Sep 19 2011
Karo Bio AB (STO:KARO)(publ) has received approval from national regulatory authorities to start its phase III patient study with eprotirome, enabling the study to start as planned with an Investigators meeting in September.
"With these approvals, we have all key pieces in place to begin the large patient study in eprotirome's phase III program. We, the clinicians and many patients are now looking forward to start this study", says Karo Bio's acting CEO Per Bengtsson.
The official start of the study takes place on September 22, when investigators from all participating clinics, gather for an investigators meeting that primarily will address the practical management of the study.
The study will be conducted at 70 clinics in 12 countries, mostly in Europe. The relatively large number of clinics is required to recruit enough patients during a limited period of time. The study will involve a total of 630 patients with the hereditary condition Heterozygous Familial Hypercholesterolemia (HeFH) who will be treated with eprotirome for two years. Patients with HeFH have high levels of LDL cholesterol and do often suffer from cardiovascular disease already at a young age. Karo Bio's goal is to complete the study so that a registration application can be submitted in the EU in 2014.
Source: Karo Bio