DBV Technologies, the firm that received the Food and Drug Administration’s (FDA) Breakthrough Therapy Designation for their peanut patch in April, issued a press release stating that the board overseeing their milk patch Phase I trial found no safety concerns and is recommending the therapy progress on to Phase II.
Phase I studies focus on the safety of a new therapy while Phase II studies focus on a therapy’s efficacy. Pending a review of the Phase I data by the FDA and approval of the proposed Phase II protocol, the firm expects to continue on to the Phase II study in the second half of 2015.
DBV describes Viaskin® as “an electrostatic patch, based on Epicutaneous Immunotherapy, or EPIT®, which administers an allergen directly onto the superficial layers of the skin to activate the immune system by specifically targeting antigen-presenting cells without allowing passage of the antigen into the bloodstream.” In other words, the patch therapy introduces increasing quantities of an allergen through the skin and by doing so desensitizes the individual to that allergen.
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In a study of discharge data collected over 5 years from over 200 hospitals in Illinois, it was determined that emergency room visits and hospitalizations of children with severe food allergies rose an average of 30% each year between 2008 and 2012.
The study, led by Dr. Ruchi Gupta, professor of pediatrics at Northwestern University Feinberg School of Medicine and attending physician at Ann & Robert H. Lurie Children’s Hospital of Chicago, focused on children that suffered anaphylaxis, a potentially fatal allergic reaction.
Previously, white children and those from higher-income families were affected most by food allergies, but the study shows that the rates of Hispanic, African American and lower-income children are skyrocketing as well.
“This study shows that severe food allergies are beginning to impact children of all races and income. This is no longer primarily a disease of children who are white and/or from middle-to-high income families. Nobody is immune to it,” said Dr Gupta.
In a study to be presented at the ongoing American Thoracic Conference (ATS) 2015, it was determined that many children suffering from asthma have a sensitivity to peanuts but their families are unaware.
“Many of the respiratory symptoms of peanut allergy can mirror those of an asthma attack, and vice versa. Examples of those symptoms include shortness of breath, wheezing and coughing,” said study lead author Robert Cohn, MD, MBA. “This study aimed to evaluate the proportion of asthmatic children who also demonstrated a sensitivity to peanuts.”
The study researched the charts of 1517 children diagnosed with asthma at Mercy Children’s Hospital in Toledo, Ohio. Of the charts reviewed, 665 (43.8%) had IgE testing for peanuts, and of this group 148 (22.3%) had positive results.
Of the children with positive IgE tests, more than half (53%) of the children and their families did not suspect there was any sensitivity to peanut.
A study of the accidental exposure of children with physician-confirmed peanut allergy was published in the Journal of Clinical and Translational Allergy earlier this month.
The parents of 1941 children were recruited from Canadian allergy clinics and allergy advocacy organizations over a ten year period beginning in 2004, who completed questionnaires regarding the accidental exposure to peanuts of their children over the preceding year and the results were correlated.
In positive news, DBV Technologies, a French firm developing skin patch therapies for various allergens, issued a press release announcing their Viaskin® Peanut patch has received “Breakthrough Therapy” (BT) designation from the US Food and Drug Administration (FDA).
DBV describes Viaskin as “an electrostatic patch, based on Epicutaneous Immunotherapy, or EPIT®, which administers an allergen directly onto the superficial layers of the skin to activate the immune system by specifically targeting antigen-presenting cells without allowing passage of the antigen into the bloodstream.”
According to a study published today in the Canadian Medical Association Journal, allergies to specific foods can be passed via blood transfusions, though such cases are extremely rare.
The research was initiated after an eight year old Canadian boy with no history of food allergies suddenly experienced an anaphylactic reaction to salmon after receiving a transfusion of platelets as part of ongoing chemotherapy treatment. Four days later he had a reaction to peanuts.
Investigators traced the source of the platelets and found that a single donor had multiple severe food allergies including fish and peanuts.
Though extremely rare, researchers found that food allergies can be passed through an antibody that reacts against allergens, immunoglobulin E (IgE). IgE is found in blood platelets.
Food challenge: where the patient consumes a food they may be allergic to while the medical staff hovers nearby, ready to inject epinephrine if the symptoms of a severe allergic reaction appear. Low-tech, dangerous, and the only reliable way to test how severely someone may react to an allergen. Until now.
A blood test resulting from a study led by researchers from The Mindich Child Health and Development Institute and the Jaffe Food Allergy Institute promises to predict which people will have severe allergic reactions to specific foods. The study was published yesterday in The Annals of Allergy, Asthma & Immunology accompanied by a press release by Mount Sinai.
Current testing relies on skin pricks and blood tests that detect proteins called allergen-specific IgE produced by the immune system, though these cannot accurately predict the severity of reactions. The study reports that measuring another immune system component, the basophil, can accurately predict how a person will react to specific allergens. The basophil activation test (BAT) requires only a small amount of blood and provides quick results.
“While providing crucial information about their potential for a severe allergic reaction to a food, having blood drawn for BAT testing is a much more comfortable procedure than food challenges.” says first author Ying Song, MD. “Although food challenges are widely practiced, they carry the risk of severe allergic reactions, and we believe BAT testing will provide accurate information in a safer manner.”
Note that BAT testing is currently only approved for research study.
The Murdoch Children’s Research Institute of Parkville, Australia today announced results of a test they conducted of a novel new twist on an existing peanut allergy therapy.
The treatment combines traditional peanut oral immunotherapy (OIT) with a probiotic, lactobacillus rhamnosus. A fixed dose of the probiotic is provided daily along with daily doses of increasing quantities of peanut protein as is customary in OIT.
60 Children were enrolled in the test, with half given the treatment and the other half a placebo. Of the 28 children given the treatment, 23 (80%) were able to include peanut in their diet at the conclusion of the 18 month course of therapy.
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A study by researchers of the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health (NIH), may shed light on why women suffer more frequent and more severe instances of anaphylaxis than men.
Anaphylaxis – a life threatening allergic reaction triggered by foods, medication, and animal stings and bites – occurs when immune cells release enzymes that cause tissues to swell and blood vessels to widen. Clinical studies have shown that women experience anaphylaxis more often than men, though the mechanism for this has not been clearly understood.
NIAID researchers found that female mice experienced more severe and longer lasting anaphylactic reactions than males. They discovered that Estradiol – a type of estrogen – enhances the effect of endothelial nitric oxide synthase (eNOS), an enzyme that causes a number of symptoms of anaphylaxis.
A study of 102 patients enrolled from adult and pediatric clinics showed that only 16% used their epinephrine auto-injectors correctly. Of the remaining 84%, more than half missed 3 or more steps for proper administration.
The most common errors included:
- Failure to hold the unit in place for at least 10 seconds after triggering
- Failure to place the needle end of the device on the thigh, and
- Failure to depress the device forcefully enough to activate the injection.
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