines in the future.”

 

The authors suggest bacterial infections caused by Salmonella, E. coli and other food and water-borne pathogens could be prevented in the future with inexpensive vaccines developed from algae that could be eaten rather than 5) ___. “It might even be used to protect against cholera itself,” said James Gregory, a postdoctoral researcher in Mayfield’s lab and the first author of the paper. In his experiments with mice, he said, Immunoglobulin G (IgG) antibodies — which are found in blood and tissues — were produced against the cholera toxin, “but not the malaria antigen and it is not known why.”

 

Part of the difficulty in creating a vaccine against malaria is that it requires a system that can produce structurally complex proteins that resemble those made by the parasite, thus eliciting antibodies that disrupt malaria transmission. Most vaccines created by engineered bacteria are relatively simple proteins that stimulate the body’s immune system to produce antibodies against bacterial invaders.

 

Three years ago, a UC San Diego team of biologists headed by Mayfield, who is also the director of the San Diego Center for Algae Biotechnology, a research consortium seeking to develop transportation fuels from algae, published a landmark study demonstrating that many complex human therapeutic proteins, such as monoclonal antibodies and growth hormones, could be produced by the common algae Chlamydomonas. The authors hypothesized that complex malarial transmission blocking vaccine candidates could also be produced by Chlamydomonas. Two billion people live in malaria endemic regions, making the delivery of a malarial vaccine a costly and logistically difficult proposition, especially when that 6) ___ is expensive to produce. So the authors set out to determine if this alga, an organism that can produce complex proteins very cheaply, could produce malaria proteins that would inhibit infections from malaria.

 

“It’s too costly to vaccinate two billion people using current technologies,” explained Mayfield. “Realistically, the only way a malaria vaccine will ever be used in the developing world is if it can be produced at a fraction of the cost of current vaccines. Algae have this potential because you can grow algae any place on the planet in ponds or even in bathtubs.”

 

While collaborating with Joseph Vinetz, a professor of medicine at UC San Diego and a leading expert in tropical diseases who has been working on developing vaccines against malaria, the authors showed in their earlier study, published in the open access journal PLoS ONE last May that the proteins produced by the algae, when injected into laboratory mice, made 7) ___ that blocked malaria transmission from mosquitoes. The next step was to see if they could immunize mice against malaria by simply feeding the genetically engineered algae. The Holy Grail is to develop an orally delivered vaccine, and the authors predict that it may be able to be done it in algae, and for about a penny a dose. As a first step, the algae-produced malarial vaccine works against malarial parasites in mice, but it needs to be injected into the bloodstream.”

 

Although an edible malarial vaccine is not yet a reality, he adds, this study shows that one can make a pretty fancy protein using algae, deliver it to the gut and get IgA antibodies that recognize that protein. The authors concluded that they now have a system that can deliver a complex protein to the right place and develop an 8) __ response to provide protection.

 

Mayfield is also co-director of the Center for Food & Fuel for the 21st Century, a new research unit that has brought together researchers from across the campus to develop renewable ways of improving the nation’s food, fuel, pharmaceutical and other bio-based industries and is this week hosting a major symposium on the subject at the Institute of the Americas at UC San Diego.

 

First Vaccine to Help Control Some Autism Symptoms

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A first-ever vaccine created by University of Guelph researchers for gut bacteria common in autistic children may also help control some autism symptoms. (Credit: © Richard Villalon / Fotolia)

 

 

A first-ever vaccine created for 9) ___ bacteria common in autistic children may also help control some autism symptoms. The groundbreaking study by Brittany Pequegnat and Guelph, Ontario chemistry professor Mario Monteiro appeared in the journal Vaccine (26 April 2013). The vaccine is a carbohydrate-based drug product against the gut bug Clostridium bolteae. C. bolteae is known to play a role in gastrointestinal disorders, and it often shows up in higher numbers in the GI tracts of autistic children than in those of 10) ___ kids. More than 90% of children with autism spectrum disorders suffer from chronic, severe gastrointestinal symptoms, and of those, about 75% suffer from diarrhea

.

Although most infections are handled by some antibiotics, a vaccine would improve current treatment. This is the first vaccine designed to control constipation and diarrhea caused by C. bolteae and perhaps control autism-related symptoms associated with this microbe.

 

Autism cases have increased almost sixfold over the past 20 years, and scientists don’t know why. Although many experts point to environmental factors, others have focused on the human gut. Some researchers believe toxins and/or metabolites produced by gut bacteria, including C. bolteae, may be associated with symptoms and severity of 11) ___, especially regressive autism.

 

The authors used bacteria grown by Mike Toh, a Guelph PhD student. The new anti- C. bolteae vaccine targets the specific complex polysaccharides, or carbohydrates, on the surface of the bug. The vaccine effectively raised C. bolteae-specific antibodies in rabbits. Doctors could also use the vaccine-induced antibodies to quickly detect the bug in a clinical setting.

 

The vaccine might take more than 10 years to work through preclinical and human trials, and it may take even longer before a drug is ready for market. But this is a significant first step in the design of a multivalent vaccine against several autism-related gut bacteria. Monteiro has studied sugar-based vaccines for two other gastric pathogens: Campylobacter jejuni, which causes travelers’ 12) ___; and Clostridium difficile, which causes antibiotic-associated diarrhea.

 

The research was supported by the Natural Sciences and Engineering Research Council.

 

New Discovery May Lead the Way to Improved Whooping Cough Vaccine

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Scientists at Trinity College Dublin have made novel discoveries concerning the current vaccine against whooping cough that may lead to the development of an improved future vaccine. The findings could help reduce the incidence of the disease which is increasing in developed countries. The research led by Professor of Experimental Immunology, Kingston Mills was published in the journal PLoS Pathogens (4 April 2013). A new vaccine against whooping cough, caused by the bacteria Bordetella pertussis was first introduced to the routine vaccination schedule for infants and children in most developed countries, including Ireland over a decade ago. Prior to the introduction of this vaccine, children were immunized with a vaccine made from whole 13) ___. Although this ‘whole cell pertussis vaccine’ was effective at preventing the infection, it had been associated with side effects. Dissatisfaction with that vaccine led to the development of an ‘acellular pertussis vaccine’ made from components of the bacteria combined with an adjuvant to boost immune responses. Following its introduction in the late 1990s, the new vaccine has proved to be very safe and has been effective in controlling the potentially fatal disease of whooping cough in children. However, protective immunity conferred with the vaccine falls quite quickly, necessitating frequent 14) ___ vaccinations. This fall off in the immunity may be contributing to the number of whooping cough cases which are increasing with quite dramatic increases reported in certain countries, including the US, Australia and the Netherlands.

 

Professor Kingston Mills’ research team at the School of Biochemistry and Immunology in the Trinity Biomedical Sciences Institute has discovered important mechanistic differences in the type of immune responses induced with the new ‘acellular’ and old ‘whole cell’ vaccine. The whole cell vaccine, although much more likely to cause adverse reactions in recipients, was capable of inducing strong cellular immune responses mediated by 15) ___ blood cells called T cells, in particular a type of T cell called Th1 cells. In contrast, the new acellular vaccine, although safer, was less effective in inducing cellular immunity, but instead induced immunity mediated by antibodies and another type of T cell called a Th17 cell.

 

Most vaccines include a component called an adjuvant to boost immune responses to the bacterial or viral antigens in the vaccine and the acellular pertussis vaccine uses an aluminum salt, called alum. However, the authors have shown that the vaccine could be improved further through the use of a different adjuvant. The current vaccine does not enhance the induction of Th1 cells, required for conferring optimum protective immunity against the bacteria. The study showed that by switching the adjuvant from alum to an adjuvant based on bacterial DNA, they could induce the crucial Th1 cells and thereby enhance the efficacy of the vaccine against Bordetella pertussis infection in a murine model. The new vaccine has the potential to protect a higher proportion of immunized children using a lower number of doses. Commenting on the significance of the findings, Professor Mills said: “Although it will not be an easy task to implement, our findings should pave the way for an improved vaccine against whooping 16) ___ in children.”

 

ANSWERS: 1) malaria; 2) genetically; 3) algae; 4) human; 5) injected; 6) vaccine; 7) antibodies; 8) immune; 9) gut; 10) healthy; 11) autism; 12) diarrhea; 13) bacteria; 14) booster; 15) white; 16) cough

Dr. Maurice Ralph Hillemann: Pioneer of Vaccines (1919-2005)

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Hilleman c. 1958, as chief of the Dept. of Virus Diseases, Walter Reed Army Medical Center

 

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Jeryl Lynn Hilleman with her sister, Kirsten, in 1966 as a doctor gave her the mumps vaccine developed by their father

 

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Credit: Merck & Co. Inc. – Dr. Maurice Hillemann and his team developed more than 40 vaccines, including ones for measles, mumps, chickenpox, rubella, hepatitis A and B, and meningitis

 

Dr. Maurice R. Hilleman, was a microbiologist who developed vaccines for mumps, measles, chickenpox, pneumonia, meningitis and other diseases, saving tens of millions of lives. At the time of his death in 2005, he was credited with having saved more lives than any other scientist in the 20th century. Over his career, he devised or substantially improved more than 25 vaccines, including 9 of the 14 now routinely recommended for children.

 

Diseases that were routine hazards of childhood for many Americans living today now seem like ancient history. And while every mother could once identify measles in a heartbeat, now even the best hospitals have to call in their eldest staff members to ask: “Is this what we think it is?”

 

At 1 a.m. on March 21, 1963, Maurice Hilleman was asleep at his home in the Philadelphia suburb of Lafayette Hill when his 5-year-old daughter, Jeryl Lynn, woke him with a sore throat. Dr. Hilleman felt the side of her face and then the telltale swelling beneath the jaw indicating mumps. He tucked her back into bed, about the only treatment anyone could offer at the time. He quickly dressed and drove 20 minutes to pick up proper sampling equipment from his laboratory. Returning home, he woke Jeryl Lynn long enough to swab the back of her throat and immerse the specimen in a nutrient broth. Then he drove back to store it in the laboratory freezer. While the name Maurice Hilleman may not ring a bell, but today 95% of American children receive the M.M.R. – the vaccine for measles, mumps and rubella that Dr. Hilleman invented, starting with the mumps strain he collected that night from his daughter. In the US, the strain that Dr. Hilleman collected from his daughter that night in 1963 has reduced the incidence of mumps to fewer than 1,000 cases a year, from 186,000.

Hilleman was born on a farm near the high plains town of Miles City, Montana. His parents were Anna and Gustav Hillemann, and he was their eighth child. His twin sister died when he was born, and his mother died two days later. He was raised in the nearby household of his uncle, Robert Hilleman, and worked in his youth on the family farm. He credited much of his success to his work with chickens as a boy; chicken eggs are often used to develop vaccines based on weakened viruses.

 

Hilleman graduated first in his class from Montana State University with family help and scholarships. He won a fellowship to the University of Chicago and received his doctoral degree in microbiology in 1941. His doctoral thesis was on chlamydia, which was then thought to be caused by a virus. Hilleman showed that the disease was in fact caused by an unusual bacteria which grew only inside of cells. After joining E.R. Squibb & Sons (now Bristol-Myers Squibb), Hilleman developed a vaccine against Japanese B encephalitis, a disease that threatened American troops in the Pacific Ocean theater of World War II. As chief of the Department of Respiratory Diseases at Army Medical Center (now the Walter Reed Army Institute of Research) from 1948 to 1958, Hilleman discovered the genetic changes that occur when the influenza virus mutates, known as shift and drift. That helped him to recognize that an outbreak of flu in Hong Kong could become a huge pandemic. Working on a hunch, he and a colleague found (after nine 14-hour days) that it was a new strain of flu that could kill millions. Forty million doses of vaccines were prepared and distributed. Although 69,000 Americans died, the pandemic could have resulted in many more US deaths. Hilleman was awarded the Distinguished Service Medal from the American military for his work.

 

In 1957, Hilleman joined Merck & Co. (Whitehouse Station, New Jersey), as head of its new virus and cell biology research department in West Point, Pennsylvania. It was while with Merck that Hilleman developed most of the forty experimental and licensed animal and human vaccines he is credited with, working both at the laboratory bench as well as providing scientific leadership.

 

The general practice on how to develop a vaccine was to isolate a disease organism, figure out how to keep it alive in the laboratory, then weaken or “attenuate” it by passing it over and over through a series of cells, typically from chicken embryos, until it could no longer reproduce in humans but could still elicit an immune response.

 

In 1963, the FDA also granted the first license for a vaccine against measles. Much of the early work on the virus had been done in the laboratory of John F. Enders at Boston Children’s Hospital, but the vaccine still commonly produced rashes and fevers when Dr. Hilleman began to work on it. Under pressure from public health officials to stop a disease then killing more than 500 American children every year, Dr. Hilleman and Dr. Joseph Stokes, a pediatrician, devised a way to minimize the side effects by giving a gamma globulin shot in one arm and the measles vaccine in the other. Dr. Hilleman then went on to refine the vaccine over the next four years, eventually producing the much safer Moraten strain that is still in use today. As always, he kept himself in the background: The name stands for “more attenuated enders.”

 

One other crucial event in the development of M.M.R. happened that spring of 1963: An epidemic of rubella began in Europe and quickly swept around the globe. In this country, the virus’s devastating effect on first-trimester pregnancies caused about 11,000 newborns to die. An additional 20,000 suffered birth defects, including deafness, heart disease and cataracts. Dr. Hilleman was already testing his own vaccine as the epidemic ended in 1965. But he agreed to work instead with a vaccine being developed by federal regulators. By 1969, Merck obtained FDA approval thus preventing another rubella epidemic. Finally, in 1971, Hilleman put his vaccines for measles, mumps and rubella together to make M.M.R., replacing a series of six shots with just two.

Or rather not finally. In 1978, having found a better rubella vaccine than his own, Dr. Hilleman asked its developer if he could use it in the M.M.R. The developer, Dr. Stanley Plotkin, then of the Wistar Institute in Philadelphia. It was an expensive choice for Merck, and might have been a painful one for anyone other than Dr. Hilleman. Once he decided that this strain was better, he did what he had to do, even if it meant sacrificing his own work.

 

Given Dr. Hilleman’s obsession with safety and effectiveness, it came as a bitter surprise toward the end of his life, The Lancet, a respected British medical journal, published an article alleging that M.M.R. had caused an epidemic of autism. The lead author, Dr. Andrew Wakefield, became a media celebrity, and some parents began to balk at having their children immunized; the vaccine’s very success had made them forget just how devastating measles, mumps and rubella could be. Since that time, multiple independent studies would eventually demonstrate that there is no link between M.M.R. and autism, and Dr. Wakefield’s work has been widely discredited. In 2010, the British medical authorities stripped him of the right to practice medicine, and The Lancet retracted the 1998 article. However, it came too late, not just for Dr. Hilleman, who by then had died of cancer, but also for many parents who mistakenly believed that avoiding the vaccine was the right way to protect their children. In 2011 alone, a measles outbreak in Europe sickened 26,000 people and killed 9.

 

But Dr. Hilleman would probably still find reason to be encouraged. The Measles and Rubella Initiative, a global campaign organized in 2001, has given the M.M.R. vaccine to a billion children in this century, preventing 9.6 million deaths from measles alone, for less than $2 a dose. According to Dr. Stephen L. Cochi, a global immunization adviser at the C.D.C., the initiative is “on the verge of setting a target date” to eradicate the disease.

 

Much of modern preventive medicine is based on Dr. Hilleman’s work, though he never received the public recognition of Salk, Sabin or Pasteur. He is credited with having developed more human and animal vaccines than any other scientist, helping to extend human life expectancy and improving the economies of many countries.

 

One of Dr. Hilleman’s goals was to develop the first licensed vaccine against any viral cancer. He achieved it in the early 1970’s, developing a vaccine to prevent Marek’s disease, a lymphoma cancer of chickens caused by a member of the herpes virus family. Preventing the disease helped revolutionize the economics of the poultry industry.

 

Dr. Hilleman’s vaccines have also prevented deafness, blindness and other permanent disabilities among millions of people, a point made in 1988 when President Ronald Reagan presented him with the National Medal of Science, the nation’s highest scientific honor. Source: The New York Times: Lawrence K. Altman MD and Richard Conniff, May 6, 2013

VACCINES

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Why a Flu Vaccine is a Good Idea as Flu in Pregnancy May Quadruple Child’s Risk For Bipolar Disorder

 

According to an article published online in JAMA Psychiatry (8 May 2013), Pregnant mothers’ exposure to the flu was associated with a nearly fourfold increased risk that their child would develop bipolar disorder in adulthood. The findings add to mounting evidence of possible shared underlying causes and illness processes with schizophrenia, which some studies have also linked to prenatal exposure to influenza.

 

According to the authors, prospective mothers should take common sense preventive measures, such as getting flu shots prior to and in the early stages of pregnancy and avoiding contact with people who are symptomatic. However, in spite of public health recommendations, only a relatively small fraction of such women get immunized. The weight of evidence now suggests that benefits of the vaccine likely outweigh any possible risk to the mother or newborn.”

 

Although there have been hints of a maternal influenza/bipolar disorder connection, the new study is the first to prospectively follow families in the same HMO, using physician-based diagnoses and structured standardized psychiatric measures. Access to unique Kaiser-Permanente, county and Child Health and Development Study databases made it possible to include more cases with detailed maternal flu exposure information than in previous studies.

 

For the study, among nearly a third of all children born in a northern California county during 1959-1966, the authors followed, 92 who developed bipolar disorder, comparing rates of maternal flu diagnoses during pregnancy with 722 matched controls. The nearly fourfold increased risk implicated influenza infection at any time during pregnancy, but there was evidence suggesting slightly higher risk if the flu occurred during the second or third trimesters. Moreover, the authors linked flu exposure to a nearly sixfold increase in a subtype of bipolar disorder with psychotic features.

 

A previous study, by the same authors, in a related northern California sample, found a threefold increased risk for schizophrenia associated with maternal influenza during the first half of pregnancy. Autism has similarly been linked to first trimester maternal viral infections and to possibly related increases in inflammatory molecules.

 

Bipolar disorder shares with schizophrenia a number of other suspected causes and illness features. For example, both share onset of symptoms in early adulthood, susceptibility genes, run in the same families, affect nearly 1% of the population, show psychotic behaviors and respond to antipsychotic medications.

 

Increasing evidence of such overlap between traditional diagnostic categories has led to the NIMH Research Domain Criteria (RDoC) project, which is laying the foundation for a new mental disorders classification system based on brain circuits and dimensional mechanisms that cut across traditional diagnostic categories.

 

VACCINES

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Results of the Rotavac Rotavirus Vaccine Study in India

 

Highly contagious rotaviruses are the leading cause of severe diarrheal illnesses among infants and young children in both developed and resource-limited countries. Each year, rotavirus-induced diarrheal disease kills roughly 435,000 children younger than 5 years old and hospitalizes an estimated two million children worldwide, largely in developing countries. The youngest children — those between 6 months and 2 years of age — are most vulnerable.

 

Since 2006, two oral rotavirus vaccines have been licensed and available in North and South American, European and Eastern Mediterranean countries, where they have significantly reduced the burden of rotavirus-induced diarrhea. Based on that success, the World Health Organization recommended in 2009 the inclusion of rotavirus vaccine in all national immunization programs. However, access to vaccines can be slow and limited in the areas of the world where they are needed most.

 

ROTAVAC is a new rotavirus vaccine that consists of a strain of the virus that was isolated, manufactured and tested in India. The ROTAVAC rotavirus vaccine study represents a significant victory for India’s scientific community. Based on the study’s successful findings, infants in India will gain access to a licensed vaccine and its significant protection against severe rotavirus-induced gastroenteritis.

 

The National Institute of Allergy and Infectious Diseases (NIAID), part of the U.S. National Institutes of Health, was a partner in the public/private collaboration to develop and test this important vaccine. In the early 1990s, NIAID established an interagency agreement with the Centers for Disease Control and Prevention, and made several grant awards through the NIAID Indo-U.S. Vaccine Action Program.

 

These efforts fueled the early development and characterization of two neonatal non-disease-causing strains of Indian rotavirus (strains 116E and I321, respectively) as potential vaccine candidates. In 1997 and 1998, NIAID sponsored early clinical trials of the two vaccine candidates in healthy adults and healthy children. The studies were conducted at the Cincinnati Children’s Hospital, one of eight NIAID-funded Vaccine and Treatment Evaluation Units. NIAID provided the 116E vaccine strain — the particular strain tested in the ROTAVAC vaccine trial — to Bharat Biotech through a technology transfer agreement in 2000. The company adapted the strain and produced the investigational vaccines for both animal and human clinical studies.

 

NIAID, with gift funds from PATH, further sponsored Indian investigators and their U.S. collaborators for three Phase I studies in India involving the live, attenuated (weakened) 116E rotavirus vaccine and provided clinical site monitoring for these trials. The results of these studies, which were conducted among adults, children ages 2 to 12 years, and infants ages 6 to 9 weeks, provided the basis for Bharat to further develop the vaccine. NIAID provided biostatistical vaccine development, regulatory affairs and clinical operations support for the later-stage clinical trials and sequenced the 116E strain’s genome in 2008.

 

According to the NIH, no infant or child should die as the result of rotavirus-induced severe diarrhea.

TARGET HEALTH excels in Regulatory Affairs. Each week we highlight new information in this challenging area

 

FDA Approves Simponi to Treat Ulcerative Colitis

 

 

Ulcerative colitis is a chronic disease that affects about 620,000 Americans. It causes inflammation and ulcers in the inner lining of the large intestine and is one of two main forms of chronic inflammatory bowel disease. The inflammation can lead to abdominal discomfort, gastrointestinal bleeding, production of pus and diarrhea.

 

The FDA has approved a new use for Simponi (golimumab) injection to treat adults with moderate to severe ulcerative colitis. Simponi works by blocking tumor necrosis factor (TNF), which plays an important role in causing abnormal inflammatory and immune responses. Previously approved to treat rheumatoid arthritis, psoriatic arthritis and ankylosing spondylitis (arthritis affecting the joints in the spine and the pelvis), Simponi is now approved to treat adults with moderate to severe ulcerative colitis that is resistant (refractory) to prior treatment or requires continuous steroid therapy.

 

“Simponi is an important new treatment option for patients with moderate to severe ulcerative colitis,” said Andrew E. Mulberg, M.D., deputy director of the Division of Gastroenterology and Inborn Errors Products in the FDA’s Center for Drug Evaluation and Research. “It is critical that patients suffering from the serious and painful symptoms of ulcerative colitis have additional treatment options since patients experience the effects of the disease and respond to treatments differently.”

 

The safety and effectiveness of Simponi for ulcerative colitis were established in two clinical studies. Evaluations of patients included measures of stool frequency, rectal bleeding, endoscopic findings and a physician’s overall assessment. In the first study, 513 patients with moderate to severe ulcerative colitis who could not tolerate or failed to respond to other therapies were randomly assigned to receive Simponi or a placebo. Results showed that a greater proportion of Simponi-treated patients achieved clinical response, clinical remission and, as seen during endoscopy, had improved appearance of the colon after six weeks compared with the placebo group. In the second study, 310 patients with moderate to severe ulcerative colitis who were responders to Simponi were randomly assigned to receive Simponi or placebo. A greater proportion of Simponi-treated patients maintained clinical response through week 54 and had clinical remission at both weeks 30 and 54.

 

The most common side effects in patients treated with Simponi are upper respiratory infection and redness at the site of injection. Patients treated with Simponi are at increased risk of developing serious infections, invasive fungal infections, reactivation of Hepatitis B infection, lymphoma, heart failure, nervous system disorders and allergic reactions.

 

Simponi is marketed by Horsham, Penn.-based Janssen Biotech, Inc.

 

Chickpea Feta Tomato Turmeric Salad

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This salad is so-o refreshing during warm weather. We’ve had it many, many times and never get tired of it.

 

 

1/2 to 1 cup toasted pine nuts
2/3 cup fresh cilantro, chopped
1/2 cup fresh mint, chopped
1 clove garlic, juiced
1 clove garlic, chopped
1 teaspoon turmeric
2 Tablespoons fresh lime juice
Pinch black pepper (or grind to your taste)
2 Tablespoons extra-virgin olive oil
1 onion, finely chopped
1 celery stalk, finely chopped
1 tomato, chopped
1 can (15-16 ounce) chickpeas, rinsed and drained well on paper towel
1 cup crumbled feta

 

Directions

 

Heat a dry 8-inch skillet over medium heat . Add onion, the chopped garlic, turmeric and stir for 1 minute or until fragrant. Add pine nuts and toast until golden, then remove from heat.

 

In a bowl, put the chopped celery, tomato pieces, chickpeas, cilantro and mint. Stir together.

 

Dressing: In a smaller bowl, whisk together lime juice, pepper, one clove garlic juice, until combined. Add oil, whisking until blended.

 

Place onion-garlic-nut mixture in large bowl and pour in dressing. Place celery, tomato and chickpea mixture on top of onion-nuts, without mixing. Cover and refrigerate 15 minutes.

 

15 minutes later, add feta to bowl, toss to combine and serve.

 

This salad is so tasty and health-wise, so well balanced (protein-fat-carbs), that it could stand on its own with, say, some sesame bread sticks and white wine with fruit & cheese.

 

However, it would go well with any of your favorite fish dishes with basmati rice or an easy pasta. Also, if you plan an outdoor barbecue soon, this would be a perfect salad for one of those, no matter what you’re serving. We don’t know much about beer, but guessing that this salad would go well, wherever ice cold beer is being served.

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You can use chopped basil instead of cilantro, or any of your favorite fresh herbs, or a mixture of fresh herbs.

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Cheers!