Diffusion Pharmaceuticals

Diffusion Pharmaceuticals Inc (NASDAQ:DFFN) is a publicly traded biotechnology and drug development company based in Charlottesville, Virginia, U.S.[1] It was co-founded in 2001 by American life sciences entrepreneur David Kalergis and University of Virginia Chemical Engineering Professor John L. Gainer.[1] Gainer is the inventor of the company’s platform technology of oxygen diffusion-enhancing compounds and its lead drug, trans sodium crocetinate (TSC).[2] TSC acts to increase the rate at which oxygen moves through blood plasma by the process of diffusion,[3] a phenomenon that forms the basis for the company's name. On January 8, 2016, the formerly privately-held company merged with Restorgenex Cororation to become a publicly-traded NASDAQ-listed company with the trading symbol DFFN.[4] 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).[1] Most recently, Diffusion has begun the initiation of clinical trials in the U.S. and Eastern Europe for the use of trans sodium crocetinate in the treatment of COVID-19 patients suffering from respiratory distress-related oxygen deficiency and the risk of multiple organ failure.[5]

Diffusion Pharmaceuticals Inc (NASDAQ: DFFN)
TypePublic
IndustryBiotechnology
Founded2001
HeadquartersCharlottesville, Virginia, U.S.
Key people
David Kalergis
(Co-founder, Chairman and CEO)
John L. Gainer
(Co-founder and Chief Science Officer, retired)
ProductsTrans sodium crocetinate.
Number of employees
10
Websitediffusionpharma.com

Research activities
Entrance to Diffusion Pharmaceuticals laboratories.

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.[2][3][6] 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[7] and private funding[8] 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.[3][9][10][11]

Clinical trials

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.[12] The company is currently investigating the use of trans sodium crocetinate in the treatment of COVID-19, acute stroke, and solid cancerous tumors.[13]

Intellectual property

Between 2008 and 2017, 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.[14] 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.[15] By mid-2017, the company had been issued 14 U.S. and 46 international patents.[14][16]

Awards

In 2012, Diffusion Pharmaceuticals won the Virginia Healthcare Innovators award in the “Medical Product or Device ” category for its development of TSC.[17]

References
  1. "Company Overview of Diffusion Pharmaceuticals LLC". Bloomberg Businessweek. Retrieved November 10, 2012.
  2. US patent 6,060,511, Gainer J, "Trans-sodium crocetinate, methods of making and methods of use thereof", issued 2000-05-09
  3. Gainer, J (2008). "Trans-sodium crocetinate for treating hypoxia/ischemia". Expert Opinion on Investigational Drugs. 17 (6): 917–924. doi:10.1517/13543784.17.6.917. PMID 18491992.
  4. "Diffusion Pharmaceuticals Completes Merger with RestorGenex and Becomes Diffusion Pharmaceuticals Inc" (PDF). January 8, 2016. Retrieved May 25, 2020.
  5. <!- Chris Lange (May 26, 2019). "Diffusion Pharma's COVID-19 Treatment Takes a Big Step Forward With the FDA". Retrieved May 27, 2020.
  6. 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. 51 (5): 932–938. doi:10.1097/00005373-200111000-00018. PMID 11706343.
  7. "Navy adds to Diffusion Pharmaceuticals funding". TechJournal South. February 6, 2007. Archived from the original on February 14, 2015. Retrieved October 30, 2012.
  8. "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.
  9. 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.
  10. 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.
  11. 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.
  12. "Safety, Efficacy, and Pharmacokinetics (PK) Study of Trans Sodium Crocetinate (TSC) in Patients With Intermittent Claudication". ClinicalTrials.gov. 2008. Retrieved October 22, 2012.
  13. "Diffusion Pharmaceuticals Announces FDA Accelerated Review of TSC Clinical Development Plan to Treat COVID-19 Patients with ARDS". Diffusion Pharmaceuticals. May 5, 2020. Retrieved May 25, 2020.
  14. "Diffusion Pharmaceuticals: Intellectual Property". Diffusion Pharmaceuticals. Retrieved October 30, 2012.
  15. "USFDA Results of Orphan Drug Product Designations Search". Food and Drug Administration. Retrieved October 30, 2012.
  16. <!- Chris Lange (May 26, 2019). "Diffusion Pharma's COVID-19 Treatment Takes a Big Step Forward With the FDA". Retrieved May 27, 2020.
  17. "Diffusion Pharmaceuticals Wins 2012 VA Healthcare Innovators Award". Virginia Biotechnology Association. Archived from the original on January 13, 2013. Retrieved October 30, 2012.
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