October 22, 2014 8:57 PM ET


Company Overview of Diffusion Pharmaceuticals LLC

Company Overview

Diffusion Pharmaceuticals LLC, a clinical-stage biotechnology company, develops drugs that target the unmet medical needs characterized by hypoxia at the cellular level. The company engages in the development, formulation, clinical testing, manufacture, and commercialization of small-molecule drugs that help regulate the movement of oxygen into tissue by a mechanism of action. Its development portfolio includes trans sodium crocetinate, a drug used for the treatment of solid cancerous tumors. The company was founded in 2001 and is based in Charlottesville, Virginia.

2020 Avon Court

Suite 4

Charlottesville, VA 22902

United States

Founded in 2001





Key Executives for Diffusion Pharmaceuticals LLC

Chief Financial Officer and Treasurer
Chief Medical Officer and Member of Scientific Advisory Board
Secretary and Director
Compensation as of Fiscal Year 2014.

Diffusion Pharmaceuticals LLC Key Developments

Diffusion Pharmaceuticals Clinical Trial of TSC in Brain Cancer Reaches One Year Interim Endpoint

Diffusion Pharmaceuticals LLC announced that it has reached the one year interim endpoint for its Phase I/II clinical trial of trans sodium crocetinate (TSC), the Company's lead compound for the treatment of cancer. The study enrolled 59 patients with newly diagnosed primary brain cancer (glioblastoma multiforme or GBM) at 18 major U.S. cancer centers. GBM is a deadly cancer, with only 61% of patients alive one year after diagnosis and about 26% at two years. The Diffusion study is designed to determine whether adding TSC to the current standard-of-care treatment for GBM can significantly improve survival. At the one year interim mark, the Diffusion clinical trial results surpass the historical standard of care. Further information has been submitted for presentation in connection with a major oncology medical meeting being held later in the year.

Diffusion Pharmaceuticals Receives FDA Orphan Designation for TSC, a First-In-Class Drug for the Treatment of Metastatic Brain Cancer

Diffusion Pharmaceuticals, LLC announced 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 metastatic brain cancer. Metastatic brain cancer is one of the most deadly forms of cancer, with most of its victims dying within a year of diagnosis. The FDA has previously granted Diffusion Pharmaceuticals an Orphan Drug designation for the use of TSC in the treatment of the primary brain cancer known as glioblastoma multiforme or GBM. A Phase II clinical trial testing TSC in newly diagnosed GBM patients is now enrolling patients at twenty major cancer centers around the US. A Phase II clinical study testing TSC in brain metastases is currently being planned in cooperation with these centers. Trans sodium crocetinate (TSC) is a proprietary, first-in-class small molecule belonging to the novel "oxygen diffusion-enhancing compound" family of drugs. TSC combines potent efficacy-enhancing properties with an excellent human safety profile. Many cancers, including GBM and brain metastases, contain cells that are resistant to treatment because of diminished oxygen levels (hypoxia) within the tumor. TSC causes more oxygen to diffuse into hypoxic tumor tissue without affecting normal tissue, thereby enhancing the tumor killing power of conventional treatments. Published animal studies in GBM show that TSC controls tumor growth and triples survival without observed side-effects when used in conjunction with standard-of-care radiation.

Diffusion Pharmaceuticals, LLC Completes Phase I Brain Cancer Trial

Diffusion Pharmaceuticals, LLC announced that it has successfully completed a Phase I clinical trial of its lead compound trans sodium crocetinate (TSC) in nine patients with newly diagnosed primary brain cancer (glioblastoma or GBM). A Safety Monitoring Committee comprised of expert, independent clinicians and researchers met on November 14, 2012, reviewed the Phase I patient safety data and authorized immediate open enrollment for the follow-on Phase II study. The Phase II trial will explore TSC's effects on tumor regrowth, patient quality-of-life and overall survival in newly diagnosed GBM patients when dosed in conjunction with conventional radiation therapy. The study will enroll a total of fifty patients at twenty cancer institutions throughout the U.S., with a target date of complete enrollment by early 2013. Patients in the Phase I brain cancer study were treated at six cancer institutions around the country. Fourteen additional centers will be open for the Phase II study, which has already begun enrolling patients. Further information about the study may be viewed online at Glioblastoma Clinical Trial Phase II. The Phase II study builds on several previous Phase I/II studies establishing TSC's human safety profile, pharmacokinetics and dosing regimen in eighty human subjects, including normal healthy volunteers, peripheral artery disease, and GBM patients. The current study will focus on the efficacy and safety of TSC as an addition to the standard-of-care in newly diagnosed GBM patients. Study endpoints include TSC's effects on tumor regrowth as determined by MRI, the patient's quality-of-life during and after their treatment, and their overall survival at one and two years after treatment.

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