Positive Outcome of the PURETHAL® Birch RUSH Study Results in an Approved, Accelerated up-dosing Regimen

LEIDEN, the Netherlands, March 10, 2015 /PRNewswire/ --

HAL Allergy B.V. today announced that, based on the positive outcome of the PURETHAL® Birch RUSH study, a new accelerated up-dosing regimen for all registered PURETHAL® Pollen products has been approved in Germany.

The RUSH study had a multi-centre, open, randomized, parallel group design. Patients with birch pollen induced allergic rhinitis were treated with a conventional registered up-dosing regimen (six injections over five weeks) or an accelerated up-dosing regimen (three injections over two weeks). Success rate was based on the predefined need of additional up-dosing steps because of the occurrence of local and systemic reactions. A total of 123 birch pollen allergic patients were randomized. A high proportion of patients successfully reached the maintenance dose without safety concerns in both groups (98.4% and 96.7% for the accelerated and conventional regimen, respectively) confirming non-inferiority of the accelerated regimen. At the end of study, significant increases in specific IgG and IgG4 were observed in both treatment groups.

Together with a previously performed RUSH study with PURETHAL® Grasses this study confirms the possibility of accelerated up-dosing for the PURETHAL® Pollen products in just two weeks in adults. A change of the product leaflet encompassing this accelerated up-dosing possibility for PURETHAL® Pollen has been granted by the Paul-Ehrlich-Institute, the regulatory authority in Germany.

"These results confirm the safety of our PURETHAL® Pollen range and provide physicians and patients with flexibility during the up-dosing period. An accelerated up-dosing regimen is helpful for patients with multiple pollen allergies, patients coming near the beginning of pollen season, and patients who wish to up-dose faster," says Dr. Tomasz P. Bednarczyk, CCFO of HAL Allergy.

About PURETHAL 

HAL Allergy has developed PURETHAL®, which is an aluminum hydroxide-adsorbed modified allergen preparation for subcutaneous use. It is designed for the treatment of a wide range of allergic diseases, from allergic conjunctivitis and allergic rhinitis to allergic asthma in patients inadequately controlled despite the use of symptomatic treatments. PURETHAL® Birch contains modified birch pollen allergens (allergoids). An allergoid consists of an allergen extract that has been chemically modified to reduce its allergenic potential while remaining its immunological stimulus. This provides the opportunity to administer high doses of allergens with a reduced risk of side effects.

About HAL Allergy 

HAL Allergy Group is active in the field of biopharmaceuticals and is located at the Bio Science Park in Leiden, The Netherlands. Our core business is the development and manufacturing of therapies and diagnostics for allergic diseases. In addition, we offer contract manufacturing services focusing on the production of biopharmaceutical products for (pre-) clinical studies. With offices in major European countries, HAL Allergy is one of the European top players in the allergy immunotherapy business. Established in 1959 HAL Allergy has long experience in developing, producing and selling allergy therapies with an immuno-modulatory effect causing a reduction in symptoms and long-term disease suppression. The allergy therapies are used against common allergies such as hay fever, house dust mites allergy and allergic reactions towards wasp or bee stings. More information is available on: http://www.hal-allergy.com.  

The main shareholder of HAL Allergy GmbH is Droege International Group AG, which is an independent Advisory and Investment Company, based in Düsseldorf, Germany. More information is available on: http://www.droege-group.com.