• Poster Presented at International Stroke Conference Describing Diffusion’s On-Ambulance Phase 2 Trial with TSC for Treating Acute Stroke

    Source: Nasdaq GlobeNewswire / 11 Feb 2019 16:00:10   America/New_York

    CHARLOTTESVILLE, Va., Feb. 11, 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’s needed most, today announced the presentation of a poster detailing an innovative on-ambulance Phase 2 study with the Company’s lead drug trans sodium crocetinate (TSC) for the treatment of acute stroke. The poster was presented on February 7th at the American Heart Association’s International Stroke Conference, held February 6-8 in Honolulu.

    The poster is titled “PreHospital Administration of Stroke Therapy with Trans Sodium Crocetinate (PHAST-TSC) Trial” with authors:

    • Andrew M. Southerland, MD, MSc, University of Virginia Health System;
    • Nerses Sanossian, MD, University of Southern California;
    • Timothy L. McMurray, PhD, University of Virginia Health System;
    • John L. Gainer, PhD, Diffusion Pharmaceuticals, Inc.;
    • Anna Grace, MA, RN, CCRP, Diffusion Pharmaceuticals, Inc.;
    • Amy C. Fansler, MPH, University of Virginia Health System;
    • Guy M. Chisolm, III, PhD, Chair, Diffusion Scientific Advisory Board;
    • Karen C. Johnston, MD, M.Sc., University of Virginia Health System;
    • Jeffrey L. Saver, MD, University of California, Los Angeles Health System.

    The poster presents the design of the randomized, double-blind, placebo-controlled PHAST-TSC (Pre-Hospital Ambulance Stroke Trial-TSC) trial, which will enroll 80 suspected stroke patients in the active arm (0.25 mg/kg of TSC) and 80 suspected stroke patients in the control arm (normal saline) at participating stroke centers/EMS in Los Angeles County and central Virginia. The primary trial endpoint is the extent of disability at 90 days using the utility-weighted modified Rankin Scale (UW-mRS).  Safety endpoints include serious adverse events and all-cause mortality.

    TSC holds promise as a neuroprotective agent in acute stroke as it is expected to off-set the decrease that occurs in brain oxygen caused by stroke from either a clot or a bleed.  As part of the PHAST-TSC trial protocol, all patients must be treated within two hours of their first stroke symptoms. Administering TSC while the patient is on the ambulance will start this reoxygenation process as soon as possible after the stroke occurs.

    An investigational new drug application has been approved by the U.S. Food and Drug Administration and investigational review board approval is pending at participating sites.  EMS training and community education for exception from informed consent is about to begin in Los Angeles County and central Virginia.  Anticipated enrollment of the first patient is expected this spring, subject to receipt by Diffusion of the necessary funding for the trial.

    “We are very pleased to highlight the details of this innovative trial design at such a prestigious medical conference,” said David Kalergis, Chairman and CEO of Diffusion. “We expect this poster will be helpful as we work to gain awareness for Diffusion and for TSC, both in the US and internationally.”

    In addition, the poster includes references to preclinical data suggesting that TSC has benefit for both ischemic and hemorrhagic stroke, as well as promise in glioblastoma multiforme (GBM) and peripheral artery disease.

    Additional information about the PHAST-TSC trial

    The Phase 2 randomized, double-blind, placebo controlled PHAST-TSC trial will enroll 160 suspected stroke patients age 40-85, with 128 coming from up to 20 hospitals in the greater Los Angeles area and 32 coming from three central Virginia hospitals.  Half the patients will be randomized to receive TSC and half to placebo.  The primary endpoint is mortality or patient neurological disability as measured by the modified Rankin scale administered 90 days after stroke occurrence. Because the follow-up period in the trial is only 90 days post-treatment, complete data collection is expected within 21 months of first patient enrollment, offering a timely and cost-effective assessment of a potential breakthrough therapeutic in one of healthcare’s most significant unmet medical needs. 

    The PHAST-TSC Diffusion-sponsored clinical trial is a cooperative effort by Diffusion and its Chief Science Officer and inventor of the TSC molecule John L. Gainer, PhD and Diffusion’s Scientific Advisory Board Chair Guy Chisolm, PhD, in close cooperation with the Director of UCLA’s Stroke Center Jeffrey Saver, MD and the Chair of UVA’s Department of Neurology Karen Johnston, MD.  Co-principal investigators for the study are Andrew Southerland, MD (UVA) and Nerses Sanossian, MD (University of Southern California). Other important participants include approximately 150 emergency medical transport groups based in Los Angeles and Central Virginia. Diffusion will be seeking additional financing or a partnering arrangement to fund the trial.

    More information about Diffusion’s clinical programs, including both its INTACT Phase 3 trial in inoperable GBM brain cancer and its PHAST-TSC acute stroke program, are available on Diffusion’s Website at www.diffusionpharma.com.

    About the International Stroke Conference

    The International Stroke Conference is the world’s premier meeting dedicated to the science and treatment of cerebrovascular disease. It is organized by the American Heart Association.

    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’s needed most, offering new hope for the treatment of life-threatening medical conditions.

    Diffusion’s lead drug, trans sodium crocetinate (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.

    In 2018 the Company began enrolling patients in its Phase 3 INTACT program, using TSC to target inoperable GBM brain cancer. Its on-ambulance PHAST-TSC acute stroke protocol was granted FDA clearance to proceed in September 2018.  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 the 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; 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.

    Contacts:
    David Kalergis, CEO
    Diffusion Pharmaceuticals Inc.
    (434) 220-0718
    dkalergis@diffusionpharma.com

    LHA Investor Relations
    Kim Sutton Golodetz
    (212) 838-3777
    kgolodetz@lhai.com

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