Announcement no. 21/2007 To the OMX Nordic Exchange Copenhagen, November 5, 2007 Curalogic updates from its Phase III clinical study with the ragweed product Summary: All patients in Curalogic's Phase III clinical study with the ragweed product have now completed the planned treatment. The next steps are first quality control of all data and then calculation of the results of the study. Curalogic plans to publish results from the study in the first quarter of 2008. As planned, Curalogic has completed the dosing of patients in the Phase III clinical study (RPE 04) with the product for the treatment of ragweed allergy. In the upcoming period, data from the study will be subjected to quality control and collected in a database. The study is blinded during the entire process, meaning that neither the doctors nor the persons in charge of quality control know which patients have received active treatment and which have received placebo. Work will now begin to calculate the results and conduct quality control to ensure that the calculations are correct, and only after completion of these procedures will Curalogic be ready to release the results. Curalogic expects to publish the results from the study in the first quarter of 2008 and plans to file a registration application for the ragweed product in Europe in the second half of 2008. Design of the Phase III clinical study Dr. Peter Creticos, Medical Director of the Johns Hopkins Asthma and Allergy Center, is the principal investigator of the RPE 04 study. RPE 04 is a double-blinded, randomized placebo-controlled study. The study objective is to evaluate the effect and safety of a daily dose of orally administered ragweed pollen extract to patients suffering from ragweed allergy. The study includes 545 patients with moderate to severe ragweed allergy in the United States, Italy, Hungary and Serbia. Curalogic's product for the treatment of ragweed allergy In addition to the RPE 04 study, the ragweed product has been thoroughly tested in seven completed clinical studies involving more than 1,000 patients. The results from the clinical studies have shown the same good reduction of allergy symptoms as achieved with injection-based immunotherapy, and that the product is safe and has very few adverse effects. Ragweed allergy In Denmark, ragweed is called Bynke-ambrosie. About 4 million people in Europe and 29 million people in the United States suffer from ragweed allergy. Patients experience ragweed allergy as one of the worst allergies. This is partly due to the fact that pollen from ragweed is very potent and partly that the pollen season is very long (6-8 weeks). Yours sincerely Curalogic A/S For additional information, please contact: Peter Moldt, President and CEO Phone +45 99 99 24 00, mobile +45 26 25 04 22 Helle Busck Fensvig, EVP and CFO Pnone +45 99 99 24 00, mobile +45 20 70 55 37 About Curalogic Curalogic is a Danish biopharmaceutical company listed on the OMX Nordic Exchange (CUR.CO) as a small cap + company. Curalogic develops innovative products for the treatment of allergy using a patented formulation technology. The products combine the efficacy of immunotherapy with the patient friendliness of antihistamines and have the potential to become the preferred type of allergy treatment among patients. Curalogic has a broad and mature pipeline with a product for the treatment of ragweed allergy in Phase III, a product for the treatment of grass allergy ready for Phase III, a product for the treatment of cat allergy in Phase II and a product for the treatment of house dust mite allergy being prepared for clinical trials. This announcement contains forward-looking statements regarding the Company's future financial development and performance and other statements which are not historical facts. Such statements are made on the basis of assumptions and expectations which, to the best of the Company's knowledge and belief, are reasonable, at this time, but may prove to be erroneous in the future.
Curalogic updates from its Phase III clinical study with the ragweed product
| Quelle: Curalogic A/S