GO-AHEAD FOR KARO BIO PHASE III STUDY


GO-AHEAD FOR KARO BIO PHASE III STUDY

STOCKHOLM, September 19, 2011 - Karo Bio AB (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.
 
 

For further information, please contact:
Per Bengtsson, acting President and CEO
Mobile: +46 734 47 41 28          

About Karo Bio
Karo Bio is a pharmaceutical company focused on the research and
development of innovative drugs for large medical needs. The company
runs a number of drug development projects within the indication areas
cardiovascular and metabolic diseases, neuropsychiatry, inflammation,
autoimmune diseases, cancer and women's health. An important foundation
for the company's activities is its unique knowledge of nuclear
receptors as target proteins for the development of novel
pharmaceuticals, as well as related mechanisms of action. Karo Bio is
based in Huddinge, Sweden, has around 70 employees and is listed on
NASDAQ OMX Stockholm.

This information is such that Karo Bio is required to disclose under the
Swedish Securities Market Act. The information was disclosed on
September 19, 2011, 08:30 CET.

This press release is also available online at www.karobio.se and
www.newsroom.cision.com

 

Attachments