Announcement no. 5/2007
To the Copenhagen Stock Exchange Copenhagen, March
9th, 2007
Curalogic has started clinical EU phase III trial with its ragweed product
Resume: Curalogic has dosed the first patients in the clinical EU phase III
trial (RPE 04) with the product for treatment of ragweed allergy. The trial is
planned to include 550 patients in USA and Europe.
Curalogic has dosed the first patients in the clinical EU phase III trial (RPE
04) with the product for oral treatment of ragweed allergy. The trial will be
conducted at the same time in USA and in a number of European countries, and a
total of 550 patients will be enrolled into the study by the end of May.
Professor Claudio Ortolani, investigator in the RPE 04 study said, "I am
excited to be an investigator in the RPE 04 study. Ragweed allergy is a
significant health problem in northern Italy, and we lack an efficacious and
patient friendly treatment. Oral immunotherapy using Curalogic's formulation
technology is an easy solution to the problem, and I look forward to the future
when this novel product will be available to a larger patient population in
order to prevent ragweed allergy in our region." Professor Claudio Ortolani is
Director of Istituto Allergologico Lombardo, Milan, Italy.
Top line results from the trial are expected to be released in the first
quarter of 2008. On the basis of data from the RPE 04 trial, Curalogic plans to
submit an application for registration in Europe in the second half of 2008. In
addition, the RPE 04 trial is the first of two trials, needed for submission of
an application for registration in the USA.
Design of the clinical EU phase III trial
The RPE 04 trial is a randomized, double-blind, placebo-controlled study. The
purpose of the trial is to evaluate the efficacy and safety of a single daily
dose of ragweed pollen extract administered orally to patients who are allergic
to ragweed. Dr. Peter Creticos, Medical Director of the Johns Hopkins Asthma
and Allergy Center, is the principal investigator in the RPE 04 trial.
Patients with moderate to severe ragweed allergy will be treated daily with an
active dose or placebo. The active dose is 40 Amb a 1 units (biological potency
unit) which is the dose that has previously shown similar reduction in allergy
symptoms as with injection immunotherapy. The patients will take the pill at
home and are not required to be under medical supervision. Treatment will start
at least eight weeks prior to the ragweed pollen season and will continue
throughout the entire season. The ragweed season starts in the beginning of
August, lasting until early November. The trial's primary objective is to
evaluate the efficacy measured as a total allergy symptom score (TSS).
Yours sincerely,
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
About Curalogic
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 in 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.
