Novel Agent for Intermittent Claudication, NM-702, Shows Clinical Benefit Trends in Phase II Clinical Study.Business Editors & Health/Medical Writers ORLANDO, Fla.--(BUSINESS WIRE)--Nov. 12, 2003 Results Presented at the American Heart Association American Heart Association (AHA), n.pr a national voluntary health agency that has the goal of increasing public and medical awareness of cardiovascular diseases and stroke, and thereby reducing the number of associated deaths and disabilities. Scientific Sessions 2003 Phase II clinical results for NM-702, a novel agent in development for intermittent claudication Intermittent Claudication Definition Intermittent claudicationis a pain in the leg that a person experiences when walking or exercising. The pain is intermittent and goes away when the person rests. , were presented this morning in a session titled "Peripheral Vascular Disease Peripheral Vascular Disease Definition Peripheral vascular disease is a narrowing of blood vessels that restricts blood flow. It mostly occurs in the legs, but is sometimes seen in the arms. : Improving Outcomes" at the American Heart Association Scientific Sessions. The presentation by William R. Hiatt, M.D., lead investigator for the Phase II study, was titled "Benefit of NM-702, a phosphodiesterase inhibitor in the treatment of claudication claudication /clau·di·ca·tion/ (klaw?di-ka´shun) limping; lameness. intermittent claudication ." The multi-center, double-blind parallel group dose-response study evaluated 206 patients with intermittent claudication, who were randomized ran·dom·ize tr.v. ran·dom·ized, ran·dom·iz·ing, ran·dom·iz·es To make random in arrangement, especially in order to control the variables in an experiment. to receive NM-702 1 mg, 2 mg, or 4 mg twice a day. According to Dr. Hiatt, "The results of this study showed potential benefits for the use of NM-702 on a number of key clinical parameters in intermittent claudication including peak walking time and patient-assessed quality of life while maintaining an excellent safety profile, encouraging results that warrant further clinical development." Dr. Hiatt is President of the Colorado Prevention Center and professor of medicine and chief of the Section of Vascular Medicine at the University of Colorado Health Sciences Center The University of Colorado Health Sciences Center (UCHSC) is part of the University of Colorado System. It has recently been merged with the University of Colorado at Denver (UCD) to form the University of Colorado at Denver and Health Sciences Center. in Denver. Dr. Hiatt has served as president of the Society for Vascular Medicine and Biology, and is a member of the American Heart Association, the Council on Circulation, the American College of Physicians The American College of Physicians (ACP) is a national organization of doctors of internal medicine (internists), physicians who specialize in the prevention, detection and treatment of illnesses in adults. , and the Western Association of Physicians. Nissan Chemical Industries Ltd. (Nissan Chemical) is developing NM-702 in Japan in collaboration with Taisho Pharmaceutical Co., Ltd. The companies are currently conducting a Phase IIb study of NM-702 in the United States. This study is evaluating 24 weeks of treatment with NM-702 at doses of 4 mg and 8 mg in terms of improvement in peak walking time in individuals with walking impairment due to intermittent claudication. The second study is anticipated to be completed by the end of 2004. Nissan Chemical is currently seeking a development and commercialization partner for NM-702 in the United States and Europe. Catalyst Pharmaceutical Research LLC (Logical Link Control) See "LANs" under data link protocol. LLC - Logical Link Control is Nissan Chemical's exclusive licensing representative for NM-702 in the US and Europe. About NM-702 NM-702 has a unique mechanistic profile for the treatment and chronic management of peripheral arterial disease as well as other indications related to blood flow via the overlapping effects of PDE-III and PDE-V. Pharmacologic effects of PDE-III/PDE-V inhibition include, vasodilation vasodilation /vaso·di·la·tion/ (-di-la´shun) 1. increase in caliber of blood vessels. 2. a state of increased caliber of blood vessels. , smooth muscle relaxation and platelet aggregation inhibition, due to decreased degradation of cyclic adenosine monophosphate Cyclic adenosine monophosphate (cAMP, cyclic AMP or 3'-5'-cyclic adenosine monophosphate) is a molecule that is important in many biological processes; it is derived from adenosine triphosphate (ATP). (cAMP) and cyclic guanosine monophosphate cyclic guanosine monophosphate n. Cyclic GMP. (cGMP). NM-702 has a global intellectual property package encompassing composition of matter and utility patents. About Intermittent Claudication Intermittent claudication is a common manifestation of peripheral vascular disease due to atherosclerosis. Intermittent claudication occurs when reduced blood flow to the legs results in inadequate oxygen to meet the demands of the muscles during exercise. Symptoms associated with intermittent claudication include cramping, aching, fatigue or discomfort that occurs in the muscles of the calves, thighs or buttocks buttocks /but·tocks/ (but´oks) the two fleshy prominences formed by the gluteal muscles on the lower part of the back. . According to recent estimates there are nearly 6 million individuals in the United States with intermittent claudication, with only one-fourth of this population accurately diagnosed and treated. About Nissan Chemical Industries Ltd. (Nissan Chemical) Nisan Chemical is a leading manufacturer of industrial and specialty chemicals, electronic materials, agrochemicals, and pharmaceuticals. Nissan's pharmaceutical products include anti-hypertensive, anti-inflammatory, and lipid-lowering drugs. More background information on Nissan Chemical is available at the company web site: http://www.nissanchem.co.jp/english/pharm/index.html About Taisho Pharmaceutical Co., Ltd. (Taisho) Taisho is the leading over-the-counter (OTC OTC See: Over-the-counter. OTC See over-the-counter market (OTC). ) pharmaceutical company in Japan. Taisho is using cutting-edge development techniques and working together with research facilities in Japan and around the world in search of effective, innovative new drugs. More information on Taisho can be found at http://www.taisho.co.jp/outline/index-e.htm About Catalyst Pharmaceutical Research LLC (Catalyst) Catalyst (www.catalystpharm.com) is a contract research organization (CRO) and business development representative for Asian and early-stage U.S. pharmaceutical and biotechnology companies. Headquartered in Pasadena, Calif., with a phase I facility in San Antonio Texas, Catalyst has a trans-Pacific corporate culture with proven expertise and capabilities to facilitate licensing transactions between Asian, European and U.S. companies. |
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