First Patient Enrolled in Diffusion Pharmaceuticals’ Phase 2 On-Ambulance Clinical Trial with TSC for the Treatment of Stroke

CHARLOTTESVILLE, Va., Oct. 17, 2019 (GLOBE NEWSWIRE) -- Diffusion Pharmaceuticals Inc. (Nasdaq: DFFN), a cutting-edge biotechnology company developing new treatments for life-threatening medical conditions by improving the body’s ability to bring oxygen to the areas where it is needed most, announces that the first patient has been enrolled in its Phase 2 on-ambulance study evaluating trans sodium crocetinate (TSC) for the treatment of stroke.  The 160-patient trial, named PHAST-TSC (Pre-Hospital Administration of Stroke Therapy-TSC), will involve 23 hospitals, working closely with approximately 150 emergency medical transport groups across Central Virginia and urban, suburban and rural areas in Los Angeles County. Results from the trial may be available in just under two years.

The first patient was treated by ambulance-based Emergency Medical Technicians in co-ordination with researchers at the University of Virginia Medical Center (UVA). 

Diffusion expects enrollment at the University of Los Angeles (UCLA) to begin later this quarter, where about 20 hospital sites will be participating. The PHAST-TSC trial Study Chair is Jeffrey Saver, M.D., Professor of Clinical Neurology and Director of the Stroke Unit at the David Geffen School of Medicine at UCLA. Co-Principal Investigators are Andrew Southerland, M.D. (UVA) and Nerses Sanossian, M.D. (University of Southern California).

“We are delighted the PHAST-TSC study has begun and are optimistic enrollment will pick up rapidly given the large number of participating institutions and the prevalence of stroke,” said David Kalergis, chairman and chief executive officer of Diffusion. “The study design calls either for TSC or placebo to be administered by paramedics while the stroke victim is still in the ambulance, regardless of whether the stroke is ischemic or hemorrhagic. Our preparations were time-consuming due to the extensive training and coordination of first responders, and our work to ensure adequate supply of TSC was delivered to the ambulances.

“Because we believe TSC can reduce cell death and improve outcomes by increasing the amount of oxygen directed to affected tissue, utility is expected in both major types of stroke. Our clinical research has shown that TSC has an excellent patient safety profiles, which contrasts with the leading thrombolytic, tissue plasminogen activator, or tPA, which may only be used with ischemic stroke in inpatient settings.  With stroke patients, time is of the essence to obtain treatment. Because it can be given in the ambulance, TSC may provide an important improvement in the field. In addition, our preclinical work showed that TSC in combination with tPA may extend the timeframe wherein tPA may be administered, thus expanding the potential utility of TSC in this indication,” Mr. Kalergis added.

About Stroke

Stroke is a disease that affects the arteries leading to and within the brain. According to the American Stroke Association, it is the No. 5 cause of death and a leading cause of disability in the United States.

A stroke occurs when a blood vessel that carries oxygen and nutrients to the brain is either blocked by a clot or bursts (or ruptures). When that happens, part of the brain cannot get the blood (and oxygen) it needs, so it and brain cells die. Stroke can be caused either by a clot obstructing the flow of blood to the brain (called an ischemic stroke) or by a blood vessel rupturing and preventing blood flow to the brain (called a hemorrhagic stroke). A TIA (transient ischemic attack), or "mini stroke," is caused by a temporary clot.

About Diffusion Pharmaceuticals Inc.

Diffusion Pharmaceuticals Inc. is an innovative biotechnology company developing new treatments that improve the body’s ability to bring oxygen to the areas where it is needed most, offering new hope for the treatment of life-threatening medical conditions.

Diffusion’s lead drug TSC was originally developed in conjunction with the Office of Naval Research, which was seeking a way to treat hemorrhagic shock caused by massive blood loss on the battlefield. 

Evolutions in research have led to Diffusion’s focus today: Fueling Life by taking on some of medicine’s most intractable and difficult-to-treat diseases, including stroke and GBM brain cancer. In each of these diseases, hypoxia – oxygen deprivation of essential tissue in the body – has proved to be a significant obstacle for medical providers and the target for TSC’s novel mechanism.

Its on-ambulance PHAST-TSC acute stroke protocol has begun patient enrollment. In July 2019 the Company reported favorable safety data in a 19-patient dose-escalation run-in study to its Phase 3 INTACT program, using TSC to target inoperable GBM brain cancer.  Additional preclinical data supports the potential use of TSC as a treatment for other conditions where hypoxia plays a major role, such as myocardial infarction, respiratory diseases such as COPD, peripheral artery disease, and neurodegenerative conditions such as Alzheimer’s and Parkinson’s disease.

In addition, RES-529, the Company’s PI3K/AKT/mTOR pathway inhibitor that dissociates the mTORC1 and mTORC2 complexes, is in preclinical testing for GBM.

Diffusion is headquartered in Charlottesville, Virginia – a hub of advancement in the life science and biopharmaceutical industries – and is led by CEO David Kalergis, a 30-year industry veteran and company co-founder. 

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 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 Diffusion’s actual results to be materially different than those expressed in or implied by such forward-looking statements. Particular uncertainties and risks include: the difficulty of developing pharmaceutical products, obtaining regulatory and other approvals and achieving market acceptance; ability to enroll patients, general business and economic conditions; the company's need for and ability to obtain additional financing or partnering arrangements; 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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