|Headquarters||Charlottesville, Virginia, U.S.|
(Co-founder and CEO)
John L. Gainer
(Co-founder and Chief Science Officer)
|Products||Trans sodium crocetinate.|
Number of employees
Diffusion Pharmaceuticals LLC is a biotechnology and drug development company based in Charlottesville, Virginia, U.S. It was co-founded in 2001 by American life sciences entrepreneur David Kalergis and University of Virginia Chemical Engineering Professor John L. Gainer. Gainer is the inventor of the company’s platform technology of oxygen diffusion-enhancing compounds and its lead drug, trans sodium crocetinate (TSC). TSC acts to increase the rate at which oxygen moves through blood plasma by the process of diffusion, a phenomenon that forms the basis for the company's name. TSC and other oxygen diffusion-enhancing compounds, including bipolar trans carotenoid salts (the subclass to which TSC belongs), have been investigated by Diffusion Pharmaceuticals for treatment of conditions associated with reduced oxygen availability in tissues (hypoxia).
Gainer invented the concept of oxygen diffusion-enhancing compounds and its specific embodiment, TSC, while a Professor of Chemical Engineering at the University of Virginia. He secured the first patent on the molecule and its uses in 2000. Before TSC's invention, he and colleagues conducted research on the effects of oxygen diffusion-enhancing compounds in various animal disease models, including atherosclerosis, arthritis and cancer. At that time, crocetin, a naturally occurring carotenoid compound, was the focus of their research. With the invention of TSC, their research turned to the potential use of this synthetic oxygen diffusion-enhancing compound for the improved treatment of hemorrhagic shock (shock caused by the loss of a large volume of blood) on the battlefield. This research, which was supported financially by the United States Office of Naval Research (ONR), was conducted in Gainer’s University of Virginia laboratory. Following the company's formation by Kalergis and Gainer in 2001, both ONR and private funding was obtained, enabling company researchers to set up their own laboratory and, along with collaborators, perform further preclinical studies into uses of TSC in the treatment of hemorrhagic shock and other hypoxic conditions, such as ischemic stroke, central nervous system (CNS) disorders, and cancer.
In 2007, TSC was advanced into clinical trials in humans. Clinical investigation first centered on the drug's safety and pharmacokinetic (PK) parameters in normal healthy volunteers. This was followed in 2009-2010 by a multi-center, randomized, placebo-controlled clinical trial examining TSC’s safety and efficacy in the re-oxygenation of tissues in patients affected by peripheral artery disease.
Between 2008 and 2012, Diffusion Pharmaceuticals expanded its intellectual property portfolio, having been awarded new patents (in the United States and internationally) that covered the synthesis and uses of bipolar trans carotenoid salts and related compounds in peripheral artery disease, cancer and other indications. In 2011, TSC received an orphan drug designation from the United States Food and Drug Administration for the use of TSC as a radiosensitizer in the treatment of newly diagnosed GBM patients. In accordance with standard practice, the Orphan Drug designation for TSC confers benefits including enhanced patent protection and marketing rights, waiver of certain FDA filing fees and favorable tax treatment. By mid-2012, the company had been issued nine U.S. and eleven international patents.
In 2012, Diffusion Pharmaceuticals won the Virginia Healthcare Innovators award in the “Medical Product or Device ” category for its development of TSC.
- "Company Overview of Diffusion Pharmaceuticals LLC". Bloomberg Businessweek. Retrieved November 10, 2012.
- US patent 6,060,511, Gainer J, "Trans-sodium crocetinate, methods of making and methods of use thereof", issued 2000-05-09
- Gainer, J (2008). "Trans-sodium crocetinate for treating hypoxia/ischemia". Expert Opinion in Investigational Drugs 17 (6): 917–924. doi:10.1517/13543718.104.22.1687.
- Giassi L et al. (2001). "Trans-Sodium Crocetinate Restores Blood Pressure, Heart Rate, and Plasma Lactate after Hemorrhagic Shock". Journal of Trauma-Injury Infection & Critical Care 55 (5): 932–938. doi:10.1097/00005373-200111000-00018. PMID 11706343.
- "Navy adds to Diffusion Pharmaceuticals funding". TechJournal South. February 6, 2007. Retrieved October 30, 2012.
- "Diffusion Pharmaceuticals Raises $2.1 Million in Private Equity Round Human Testing of its Lead Compound TSC Planned for 2005". TechJournal South. Retrieved October 30, 2012.
- Lapchak P, (2010). "Efficacy and safety profile of the carotenoid trans sodium crocetinate administered to rabbits following multiple infarct ischemic strokes: A combination therapy study with tissue plasminogen activator". Brain Research 1309: 136–145. doi:10.1016/j.brainres.2009.10.067. PMID 19891959.
- Manabe H et al. (2010). "Protection against focal ischemic injury to the brain by trans-sodium crocetinate". Journal of Neurosurgery 113 (4): 802–809. doi:10.3171/2009.10.JNS09562. PMC 3380430. PMID 19961314.
- Sheehan, Jason et al. (2008). "Use of trans sodium crocetinate for sensitizing glioblastoma multiforme to radiation". Journal of Neurosurgery 108 (5): 972–978. doi:10.3171/JNS/2008/108/5/0972. PMID 18447715.
- "Safety, Efficacy, and Pharmacokinetics (PK) Study of Trans Sodium Crocetinate (TSC) in Patients With Intermittent Claudication". ClinicalTrials.gov. 2008. Retrieved October 22, 2012.
- "Diffusion Pharmaceuticals: Intellectual Property". Diffusion Pharmaceuticals. Retrieved October 30, 2012.
- "USFDA Results of Orphan Drug Product Designations Search". Food and Drug Administration. Retrieved October 30, 2012.
- "Diffusion Pharmaceuticals Wins 2012 VA Healthcare Innovators Award". Virginia Biotechnology Association. Retrieved October 30, 2012.