Diffusion Pharmaceuticals Inc. (Nasdaq: DFFN), a cutting-edge biotechnology company developing new treatments for life-threatening medical conditions by improving the bodys ability to bring oxygen to the areas where its 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 Diffusions 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. Diffusions 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. Were 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.
