Karo Bio to present clinical phase III development plan for eprotirome as a novel pharmaceutical for the treatment of HeFH
STOCKHOLM, August 11, 2010. The Swedish biotech company Karo Bio AB (publ) (Reuters: KARO.ST) today announced that the development plan for the upcoming phase III studies of eprotirome as a novel pharmaceutical for the treatment of high-risk patients with heterozygous familial hypercholesterolemia (HeFH) will be presented on Thursday August 26, 2010. In connection to the presentation, Professors Steven Nissen and John Kastelein will share their insights on the regulatory landscape for dyslipidemia drugs and clinical testing of pharmaceuticals for HeFH.
Karo Bio recently announced a strategy update stating the decision to develop eprotirome (KB2115) for the indication HeFH in clinical phase III. There is currently no sufficient treatment on the market for the estimated 3 million HeFH patients worldwide. In several clinical phase II studies, eprotirome has shown to have a very compelling effect profile for the lowering of blood lipid levels
At the seminar, Jens Kristensen, Karo Bio’s Chief Medical Officer, will present the development plan and the regulatory path for eprotirome in HeFH.
Professor Steven Nissen, Chairman of Department of Cardiovascular Medicine at Cleveland Clinic, chairman of the steering committee of the clinical program for the upcoming phase III studies, will discuss the regulatory landscape for dyslipidemia drugs.
Professor John Kastelein, Chairman of Department of Vascular Medicine at Academic Medical Center in Amsterdam, principal investigator in the upcoming phase III studies, will provide an introduction on HeFH, its diagnosis and treatment, and insights into clinical testing of pharmaceuticals for HeFH.
“In our latest interim report we announced our plans to communicate further on the development of eprotirome in form of a seminar. This presentation will shed further light on the strategic route for eprotirome and our decision to start with the selected niche indication HeFH before the broader dyslipidemia indication” commented Fredrik Lindgren, CEO of Karo Bio.
The seminar will take place on Thursday, August 26 at 16.00 (4 pm) in the Lecture Hall, Novum, 4th floor, at Karolinska Institute, Huddinge, Sweden. For attendance please register at eva.kruse@karobio.se or alt. Eva Kruse, phone +46 8 608 6027.
For further information please contact:
Fredrik Lindgren, CEO
Mobile: +46 705 616 177
Erika Söderberg Johnson, CFO
Mobile: +46 70 720 4820
About the guest-speakers
Professor Steven Nissen, Chairman of Department of Cardiovascular Medicine at Cleveland Clinic.
Professor Nissen’s research during the last two decades has focused on the application of intravascular ultrasound (IVUS) imaging for the assessment of progression and regression of coronary atherosclerosis. He has served as International Principal Investigator for several large IVUS multi-center atherosclerosis trials. Contributions to scientific literature include more than 300 journal articles with a respectable number of manuscripts in NEJM, Circulation, and JAMA, in addition to 60 book chapters and electronic publishings. In recent years, he has also written on the subject of drug safety and was the author of manuscripts highlighting concerns about the COX-2 inhibitors, muraglitazar and rosiglitazone. Other contributions include current service as editor of Current Cardiology Report, and senior consulting editor to the Journal of the American College of Cardiology.
Professor Nissen has been engaged by Karo Bio as the chairman of the steering committee of the clinical program for the upcoming phase III studies on eprotirome as a novel pharmaceutical for the treatment of high-risk patients with heterozygous familial hypercholesterolemia (HeFH).
Professor John Kastelein, Chairman of Department of Vascular Medicine at Academic Medical Center in Amsterdam.
Professor Kastelein’s current research interests can be found in the etiology, diagnosis, prevention and treatment of hypertriglyceridaemia, hypercholesterolaemia and low HDL cholesterol, all conditions associated with atherosclerosis and cardiovascular disease. He has published over 580 research papers in peer reviewed journals, including Nature Genetics, Lancet, New England Journal of Medicine, JAMA and Circulation and has a Hirsch index of 62. Professor Kastelein is an investigator of the Bloodomics and CardioGenics consortia, two large European Union supported endeavours under the Framework Programme 7, that aim to elucidate the molecular basis of atherosclerosis and premature coronary disease.
Professor Kastelein has been engaged by Karo Bio as principal investigator in the upcoming phase III studies on eprotirome, a novel pharmaceutical for the treatment of high-risk patients with heterozygous familial hypercholesterolemia (HeFH).
About Karo Bio
Karo Bio is a pharmaceutical company focused on the research and development of innovative drugs for unmet medical needs. Karo Bio’s vision is to become a pharmaceutical company with sustainable profitability, products on the market and a competitive project portfolio.
Karo Bio runs a number of development projects within the indication areas cardiovascular and metabolic diseases, neuropsychiatry, inflammation, cancer and women’s health. An important foundation for the company’s activities is the unique knowledge around nuclear receptors as target proteins for the development of novel pharmaceuticals, as well as the related mechanisms of action. Important processes and competences within the company are structurally based research, drug discovery, pre-clinical and clinical development, and medical and regulatory expertise.
Kar Bio has the possibility to take selected compounds for niche indications through the whole development chain, while compounds addressing large patient groups need development collaborations or out-licensing at some stage in the process. In addition to the proprietary projects, Karo Bio has three strategic collaborations with international pharmaceutical companies.
Karo Bio, headquartered in Huddinge, has 70 employees, and is listed on NASDAQ OMX Stockholm since 1998 (Reuters: KARO.ST).
This press release is also available online at: www.karobio.com and www.newsroom.cision.com