SemBioSys Completes pre-IND Meeting with U.S. FDA for APO AIMilano
News Aug 12, 2009
SemBioSys Genetics Inc. has announced that it has received the minutes of a successful and productive pre-investigational new drug (pre-IND) meeting with the U.S. Food and Drug Administration (FDA) regarding Apo AIMilano, a next-generation cardiovascular drug.
The meeting focused on the development plans for Apo AIMilano, during which the FDA confirmed SemBioSys’ development strategy necessary to file an IND application and addressed the proposed design of clinical trials for Apo AIMilano.
“We are encouraged by the feedback we have received from the FDA, particularly in regard to our development plan required to advance Apo AIMilano to clinical trials. This will be the second pharmaceutical candidate to be studied in human clinical trials produced using SemBioSys’ plant-based production system,” said James Szarko, Chief Executive Officer of SemBioSys. “Because of its unique ability to promote plaque regression, Apo AIMilano has the potential to revolutionize clinical practice and significantly improve outcomes in patients with cardiovascular disease.”
In collaboration with leading cardiologists and cardiovascular researchers, SemBioSys has confirmed the activity of plant-derived Apo AIMilano in seven preclinical models.
The Company has demonstrated the anti-atherosclerotic effects of Apo AIMilano based on cholesterol mobilization from the arterial wall, lipid content of atherosclerotic plaques, and the reduction of overall volume of atherosclerotic plaque after multiple injections.
The cholesterol-lowering drugs called statins have demonstrated substantial benefits in reducing the risk of heart attacks and strokes caused by blood clots (ischemic strokes) in at-risk patients. Since statins are associated with a low risk of side effects, the benefits of taking them outweigh the risks, according to a scientific statement from the American Heart Association that reviewed multiple studies evaluating the safety and potential side effects of these drugs.READ MORE
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