CHARLOTTESVILLE, Va., Sept. 28 /PRNewswire/ -- Diffusion Pharmaceuticals LLC, a clinical-stage drug development company commercializing first-in-class drugs utilizing a novel mechanism of action that enhances oxygen diffusion, today announced the results of a Phase I safety trial of its lead drug candidate, trans sodium crocetinate (TSC). In addition, the company announced the completion of a $4.5 million private placement, the proceeds of which will support the company's overall growth and advance TSC into Phase II clinical trials in early 2008.
Diffusion Pharmaceuticals' initial safety study was a double-blind, placebo-controlled, dose-escalation study designed to evaluate the tolerability and pharmacokinetics of a single intravenous bolus injection of TSC in healthy human subjects. The study demonstrated that TSC is very well-tolerated, raising no significant clinical issues in humans at doses significantly higher than the doses to be used in upcoming clinical trials in patients.
"Successful completion of this study is a key milestone in the clinical development of TSC and significantly advances our lead product candidate toward commercialization," said David G. Kalergis, Chief Executive Officer of Diffusion Pharmaceuticals. "The results of our Phase I trial and recent preclinical studies, coupled with completion of the private placement, will enable us to move quickly into Phase II proof-of-concept studies with TSC in two diverse patient populations -- peripheral vascular disease and cancerous brain tumors -- both of which exhibit oxygen deprivation at the cellular level," said Kalergis.
The company's next clinical study will examine the safety and effects of TSC on oxygenation levels of cancerous tumor tissue in primary brain tumor patients who have glioblastoma multiforme (GBM) and will be undergoing a surgical procedure for tumor biopsy and/or tumor resection. Further trials in GBM patients will examine the safety and effects of TSC, including impact on patient survival, when combined with radiation therapy. These clinical trials will be sponsored by Diffusion Pharmaceuticals LLC, and conducted in collaboration with The Johns Hopkins University School of Medicine and the New Approaches to Brain Tumor Therapy (NABTT) Central Nervous System (CNS) Consortium.
Dr. Stuart Grossman, Director of Clinical and Laboratory Neuro-Oncology Programs at Johns Hopkins and project leader for NABTT said, "TSC's novel mechanism of action provides a whole new approach to enhancing radiation therapy. We are excited by its prospects and intend to start clinical trials in patients with primary brain tumors as soon as possible."
In addition, the company is planning a clinical trial in peripheral vascular disease patients suffering from intermittent claudication (i.e., intense leg pain while walking) to evaluate the effect of TSC on tissue oxygenation in these patients using a standardized treadmill test. Site selection for this study is currently underway.
Diffusion Pharmaceuticals' pipeline of first-in-class small molecules uses a novel mechanism of action allowing more oxygen to reach oxygen-deprived (hypoxic) tissues in the body. The diffusion of oxygen through blood plasma and into tissue is a critical step in delivering oxygen to hypoxic tissue; Diffusion Pharmaceuticals' drugs affect this process. In preclinical studies, TSC has been shown to increases the rate of oxygen diffusion by about 30 percent. TSC has been shown in animal models to increase the diffusion of oxygen into hypoxic cancerous tumor tissue, making the cancer more susceptible to radiation therapy and increasing survival. In addition, animals suffering severe blood loss have a higher rate of survival if treated with TSC.
The ability to enhance oxygen diffusion into hypoxic tissue represents a transformative technology, with potentially far-ranging implications for human health and the practice of medicine. Diffusion Pharmaceuticals' family of drugs can potentially be used in a broad range of conditions such as cardiovascular disease, cancer, respiratory disorders and other serious or life-threatening medical conditions. If approved for marketing by the U.S. Food and Drug Administration (FDA), the patient population for successful Diffusion-owned, patent-protected molecules such as TSC could be in the millions.
To date, Diffusion Pharmaceuticals has raised $10.2 million in private equity and has received $2.6 million in government research and development funding from the Office of Naval Research (ONR), bringing the company's total funding to $12.8 million.
About Diffusion Pharmaceuticals LLC
Diffusion Pharmaceuticals LLC is a clinical-stage drug-development company commercializing a family of first-in-class drug candidates to treat serious or life-threatening medical conditions. These proprietary small molecules use a novel method of action to enhance oxygen diffusion to oxygen deprived (hypoxic) tissue. Potential clinical applications include critical care uses such as trauma, hemorrhage, stroke and heart attack, as well as chronic conditions such as cardiovascular disease, respiratory disorders and peripheral vascular disease. Additionally, enhanced diffusion of oxygen into hypoxic tissue also has an important application in oncology by improving the efficacy of radiation therapy in cancerous tumors. The Company's first Phase I clinical trial for its lead molecule, trans sodium crocetinate (TSC), shows the drug is well-tolerated in healthy human subjects at doses significantly higher than the estimated efficacious human dose. Clinical trials will begin in early 2008 in cancer patients undergoing radiation therapy and in peripheral vascular disease patients suffering from intermittent claudication. Diffusion Pharmaceuticals, which is privately held, is located in Charlottesville, Virginia. For more information, visit http://www.diffusionpharma.com/.
Diffusion Pharmaceuticals LLC
