Press Release

Diffusion Pharmaceuticals Awarded U.S. Patent for TSC as Therapeutic in Five Hypoxia-Related Indications

Company Release - 4/4/2017 8:41 AM ET

CHARLOTTESVILLE, Va., April 04, 2017 (GLOBE NEWSWIRE) -- Diffusion Pharmaceuticals Inc. (NASDAQ:DFFN), a clinical stage biotechnology company focused on the development of novel small molecule therapeutics for cancer and other hypoxia-related diseases, today announced that a key patent has been issued by the U.S. Patent and Trademark Office (USPTO) on March 28, 2017 for its lead drug candidate trans sodium crocetinate (TSC).

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.

Forward-Looking Statements
To the extent any statements made in this news release deal with information that is not historical, these are forward-looking statements under the Private Securities Litigation Reform Act of 1995. Such statements include, but are not limited to, statements about the company's plans, objectives, expectations  and intentions with respect to future operations and products, the potential of Diffusion’s technology and product candidates, the anticipated timing of future clinical trials, the anticipated financial position, operating results and growth prospects of the company and other statements that are not historical in nature, particularly those that utilize terminology such as "would," "will," "plans," "possibility," "potential," "future," "expects," "anticipates," "believes," "intends," "continue,"  “estimates,” “targets,” “projects,” “intends,” other words or expressions of similar meaning, derivations of such words or expressions and the use of future dates. Forward-looking statements by their nature address matters that are, to different degrees, uncertain and involve both known and unknown risks. Uncertainties and risks may cause Diffusion's actual results to be materially different than those expressed in or implied by such forward-looking statements. Particular uncertainties and risks include; general business and economic conditions; Diffusion’s need for and ability to obtain additional financing;  the difficulty of developing pharmaceutical products, obtaining regulatory and other approvals and achieving market acceptance; and the other factors discussed in Diffusion’s public filings, including the risk factors included in Diffusion’s most recent Annual Report on Form 10-K. All forward-looking statements in this news release speak only as of the date of this news release and are based on management's current beliefs and expectations. Diffusion undertakes no obligation to update or revise any forward-looking statement, whether as a result of new information, future events or otherwise.

Diffusion Pharmaceuticals Contacts

David Kalergis
Chief Executive Officer
Diffusion Pharmaceuticals Inc.
(434) 220-0718

Stephanie Carrington
ICR Inc.
(646) 277-1282
Stephanie.Carrington@icrinc.com

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Source: Diffusion Pharmaceuticals, Inc.