Basel, 18 November 2009
Roche announces start of new atherosclerosis study (dal-PLAQUE 2) for dalcetrapib
New preclinical data presented at the American Heart Association support the unique properties of Roche’s dalcetrapib
Roche (SIX: RO, ROG; OTCQX: RHHBY) today presented new preclinical data further supporting the differentiation of its novel cholesteryl ester transfer protein inhibitor (CETPi) dalcetrapib at this year's Scientific Sessions of the American Heart Association taking place from 14-18 November in Orlando. Based on the current safety and efficacy profile of dalcetrapib, Roche announced a new Phase III clinical trial, dal-PLAQUE 2. This trial is designed to further evaluate the effect of dalcetrapib on atherosclerotic disease progression in over 900 cardiovascular patients and will be conducted in collaboration with the Canadian Atherosclerosis Imaging Network and Montreal Heart Institute. dal-PLAQUE 2 is the first study of its kind to use both IMT and IVUS* imaging techniques in a single study.
Roche’s dalcetrapib is an innovative molecule that is being developed to reduce cardiovascular events by raising the ‘good’ high-density lipoprotein cholesterol (HDL-C). It is hoped that the drug can further reduce cardiovascular events in high risk patients as epidemiology studies indicate that the level of HDL-C correlates inversely with cardiovascular risk.
“The dal-PLAQUE 2 study aims to show benefits of dalcetrapib on atherosclerosis over a twenty-four month period, said Professor Jean-Claude Tardif, Director of the Research Centre at the Montreal Heart Institute and principal investigator on the dal-PLAQUE 2 Study. “This is a landmark study, the first of its kind evaluating both the carotid and coronary arteries using IMT and IVUS techniques in the same patient population.”
The dal-PLAQUE 2 study, using both IMT and IVUS ultrasound imaging techniques, was designed incorporating input from the FDA with an objective to support an indication for dalcetrapib in the treatment of atherosclerotic disease progression.
Further to the development programme, the dal-OUTCOMES morbidity and mortality study in 15,600 patients, which aims to evaluate dalcetrapib’s effect in the reduction of cardiovascular events beyond and above the best standard of care, is on track. Over 9,000 patients have been enrolled. An independent Data Safety Monitoring Board is reviewing the study on a regular basis and dal-OUTCOMES can continue as planned.
Additionally, pre-clinical data, presented at the American Heart Association 2009 scientific sessions, confirm the unique profile of dalcetrapib in terms of mechanism of action, molecular structure, binding site and interaction with CETP and further supports the differentiation between dalcetrapib and other CETP inhibitors. Dalcetrapib binds to a unique site of CETP inducing a conformational change of CETP and promotes reverse cholesterol transport in an animal model.
Dalcetrapib was in-licenced by Roche from Japan Tobacco, Inc. in late 2004. Roche acquired exclusive worldwide rights to develop and commercialise dalcetrapib, excluding Japan, where Japan Tobacco has retained these rights. The collaboration with Japan Tobacco is a successful partnership and the companies have a very positive working collaboration.
*Intima-media thickness (IMT), also called intimal medial thickness, and intravascular ultrasound (IVUS) both measure the thickness of artery walls usually by external ultrasound, occasionally by internal, invasive ultrasound catheters. Both detect the presence, and to track the progression, of atherosclerotic disease in humans.
Headquartered in Basel, Switzerland, Roche is a leader in research-focused healthcare with combined strengths in pharmaceuticals and diagnostics. Roche is the world’s largest biotech company with truly differentiated medicines in oncology, virology, inflammation, metabolism and CNS. Roche is also the world leader in in-vitro diagnostics, tissue-based cancer diagnostics and a pioneer in diabetes management. Roche’s personalised healthcare strategy aims at providing medicines and diagnostic tools that enable tangible improvements in the health, quality of life and survival of patients. In 2008, Roche had over 80,000 employees worldwide and invested almost 9 billion Swiss francs in R&D. The Group posted sales of 45.6 billion Swiss francs. Genentech, United States, is a wholly owned member of the Roche Group. Roche has a majority stake in Chugai Pharmaceutical, Japan. For more information: www.roche.com.
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