Thrombolytic Science, LLC to Collaborate With National Institutes of Health to Test a Novel Thrombolytic Regimen for the Treatment of Acute Ischemic Stroke in Phase IIa Clinical Trial
CAMBRIDGE, Mass., June 1, 2015 /PRNewswire/ -- Thrombolytic Science, LLC (TSI) announced today that is has entered into an agreement with the National Institutes of Health (NIH). Under a Cooperative Research and Development Agreement (CRADA) with the National Institute of Neurological Disorders and Stroke (NINDS), and upon receipt of an IND from the FDA, TSI will work with leading researchers at the NINDS / Intramural Stroke Program to test the safety of dual thrombolytic therapy using tissue plasminogen activator and an improved version of prourokinase (HisproUK) in patients suffering from acute ischemic stroke (AIS).
"TSI's HisproUK-based clot buster treatment represents a novel approach to thrombolysis and the treatment of AIS," said Victor Gurewich, MD, Professor of Medicine at Harvard Medical School and Chief Scientific Officer of TSI. "Both natural thrombolytics, being complementary, are used sequentially, as in Nature, resulting in a synergistic therapeutic effect achieved at much lower doses than the ones used in standard monotherapy today. The treatment is designed to combine greater thrombolytic efficacy with improved safety and we are eager to test it in the clinic together with the NINDS team."
TSI will provide the study drug while NINDS will conduct a phase IIa trial. The multicenter trial will be performed in a population of AIS patients recruited by the NIH intramural stroke program, using a combined clinical and MRI-guided approach to patient selection.
"This important collaboration with NINDS will ultimately support TSI in extending treatment to more individuals impacted by AIS," said Alexis C. Wallace, President and Chief Executive Officer of TSI. "The current intravenous treatment is given to less than 10% of patients. The addition of endovascular thrombectomy to intravenous tPA has recently been shown to improve outcomes, yet requires an uncommon level of expertise. Augmenting treatment options with a simple intravenous regimen that is both effective, safer and could be made available much earlier to a wider population will likely have a substantial beneficial impact on acute stroke care."
About Stroke
Each year, strokes affect 15 million people worldwide and, with 6.7 million deaths, stroke is the second leading cause of death in the world. In the United States, stroke is the leading cause of long-term disability in adults and the fifth leading cause of death, costing the US healthcare system in excess of $73 billion each year. Approximately 80 percent of all strokes are caused by blood clots (Acute Ischemic Stroke).
About Thrombolytic Science, LLC
Thrombolytic Science, LLC is a privately-held vascular medicine and biotechnology company based in Cambridge, MA, currently developing a new-generation clot-dissolving therapy with the first novel mechanism of action in 20 years for stroke and other thrombotic diseases. TSI's technology is based upon pioneering earlier work on prourokinase by its cofounders.
For more information, please visit www.tsillc.net or call us at +1 (866)-973-5810
SOURCE Thrombolytic Science, LLC
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