STALLERGENES: Immunotherapy Tablet Containing Recombinant Allergen rBet V 1 Of Birch Pollen: Positive Results For A Phase IIb III Trial
Stallergenes S.A. has announced the first results of a new phase IIb/III clinical trial (VO59.08) conducted in allergic rhinitis caused by birch pollen and concerning the development of a sublingual immunotherapy tablet containing the recombinant allergen of this pollen, rBet v 1. This study is the first ever to use a recombinant allergen as an active substance. To Stallergenes' knowledge, the use of a recombinant protein in dry form is also a world first. The VO59.08 study, conducted during the 2009 pollen season, was a randomized, double-blind, placebo-controlled trial. It included 483 adult patients allergic to birch pollen and suffering from rhinoconjunctivitis symptoms in 30 centers in 8 different countries. The patients were divided into 4 groups: 3 groups treated with sublingual tablets containing 12.5 microg, 25 microg and 50 microg of rBet v 1, respectively, with no dose-titration phase, and one group receiving placebo. The primary endpoint for analysis of the results was the reduction in average adjusted symptom score (AASS).
Dr Elaine Vickers, Research Relations Manager at Asthma UK, says: 'There are a few studies which suggest that the chemicals present in indoor swimming pools, like chlorine, may be involved in the development or worsening of asthma and other allergic conditions. This is due to the fact that the chemicals in the water may compromise protective cell barriers within the lungs, meaning people with allergic asthma are more vulnerable to allergens. 'However, asthma develops as a result of a complex mix of genetic and environmental factors, so more research is needed in this area before we can make a conclusive link between asthma and the use of chemicals in swimming pools. 'Swimming is an excellent form of exercise for children and young people with asthma as it can help improve lung capacity and the warm, humid air inside indoor pools is less likely to trigger asthma symptoms. We would therefore advise parents of children with asthma not to worry about letting their child go swimming, unless they develop asthma symptoms in the pool environment.
Health Canada Updating Proposal For Food Allergen Regulatory Amendments Based On Consultation Results
In July 2008, Health Canada published in Canada Gazette, Part I proposed regulatory amendments for the labelling of food allergens, gluten sources and added sulphites. The department has now reviewed the comments received and is publishing documents detailing some of the changes being made to the proposal as a result of the consultations. As a result of the over 140 comments received up until early December 2008 following the publication of the proposed regulatory amendment in Canada Gazette, Part I in July 2008, Health Canada has made several decisions and changes to its regulatory proposal to address concerns raised by stakeholders and Canadian consumers. These include: - The development of Canadian criteria for the establishment of new priority food allergens; - The decision to add mustard as a priority allergen in the regulations based on this criteria document; - The decision to not add onions and garlic to the list of priority allergens in the regulations based on this criteria document;
Amira Pharmaceuticals Announces Initial Positive Phase 1 Clinical Data For AM461, A Back-Up To Amira's Lead DP2 Antagonist, AM211
Amira Pharmaceuticals, Inc. announced initial positive data from a Phase 1 clinical study of AM461, the Company's second oral selective antagonist of the DP2 (also known as CRTH2) receptor. The interim results demonstrate that a dose proportional pharmacodynamic (PD) effect can be achieved with AM461. Additionally, AM461 Phase 1 data to date demonstrates a good safety profile. AM461 is a back-up to Amira's lead DP2 antagonist, AM211, which has successfully completed Phase 1 clinical studies. "The AM461 clinical data further strengthens our commitment to the DP2 receptor as a clinical target. Amira now has two structurally distinct, clinical-stage compounds targeting the receptor, " said Isabelle DeArmond, Vice President, Clinical Development. "Our approach to drug development is based upon bringing multiple structurally and metabolically distinct compounds forward in development. In addition to AM211 and AM461, we have additional novel DP2 antagonist molecules in reserve, " said Bob Baltera, Chief Executive Officer.
Asthma, nasal symptoms and eczema is a major public health problem in Sweden, not least among young people. Half of all teenagers are affected in VГ stra GГ taland County in West Sweden. This is shown in a study conducted in 2008 by the Sahlgrenska Academy at the University of Gothenburg, on the request of the Public Health Committee, Region VГ stra GГ taland. The study also shows that the prevalence of allergies among young people has increased by ten percentage points since the year 2000. The study includes all residents of VГ stra GГ taland County (pop. 1.5 million) born in 1992, and is a follow-up to a similar study conducted in 2000. The results show that 49 percent of the teenagers suffer from physician-diagnosed asthma, nasal symptoms or atopic eczema. The most common problem is nasal symptoms, followed by asthma and atopic eczema, and allergies are more common among girls than boys. The proportion of teenagers with allergies is almost ten percentage points larger in this study than in 2000.
Nontuberculous mycobacteria (NTM) are environmental organisms found in both water and soil that can cause severe pulmonary (lung) disease in humans. Pulmonary NTM is on the rise in the United States, according to a large study of people hospitalized with the condition. A research team led by epidemiologists from the National Institute of Allergy and Infectious Diseases, part of the National Institutes of Health, analyzed hospital discharge records of patients in 11 states whose combined total population represents 42 percent of the country. They reviewed database records spanning 1998 to 2005, and identified more than 16, 475 hospitalizations associated with pulmonary NTM in people without AIDS. Before the widespread availability of combination antiretroviral therapy, pulmonary NTM disease was a common opportunistic infection among people with AIDS infection; in this study, the researchers limited their analysis to non-AIDS NTM disease. Of the 11 states studied, Florida, New York and California had 62 percent of the pulmonary NTM hospitalizations.
A recent commentary suggests that the U.S. should spend roughly $197 million more than it currently does to research the impact of climate change on public health. The analysis found that the U.S. spends about $3 million in federal funds on research related to the health impacts of climate change, says Marie S. O'Neill, one of the commentary co-authors. This isn't nearly enough to adequately address the public health issues related to global warming, the group concluded. The commentary's lead author was Kristie Ebi, a University of Michigan-trained epidemiologist and expert on climate change and public health, who is an adjunct professor of Environmental Health Sciences. The article was inspired by another study, mandated by Congress, that assesses the importance of global climate change on health, also led by Ebi. During their research and in preparing testimony for Congressional hearings on the topic, the team realized that the U.S. is woefully underfunding climate change health-related research.
A study conducted in Vietnam has added further weight to the view that parasitic gut worms, such as hookworm, could help in the prevention and treatment of asthma and other allergies. Led by Dr Carsten Flohr, a Clinical Scientist from The University of Nottingham, and Dr Luc Nguyen Tuyen from the Khanh Hoa Provincial Health Service in central Vietnam, the study is the largest double-blind placebo controlled clinical trial to date looking at the potential links between hookworm and other gut worm infections and allergic conditions such as asthma and eczema. Thanks to improved hygiene practices parasitic worms have been mostly eradicated among human populations living in developed countries. However, experts believe that over millions of years of co-evolution worms have found methods to dampen down host immune responses to prolong their own survival inside humans. This relationship seems to have become so intertwined that without gut worms or other parasites, our immune system can become unbalanced, which in turn could contribute to the development of asthma and other allergies.
Heparin, a commonly used anticoagulant, can cause skin lesions, reports a study http://www.cmaj.ca/press/cmaj081729.pdf in CMAJ (Canadian Medical Association Journal). Skin lesions caused by heparin may indicate the presence of a life-threatening decrease in the number of platelets, a condition called "heparin-induced thrombocytopenia" or, in most cases, a self-limiting, allergic skin reaction. The study looked at 320 patients undergoing heparin injections over 12 months at The Hospital of The Johann Wolfgang Goethe University in Frankfurt, Germany. Twenty-four patients - 7.5% of the study group - exhibited heparin-induced skin lesions, considerably above the expected rate of 2%. "During the study, we were surprised by the high number of patients with heparin-induced skin lesions, " state Dr. Ralf Ludwig, University of Lubeck, and coauthors. For most patients, the diagnosis was made because of our study." After clinical examination, they suggested "a delayed-type hypersensitivity response was the most common cause for all the observed lesions, " which was confirmed by subsequent allergologic and histologic testing.
For men with type 2 diabetes, a cell type linked to allergic inflammation is closely linked to a key indicator of diabetic kidney disease (nephropathy), suggests a study in the November Clinical Journal of the American Society of Nephrology (CJASN). "Allergy is a common disease that is increasing worldwide, so our findings may have important implications for diabetic nephropathy, " comments Michiaki Fukui, MD (Kyoto Prefectural University of Medicine, Japan). The researchers compared the eosinophil count with albumin excretion rate in nearly 800 patients with type 2 diabetes. Eosinophils are a type of white blood cell that contributes to inflammation in allergic diseases. The albumin excretion rate is a key indicator of kidney disease, one of the major complications of diabetes. In men, a higher number of eosinophils in the blood correlates with higher urinealbumin - a critical early sign of diabetic kidney disease. Surprisingly, the link between eosinophil count and albumin excretion rate was even stronger than for known risk factors like high blood pressure and poor diabetes control.