Diffusion Pharmaceuticals Resumes Toxicology Studies With MPI Research; Company Advances Toward Filing Investigational New Drug Application
CHARLOTTESVILLE, Va., Feb. 21 /PRNewswire/ -- Diffusion Pharmaceuticals LLC, a drug discovery and development company pioneering a revolutionary mechanism of action to treat life-threatening diseases, today announced that toxicology testing of its lead drug, TSC, is currently underway at MPI Research, a leading provider of preclinical services. These studies are funded in part by a grant from the Office of Naval Research.
"These preclinical studies are exacting, expensive, and critical as they represent the last required animal milestone before we file our application with the FDA for first human testing," said David G. Kalergis, JD/MBA, Diffusion's Chief Executive Officer. "The results of these studies will help guide the design of our clinical trials," he continued.
Diffusion Pharmaceuticals LLC plans to begin human testing of TSC in 2006 with a phase I study in normal healthy volunteers. Completion of this study will provide the foundation for further testing of TSC in populations suffering from such life-threatening conditions as hemorrhagic shock, treatment-resistant cancerous tumors, stroke and respiratory disorders.
About MPI Research
The company's Corporate headquarters and primary site -- the largest single-site nonclinical facility in North America -- are located in Mattawan, part of the life sciences corridor of southwest Michigan. MPI employs more than 1,000 professionals who specialize in a wide variety of scientific disciplines including toxicology, pharmacology, metabolism, pathology, clinical pathology, reproductive and developmental biology, veterinary science, neuroscience, analytical chemistry, computer science, regulatory science, molecular imaging and statistics. They take pride in conducting top quality research for pharmaceutical, animal health and chemical companies as well as governmental agencies.
About Diffusion Pharmaceuticals LLC
Diffusion Pharmaceuticals LLC is a drug discovery and development company that owns a platform technology of patented small molecule therapeutics that enhance the diffusion of oxygen to hypoxic (oxygen-starved) tissues. By applying a revolutionary mechanism to increase oxygen diffusion into tissue cells, Diffusion's lead molecule trans sodium crocetinate (TSC) treats life- threatening conditions, such as trauma, stroke, cardiovascular, respiratory, and other conditions characterized by oxygen deprivation at the cellular level. The company's pipeline drugs, known as trans bipolar carotenoid or TBC molecules, are currently in the preclinical stage. Clinical trials are planned to begin in 2006 to support the use of TSC in ischemic indications. Diffusion Pharmaceuticals, which is privately held, is located in Charlottesville, Virginia. For more information, visit http://www.diffusionpharma.com.
Diffusion Pharmaceuticals LLCCONTACT: Tracey Linkous, Director of Communications of DiffusionPharmaceuticals LLC, +1-434-220-0718, tlinkous@diffusionpharma.com
Web site: http://www.diffusionpharma.com/