Diffusion Pharmaceuticals Announces Validation of European Patent for Oral Formulations of TSC

CHARLOTTESVILLE, Va., June 12, 2018 (GLOBE NEWSWIRE) -- Diffusion Pharmaceuticals Inc. (NASDAQ:DFFN) (“Diffusion” or “the Company”), a clinical-stage biotechnology company focused on extending the life expectancy of cancer patients, today announced the validation of European Patent No.: 2 575 487, entitled “Oral Formulations of Bipolar Trans Carotenoids.”  This patent is directed to oral formulations of bipolar trans carotenoids including trans sodium crocetinate (“TSC”). Embodiments of the invention include the novel compositions in the form of a tablet, pill or capsule. The claims also include compositions for the treatment of hypoxia caused by many disorders. This European Patent is based on the same patent application that was allowed by the U.S. Patent and Trademark Office (PTO) in January 2018.

“This is another important step in building worldwide intellectual property protection for TSC, its composition of matter and many applications in hypoxic conditions, including cancers, such as glioblastoma multiforme, and stroke and cardiovascular disease,” said David Kalergis, Chief Executive Officer of Diffusion Pharmaceuticals. “TSC or related compounds delivered orally for hypoxia related disorders may be more patient friendly than intravenous administration. As we speak with potential partners outside of the U.S., this European patent will support the growing value of TSC.  More than 40 patents related to TSC have either been allowed or issued in all geographic areas, and we are pleased that the EU, with a pharmaceutical market size comparable to that of the U.S., has validated our patent,” Mr. Kalergis added.  

About Diffusion Pharmaceuticals Inc.

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.

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 the company's technology and product candidates, the anticipated timing of future clinical trials and protocol review, 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," "expects," other words of similar meaning, derivations of such words and the use of future dates. Forward-looking statements by their nature address matters that are, to different degrees, uncertain. Uncertainties and risks may cause the company'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; the company's need for and ability to obtain additional financing; and the difficulty of developing pharmaceutical products, obtaining regulatory and other approvals and achieving market acceptance, and the various risk factors (many of which are beyond Diffusion’s control) as described under the heading “Risk Factors” in Diffusion’s filings with the United States Securities and Exchange Commission. 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.

Contacts:

David Kalergis, CEO

Diffusion Pharmaceuticals Inc.

(434) 220-0718



or

LHA Investor Relations

Kim Sutton Golodetz

(212) 838-3777