Diffusion Pharmaceuticals Inc (

NASDAQ The Nasdaq Stock Market () (National Association of Securities Dealers Automated Quotations Stock Market) is an American stock exchange based in New York City. It is the most active stock trading venue in the US by volume, and ranked second ...

:DFFN) is a publicly traded biotechnology and drug development company based in

Charlottesville, Virginia Charlottesville, colloquially known as C'ville, is an independent city in the Commonwealth of Virginia. It is the county seat of Albemarle County, which surrounds the city, though the two are separate legal entities. It is named after Queen ...

, U.S. It was co-founded in 2001 by American

life science Life is a quality that distinguishes matter that has biological processes, such as signaling and self-sustaining processes, from that which does not, and is defined by the capacity for growth, reaction to stimuli, metabolism, energy ...

s entrepreneur David Kalergis and

University of Virginia The University of Virginia (UVA) is a public research university in Charlottesville, Virginia. Founded in 1819 by Thomas Jefferson, the university is ranked among the top academic institutions in the United States, with College admission ...

Chemical Engineer In the field of engineering, a chemical engineer is a professional, equipped with the knowledge of chemical engineering, who works principally in the chemical industry to convert basic raw materials into a variety of products and deals with the ...

ing Professor

John L. Gainer John L. Gainer (born July 19, 1938) is an American chemical engineer and co-founder and former chief scientific officer of Diffusion Pharmaceuticals, a biotechnology and pharmaceutical company based in Charlottesville, Virginia, U.S. Professor ...

. Gainer is the inventor of the company's platform technology of

oxygen diffusion-enhancing compound An oxygen diffusion-enhancing compound is any substance that increases the availability of oxygen in body tissues by influencing the molecular structure of water in blood plasma and thereby promoting the movement (diffusion) of oxygen through plas ...

s and its lead drug,

trans sodium crocetinate Crocetin is a natural apocarotenoid dicarboxylic acid that is found in the crocus flower together with its glycoside, crocin, and '' Gardenia jasminoides'' fruits. It forms brick red crystals with a melting point of 285°C. The chemical struc ...

(TSC). TSC acts to increase the rate at which

oxygen Oxygen is the chemical element with the symbol O and atomic number 8. It is a member of the chalcogen group in the periodic table, a highly reactive nonmetal, and an oxidizing agent that readily forms oxides with most elements as we ...

moves through

blood plasma Blood plasma is a light amber-colored liquid component of blood in which blood cells are absent, but contains proteins and other constituents of whole blood in suspension. It makes up about 55% of the body's total blood volume. It is the ...

by the process of

diffusion Diffusion is the net movement of anything (for example, atoms, ions, molecules, energy) generally from a region of higher concentration to a region of lower concentration. Diffusion is driven by a gradient in Gibbs free energy or chemical p ...

, 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. 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). Most recently, Diffusion has begun the initiation of clinical trials in the U.S. and

Eastern Europe Eastern Europe is a subregion of the European continent. As a largely ambiguous term, it has a wide range of geopolitical, geographical, ethnic, cultural, and socio-economic connotations. The vast majority of the region is covered by Russia, wh ...

for the use of

in the treatment of

COVID-19 Coronavirus disease 2019 (COVID-19) is a contagious disease caused by a virus, the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). The first known case was identified in Wuhan, China, in December 2019. The disease quickl ...

patients with

respiratory distress Shortness of breath (SOB), also medically known as dyspnea (in AmE) or dyspnoea (in BrE), is an uncomfortable feeling of not being able to breathe well enough. The American Thoracic Society defines it as "a subjective experience of breathing di ...

-related oxygen deficiency and the risk of

multiple organ failure Multiple organ dysfunction syndrome (MODS) is altered organ function in an acutely ill patient requiring medical intervention to achieve homeostasis. Although Irwin and Rippe cautioned in 2005 that the use of "multiple organ failure" or "multis ...

Research activities

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 Atherosclerosis is a pattern of the disease arteriosclerosis in which the wall of the artery develops abnormalities, called lesions. These lesions may lead to narrowing due to the buildup of atheromatous plaque. At onset there are usually ...

arthritis Arthritis is a term often used to mean any disorder that affects joints. Symptoms generally include joint pain and stiffness. Other symptoms may include redness, warmth, swelling, and decreased range of motion of the affected joints. In some ...

and cancer. At that time, crocetin, a naturally occurring

carotenoid Carotenoids (), also called tetraterpenoids, are yellow, orange, and red organic pigments that are produced by plants and algae, as well as several bacteria, and fungi. Carotenoids give the characteristic color to pumpkins, carrots, parsnips, cor ...

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 Hypovolemic shock is a form of shock caused by severe hypovolemia (insufficient blood volume or extracellular fluid in the body). It could be the result of severe dehydration through a variety of mechanisms or blood loss. Hypovolemic shock is a ...

(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 The Office of Naval Research (ONR) is an organization within the United States Department of the Navy responsible for the science and technology programs of the U.S. Navy and Marine Corps. Established by Congress in 1946, its mission is to pla ...

(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 Stroke (also known as a cerebrovascular accident (CVA) or brain attack) is a medical condition in which poor blood flow to the brain causes cell death. There are two main types of stroke: ischemic, due to lack of blood flow, and hemorrhagic, ...

central nervous system The central nervous system (CNS) is the part of the nervous system consisting primarily of the brain and spinal cord. The CNS is so named because the brain integrates the received information and coordinates and influences the activity of all p ...

(CNS) disorders, and cancer.

Clinical trials

In 2007, TSC was advanced into

clinical trial Clinical trials are prospective biomedical or behavioral research studies on human subject research, human participants designed to answer specific questions about biomedical or behavioral interventions, including new treatments (such as novel v ...

s 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. The company is currently investigating the use of

in the treatment of

, acute stroke, and solid

cancer Cancer is a group of diseases involving abnormal cell growth with the potential to invade or spread to other parts of the body. These contrast with benign tumors, which do not spread. Possible signs and symptoms include a lump, abnormal bl ...

ous tumors.

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. In 2011, TSC received an

orphan drug An orphan drug is a pharmaceutical agent developed to treat medical conditions which, because they are so rare, would not be profitable to produce without government assistance. The conditions are referred to as orphan diseases. The assignment o ...

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-2017, the company had been issued 14 U.S. and 46 international patents.

Awards

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

References

External links

{{Pharmaceutical companies of the United States Pharmaceutical companies of the United States Health care companies based in Virginia