Diffusion Pharmaceuticals (DFFN) Awarded Patent for Use of TSC in Conjunction with Only FDA-Approved Stroke Therapeutic

December 17, 2018 10:07 AM EST
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Diffusion Pharmaceuticals Inc. (Nasdaq: DFFN) 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.

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