Diffusion Pharmaceuticals Inc.

Company Snapshot: Diffusion Pharmaceuticals Inc.

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Company Overview

Diffusion Pharmaceuticals Inc. is a clinical-stage biotechnology company focused on improving patient outcomes in unmet medical needs using its novel small molecule trans sodium crocetinate (TSC). Diffusion is developing TSC for use in conditions where hypoxia (oxygen deprivation) is known to diminish the effectiveness of standard of care (SOC) treatments. In oncology, TSC targets the cancer's hypoxic micro-environment, re-oxygenating treatment-resistant tissue and making the cancer cells more vulnerable to the therapeutic effects of SOC treatments without the apparent occurrence of any serious side effects. In non-oncology indications, therapeutic benefit would be achieved directly through re-oxygenation of the tissue threatened with cell death from hypoxia.

A Phase 3 randomized, controlled registration trial with TSC and SOC chemotherapy and radiation, compared with SOC alone in 236 patients newly diagnosed with inoperable glioblastoma multiforme (GBM), a type of brain cancer, is underway. A Phase 2 clinical program was completed in the second quarter of 2015 and evaluated 59 patients with newly diagnosed GBM. This open-label, historically controlled study demonstrated a favorable safety and efficacy profile for TSC combined with SOC, including a 37% improvement in overall survival compared with the control group at two years.  A particularly strong efficacy signal was seen in the subset of inoperable patients where survival of TSC-treated patients at two years was nearly four-fold higher compared with the controls. Due to its novel mechanism of action, TSC has safely re-oxygenated a range of tumor types in preclinical and clinical studies.  Diffusion believes the therapeutic potential of TSC is not limited to specific tumors, thereby making it potentially useful to improve SOC treatments of other life-threatening cancers.  Additional studies under consideration include Phase 2 trials in pancreatic cancer and brain metastases, with study initiation subject to receipt of additional funding or collaborative partnering. The Company also believes that TSC has potential application in other indications involving hypoxia including stroke, where the Company recently announced its PHAST-TSC study which will be conducted in co-operation with the University of California Los Angeles (UCLA) and the University of Virginia (UVA) to test TSC in stroke patients in an in-ambulance clinical trial setting.

Client News

  1. Aug 8 2019 Diffusion Pharmaceuticals Reports Second Quarter 2019 Financial Results and Provides Business Update
  2. Jul 23 2019 Diffusion Pharmaceuticals Reports Favorable Safety Data for Dose-Escalation Run-in of Phase 3 INTACT Study in Glioblastoma Multiforme Patients
  3. May 28 2019 Diffusion Pharmaceuticals Inc. Announces Closing of $6.45 Million Offering Priced At-the-Market
  4. May 24 2019 Diffusion Pharmaceuticals Inc. Announces $6.45 Million Registered Direct Offering & Private Placement
  5. May 23 2019 Diffusion Pharmaceuticals Receives Notice of Intention to Grant a Patent Related to Use of TSC in Combination with tPA in Ischemic Stroke from European Patent Office