Abstract Outlining Pre-Hospital Stroke Study With Diffusion Pharmaceuticals’ TSC To Be Presented at the International Stroke Conference

CHARLOTTESVILLE, Va., Jan. 24, 2018 (GLOBE NEWSWIRE) -- Diffusion Pharmaceuticals (Nasdaq:DFFN) (“Diffusion” or “the Company”), a clinical-stage biotechnology company focused on improving patient outcomes in unmet medical needs using its novel small molecule trans sodium crocetinate (TSC), today announced that an abstract titled “PreHospital Acute Stroke Therapy with Trans Sodium Crocetinate (PHAST-TSC),” will be presented at the International Stroke Conference, being held January 24-26, 2018 in Los Angeles. The abstract is authored by Andrew Southerland, M.D., University of Virginia; Nerses Sanossian, M.D., University of Southern California; John Gainer, Ph.D., Diffusion Pharmaceuticals Inc.; Jeffrey Saver, M.D., UCLA; Karen Johnston, M.D., University of Virginia; and Steven Piantadosi, M.D. Cedars-Sinai Medical Center.

The abstract introduces the design and rationale for the planned Phase 2 PHAST-TSC study, highlighting the potential benefits of TSC in patients with acute ischemic or hemorrhagic stroke in a pre-hospital setting. The abstract notes that TSC is a promising neurotherapeutic that enhances the diffusion of oxygen in hypoxic tissues by altering the structure of water molecules in blood plasma, thus facilitating the transport of oxygen to the site of the stroke and helping prevent brain tissue damage and neuronal death. TSC has shown benefit for both ischemic and hemorrhagic stroke in preclinical studies, and has demonstrated safety and efficacy signals in human trials in patients with glioblastoma multiforme (GBM) and peripheral arterial disease (PAD).

The planned Phase 2, randomized, double-blind, placebo-controlled trial calls for administering TSC to ambulance-transported patients within two hours of the onset of a suspected acute stroke. It is anticipated that 160 patients will be enrolled in this trial, which could begin in 2018. The pre-hospital, ambulance-based treatment strategy originated at UCLA with the FAST-MAG trial. Two of the physicians involved in that trial, Drs. Saver and Sanossian, will be principal investigators in Los Angeles.  A smaller number of patients will be enrolled at the University of Virginia Medical Center in Charlottesville, with Drs. Johnston and Southerland as principal investigators.

David Kalergis, Chairman and Chief Executive Officer of Diffusion Pharmaceuticals, stated, “Stroke is known to be a very difficult condition to treat. Stroke experts have predicted that it will take a new type of treatment – one which can be delivered quickly to all patients displaying stroke symptoms, without regard to whether the stroke is ischemic (from a clot) or hemorrhagic (from a bleed) – to overcome past failures and improve the standard of care. Ideally, this new treatment would be delivered within two hours of stroke symptom onset. The combination of TSC – a small molecule with a novel mechanism of action – delivered in the pre-hospital (ambulance) setting, meets these conditions and distinguishes this trial approach from any that have preceded it.” 

“Enrollment will include both hemorrhagic and ischemic stroke patients. With funding support, it could begin this year. Patients will be followed for 90 days and data readout is expected in 2019. This trial is expected to reach an important milestone and address a worldwide market of over $9 billion. Our goal is to improve outcomes for the nearly 800,000 stroke victims in the U.S. annually.”

“TSC is a versatile compound,” he added, “with utility in many hypoxic conditions, including cancers, such as GBM, which is the target of our on-going Phase 3 trial, anticipated to be completed in 2021. We expect data will be generated from the stroke trial before the readout of the GBM trial.”

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 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, particularly in stroke, where the PHAST-TSC study is being planned, and also in neurodegenerative diseases and emergency medicine.

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, satisfying Nasdaq continued listing standards 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; Nasdaq’s acceptance of the warrant reclassification to enable satisfaction of its continued listing standards; 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.

David Kalergis, CEO
Diffusion Pharmaceuticals Inc.
(434) 220-0718
LHA Investor Relations
Kim Sutton Golodetz
(212) 838-3777


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