Dr. Roger Kenneth
Hershline, PhD, MD, the CEO of Global Humanceuticals, Inc.
and founder and chairman of the not-for-profit public
charity Curehiv.us, announces that he is reaching out
to the funder community, including funding initiatives such as
the Grand Challenges in Global Health initiative. The monies
would be used to begin clinical studies of a new drug and
treatment method, LiSAVIOR.

This unique new drug is also known as compound NIAID #11039
and has received a patent from the United States with patent
number 6,821,958 on November 23, 2004. Also, the World
International Patent Organization published the
International Application Number as PCT/US2005/039528 on
November 5, 2006.

Dr. Hershline hosted Session V at the World AIDS Day
Conference in China from December 1 to December 3, 2006, to
initially present LiSAVIOR.

The proposed roadblock to cure HIV is that current drug and
vaccination treatments do not treat the growth of HIV in the
gastrointestinal tract. HIV virus multiplies and mutates in
the gastrointestinal tract and then is reabsorbed into the
blood. This process is known to occur when HIV infection
results from the use of contaminated needles or during
sexual intercourse. The gastrointestinal tract is comprised
of the mouth and its structures, the pharynx, the esophagus,
the stomach, the small intestines, the large intestines and
the anus.

The proposed solution to overcome this roadblock is the oral
clinical use of LiSAVIOR, a drug that is an early stage HIV
life cycle inhibitor. LiSAVIOR blocks not only viral entry
into cells but also cell-to-cell transfer of the virus.
LiSAVIOR is proposed to be used alone or with any known HIV
drug and vaccine therapy.

Pre-clinical efficacy testing of LiSAVIOR has shown that the
effective concentration of LiSAVIOR is found to be
equivalent to diluting a 1% solution of LiSAVIOR one million
times. LiSAVIOR is a dry, palatable, non-toxic powder that
is stable at room temperature and humidity.

“I am thinking in terms of problem solving. Traditional
commercial drug design and projects funding from the NIH has
completely ignored this approach to date,” stated Dr.
Hershline. “I think we have to talk in terms of a cure for
HIV. I want to cure HIV and that is why my foundation is
called CureHIV.us,” concluded Dr. Hershline.

Dr. Hershline is hopeful that the foundation community,
including the Grand Challenges in Global Health initiative,
looks into the work and progress that he has made towards
solving this problem and fills the gap in funding.

Dr. Hershline has a doctorate degree in drug design and a
medical degree. Pre-clinical development of LiSAVIOR has
been twenty years in the making. Despite the critical need
for such a unique and potentially lifesaving invention,
LiSAVIOR remains completely un-funded.

curehiv.us Continue reading →

Last year alone, Salmonella caused nearly 2,300 hospitalizations and 29 deaths. The U.S. Centers for Disease Control and Prevention tracks nine food borne illnesses and salmonella cases are up 10% over a 15 year period according to a new report released by the organization. E. coli is down. The rate of reported cases of E. coli O157 was two cases per 100,000 people in 1997 and, by 2010, had decreased to 0.9 cases per 100,000 people.

The CDC credits the reduction in E. coli to better detection and investigation of outbreaks, increased awareness by consumers and restaurants on the importance of properly cooking beef, and more regulation and testing of meat.

Last year, eggs tainted with Salmonella may have sickened as many as 56,000, the CDC estimated. Those cases probably contributed to the 2010 increase, said Dr. Christopher Braden, a CDC epidemiologist.

Salmonella is a pesky gram-negative, rod-shaped bacilli that can cause diarrheal illness in humans. They are microscopic living creatures that pass from the feces of people or animals to other people or other animals.

CDC director Dr. Thomas Frieden said:

“Although food borne infections have decreased by nearly one-fourth in the past 15 years, more than 1 million people in this country become ill from salmonella each year.”

Although anyone can get a Salmonella infection, older adults, infants, and people with impaired immune systems are at increased risk for serious illness. In these people, a relatively small number of Salmonella bacteria can cause severe illness.

Food poisoning was up too. More than 19,000 cases of food poisoning were reported in the last year, up from 17,500 in 2009 and 18,500 in 2008, the CDC said.

Other food borne illnesses such as vibrio, which are associated with shellfish, also increased in the U.S. There were just under 200 vibrio cases reported in 2010, more than double the numbers seen in the 1990s.

The Salmonella family includes over 2,300 serotypes of bacteria which are one-celled organisms too small to be seen without a microscope. Two serotypes, Salmonella Enteritidis and Salmonella Typhimurium are the most common in the United States and account for half of all human infections. Strains that cause no symptoms in animals can make people sick, and vice versa. If present in food, it does not usually affect the taste, smell, or appearance of the food. The bacteria live in the intestinal tracts of infected animals and humans.

Although in some people salmonellosis could be asymptomatic, most people experience diarrhea, abdominal cramps, and fever within 8 to 72 hours after the contaminated food was eaten.

Additional symptoms may be chills, headache, nausea, and vomiting. Symptoms usually disappear within 4 to 7 days.

Europe is currently going through its own E. coli woes. The outbreak, of a newly identified and especially virulent strain of the E. coli bacterium has killed 23 people, all either in, or recently returned from, northern Germany, according to figures compiled by the European Centre for Disease Control.

More than 4,200 people have become ill, almost 700 of whom have developed haemolytic uraemic syndrome, a serious complication that affects the blood, kidneys and nervous system.

Sources: U.S. Centers for Disease Control and Prevention and The USDA Food Safety and Inspection Service

Sy Kraft

Continue reading →

Chile’s President Michelle Bachelet has accepted the resignation of Health Minister Maria Soledad Barria following an incident in which the government failed to notify people who tested HIV-positive, presidential spokesperson Francisco Vidal said on Tuesday, the AP/Boston Globe reports. Earlier this month, a television station reported that officials at a hospital in the city of Iquique did not notify people who had tested HIV-positive. Two of the HIV-positive people have died, according to the AP/Globe (AP/Boston Globe, 10/28).

“I am quitting so that we can set aside political accusations that seek to sling mud at a (health) system, which is good,” Barria said, adding, “Our nation’s institutions cannot be a target for those who seek to make political capital and want to force a government defeat.” Before resigning, Barria removed the head of medicine, the supervising nurse and the head of the blood bank at the hospital while an investigation into possible negligence is conducted (Jara, Reuters, 10/28). Bachelet appointed Deputy Health Minister Jeanette Vega in Barria’s place, according to BBC News. Bachelet’s administration has “faced growing public opposition in recent months and lost ground to right wing parties in local elections held last week,” BBC News reports (BBC News, 10/29).

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.

© 2008 Advisory Board Company and Kaiser Family Foundation.?  All rights reserved. Continue reading →

Continuing a service it has provided for decades, the Muscular Dystrophy Association (MDA) is again offering seasonal flu shots to people who have muscular dystrophy and related diseases.

To assist individuals in obtaining an immunization this flu season, MDA is again teaming up with Walgreens to offer shots at more than 7,000 Walgreens points of care across the country, including its stores in all 50 states and 340 Take Care Clinics, through a voucher program beginning Sept. 1.

Muscular dystrophy and related diseases, especially those that progress in severity, can damage muscles involved with breathing. The flu is particularly hazardous for those with muscular dystrophy, spinal muscular atrophy and amyotrophic lateral sclerosis (ALS, or Lou Gehrig’s disease).

MDA Medical Director Valerie Cwik said, “Both adults and children with these diseases may already have weakened respiratory systems. MDA provides flu shots to reduce their likelihood of catching another possibly life-threatening illness.”

This program covers the seasonal flu vaccine that’s made available each year. MDA will also be offering the H1NI (swine flu) vaccine when it’s made available by the government later in the fall. Further information on that program will be provided through MDA’s Web site, mda.

Walgreens is offering seasonal flu shots beginning Sept. 1. Shots are also being offered any time between the hours of 10 a.m. and 4 p.m. on a walk-in basis starting Sept. 8. Individuals can also visit Walgreens/flu or call 1-800-WALGREENS (1-800-925-4733) for further information. MDA has more than 200 clinics nationwide where shots may also be obtained.

For information about obtaining a flu shot for someone with a disease covered by MDA or securing a flu shot voucher, call the MDA office in your city or visit mda.

Source
MDA Continue reading →

EFE News Service on Tuesday examined how HIV/AIDS has had a particularly “devastating” impact on the large Latino population living in the New York City borough of the Bronx. About 16.6% of New York City residents live in the Bronx, but nearly 25% of HIV-positive people in the city live in the borough, including almost 60% of the city’s HIV-positive Latinos. To address the epidemic, about 400 civil and religious organizations, hospitals and groups of HIV-positive people have formed the Attention Network for AIDS in the Bronx, which aims to increase HIV/AIDS awareness and educate the Latino community about how to prevent the virus. About 48% of HIV-positive Latinos discover they are infected after the disease is advanced and treatment is less effective, according to the New York City-based Latino Commission on AIDS, a national and regional organization dedicated to improving the health of Latino communities. Latinos in the U.S. account for 14% of the population but 20% of the HIV cases in the country (Paz, EFE News Service, 10/18).

“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. Continue reading →

The word “meningitis” comes from the Modern Latin word meninga and the Greek word Menix meaning “membrane”. The suffix “itis” comes from the Greek word itis meaning “pertaining to”. In medical English, the suffix “-itis means” “inflammation of”. The membranes that surround the brain and the spinal cord are collectively known as the meninges – meningitis means inflammation of the meninges. According to According to According to Medilexicon’s medical dictionary, meningitis is “Inflammation of the membranes of the brain or spinal cord”.

A recent study found that rates of meningitis have decreased in Canadian provinces introducing routine immunization of children and adolescents against one specific strain of meningococcal bacteria.
What causes meningitis?
Meningitis is generally caused by infection of viruses, bacteria, fungi, parasites, and certain organisms. Anatomical defects or weak immune systems may be linked to recurrent bacterial meningitis. In the majority of cases the cause is a virus. However, some non-infectious causes of meningitis also exist.

Bacteria mimic human cells to get in and stay in

A study carried out by researchers at the University of Oxford and Imperial College London, England, revealed the way in which bacteria that cause bacterial meningitis mimic human cells is to evade the body’s innate immune system.

Viral meningitis

Although viral meningitis is the most common, it is rarely a serious infection. It can be caused by a number of different viruses, such as mosquito-borne viruses. There is no specific treatment for this type of meningitis. In the vast majority of cases the illness resolves itself within a week without any complications.
Bacterial Meningitis

Bacterial meningitis is generally a serious infection. It is caused by three types of bacteria: Haemophilus influenzae type b, Neisseria meningitidis, and Streptococcus pneumoniae bacteria. Meningitis caused by Neisseria meningitides is known as meningococcal meningitis, while meningitis caused by Streptococcus pneumoniae is known as pneumococcal meningitis. People become infected when they are in close contact with the discharges from the nose or throat of a person who is infected.

Twenty years ago Hib was the main cause of bacterial meningitis – it is not any more thanks to new vaccines which are routinely administered to children.

The doctor needs to know what type of meningitis has infected the patient. Certain antibiotics can stop some types from infecting others.
Bacterial meningitis in newborns and premature babies

A type of streptococci, called group B streptococci commonly inhabits the vagina and is a common cause of meningitis among premature babies and newborns during the first week of life. Escherichia coli, which inhabit the digestive tract, may also cause meningitis among newborns. Meningitis that occurs during epidemics can affect newborns – Listeria monocytogenes being the most common.
Bacterial meningitis in children under 5

Children under five years of age in countries that do not offer the vaccine are generally infected by Haemophilus influenzae type B.
Bacterial meningitis in older children

Older children generally have meningitis caused by Neisseria meningitides (meningococcus), and Streptococcus pneumoniae (serotypes 6, 9, 14, 18 and 23) .
Bacterial meningitis in adults

About 80% of all adult meningitis are caused by N. meningitidis and S. pneumoniae. People over 50 years of age have an increased risk of meningitis caused by L. monocytogenes.
Bacterial meningitis and people with skull damage implanted devices

People who received a recent trauma to the skull are at increased risk of bacteria in their nasal cavity entering the meningeal space. Patients with a cerebral shunt or related device also run a higher risk of infection with staphylococci and pseudomonas through those devices.
Bacterial meningitis and weak immune systems

People with weak immune systems are also at higher risk of infection with staphylococci and pseudomonas.
Bacterial meningitis and ear infections and procedures

Rarely, otitis media, mastoiditis, or some infection to the head or neck area may lead to meningitis.
People who have received a cochlear implant run a higher risk of developing pneumococcal meningitis. (Cochlear Implantation Increases Meningitis Risk). Another study found that Children who are stricken with severe hearing loss are five times more likely to contract meningitis.

In countries where tuberculous meningitis is common, there is a higher incidence of meningitis caused by Mycobacterium tuberculosis.
Anatomical defects or disorders of the immune system

Either congenital or acquired anatomical defects may be linked to recurrent bacterial meningitis. An anatomical defect might allow a way to penetrate into the nervous system from the external environment. The most common anatomical defect which leads to meningitis is skull fracture, especially when the fracture occurs at the base of the brain, or extends towards the sinuses and petrous pyramids.

59% of recurrent meningitis cases are due to anatomical defects, while 36% are due to weakened immune systems.

What are the symptoms of meningitis?

Some meningitis statistics:

10-12% of meningitis cases in the industrialized countries are fatal

20% of meningitis survivors suffer long-term consequences, such as brain damage, kidney disease, hearing loss, or limb amputation

There are 2,300 cases of meningitis and meningococcal septicemia in the UK each year

70% of meningitis patients are aged under 5 or over 60

In the USA bacterial meningitis affects about 3/100,000 people annually

In the USA viral meningitis affects about 10/100,000 people annually

Bacterial meningitis caused by Haemophilus influenzae type b has fallen 90% since the Hib vaccine was introduced

Antibiotic resistance is a major factor in global rising rates of meningitis

As meningitis and septicemia tend to show similar symptoms and incidences of both tend to rise and fall at the same time in geographical areas, this section refers to both meningitis and septicemia.

Meningitis is not always easy to recognize. In many cases meningitis may be progressing with no symptoms at all. In its early stages, symptoms might be similar to those of flu. However, people with meningitis and septicemia can become seriously ill within hours, so it is important to know the signs and symptoms. Early symptoms of meningitis broadly include:

Vomiting
Nausea
Muscle pain
High temperature (fever)
Headache
Cold hands and feet
A rash that does not fade under pressure. This rash might start as a few small spots in any part of the body – it may spread rapidly and look like fresh bruises. This happens because blood has leaked into tissue under the skin. The rash or spots may initially fade, and then come back.

In babies, you should look out for at least one of the following symptoms:

a high-pitched, moaning cry
a bulging fontenelle
being difficult to wake
floppy and listless or stiff with jerky movements
refusing feeds
rapid/ unusual/ difficult breathing
pale or blotchy skin
red or purple spots that do not fade under pressure

In older children, you should look out for:

a stiff neck
severe pains and aches in your back and joints
sleepiness or confusion
a very bad headache (alone, not a reason to seek medical help)
a dislike of bright lights
very cold hands and feet
shivering
rapid breathing
red or purple spots that do not fade under pressure

What is the glass test?

Press the side of a drinking glass firmly against the rash.
If the rash fades and loses color under pressure it is not a meningitis rash.
If it does not change color you should contact a doctor immediately.

What is the treatment for meningitis?
In an interesting study, UK researchers looked at whether children with suspected meningitis should be given antibiotics before their transfer to hospital.

Meningitis treatment will generally depend on four main factors:

The age of the patient
The severity of the infection
What organism is causing it?
Are other medical conditions present?

Viral meningitis will resolve itself fairly quickly and does not usually need any medical treatment. If symptoms continue after two weeks the person should see his/her doctor.

The treatment for severe meningitis, which is nearly always bacterial (but can be viral), may require hospitalization, and includes:

Antibiotics – usually administered intravenously by injection, or through an IV.
Corticosteroids – if the patient’s meningitis is causing pressure in the brain, corticosteroids, such as dexamethasone, may be administered to adults and children.
Acetaminophen (paracetamol) – effective in bringing the patient’s temperature down. Other methods for reducing the patient’s fever may include a cool sponge bath, cooling pads, plenty of fluids, and good room ventilation.
Anti-convulsants – if the patient has seizures (fits), he/she will be given an anti-convulsant, such as phenobarbital or dilantin.
Oxygen therapy – if the patient has breathing difficulties oxygen therapy may be given. This may involve a face mask, a nasal cannula, a hood, or a tent. In more severe cases a tube may be inserted into the trachea via the mouth.
Fluid control – dehydration is common for patients with meningitis. If a meningitis patient is dehydrated he/she may develop serious problems. It is crucial that he/she is receiving adequate amounts of fluids. If the patient is vomiting, or cannot drink, liquids may be given through an IV.
Blood tests – measuring the patient’s blood sugar and sodium is important, as well as other vital body chemicals.
Sedatives – these are given if the patient is irritable or restless.

If the meningitis is severe the patient may be placed in an ICU (intensive care unit).

Scientists at the University of Nottingham have finally discovered how the deadly meningococcal bacteria is able to break through the body’s natural defence mechanism and attack the brain. This could lead to better treatment and vaccines for meningitis. (click here to read about it).

Sources: National Health Service (NHS), UK, The Mayo Clinic, Wikipedia, HHS (Department of Health and Human Services USA), NIH (National Institutes of Health, USA).

Original article date: 08 Jun 2004
Article updated: 19 May 2009

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New data from a pivotal study in more than 1,800 infants show that Novartis candidate vaccine Bexsero® (Multicomponent Meningococcal Serogroup B Vaccine) induces a robust immune response to meningococcalserogroup B when given alone or when co-administered with other routine vaccines1. These results also show thatBexsero can fit into various vaccination schedules in the first year of life1, 4, when the likelihood of contracting this often-deadly disease is greatest2. The study also demonstrated that Bexsero has an acceptable tolerability profile4.

Data from another pivotal study in more than 1,500 toddlers shows that Bexsero provides protective immune response when used as a booster in toddlers already primed, or after two doses in those not previously vaccinated with Bexsero5, 6. A third study presented showed that Bexsero induces a strong immune response in adolescents against meningococcalserogroup B (MenB)7. The data were presented at The European Society for Paediatric Infectious Diseases (ESPID) in The Hague, The Netherlands.

These data are included in the comprehensive clinical program with Bexsero in more than 8,000 infants, toddlers, adolescents and adults which served as the basis of the registration file submitted to the European Medicines Agency (EMA) in December 20101, 4, 5, 6, 7, 8.

“MenB disease poses a significant burden to people around the world9, 10, particularly infants, the population at greatest risk for the disease2a,” said Andrin Oswald, Head of Novartis Vaccines and Diagnostics Division. “The data show thatBexsero, our innovative multicomponent MenB vaccine, holds great promise in providing a solution to a major public health concern that can have a devastating impact on vulnerable populations1, 2, 4, 5, 6, 7.”

MenB is the most common cause of bacterial meningitis9, 10 for which there is no effective routine vaccine2, and it is responsible for up to 90% of meningococcal disease cases in Europe11, and over 80% of meningococcal cases in infants in Canada12. Survivors may suffer permanent brain damage, learning disabilities, hearing loss, and limb loss13.

“The serious and long-term effects of MenB are often devastating to its victim, family members and the community at large13,” said Jamie Findlow PhD, Deputy Head of the Health Protection Agency, Vaccine Evaluation Unit, Manchester, UK. “The rapid disease progression3 and flu-like symptoms14 of MenB can be difficult to recognize, particularly in infants14, making prevention through vaccination the most effective way to control this disease9.”

Bexsero has the potential to provide protection against a broad range of MenB strains15. If licensed, Bexsero could fill a public health need across multiple regions that is not met by currently available vaccines2. Recent data have shown thatBexsero could be expected to provide protection against approximately 80% of more than 1,000 disease-causingMenB strains isolated in Europe in 2007-200816.

Infant Study Design and Results

Novartis Study P12, ESPID Abstracts 1205 and 1187

- This Phase IIb open-label immunogenicity study analysis randomized more than 1,800 infants to receive Bexseroat 2, 4, 6 months or at 2, 3, 4 months with or without routine vaccines (7-valent pneumococcal glyco-conjugate-vaccine and a combined diphtheria-toxoid, tetanus-toxoid, inactivated-polio, acellular-pertussis, hepatitis B andHaemophilus influenza type-b vaccine). Immune response was measured using the human serum bactericidal antibody (hSBA) assay1.

- The study met its primary endpoints, and showed that the majority of infants vaccinated with Bexsero, at either dosing schedule with or without routine vaccines, achieved hSBA ?‰? 1:5 against all vaccine antigens in tested MenBstrains (H44/76, 5/99, NZ98/254)1.

- More than 99% of participants receiving Bexsero at 2, 4, 6 months (concomitantly or without routine-vaccines) or at 2, 3 and 4 months (with routine-vaccines) developed hSBA titers ?‰?1:5 against strains 44/76 and 5/99. For NZ98/254 the correlate was reached or exceeded in 79% (2, 4, 6 months with routine-vaccines), 87% (2, 4, 6 months without routine-vaccines) and 81% (2, 3, 4 months with routine vaccines)1.

- Data also show that responses to the routine vaccine antigens, when co-administered with Bexsero, were generally similar, except for a slightly lower immune response to pneumococcal serotype 6B, which was not clinically meaningful1.

- The data also show that Bexsero, when administered alone, had a reactogenicity profile that was comparable to those of the routine vaccines. Fever, which is a common event following routine childhood immunizations, was observed more frequently in infants who received Bexsero together with routine infant vaccines compared to infants receiving routine vaccines alone4. Fever was generally low-grade, mild and of short duration, with more than 95% of cases resolving within 24-48 hours4.

Toddler Study Results and Design

Novartis Study P13E1, ESPID Abstracts 877 and 900

Booster

- This Phase III, open-label immunogenicity and tolerability extension analysis included more than 1,500 toddlers who had been administered a three-dose primary series of Bexsero at 2, 4, 6 months. Toddlers were randomized to receive either a fourth (booster) dose of Bexsero concomitantly with measles, mumps, rubella, and varicellavaccine (MMR-V), or Bexsero at 12 months followed by MMR-V at 13 months. Immunogenicity was measured using the hSBA assay and was assessed one month post booster dose5.

- This study met all primary endpoints. The data show Bexsero to be highly immunogenic in this age group against all vaccine antigens in all MenB strains tested (H44/76, 5/99, NZ98/254), with 11-19 fold increases in hSBA titers5.

- The percentage of toddlers with an hSBA ?‰? 1:5 who received Bexsero alone or Bexsero concomitantly with MMR-V was 100% against H44/76 and 5/99, and 97% and 94% against strain NZ98/254, respectively5.

- Results show that immune responses to Bexsero and MMR-V were not affected when both vaccines were administered concomitantly, and that adverse events, notably fever, were not increased by the concomitant use ofBexsero and MMR-V5.

Catch Up

- The study also evaluated a two-dose schedule in toddlers, suitable for a catch-up vaccination, when administered alone or concomitantly with MMRV vaccine6.

- In this open-label study, healthy toddlers not previously vaccinated with Bexsero either received MMR-V at 12 months followed by two doses of Bexsero at 13 and 15 months (alone), or MMR-V and Bexsero at 12 months andBexsero at 14 months (concomitant). Immunogenicity against three reference strains was assessed in subsets one month later by hSBA assay using human complement. Solicited post-vaccination reactions were recorded for seven days6.

- Immune responses were similar in both groups; hSBA GMTs for alone and concomitant groups were 271 and 248 against strain H44/76; 599 and 627 against strain 5/99; 43 and 32 against NZ98/254, respectively. Seroprotectionrates (% hSBA ?‰? 5) against strains H44/76, 5/99, and NZ98/254 were 100%, 100% and 96% in the concomitant group, respectively, and 100% against all three strains in the alone group6.

- Two doses of Bexsero two months apart were sufficient to elicit protective immune responses against all three reference strains for the component antigens, unaffected by concomitant MMR-V administration, with minimal impact on reactogenicity, so facilitating catch-up vaccination in current toddler vaccination schedules6.

Adolescent Study Design and Results

Novartis Study P10, ESPID Abstract 905

- In an observer-blind study, 11-17 year-old adolescents were randomized to receive one to three doses of Bexseroor placebo at baseline, one and/or two months later. Primary immunogenicity outcome was a titer ?‰?4 in a serum bactericidal assay using human complement (hSBA) against three test strains selected to evaluate the contribution of individual vaccine antigens. Tolerability was assessed by solicited local and systemic reactions within seven days of each study vaccination. Adverse events were monitored throughout the study7.

- This study met all primary endpoints. One month after vaccination 92-97% of recipients of one Bexsero dose, 99-100% after two or three Bexsero doses and 29-50% of placebo recipients had hSBA titers ?‰?4 against the three test strains7. Similar proportions of placebo and Bexsero recipients reported solicited local (89-94%) and systemic (70-79%) reactions after the first study injection7. Bexsero induced robust immune response and had an acceptable tolerability profile following one, two, or three doses and in all schedules administered. No evidence of increased reactogenicity was observed with two or three doses compared with one dose of Bexsero. Fever observed in adolescents vaccinated with Bexsero was comparable to those who received placebo alone7.

About Meningococcal Disease

Meningococcal disease is a sudden17, aggressive illness that can lead to death within 24-48 hours of the first symptoms3. Survivors may suffer permanent brain damage, learning disabilities, hearing loss, and limb loss13. The disease is a leading cause of bacterial meningitis9, 13 – an infection of the membrane around the brain and spinal cord3 – and sepsis – a bloodstream infection13c. Five main serogroups of meningococcal bacteria (A, B, C, W-135 and Y) cause the majority of all cases around the world18.

Licensed vaccines are available to protect against meningococcal disease caused by serogroups A, C, W135 and Y3; however, MenB remains an important unmet public health challenge2. MenB is the most common cause of bacterial meningitis9, 10 for which there is no effective routine vaccine2, and it is responsible for up to 90% of meningococcal disease cases in Europe11.

About Bexsero

The Novartis Bexsero vaccine was developed using a pioneering approach known as “reverse vaccinology19.” In contrast to conventional methods of developing vaccines, reverse vaccinology decodes the genetic makeup (genome sequence) ofMenB and selects those proteins that are most likely to be broadly-effective vaccine candidates19. Bexsero (also known as 4CMenB) contains multiple components, which independently are highly immunogenic and, taken together, have the potential to protect against a broad range of disease-causing strains15. To date, more than 8,000 infants, toddlers, and adults have been enrolled in studies of Bexsero1, 4, 5, 6, 7, 8.

References

1. Gossger, N et al. Immunogenicity of an Investigational Multicomponent Meningococcal Serogroup B Vaccine (4CMenB) Administered With or Without Routine Infant Vaccinations in Different Schedules, presented at the 29th European Society for Paediatric Infectious Diseases Conference, June 7-11, 2011, The Hague, The Netherlands.

2. Perrett KP, Pollard AJ. Towards an improved serogroup B Neisseria meningitidis vaccine. Expert Opin Biol Ther. 2005; 5:1611-1625.

3. World Health Organization. Meningococcal meningitis fact sheet. Available here. Accessed on June 2, 2011.

4. Beeretz, I et al. Reactogenicity and Safety of Multicomponent Meningococcal Serogroup B Vaccine (4CMenB) Administered With or Without Routine Infant Vaccinations in Different Schedules, presented at the 29th European Society for Paediatric Infectious Diseases Conference, June 7-11, 2011, The Hague, The Netherlands.

5. Vesikari, T et al. Booster Dose at 12 Months of an Investigational Meningococcal Serogroup B Vaccine (4CMenB) in Healthy Toddlers Previously Primed at 2,4,6 Months, presented at the 29th European Society for Paediatric Infectious Diseases Conference, June 7-11, 2011, The Hague, The Netherlands.

6. Prymula, R et al. Catch-Up Vaccination of Healthy Toddlers with an Investigational Multicomponent Meningococcal Serogroup B Vaccine (4CMenB) – Exploration of a Two-Dose Schedule, presented at the 29th European Society for Paediatric Infectious Diseases Conference, June 7-11, 2011, The Hague, The Netherlands.

7. Santolaya, ME et al. Immunogenicity and Tolerability of an Investigational Multicomponent Meningococcal Serogroup B (4CMenB) Vaccine in Healthy Adolescents, presented at the 29th European Society for Paediatric Infectious Diseases Conference, June 7-11, 2011, The Hague, The Netherlands.

8. Novartis Data on File.

9. World Health Organization. Meningococcal position paper. Weekly epidemiological record No. 44, 2002, 77, 329-340. Available here. Accessed on June 2, 2011.

10. Harrison LH. Prospects for vaccine prevention of meningococcal infection. Clin Microbiol Rev. 2006; 19(1):142-1643. Available here. Accessed on June 2, 2011.

11. Health Protection Agency. Infectious Diseases: Meningococcal disease. Meningococcal Reference Unit isolates of Neisseria Menengitidis: England and Wales, by serogroup & epidemiological year, 1998/99-2008/09. Available here. Accessed on June 2, 2011.

12. Public Health Agency of Canada. Canada Comm Dis Rep. 2009; 36:1-40.

13. Centers for Disease Control and Prevention. Epidemiology and Prevention of Vaccine-Preventable Diseases (The Pink Book: Course Textbook). 10th Edition, 2nd printing. February 2008 update. Available here. Accessed on June 2, 2011.

14. Mayo Foundation for Medical Education and Research. Meningitis: Symptoms. August 2010. Available here. Accessed on June 2, 2011.

15. Donnelly, J et al. Qualitative and quantitative assessment of meningococcal antigens to evaluate the potential strain coverage of protein-based vaccines. Proceedings of the National Academy of Sciences. November 2010. Available here. Accessed on June 2, 2011.

16. Donnelly, J et al. Estimating the potential strain coverage in Europe of a multicomponent vaccine targeting serogroup B meningococci, presented at the European Monitoring Group on Meningococci (EMGM) meeting, 18-20 May 2011, Ljubljana, Slovenija.

17. Centers for Disease Control and Prevention. Meningitis: Diagnosis. June 2009 update. Available here. Accessed on June 2, 2011.

18. Schaffner, W. et al. The Changing Epidemiology of Meningococcal Disease Among US Children, Adolescents, and Young Adults. National Foundation for Infectious Diseases. November 2004. Available here. Accessed on June 2, 2011.

19. Rappuoli, R. Reverse vaccinology, a genome-based approach to vaccine development. Vaccine. 2001; 19: 2688-2691.

Source:

Novartis Continue reading →

Arpida Ltd.
(SWX: ARPN) announced that a total of 13 abstracts on iclaprim have
been accepted for the upcoming 18th European Congress of Clinical
Microbiology and Infectious Diseases (ECCMID) which takes place in
Barcelona, 19-22 April 2008. ECCMID is a premier European conference where
thousands of scientists and physicians gather to discuss the latest
developments in their field.

Arpida will be presenting additional efficacy and safety data regarding
ASSIST-2, the second pivotal Phase III trial with intravenous iclaprim in
complicated Skin and Skin Structure Infections (cSSSI). Moreover, data from
Phase I studies with intravenous iclaprim, as well as preclinical data will
be presented. Arpida’s senior scientists and external partners have been
invited to present four of the accepted abstracts as oral presentations for
a broad audience at the conference.

The abstracts are expected to be available online on the conference
website starting, 9 April 2008.

About Arpida Ltd.

Arpida (SWX: ARPN) is a biopharmaceutical company with research
facilities in Reinach, Switzerland and in the USA. It focuses on the
discovery and development of novel drugs that seek to overcome the growing
problem of microbial resistance. The most advanced compounds include an
antibacterial under regulatory review and an antifungal in Phase III.

Arpida’s leading product candidate is intravenous iclaprim, a potent
antibacterial that targets severe infections requiring hospital treatment,
including those caused by methicillin-resistant Staphylococcus aureus
(MRSA). The clinical programme for the first indication, complicated skin
and skin structure infections (cSSSI), has been completed. The submission
of the NDA to the US FDA was completed in March 2008.

In December 2007, Arpida announced the enrolment of the first patients
in a Phase II clinical study with intravenous iclaprim in the treatment of
patients with hospital-acquired pneumonia (HAP), ventilator-associated
pneumonia (VAP) or healthcare associated pneumonia (HCAP).

In January 2008, the US FDA granted authorisation to progress oral
iclaprim into a Phase II ‘intravenous-to-oral’ switch trial. Iclaprim could
be offered not only as an intravenous therapy for hospital use in acute
situations, but also as an oral formulation, allowing early patient
discharge followed by outpatient treatment. This switch could be a valuable
instrument in reducing healthcare costs and enhancing patient comfort.

Arpida’s fourth most advanced antibiotic programme, AR-709, targets
upper and lower respiratory tract infections acquired in the community
setting. AR-709 exhibited potent activity against a large panel of
pneumococcal clinical isolates including those resistant to currently used
drugs. Promising results of “first-in-man” studies with AR-709 were
published in March 2007.

An additional compound, AR-2474, has achieved in vivo proof of concept.
AR-2474 has been shown to be effective in eradicating pathogens in
preclinical models of skin infection and nasal carriage.

Apart from the antibiotic programmes, Arpida has an innovative
antifungal therapy (TLT) which is in Phase III clinical trials in Europe,
targeting onychomycosis.

Moreover, the company has several other leads in optimisation and
additional discovery programmes derived from its own discovery platform at
various research stages.

This press release contains specific forward-looking statements, e.g.
statements including terms like believe, assume, expect or similar
expressions. Such forward-looking statements are subject to known and
unknown risks, uncertainties and other factors which may result in a
substantial divergence between the actual results, financial situation,
development or performance of the company and those explicitly or
implicitly presumed in these statements. Against the background of these
uncertainties readers should not place undue reliance on forward-looking
statements. The company assumes no responsibility to update forward-looking
statements or to adapt them to future events or developments.

Arpida Ltd
arpida.ch Continue reading →

Asthma may have a surprising relationship with the composition of the species of bacteria that inhabit bronchial airways, a finding that could suggest new treatment or even potential cures for the common inflammatory disease, according to a new UCSF-led study.

Using new detection methods, researchers learned that the diversity of microbes inside the respiratory tract is far vaster than previously suspected – creating a complex and inter-connected microbial neighborhood that appears to be associated with asthma, and akin to what has also been found in inflammatory bowel disease, vaginitis, periodontitis, and possibly even obesity.

Contrary to popular belief, the scientists also learned that the airways are not necessarily entirely sterile environments, even in healthy people, while the airways of asthmatics are infected by a richer, more complex collection of bacteria. These findings could improve understanding of the biology of asthma, and potentially lead to new and much-needed therapies.

“People thought that asthma was caused by inhalation of allergens but this study shows that it may be more complicated than that – asthma may involve colonization of the airways by multiple bacteria,” said study co-author Homer Boushey, MD, a UCSF professor of medicine in the division of Pulmonary and Critical Care Medicine.

The study is published online in the Journal of Allergy and Clinical Immunology.

Asthma is one of the most common diseases in the world, with approximately 300 million asthmatics globally, including 24 million in the United States, according to the Centers for Disease Control. The disease has been on the rise for the last 60 years.

“It has gone from 3 percent of the population to slightly more than 8 percent of the population in the U.S.,” said Boushey. “It is most prevalent in western, developed nations – and we don’t know why.”

In recent years, scientists began studying communities of mixed-species microorganisms (microbiome) found in both diseased and healthy people to better understand their role in a variety of diseases. But research on the microbiome in respiratory disease is relatively uncharted terrain.

“We know fairly little about the diversity, complexity and collective function of bacteria living in the respiratory tract, and how they might contribute to diseases like asthma,” said Yvonne J. Huang, MD, the paper’s first author. She is a research fellow and clinical instructor in the UCSF Pulmonary Division.

“Traditionally, the airways have been thought to be sterile. However, this study suggests this is not the case. Certain asthma patients who require inhaled corticosteroid therapy possess a great abundance of bacteria compared to healthy individuals, and have an increased relative abundance of specific organisms that is correlated with greater sensitivity of their airways.”

In their three-year pilot project, the scientists collected samples from the airway linings of 65 adults with mild to moderate asthma and 10 healthy subjects. Then, using a tool that can identify approximately 8,500 distinct groups of bacteria in a single assay, the scientists profiled the organisms present in each sample to look for relationships between bacterial community composition and clinical characteristics of the patients’ asthma.

The researchers found that bronchial airway samples from asthmatic patients contained far more bacteria than samples from healthy patients. The scientists also found greater bacterial diversity in the asthmatic patients who had the most hyper-responsive or sensitive airways (a feature of asthma).

“People have viewed asthma as a misdirected immune reaction to environmental exposures, but few have thought of it in the context of airway microbiota composition,” said senior author Susan Lynch, PhD, an assistant professor of medicine and director of the UCSF Colitis and Crohn’s Disease Microbiome Research Core in the division of gastroenterology.

“We took an ecological approach, considering the bacteria in the context of their microbial neighborhoods to identify relationships between characteristics of these communities and features of the disease…This new approach will help us to better understand the microbiota-host relationships that define human health.”

The authors say that further studies are needed to determine how these specific bacteria identified in the study may influence the cause and development of asthma.

Notes:

The study was supported by the National Heart, Lung and Blood Institute and by the Strategic Asthma Basic Research Center at UCSF, supported by the Sandler Family Foundation. Huang was funded by a National Institutes of Health grant and by a UC Tobacco-related Disease Research Program award; Lynch receives research support from the NIH; Boushey is an ad-hoc consultant for KaloBios Pharmaceuticals, Inc., is on the advisory committee for Pharmaxis, is on ad-hoc advisory committees for GlaxoSmithKline and Merck, and receives research support from GlaxoSmithKline.

Source:
Elizabeth Fernandez
University of California – San Francisco Continue reading →

As World AIDS Day, December 1st,
approaches an estimated 38.6 million people are living with HIV worldwide.
In 2005, 4.1 million people were newly infected with HIV, according to data
in the UNAIDS 2006 Report on the global AIDS epidemic. World AIDS Day is an
opportunity for leaders from national AIDS programs, community
organizations, the government, and churches to step up in the fight against
HIV/AIDS.

Yesterday, leaders from the National Catholic AIDS Network (NCAN), the
Secretariat for Hispanic Affairs of the United States Conference of
Catholic Bishops (USCCB), the Secretariat for African American Catholics of
the USCCB, and The Leadership Campaign on AIDS, a program in the Office of
HIV/AIDS Policy in the U.S. Department of Health and Human Services, joined
with Cardinal Francis George, Archbishop of Chicago and Vice President of
the USCCB, Admiral Kenneth Moritsugu, Acting U.S. Surgeon General, and Dr.
Kevin Fenton, Director of the National Center for HIV, STD, and TB
Prevention at the Centers for Disease Control and Prevention (CDC), in a
second annual conference call to help raise awareness about HIV/AIDS and to
share World AIDS Day resources for Catholic parishes.

“We will soon be observing World AIDS Day, an event that is observed
each December 1st, and this is an opportunity for us to focus on the
important opportunities we have to improve our ministry to our brothers and
sisters living with, and affected by, HIV/AIDS,” said Cardinal Francis
George. He continued, “It is also an opportunity for us to recognize and
thank those in the church who so actively work to prevent the spread of
AIDS and to take care of those living with the virus. We recall the words
of the late Holy Father, Pope John Paul II, who stated in 1995, “The battle
against AIDS ought to be everyone’s battle.”

Speakers on the call included, Cardinal Francis George, Ms. Beverly A.
Carroll, Executive Director of the USCCB’s Secretariat for African American
Catholics, Mr. Ron Cruz, Executive Director of the USCCB’s Secretariat for
Hispanic Affairs, Mr. Dan Lunney, Executive Director of NCAN, Dr. Kevin
Fenton, Admiral Kenneth Moritsugu, and several people from HIV/AIDS service
organizations.

During the call, Dr. Kevin Fenton and Admiral Kenneth Moritsugu talked
about the importance of HIV testing in stopping the spread of HIV. Dr.
Fenton discussed the recent release of the CDC’s new testing guidelines
which recommend that all Americans aged 13-64 get tested for HIV as part of
their routine health care.

Several speakers highlighted success stories from work within their
communities and also put forth recommendations of next steps leaders in the
Catholic Church can take to help stop the spread of HIV/AIDS. As Ms.
Carroll said, “we need to remember the three Ts in addressing HIV/AIDS in
our parish communities: talk, get tested, and access treatment.”

National Catholic AIDS Network
ncan Continue reading →