Pharming Group N.V.
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Publicatie datum
30 aug 2007 - 07:52
Statutaire naam
Pharming Group N.V.
Titel
PHARMING PRESENTS POSITIVE RESULTS FROM EUROPEAN PHASE III TRIAL OF RHUCIN®
Bericht
Leiden, The Netherlands, August 30, 2007. Biotech company Pharming Group N.V. (“Pharming” or “the Company”) (Euronext: PHARM) announced today positive safety and efficacy results from its European randomized placebo-controlled Phase III clinical trial of Rhucin® for the acute treatment of Hereditary Angieoedema (HAE). The positive results from an interim analysis of its European randomized placebo-controlled Phase III clinical trial follow earlier studies showing the strong positive effect of Rhucin® coupled to an excellent safety profile.
The Phase III double-blind placebo-controlled study with Rhucin® was conducted at several centres across Europe. The trial assessed the safety and efficacy of Rhucin® in patients who presented with different sites of acute HAE attacks. In the analysis, data were analyzed from the first 28 patients randomized to either Rhucin® or placebo. Patients receiving Rhucin® reported first relief at a median time of 60 minutes compared to 8.5 hours for those patients who received placebo. The primary endpoint, time to beginning of symptom relief, achieved statistical significance with a p-value of 0.0009 using the so-called log-rank test which is a common type of statistical analysis in these studies. Typically, if the p-value is below 0.05, the data are considered to be statistically significant. The result achieved at the primary endpoint was also clinically relevant.
In addition, patients receiving Rhucin® reported minimal symptoms at a median time of 6.1 hours compared with 20.2 hours for patients who received placebo. The secondary endpoint which measured time to minimal symptoms, achieved statistical significance with a p-value of 0.0038. The result achieved at the secondary endpoint was also clinically relevant. The analysis demonstrated that 100% of patients in the Rhucin® group responded to treatment and that all of these patients experienced sustained relief without a relapse of their attack symptoms.
Datum laatste update: 02 september 2024