Biopeer

Femara receives FDA approval for early breast cancer treatment

The FDA has given a green signal for Femara to be used as a treatment for women past menopause who have initial symptoms of breast cancer. Femara, an already licensed product for medication of advanced breast cancer will now serve a dual purpose. Novartis brought out the announcement of Femara getting US regulatory approval. Researchers claim that femara reduced the risk of breast cancer by 29 per cent in women whose breast cancer had reached the lymph nodes at the time of diagnosis and by 30 per cent for those who had resorted to chemotherapy.

According to the breast international group (BIG) I-98 study aromatase inhibitor Femara (letrozole) is more effective in the treatment of breast cancer as compared to the adjuvant medication of tamoxifen. Femara works to restrict the production of the hormone estrogen responsible for fuelling growth of cancerous tumors after menopause. In contrast, tamoxifen functions by inhibiting the activity of the estrogen by competitively binding to the estrogen receptor.

An analysis of the experiment conducted by researchers where one group was treated with femara and the other group on tamoxifen, revealed an estimated disease-free survival rate in the femara group as 84 per cent while the other group figured at 81.4 per cent. Further the study showcased a considerable reduction in the risk of recurrence and the risk of distant recurrence of the disease in comparison to the tamoxifen group. Moreover, instances of thromboembolism, endometrial cancer, and vaginal bleeding were more frequent in the tamoxifen group whereas women in the femara group had a higher rate of skeletal and cardiac events, and of hypercholesterolemia.

Technorati Tags : FDA-approvals

New rays of hope for Alzheimer’s

Neurologists claim to have made progress towards diagnosing early-stage Alzheimer's disease through brain scans. Researchers studied a group of 24 people, some of whom had cognitive impairments believed to be signs of mild Alzheimer's disease and some who were cognitively normal. Subjects suspected of Alzheimer’s had low levels of amyloid- beta 42 in their cerebrospinal fluid (CSF). A-beta 42 is known to be the primary ingredient in the plaque buildups that are consistently found in Alzheimer's patients' brains. The next component of the research for the scientists was the positron emission tomography (PET) scan results of the patients’ brains. The scans employed a new imaging device called PIB (Pittsburg compound B) to help the amyloid plaque to stick enough to be detected through a PET scan. The scan reports revealed the patients with low CSF levels of A-beta 42 thus detecting the presence of Alzheimer’s. The study is a significant development, as early detection of the disease can eventually prove useful in the clinical prevention and treatment of the disease.

Meanwhile, a study conducted by researchers in Switzerland has found that a compound isolated from a cynobacterium, a type of blue-green algae known as Nostoc, could become a natural remedy to combat Alzheimer’s and other mental disorders. Promising possibilities to battle a variety of human diseases have been increasingly found in cynobacterium and marine natural products. This is believed to be the first attempt of isolating cyanobateria from a potent agent to fight Alzheimer’s.

In another development related to Alzheimer’s, AstraZeneca has agreed to pay USD 300 million to Targacept to obtain rights for developing and marketing a drug to treat Alzheimer’s and schizophrenia. AstraZeneca, for whom exploring therapies for Alzheimers and other cognitive disorders is a core focus area, has signed an exclusive global licensing and research collaboration agreement with Targacept.

Green tea and cancer cure: A tenuous link

Green Tea seems to be the flavour of the season with various studies pointing to its ability to not only be an effective remedy for cancer, but also help boost the immune system for a healthier lifestyle.

Specifically speaking, a green tea extract—Epigallocatechin Gallate (EGCG)—has been identified as being beneficial for people with Chronic Lymphocytic Leukemia (CLL). According to preliminary evidence in a case study of four patients, an improvement in the clinical state of their disease was noticeable after they starting taking over-the-counter products that contained EGCG.  Per the author of the study, Dr. Tait Shanafelt, “The experience of these individuals provides some suggestion that our previously published laboratory findings may actually translate into clinical effects for patients with the disease”. However, it is not known as to how many patients were taking similar products and failed to have any benefit. Also, the optimal dose, the frequency of the medication, and its long-term side effects are not known yet. CLL is a blood and bone marrow cancer, which affects white blood cells. It is the commonest type of leukaemia and is yet to have a cure. However, more research is needed to prove the findings on a larger scale and it is still premature to say that this is a new treatment for cancer.

Meanwhile, researchers from the University of Minnesota have performed a meta-analysis of 13 studies and concluded that green tea consumption lowers the risk of breast cancer. However, only controlled randomized trials can confirm the above observations.

 

Technorati Tags : cancer+leukemia

 

Canadian firm to use Christmas trees for Tamiflu ingredient

Biolyse Pharma Corp, a Canadian company plans to extract shikimic acid, a chemical found in Tamiflu from discarded Christmas trees. These trees contain shikimic acid in their pine, spruce and fir needles. The acid is used in Roche Holding AG’s Tamiflu and is mainly extracted from star anise trees in China.

The company will use needles of up to 5,00,000 used Christmas trees for the extraction. It will get the trees in January from a Toronto-based firm called Gro-Bark Ltd, which recycles forest products. Biolyse has a production capacity of about two tons a month and plans to get more tree needles from forestry companies. Biolyse plans to sell the acid to companies and governments not covered by Roche’s patents on Tamiflu and who wish to make generic versions of the drug.

Biolyse turned to manufacturing shikimic acid after being rejected by Roche as a Tamiflu supplier. Demand for shikimic acid has increase manifold due to a number of bird flu outbreaks this year. Currently the Chinese production of the acid is very limited as star anise tree takes eight years to grow to maturity and can only be harvested for two months a year. To overcome this shortfall Biolyse is working with particular species of pine, spruce and fir that is far more abundant than the seedlings of star anise. Due to strong demand and relatively scarce supply price of the acid from China has gone up from $45 a kilogram to over $600 in the last year. There are also concerns that China may ban export of the element in order to secure its own supplies.

Considering these factors Biolyse is likely to make huge profits by manufacturing the chemical component.

Technorati Tags : avian+flu

Stem cell research: Creating news

Stem cell research has been in the news for all the wrong reasons, these last few weeks. It has been alleged that the results of a landmark 2005 paper on production of tailored embryonic stem cells were fabricated. A nine-member panel from Seoul National University that has been examining the work of celebrated scientist Hwang Woo-suk, has stated that the data in 2005 was intentionally fabricated. Hwang is best known to the international public for leading a team that created the world’s first cloned dog, Snuppy.

However, there is also some good news on the horizon. Australian researchers have achieved a major breakthrough as far as plant stem cell research is concerned. Scientists from the Max Planck Institute for Developmental Biology have uncovered a feedback mechanism, involving a growth-enhancing hormone and a regulatory protein, which controls the number of stem cells the plant produces.

Unlike the stem cells of animals, which can only produce specific kinds of tissue after the animal is past its embryonic stage, plant stem cells retain their totipotency and, therefore plants continue growing over many years, developing new organs. But this ability comes at a price. If the number of meristematic stem cells increases too quickly, then there could be uncontrolled growth, similar to cancer. On the other hand, if the stem cell pool shrinks too quickly, the plant could have stunted growth.

Meanwhile in India, the country’s first exclusive stem cell transplant center will come up in Chennai, Tamil Nadu, next year. Per Abhayakumar, CEO of LifeCell (India’s first umbilical cord stem cell bank), the center would be a state-of-the-art facility meant exclusively for stem cell transplants. In a related development, a world-class state-of-the-art facility for biotech research and development will be inaugurated shortly in the eastern state of Orissa, at Bhubaneshwar. Major objectives of the organization are to provide research tools at a reasonable price and to promote academic and industry collaborations.

Technorati Tags : stem+cells

Another round of initiatives to tackle bird flu

Even as the New England Journal of Medicine reported the possibility of bird flu strains developing resistance to Tamiflu, another step in the endeavor to find a remedy for the looming pandemic has been taken. China has started human trials of its homespun bird flu vaccine with six volunteers receiving shots. Per reports, volunteers did not experience any bad reaction to the vaccine. Although the trials will encompass another nine months of tests, initial results are expected within the first three. China, which has had more than 30 outbreaks of the deadly H5N1 strain and six confirmed fatalities from the infection, started the development of this vaccine called Panflu last year.

Elsewhere, in Kazakhastan, the health ministry has taken several preventive measures to ward off the threat of bird flu in the country over the next few months. Per the health minister, “The government has provided 63 ml tenge from the reserve and today we procure the only efficient anti-infective agents for the time being. We believe that the delivery will take place next year”. This is in keeping with the views of experts of the World Health Organization that Kazakhstan has a very high level of preparation for probable bird flu pandemic.

In India too, the contingency plan to be undertaken in the event of an outbreak of avian influenza in the country has been outlined. Steps such as surveillance of the local community, multi-disciplinary rapid response teams by National Institute of Communicable Diseases (NICD), laboratory preparedness for quick testing of samples and logistic and supplies, etc, have been proposed against the virus by the Health Ministry.

Technorati Tags : avian+flu

New hope for diabetics

There is good news for diabetes patients. According to a report published in the latest issue of the New England Journal of Medicine, diabetics who used insulin aggressively to control their blood sugar levels for over six years cut the risk of cardiovascular ailments by half, as compared to those who did not.

Over 1,400 people with Type-1 diabetes were enrolled for the study and they were randomly assigned to either conventional or intensive treatment. Conventional treatment involved administering one or two insulin injections a day, along with blood or urine glucose testing. Conversely, intensive treatment meant either administering at least three insulin injections a day or using a pump in order to keep the patient’s glucose levels as close to normal as possible. Researchers observed a greater reduction in cardiovascular events from intensive blood glucose control than from drugs that lower blood pressure and cholesterol.

The findings are particularly important considering the fact that people with Type-1 diabetes have 10-times greater risk of heart diseases than people without diabetes. Additionally, intensive glucose control has also been found to reduce the risk of damage to eyes, nerves and kidneys as well as the risk of atherosclerosis.

WHO has estimated that 177 million people worldwide have diabetes and this figure is expected to surpass 300 million by 2025. In Asia alone, about 89 million people are diabetic and four of the five largest diabetic populations are found on this continent. India has an estimated 32.7 million diabetics, China 22.6 million, Pakistan 8.8 million and Japan 7.1 million. Moreover, the disease is rapidly spreading and is estimated to hit 170 million by 2025. India and China will together account for almost 100 million diabetics. Unfortunately, most of the countries in the continent are totally unprepared to face this health crisis, which could have severe repercussions both economically and socially.

Technorati Tags : diabetes

Growing concern over development of resistant bird flu strain

There are new concerns in the battle against bird flu, as there are signs that Tamiflu may not be successful against every case of the illness. Till date Tamiflu is the most popular drug and is considered a frontline defense against the dreaded disease.

However, according to a report published in the New England Journal of Medicine, there is evidence that this strain of the flu virus (H5N1) can mutate into a form unaffected by Tamiflu. If the strain were to mutate and spread, it could render the growing stockpiles of the drug ineffective.

Dr Menno de Jong of the Hospital for Tropical Diseases in Ho Chi Minh City, Vietnam who conducted a study found that four out of eight avian flu patients who were administered Tamiflu died despite the treatment. This has cast serious doubts on the effectiveness of the medication in the eventuality of a pandemic.

Health officials had earlier predicted that the H5N1 strain of the bird flu virus would evolve into resistant forms as is common with virus-fighting medication. The deaths have however, come as a warning that numerous countries around the world are not at all prepared to deal with an avian flu pandemic. Though they are unsure whether the pandemic is imminent, experts fear that if the H5N1 virus becomes highly contagious, it could trigger one.

Another concern voiced by experts is that the stockpiling of the limited supplies of the flu drug could lead to resistance against the drug, if people begin to consume the medication unsupervised. Around the world, governments are stockpiling Tamiflu amid rising fears that the virus strain will mutate into a form, which will easily spread among humans.

In other developments, 18 websites across the globe have been identified as illegal sellers of products that claim to be Tamiflu. Seven of these are US-based, three from Britain and two in Canada. Switzerland, Singapore, Bahrain, Malta, Jersey and Cyprus had one website each. The authorities fear that the soaring demand for the drug will prompt people to attempt to buy them online—a practice laden with risks.

Technorati Tags : tamiflu

Human trials for anti-cancer drug compounds

Kiwi drug manufacturer Proacta Inc, on the back of government support, has announced that it will commence human clinical trials for an anti-cancer drug, shortly. These trials will begin at Waikato Hospital, in which 10 North Island cancer patients will participate.

Proacta Inc is a company founded by leading cancer researchers of the University of Auckland and the Stanford University in California. According to the scientists involved in the project, the drug is complex and it has taken years to bring it to this point.

Emphasizing on how the research indicates that New Zealand is taken seriously as a nation responsible for innovation, Trevor Mallard, the Economic Development Minister called the anti-cancer drugs clinical trials a major milestone for the science and medical communities.

The researchers have claimed that the drug is inimitable in the way it attacks tumors. They have described PR-104 as a unique anti-cancer drug that is converted to a DNA damaging agent in the hypoxic (oxygen deficient) regions in tumors. They further added that the first clinical trial is a very important step in their effort to seek to exploit the abnormality of tumors as a basis for treatment.

Meanwhile, US based ViaCell, which had stopped the early stage human clinical trial of its potential cancer treatment compound known as CB001 in September, said that it will seek a resumption of enrolment for the trial at all its early study sites. The trial was stopped after two patients experienced a common side effect known as acute graft-versus-host disease. They have since recovered and the US Food and Drug Administration that had placed a formal hold on the trial has now lifted the hold on the study.

Technorati Tags : cancer+drug

Efforts to counter bird flu menace gather steam

China has signed a draft agreement with the World Health Organization (WHO) on its commitment to share virus samples isolated from human cases affected by the H5N1 strain of the avian virus. The agreement, which was signed in Beijing by the WHO and the Chinese Ministry of Health, follows the Chinese Health Minister’s pledge at the bird flu summit in Ottawa a couple of months ago.

In its contribution to the global fight against the avian influenza epidemic, the Chinese Center for Disease Control and Prevention (CDC) forwarded two strains of bird flu isolated from human infection in China to the WHO for further research. These strains will help trace virus mutation and develop anti-retroviral drugs.

Meanwhile, tighter controls on lower-risk strains of avian flu virus and raised compensation payments to poultry owners have been approved by the European Union (EU) farm ministers. These steps have been taken as a measure to help tackle the spread of bird flu more effectively. According to Markos Kyprionou, the EU Health Commissioner, these directives will help to strengthen the EU’s defenses against outbreaks of the flu, and as a result help them swiftly manage outbreaks and minimize their negative impact. 

They have also agreed to reimburse poultry owners half of their costs incurred in fighting the deadly epidemic. The compensation payment, which will commence in January 2006, will mainly cover costs of slaughter, cleaning and disinfection. Additionally, European governments have been ordered to beef up surveillance, vaccination and elimination of infected flocks under strictly controlled conditions. The EU will compensate the costs incurred for these vaccinations.

In a welcome break, the tests conducted on dead and sick birds in Ethiopia have returned negative. Earlier this month, hundreds of dead pigeons were discovered and it was feared that the deadly avian virus had made its first appearance in Africa. Spokespersons of the agriculture ministry said that the birds had died of Newcastle disease, a common occurrence in poultry. 

Technorati Tags : China+flu