Diffusion Pharmaceuticals

Fueling Life

Diffusion Pharmaceuticals is a clinical-stage biotechnology company developing first-in-class drugs to treat hypoxia. Hypoxia – lack of oxygen in tissue – is a primary underlying cause for failure of cancerous tumors to fully respond to radiation and chemo-therapy, as well as for morbidity and death in life-threatening conditions ranging from stroke to peripheral artery disease.

The Company’s lead drug candidate, trans sodium crocetinate (TSC), is a proprietary, first-in-class oxygen diffusion enhancing compound formulated for IV delivery. Based on a novel mechanism of action, TSC safely re-oxygenates hypoxic tissue without causing hyper-oxygenation of normal tissue.

The Company has successfully completed Phase I trials of TSC, demonstrating an excellent safety profile and allowing for an accelerated clinical development program in the selected initial commercial use of the technology — the improved treatment of life threatening cancerous tumors, an unmet medical need with an accessible annual market valued at well over $1 billion.

Published studies demonstrate a tripling of survival and superior tumor control when TSC is combined with radiation and chemotherapy in animal models of cancer. Based on this work, the Company is initiating a Phase II clinical trial of TSC in primary brain cancer (GBM) patients. This trial will examine the survival of newly diagnosed GBM patients when TSC is combined with the current standard-of-care (radiation plus chemotherapy) with enrollment beginning in late 2011. Follow-on clinical studies in the treatment of brain metastasis and other cancers is under development. The Company is also continuing development of its pipeline of other novel diffusion-enhancing small molecules, targeted at a range of unmet medical needs characterized by hypoxia.

Diffusion Pharmaceuticals, which is privately held, is located in Charlottesville, Virginia.

July 26, 2011
Diffusion Pharmaceuticals Receives FDA Orphan Status for TSC, a First-in-Class Drug for the Treatment of Primary Brain Cancer

Charlottesville, VA – July 26, 2011 – Diffusion Pharmaceuticals LLC announced today that trans sodium crocetinate (TSC), the company’s lead drug candidate, has been granted an Orphan Drug Designation by the U.S. Food and Drug Administration (FDA) for the treatment of primary brain cancer, also known as glioblastoma multiforme or GBM. GBM is one of [...]

May 1, 2011
Diffusion Pharmaceuticals Closes on $2.2 Million Financing; Plans Clinical Trial In Primary Brain Cancer

CHARLOTTESVILLE, VA – May 1, 2011 – Diffusion Pharmaceuticals LLC, a clinical-stage drug-development company commercializing first-in-class drugs to treat life-threatening unmet medical conditions, today announced that it closed on an additional $2.2 million in private financing during the first quarter of 2011. The financing consisted of convertible notes issued to existing investors. Proceeds will support [...]

November 15, 2010
Diffusion Pharmaceuticals Achieves Positive Results in Phase I/II Clinical Trial of Trans Sodium Crocetinate in Peripheral Artery Disease; Drug Offers Promise for Range of Serious Hypoxia-Related Medical Conditions

“Given the dearth of successful clinical research options in PAD, these study results are exciting,” said study presenter William Hiatt, MD, professor of cardiovascular research in the Department of Medicine, University of Colorado School of Medicine; President of CPC Clinical Research and chairman of the American Heart Association’s Peripheral Vascular Disease Council.