• U.S. Patent Office Awards Diffusion Exclusive Rights for Use of TSC in Conjunction with Only FDA-Approved Stroke Therapeutic

    Source: Nasdaq GlobeNewswire / 17 Dec 2018 09:55:23   America/New_York

    CHARLOTTESVILLE, Va., Dec. 17, 2018 (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, announced today that it has been awarded a patent for the use of its breakthrough drug, trans sodium crocetinate (TSC), in conjunction with Tissue Plasminogen Activator (tPA) for the treatment of stroke. Currently, tPA – a thrombolytic used to break down blood clots in patients suffering from ischemic stroke – is the only FDA-approved therapeutic stroke treatment. Worldwide, stroke is the second leading cause of death and is responsible for an estimated 6.2 million deaths per year.

    The granting of Diffusion’s patent follows the recent news that the Company received FDA approval to enroll patients in an ambulance-based Phase 2 clinical trial testing TSC for the treatment of both ischemic and hemorrhagic stroke.

    The use of TSC represents a potential breakthrough in the treatment of stroke, which afflicts nearly 800,000 Americans each year. Diffusion’s FDA-approved Phase 2 clinical trial will focus on the concept of early intervention – allowing patients suffering from either ischemic or hemorrhagic stroke to receive TSC on the ambulance or in the emergency department immediately upon onset of symptoms. Patients can then, separately, receive tPA in-hospital if they are found to be suffering from ischemic stroke. If the clinical trial is successful, there is the potential to establish a new standard of care, with a combination drug therapy which could generate over $1 billion annually. 

    “The granting of exclusive rights for the use of TSC in conjunction with tPA for the treatment of stroke is a significant development for Diffusion,” said Thomas E. Byrne, General Counsel of Diffusion. “We’re excited about the opportunity this patent affords, as it gives Diffusion exclusive rights over the use of these two drugs together, a combination which may make a real difference for patients suffering from stroke.”

    With the notification by the United States Patent Office of the issuance of U.S. Patent 10,130,689, Diffusion now has patent protection over the use of TSC in conjunction with tPA in the United States, Japan, and Korea, with pending applications in Europe, Canada, China, Israel, and India.

    Nearly two million brain cells die each minute during a stroke, and TSC is a significant innovation in how patients receive care, given that it will potentially be the first and only front-line treatment,” said David Kalergis, Chairman and CEO of Diffusion. “Our company is committed to fighting life-threatening medical conditions, and there’s no doubt that stroke is a life-threatening and life-altering condition for families throughout our country and around the world.  This patent is an extension of that commitment, as our research indicates that using TSC in conjunction with tPA – which remains the only FDA approved therapeutic for stroke – improves outcomes for patients.

    “As we continue to explore national and international strategic partnerships, we believe this patent will provide additional opportunities for conversation while strengthening the company’s position within the industry,” said Bill Hornung, Chief Financial Officer of Diffusion. “We look forward to the legal protection this patent affords as we continue our efforts to grow Diffusion and pursue the possibilities for our lead drug, TSC.”

    In order to enhance value to its investors and stockholders, Diffusion has a robust intellectual property program aimed at protecting its existing and potentially expanded assets. The Company’s patents relating to TSC include claims to compositions of matter, treatment of cancer in combination with radiation and/or chemotherapy, and treatment of a full range of non-cancer hypoxic conditions, including stroke, heart attack, pulmonary embolism, respiratory conditions and neurodegenerative diseases. Fourteen US patents have been issued; forty-six have issued abroad. Patents cover the major markets (The United States, European Union, and Japan), with key patent life until 2026, plus expected extensions until 2031. 

    Seven-year Orphan exclusivity provides additional protection, and formulation patents provide protection for the TSC oral drug product until 2031, with possible extensions.

    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 Crocinate (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, GBM brain cancer, pancreatic cancer, and brain metastases. In each of these diseases, hypoxia – when essential tissue in your body is deprived of oxygen – 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. It’s on-ambulance Phase 2 acute stroke protocol was granted FDA clearance to proceed in September, 2018.  Additional pre-clinical 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.

    In addition, RES-529, the Company’s PI3K/AKT/mTOR pathway inhibitor that dissociates the mTORC1 and mTORC2 complexes, is in the preclinical testing phase 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 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 or partnering arrangement; 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.

    Contact:
    Rob Corradi
    rob@penpublicaffairs.com
    410-212-5483

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