Diffusion Earns Patent For Lead Drug Candidate

Diffusion Pharmaceuticals (NASDAQ:DFFN) received a patent for their lead drug candidate trans sodium crocetinate (TSC) from the US Patent and Trademark Office.
As quoted in the press release:

U.S. patent (#9,604,899), entitled “Bipolar Trans Carotenoid Salts and Their Uses,” expands coverage of the therapeutic use of TSC and other related compounds to five hypoxia-related conditions including congestive heart failure, chronic renal failure, acute lung injury (ALI), chronic obstructive pulmonary disease (COPD), and respiratory distress syndrome (RDS).  Diffusion’s patent estate currently includes the use of TSC in oncology, stroke, and neurodegenerative disease (such as Alzheimer’s disease) indications.

David Kalergis, Chairman and Chief Executive Officer of Diffusion, commented, “Receiving the patent from the USPTO validates the potential of TSC to serve as a primary therapeutic agent in many conditions involving hypoxia and expands our patent estate.  We look forward to advancing the clinical development of our lead compound.”

About Hypoxia and TSC
Hypoxia is a condition in which the body or a region of the body is deprived of adequate oxygen supply. Hypoxia related diseases such as ischemic heart disease, stroke, respiratory disease and cancer, are the leading causes of human deaths worldwide. The Diffusion technology is a paradigm shift in the approach to the treatment of diseases involving hypoxia in that it facilitates, via its proprietary compounds including lead drug TSC, the diffusion of oxygen to the hypoxic (oxygen deprived) tissues.

About Diffusion Pharmaceuticals Inc.
Diffusion Pharmaceuticals Inc. is a clinical stage biotechnology company focused on treating the many life threatening diseases that involve hypoxia. The current primary focus is extending the life expectancy of cancer patients by improving the effectiveness of current standard of care treatments including radiation therapy and chemotherapy. Diffusion is developing trans sodium crocetinate (TSC), for use in the many cancer types in which tumor hypoxia (oxygen deprivation) is known to diminish the effectiveness of current treatments. 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 treatments such as radiation therapy and chemotherapy, without the apparent addition of any serious side effects.

A Phase 2 clinical program, completed in the second quarter of 2015, evaluated 59 patients with newly diagnosed glioblastoma multiforme (GBM). This open label, historically controlled study demonstrated a favorable safety and efficacy profile for TSC combined with standard of care. A strong efficacy signal was seen in the subset of inoperable patients, where survival of TSC-treated patients at two years was increased by 380% over the controls. The U.S. Food and Drug Administration has provided guidance on the design of a Phase 3 trial in newly diagnosed GBM. Additional planned studies include a Phase 2 trial in pancreatic cancer and a study in brain metastases. Due to its novel mechanism of action, TSC has safely re-oxygenated a range of tumor types in our preclinical and clinical studies. Diffusion believes its therapeutic potential is not limited to specific tumors, thereby making it potentially useful to improve standard-of-care treatments of other life-threatening cancers. We also believe that TSC has potential application in other indications involving hypoxia, such as stroke and neurodegenerative diseases, and an in-ambulance trial of TSC in stroke is under consideration.

Click here to read the full press release.