Curalogic has started clinical phase II trial with its grass product
- Category: Vaccines
- Published on Monday, 15 January 2007 02:00
- Hits: 5083
COPENHAGEN, DenmarK | Jan 11, 2007 | Curalogic has started the treatment of the first patients in a clinical phase II trial (GPE 02) with the product for treatment of grass allergy. The purpose of the trial is to determine a maximum tolerateddose (MTD) of orally administered grass pollen extract to patients suffering from grass allergy.
According to the plan, 30 patients will participate in this trial, which will be carried out at a single clinical center in Berlin, Germany. Top line results from the trial are expected to be released in the second quarter of 2007.
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.
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.).
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
Curalogic A/S • Amagertorv 29A, 4th floor, DK 1160 Copenhagen K, Denmark •
Phone +45 33 11 41 01 • Fax +45 33 11 31 01 • www.curalogic.com • CVR no. 27 97 06 05
Curalogic is a Danish biopharmaceutical company listed on the Copenhagen Stock Exchange
(CUR.CO). Curalogic develops innovative pharmaceuticals for the treatment of allergy. By combining the best of two worlds - the efficacy of immunotherapy combined with the safety and patient convenience of symptomatic treatments – Curalogic aims to develop a novel and user-friendly form of allergy treatment, and make it the preferred type of allergy treatment among patients. Curalogic has a broad and mature pipeline with a product for treatment of ragweed allergy ready for Phase III, products for treatment of grass allergy and cat allergy in Phase II and a product for treatment of house dust mite allergy preparing 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, are reasonable at this time, but may prove to be erroneous in the future.