Design of the clinical phase II trial: The main objective of the trial is to determine a maximum tolerated dose, which is the highest dose that can be administered to patients without to many adverse events. A secondary objective of the trial is to evaluate the safety of the grass product. The trial is a double blinded randomized placebo controlled trial. 30 patients with moderate to severe grass allergy will be treated daily with increasing doses of microencapsulated grass pollen extract. Each dose level will be given for one week. The dose level is increased weekly following a careful review of the safety of the previous dose level. In this trial, patients will be receiving treatment for up to 7 weeks.
Curalogic’s product for treatment of grass allergy Curalogic’s product for treatment of grass allergy is currently in clinical phase II. The grass product has been tested previously in a clinical trial where 48 patients received increasing doses of grass pollen extract or placebo over a 10-week period. Results from the clinical trial showed that the grass product was well tolerated and furthermore, the trial gave the first indications of a down regulation of the immune response to grass pollen. In GPE 02 higher doses will be tested than was the case in the first clinical trial.
Grass allergy Approx. 51 million people in Europe and 30 million people in USA suffer from grass allergy. The active ingredient of the microencapsulated grass product candidate is an extract of Timothy grass pollen (Phleum pratense L.).
Curalogic A/S For additional information, please contact: Peter Moldt, President and CEO, Phone +45 33 11 41 01, mobile +45 26 25 04 22 Helle Busck Fensvig, EVP and CFO, Phone +45 33 11 41 01, mobile +45 20 70 55 37
