EUREKA project E! 3292 MULTI-PATCH has been provided key support in developing a new range of 'DIALLERTEST'® products, aimed at detecting the most frequently observed children's allergies, including milk, corn, soy and house dust mites. Already being marketed internationally, MULTI-PATCH results represent a major success for European medical research and development, and a big commercial hit for project partners.
"In the past decade, food allergies have become a major point of concern for paediatricians," explains Pierre-Henri Benhamou of France's DBV Technologies, "especially those treating very young children. Specifically, there has been a steady increase in the number of cases, a trend confirmed by statistics of the French drug agency showing the frequency of food allergies almost doubling over the last ten years."
At the same time, says Benhamou, the scientific approach to allergies has also evolved. Aside from the well-known 'immediate' forms of allergy, which rapidly present acute symptoms upon allergen ingestion, 'delayed' types have also been described since the 1990s. Here, clinical symptoms, usually digestive or cutaneous reactions, occur several hours, days or even weeks after ingestion.
"Food allergies have become a major point of concern for paediatricians, especially those treating very young children."
"These allergies are caused by foods that form the base of the day-to-day diet, and to which the patient becomes only gradually sensitised. Unlike the more traditional forms of allergy, the delayed forms pose important problems in terms of diagnosis."
The first DBV Technologies project began in the summer of 2000, when DBV colleagues Benhamou and Christophe Dupont, two paediatricians with extensive experience researching food allergies in children, joined with engineer Bertrand Dupont to develop a simple and reliable diagnostic test for food allergies.
'Patch tests' are used to determine if a specific substance causes skin inflammation. In simple terms, a suspected irritant is applied to the skin and held in place with an adhesive patch.
The DIALLERTEST patch test is directly and painlessly applied onto the child's back either at the doctor's office or by the parents at home. Another patch, containing no irritant, is also applied as a control. Patches are removed 48 hours later by the parents and, when another 24 hours have elapsed, the doctor reads the results. If the skin under the suspect patch is red and swollen, the result is positive and the child is probably allergic to the substance.
"What's different about the DIALLERTEST system is that it uses DBV's new E-patch® technology," explains Benhamou. "This allows us to set dry powdered milk onto the patch by means of electrostatic forces. Thus, no additive or wet substance is needed to hold the suspected allergen in place."
"This represents an important simplification of the patch test," says Benhamou. "With this method, we can maintain much tighter control over the quantity of allergen delivered. This means a more measurable and reproducible reaction, and, ultimately, more reliable and standardised screening for cow's milk protein allergy. This also allows doctors to keep allergens in their best reactive state, the powdered form."
The materials used in DIALLERTEST patch tests are all bio-compatible, specially conceived for the pharmaceutical industry. The ready-to-use kit contains a felt pen for marking the skin, an instruction leaflet and two applicators, one containing a milk patch and the other a control patch.
"Financial support from the EUREKA programme made it possible to continue with essential studies and to further develop industrial tools for the DIALLERTEST product range," says Benhamou, "in cooperation with our Polish partner P.P.F. Hasco-Lek. Today, our products are being distributed in Mexico, Australia and the countries of the ex-USSR, and the necessary paperwork is also being completed for distribution in the US and with the European drug agency (EMEA)."
At the beginning of 2006, new investors SOFINOVA and APAX provided further impetus to DBV's efforts. The company is now working in several related directions, collaborating with laboratories and universities both in Europe and the United States. "The technologies developed by our researchers have led to a new method of cutaneous administration, which we call 'VIASKIN'," says Benhamou. "This method has made it possible to consider some completely new applications. For example, work on topical vaccination, i.e. without breaking the skin, is now ongoing."
With support from EUREKA and thanks to a particularly dynamic research team, DBV has developed a range of completely original tests."
Another project is looking at a desensitising technique using VIASKIN that would eliminate the risk of anaphylactic shock during allergy treatments. Phase 2 clinical studies are now being undertaken in France with several allergens, in particular the groundnut, for which it has so far been impossible to consider desensitisation by traditional techniques because of the risk of acute reactions.
Benhamou says the Nutricia laboratory, a world leader in infant nutrition, has agreed to undertake the commercial marketing of DIALLERTEST, confirming one of the most outstanding success stories in recent years in the field of child allergies.
"With support from EUREKA and thanks to a particularly dynamic research team, DBV has developed a range of completely original tests," he says, "creating strong commercial alliances on the basis of an extremely original and innovative concept."