|
In a phase II clinical trial, Curalogic has shown that its grass product is well tolerated without up-dosing |
|
|
|
16 May 2007 |
Curalogic has concluded a Phase II clinical trial that explored the possibility of eliminating up-dosing (titration) at initiation of treatment. The result shows that that the grass product is welltolerated without up-dosing. This is important because it is easier for the patients to taker the same dose throughout the full treatment period. The market for Curalogic’s grass product is large, as there are approximately 51 million people in Europe and 30 million people in the USA suffering from grass allergy.
COPENHAGEN, Denmark | May 15, 2007 | In the phase II clinical trial, GPE 02, which Curalogic has already reported on in May 2007, it was shown that high doses of the grass product were well-tolerated with up-dosing. As an extension to GPE 02, Curalogic has administered the grass product to a new group of patients (cohort B) and can now report that a high dose of the grass product also is well tolerated without preceding up-dosing. This result is important because it is easier for the patients to administer the same dose of the product through the full treatment regime.
Dr. Jörg Kleine-Tebbe of the Allergy & Asthma Center Westend, Berlin, Germany was the principal investigator in this trial. The trial was double-blinded, randomised, and placebo-controlled. In cohort B, 15 patients with moderate to severe grass pollen allergy, were treated daily for a week outside the grass pollen season with 32,000 BAU of microencapsulated grass pollen extract (10 patients) or placebo (5 patients). BAU is the biological potency of the product defined relative to a FDA reference standard for grass pollen extract.
The key results from the cohort B trial were:
All patients completed the entire trial.
No serious adverse events or severe adverse events were observed in the trial.
32,000 BAU of the grass product was well-tolerated and all adverse events were mild.
A comparison with the tolerability from the GPE 02 trial, indicate that at a dose level of 32,000 BAU, tolerability is similar with or without preceding up-dosing. Curalogic expect, based on the results from this trial, to be able to omit up-dosing with the grass product in the coming EU phase III trial. Further, the results from this trial support the good tolerability of oral immunotherapy using
Curalogic's formulation technology.
Curalogic's product for the treatment of grass allergy
The active ingredient of the micro-encapsulated grass product candidate is an extract of Timothy grass pollen (Phleum Pratense L.).
Curalogic's microcapsulated formulation has been used to administer grass pollen extract in two clinical trials. The trials included a total of 93 patients with moderate to severe grass allergy who were dosed on a daily basis for 1 to 10 weeks. The highest dose tested is 64,000 BAU, which is approximately 30 times higher than the maintenance dose with injection immunotherapy recommended in the US. No treatment related serious adverse events or anaphylactic reactions were reported during the trials. The grass product was well-tolerated and the adverse events were similar in nature as those observed for the ragweed product. The next step in development is an EU Phase III trial and Curalogic is discussing the conduct of this study with the company’s clinical advisors.
Source: Curalogic A/S |
