Month: January 2014

Oral insulin capsule trial a success, company says

Israel’s Oramed, which is racing Novo Nordisk of Denmark to develop the world’s first insulin pill, moved a step closer to its goal on Thursday by announcing successful results from a small mid-stage test.

The oral drug delivery specialist said its insulin capsule had met all primary and secondary endpoints in a Phase IIa clinical trial and it now plans to launch a larger mid-stage study in the third quarter.

Shares in the Nasdaq-listed company opened 10 percent higher at $28.50 on the news. The stock has surged from around $4 since the end of 2012 on rising hopes for its insulin pill.

The concept of oral insulin as a way to relieve diabetics of several daily injections has been around since the 1930s, but making it a reality is extremely difficult because insulin is destroyed by enzymes in the digestive system.

Oramed believes that it has now found a solution to allow enough insulin to survive the onslaught of digestive juices to still do some good.

At least 90 percent of the more than 382 million diabetes sufferers worldwide are in the type 2 category, according to the International Diabetes Foundation, which expects the number of diabetes patients to near 600 million by 2035.

Consensus analyst forecasts suggest that the overall diabetes drug market, worth $37 billion a year at present, will reach more than $57 billion by 2018, according to Thomson Reuters Pharma.

Oral insulin could make it easier for sufferers to start early treatment, slow progression of the disease and delay the need for injections, Oramed said. Unlike injections, the ingested form passes first into the liver, which regulates the secretion of insulin into the bloodstream.

The new year-long Phase IIb study in the United States will study 150 type 2 diabetes patients and mainly test for the drug’s effectiveness, Chief Executive Nadav Kidron told Reuters after the company issued results of the Phase IIa trial.

During the Phase IIa trial, conducted under a new U.S. Food and Drug Administration (FDA) drug protocol, 30 patients with type 2 diabetes entered an in-patient setting for one week.

“The FDA wanted us to show one thing – that it was safe so they will let us do a IIb trial,” Kidron said.

While Oramed was not checking for efficacy, Kidron said the IIa trial revealed that it was effective, though the sample size was too small for FDA purposes.

Oramed will also need to conduct a final large-scale Phase III trial before the drug is licensed for sale, so the capsule is still years away from hitting the market.

The company is, however, ahead of Novo Nordisk, which has yet to start Phase II testing.

Oramed is hoping to partner with large pharmaceutical firms for development and sales of the drug. But Kidron said that only preliminary discussions have taken place so far.

The company also plans to initiate a Phase IIa FDA study for type 1 diabetes in the near term.

The global expense for diabetes is about $500 billion and an oral version could bring a large drop in costs.

Oramed noted that the pill would not eliminate the eventual need for injections but could delay the shift to needles by many years.

Source: Yahoo news

Being shorter may lead to feelings of inferiority, study says

A new study published in Psychiatry Today found that people who had their height “virtually lowered” felt inferior and mistrustful.

British researchers studied a group of 60 adult women who used a virtual reality (VR) simulation to take two rides on the London Underground subway. On the first trip, the participant’s perceived height was unaltered, but on their second simulated trip, their perceived height was lowered by 9.84 inches.

The participants commented on their experience, and after the second ride, there was a significant increase in reports of negative feelings – such as incompetence, inferiority and feeling unlikeable. Respondents also showed an increase in feelings of paranoia toward other virtual “passengers” on the train. Most participants did not realize their height had been lowered for the second round of the simulation.

Researchers said that people mostly behave the same in a VR environment as they do in real life.

The researchers noted that the participants were women who “were prone to having mistrustful thoughts,” but they say the new study provides key insight into paranoia.

people’s excessive mistrust of others directly builds upon their own negative feelings about themselves, lead researcher Daniel Freeman, professor at the University of Oxford, told Medical News Today. “The important treatment implication for severe paranoia that we can take from this study is that if we help people to feel more self-confident, then they will be less mistrustful.”

Source: News BCC

Sharing your stress can reduce fears, study shows

A new study from the University of Southern California’s Marshall School of Business in Los Angeles suggests stress isn’t something you should keep to yourself.

Research published in Social Psychological and Personality Science suggests sharing your stress with someone who is having a similar emotional reaction may reduce stress levels more than sharing with someone who is not experiencing similar stress levels.

In the study, researchers measured participants’ emotional states, levels of the stress hormone cortisol and perception of threat when faced with the task of preparing and giving a videotaped speech. The 52 female undergraduate participants were divided into pairs and encouraged to discuss how they felt about the situation before giving their speeches.

Researchers found that when the pairs were in a similar emotional state, it helped buffer each individual against high levels of stress.

Their findings could be useful for people experiencing stress at work.

“For instance, when you’re putting together an important presentation or working on a high-stakes project, these are situations that can be threatening and you may experience heightened stress,” study leader Sarah Townsend, assistant professor of management and organization at the USC Marshall School of Business, told Medical News Today. “But talking with a colleague who shares your emotional state can help decrease this stress.”

Source; Fox news

Faster way to catch food poisoning microbes

A team of scientists, led by an Indian-origin researcher Sibani Lisa Biswal, has developed a faster method to catch unwanted microbes before they can make people sick with food poisoning.

The Rice University scientists used an array of tiny ‘nanomechanical cantilevers’, anchored at one end, kind of like little diving boards.

The cantilevers have peptides attached to them that bind to Salmonella – one of the pathogens most commonly associated with foodborne illness which can cause fever, diarrhoea and abdominal cramps.

When the bacteria bind to the peptides, the cantilever arm bends, creating a signal.

The screening system rapidly distinguished Salmonella from other types of bacteria in a sample.

One of the peptides could tell eight different types of Salmonella apart from each other.

The researchers stated that the technique could be applied to other common food pathogens.

“The new approach for pathogen screening is far faster than current commercial methods,” said Biswal, assistant professor of chemical and biomolecular engineering at Rice University.

Conventional methods to detect harmful bacteria in food are reliable and inexpensive, but they can be complicated, time consuming and thus allow contamination to go undetected.

The findings are reported in the ACS journal Analytical Chemistry.

Source: sify

 

Raman Effect Comes to Improve Brain Tumour Surgery

Scientist have turned to Raman effect – named after Nobel Laureate Indian physicist C.V. Raman who discovered inelastic scattering of light 80 years ago – to solve complicated brain tumour surgeries.

A research by the Innovation Institute at Henry Ford Hospital shows promise for developing a new method to clearly identify cancerous tissue during surgery on one of the most common and deadliest types of brain tumour.

The findings offer improved outcome for those undergoing surgery to remove glioblastoma multiforme (GBM) – a tumour that attacks tissue around nerve cells in the brain.

While some tumours have clearly defined edges, or margins, that differentiate it from normal brain tissue, GBM margins are diffuse, blending into healthy tissue.

“This leaves neurosurgeons uncertain about successfully finding and removing the entire malignancy,” said neurosurgeon and lead author Steven N. Kalkanis.

“Even with intensive treatment, including surgical removal of as much cancerous tissue as is currently possible combined with radiation and chemotherapy, the prognosis for GBM patients remains dismal,” he added.

The Henry Ford team set out to develop a highly accurate, efficient and inexpensive tool to distinguish normal brain tissue from both GBM and necrotic (dead) tissue rapidly, in real time, in the operating room.

The researchers chose Raman spectroscopy, which measures scattered light to provide a wavelength ‘signature’ for the material being studied.

It was only very recently that the processing technology was able to be condensed into a tiny space.

The researchers decided to take full advantage of these advancements that lend themselves exceptionally well to a small, portable hand-held device, potentially yielding immediate results in real-time.

“When developed, it would be the first of its kind in the world for this sort of brain tumour application,” said Kalkanis.

With this method, the researchers were able to distinguish the three types of tissue with up to 99.5 per cent accuracy.

Future studies would focus on methods of collecting and identifying Raman ‘signatures’ from tissue with freeze artefact, said the study appeared in the Journal of Neuro-Oncology.

Source: New Indian Express

China: Three infected with bird flu virus, one dead

A Chinese man has died of H7N9 bird flu and two other members of his family were infected with the deadly virus, raising concerns about the prospect of human-to-human transmission of disease.

Chinese health authorities said a family of three was infected with H7N9 bird flu in east China’s Zhejiang, the province worst-affected by the current spike in cases.

A 49-year-old man in Hangzhou city was on January 20 confirmed to have been infected with the virus. His wife and daughter, who accompanied him to the hospital, were later also confirmed infected.

The man has died while his daughter is in a serious condition and his wife is stable, local officials said. Experts have reached no firm conclusion on how the virus spread between the family members.

They all may have had contact with poultry, or the father may have transmitted the flu to his wife and daughter, state-run Xinhua news agency reported. Even if the case is confirmed as person-to-person transmission, there is no need to panic, said Li Lanjuan, an academician at the Chinese Academy of Engineering and a specialist in H7N9 prevention.

“So far there have not been any cases in which one person transmits the flu to another, and the latter transmits the virus to a third person,” said Li. In this year’s epidemic, transmission has been limited to a second person, who does not transmit the virus to a third. H7N9 is not likely to be spread in schools, workplaces or at gatherings, said Chen Zhiping, deputy head of the provincial disease control and prevention centre.

China has already sounded a nation-wide alert like last year, when the virus first struck, leaving 45 dead. Three new human H7N9 cases were reported in Zhejiang yesterday, bringing the number of infections in the province this year to 56. All three are in a critical condition. In neighbouring Fujian province, a two-year-old child tested positive for bird flu, according to the provincial health commission. The patient is now recovering.

South China’s Guangxi Zhuang Autonomous Region also reported one new case yesterday. The National Health and Family Planning Commission said yesterday that live poultry markets would close if a case of H7N9 was detected. Chicken has been a required dish on Chinese dining tables for centuries during Spring Festival, which begins on Friday.

Source: firstpost

Health benefits of Hemp seed oil

Hemp seed oil, pressed from the seeds of the Cannabis sativa plant, is making a comeback, not just as a source of fibre for textiles, but also as a crop packed with oils that have potential health benefits.

Long been stigmatized because of its “high”-inducing cousins, hemp – derived from low- hallucinogenic varieties of cannabis – have high levels of vitamins A, C and E and beta carotene, and is rich in protein, carbohydrates, minerals and fibre.

Maria Angeles Fernandez-Arche and colleagues note that for millennia, people around the world cultivated cannabis for textiles, medicine and food.

With increasing interest in plant oils as a source of healthful compounds, Fernandez-Arche’s team wanted to investigate hemp seed oil’s potential.

They did a detailed analysis of a portion of hemp seed oil. They found it has a variety of interesting substances, such as sterols, aliphatic alcohols and linolenic acids, that research suggests promote good health. For example, it contains linolenic acid, which is an omega-3 fatty acid that some studies suggest helps prevent coronary heart disease.

The research is published in ACS’ Journal of Agricultural and Food Chemistry.

Other known health benefits of Hemp seeds are:

Hemp seed oil, which contains Omega 3, 6, and 9, is a great alternative to fish oil. The essential fatty acids help restore health and immune function.

It is said to help with eczema, asthma, heart disease, high blood pressure.

It is not only used to nourish dry skin but blotches and lesions as well. It can detoxify the skin and even out skin tone. It is also a natural sunblock.

It has unequalled anti-inflammatory properties

Helps relieve premenstrual stress

Source: Zee news

Testosterone no hope for early menopause

Bringing testosterone levels up to normal for women who lose ovarian function owing to early natural menopause or hysterectomy is of no good, shows research.

Before age 40, ovaries stop functioning in about 1 percent of women without some obvious genetic abnormality to blame, bringing on an early menopause.

Called ‘primary ovarian insufficiency’ or POI, the condition can spell not only infertility and other physical problems but also depression and decreased quality of life.

Adding back lost estrogen and progesterone helps.

But ovaries normally produce testosterone too which has mental and physical effects.

According to a study by the National Institutes of Health Clinical Center in Bethesda, Maryland, adding testosterone for women who lose ovarian function have not yielded consistent results.

In the controlled study, 61 women used placebo patches and 67 women used patches that delivered 150 micrograms of testosterone a day.

After 12 months, testosterone levels were back up to normal for the women who got the treatment.

The researchers saw no detrimental effects of testosterone but they found no significant improvement either in measurements of quality of life, self esteem and mood compared with placebo, said the study published in Menopause, the journal of The North American Menopause Society (NAMS).

“Bringing testosterone back to normal doesn’t help these aspects of life, suggesting that it’s something other than testosterone that plays a role in mood problems for women with POI,” said researchers.

“This study makes an important contribution toward understanding what testosterone can and cannot do,” added NAMS executive director Margery Gass.

Source: Times of India

Study confirms ‘he hormone’ link to heart attacks

Heavily promoted male hormone products may be sending men flocking to stores, but their next stop may be the emergency room, according to a new study published Wednesday.

The research confirms earlier studies that show men with heart disease double their risk of heart attack soon after they start using testosterone gels or other supplements. And testosterone doubled the risk in men over 65 with or without heart disease.

“Patients and their physicians should discuss the risk of heart attacks when considering testosterone therapy,” said Sander Greenland, a professor of epidemiology at the UCLA Fielding School of Public Health, who led the study.

It’s a similar pattern to women using hormone replacement therapy after menopause — doctors used to think it lowered the risk of heart attacks and cancer, but it in fact has the opposite effect.

The study, published in the Public Library of Science journal PLoS ONE, confirms the results of several smaller studies. One published in November found that the use of “low T” therapy boosted the risk of serious problems including heart attack, stroke and death in men who already had heart trouble and who had low testosterone.

And another one released in December found that men with higher levels of the male hormone are more likely to have weak or no response to a flu vaccine, meaning that their bodies don’t mount a strong defense.

Nonetheless, the testosterone products are very heavily marketed to older men. And an influential essay in the New York Times Magazine, titled “The He Hormone,” brought even more attention to the idea of “man-opause”.

Greenland’s team, along with experts at the National Cancer Institute and Consolidated Research, Inc., looked at the records of more than 55,000 men. Heart attack rates more than doubled in men over 65 in the 90 days after getting a testosterone prescription, and it more than tripled for men 75 or older.

To be sure, they compared the men getting testosterone to those getting prescriptions for erectile dysfunction drugs, as the two groups are similar in many ways. The ED drugs, which include brands such as Viagra and Cialis, only very slightly raised the risk of heart attack.

“Taken together, the evidence supports an association between testosterone therapy and risk of serious, adverse cardiovascular-related events — including non-fatal myocardial infarction (heart attack) — in men,” they concluded.

Source: NBC news

Peanut allergy treatment ‘a success’

Doctors say a potential treatment for peanut allergy has transformed the lives of children taking part in a large clinical trial.

The 85 children had to eat peanut protein every day – initially in small doses, but ramped up during the study.

The findings, published in the Lancet, suggest 84% of allergic children could eat the equivalent of five peanuts a day after six months.

Experts have warned that the therapy is not yet ready for widespread use.

Peanuts are the most common cause of fatal allergic reactions to food.

There is no treatment so the only option for patients is to avoid them completely, leading to a lifetime of checking every food label before a meal.

The trial, at Addenbrooke’s Hospital in Cambridge, tried to train the children’s immune systems to tolerate peanut protein.

Every day they were given a peanut protein powder – starting off on a dose equivalent to one 70th of a peanut.

The theory was that patients started at the extremely low dose, well below the threshold for an allergic response.

Once a fortnight the dose was increased while the children were in hospital, in case there was an reaction, and then they continued taking the higher dose at home.

The majority of patients learned to tolerate the peanut.

Lena Barden, 11, from Histon in Cambridgeshire, said: “It meant a trip to the hospital every two weeks.

“A year later I could eat five whole peanuts with no reaction at all.

“The trial has been an experience and adventure that has changed my life and I’ve had so much fun, but I still hate peanuts!”

‘Dramatic transformation’
One of the researchers, Dr Andrew Clark, told the BBC: “It really transformed their lives dramatically; this really comes across during the trial.

“It’s a potential treatment and the next step is to make it available to patients, but there will be significant costs in providing the treatment – in the specialist centres and staff and producing the peanut to a sufficiently high standard.”

Fellow researcher Dr Pamela Ewan added: “This large study is the first of its kind in the world to have had such a positive outcome, and is an important advance in peanut allergy research.”

But she said further studies would be needed and that people should not try this on their own as this “should only be done by medical professionals in specialist settings”.

The research has been broadly welcomed by other researchers in the field, but some concerns about how any therapy could be introduced have been raised.

Caution
Prof Gideon Lack, who is running a peanut allergy trial at the Evelina Children’s Hospital in London, told the BBC: “This is a really important research step in trying to improve our management of peanut allergy, but is not yet ready for use in clinical practice.

“We need a proper risk assessment needs to be done to ensure we will not make life more dangerous for these children.

He warned that 60% of people with a peanut allergy were also allergic to other nuts so a carefree lifestyle would rarely be an option.

Prof Barry Kay, from the department of allergy and clinical immunology at Imperial College London, said: “The real issues that still remain include how long the results will last, and whether the positive effects might lead affected individuals to have a false sense of security.

“Another issue to address is whether there will be long term side-effects of repeated peanut exposure even where full allergic reaction does not occur, such as inflammation of the oesophagus.

“So, this study shows encouraging results that add to the current literature, but more studies are needed to pin down these issues before the current advice to peanut allergy sufferers, which is to avoid eating peanuts, is changed.”

Maureen Jenkins, director of clinical services at Allergy UK, said: “The fantastic results of this study exceed expectation.

“Peanut allergy is a particularly frightening food allergy, causing constant anxiety of a reaction from peanut traces.

Source: BBC news