Inotek Pharmaceuticals Announces Designation of INO-1001 as a Fast Track Product for Complications associated with Thoracoabdominal Aortic Aneurysm Surgery.Business Editors/Health/Medical Writers BIOWIRE2K BEVERLY, Mass.--(BUSINESS WIRE)--May 24, 2004 Inotek Pharmaceuticals Corporation announced today that it has received notification from the Food and Drug Administration that one of its lead compounds, INO-1001, has been designated a Fast Track Drug Product for complications associated with Thoracoabdominal aortic aneurysm Aortic Aneurysm Definition An aneurysm is an abnormal bulging or swelling of a portion of a blood vessel. The aorta, which can develop these abnormal bulges, is the large blood vessel that carries oxygen-rich blood away from the heart to the rest of the (TAAA TAAA Tucson Amateur Astronomy Association TAAA Thoraco-Abdominal Aortic Aneurysm TAAA Total Active Aircraft Authorization ) repair surgery. Phase II clinical trials are expected to begin at the beginning of the third quarter. INO-1001 is a potent inhibitor of the nuclear cell death enzyme Poly (ADP-ribose) Polymerase (PARP PARP Poly ADP-Ribose Polymerase PARP Planning And Review Process PARP PfP Planning and Review Process (NATO) PARP Pajarito Archaeological Research Project PARP Possible Acknowledgement Returning Period PARP Proxy Attribute Request Protocol ) and is being evaluated in Phase II trials for a variety of critical care diseases associated with reperfusion injury and inflammation, including ischemic stroke, acute respiratory distress syndrome acute respiratory distress syndrome n. See adult respiratory distress syndrome. , TAAA repair surgery and the prevention of complications associated with cardiopulmonary bypass surgery among others. Thoracoabdominal aortic aneurysm is a serious, life threatening disease caused by a dilation dilation /di·la·tion/ (di-la´shun) 1. the act of dilating or stretching. 2. dilatation. di·la·tion n. 1. of the thoracic abdominal aorta which can lead to a rupture of the aorta. Mortality associated with TAAA repair surgery is approximately 10%. The most common complications associated with TAAA repair surgery are myocardial infarction, renal failure, pulmonary failure and paraplegia paraplegia (pâr'əplē`jēə), paralysis of the lower part of the body, commonly affecting both legs and often internal organs below the waist. When both legs and arms are affected, the condition is called quadriplegia. . "This is an extremely important milestone for Inotek" said Dr. Andrew Salzman, President and CEO (1) (Chief Executive Officer) The highest individual in command of an organization. Typically the president of the company, the CEO reports to the Chairman of the Board. of Inotek Pharmaceuticals. "We believe that INO-1001 will be an important drug for treating a number of very serious and life threatening diseases. Thoracoabdominal aortic aneurysm surgery is certainly a procedure where the need for improved therapies is great. We look forward to working with the FDA FDA abbr. Food and Drug Administration FDA, n.pr See Food and Drug Administration. FDA, n.pr the abbreviation for the Food and Drug Administration. as we move forward with our clinical programs." Under the FDA Modernization Act of 1997, the Fast Track program is designed to facilitate the development and expedite review of the application for the approval of a new drug that is intended to treat serious or life-threatening conditions and that demonstrates the potential to address unmet medical needs. About Inotek Pharmaceuticals Corporation Inotek Pharmaceuticals is a research-based pharmaceutical company engaged in the discovery and development of novel, small-molecule therapeutics for the treatment of reperfusion injury, inflammation, and vascular dysfunction. The Company has developed a deep and diverse pipeline of products which are based on industry leading expertise in the area of vascular biology and free radical and oxidant oxidant /ox·i·dant/ (ok´si-dant) the electron acceptor in an oxidation-reduction (redox) reaction. ox·i·dant n. See oxidizer. mediated mechanisms of tissue injury, cellular necrosis, and inflammation. In 2004, the Company will have two drug products in Phase II of development, targeting a variety of important critical care conditions. Additionally, the Company has six (6) other products that are expected to enter human clinical trials in the next 6-12 months. Inotek's headquarters and research laboratories are located in Beverly, Massachusetts with overseas clinical and research operations in Israel and Hungary. |
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