Market Overview

Thrombolytic Science Initiates Phase 2 Clinical Trial of its Novel Treatment Regimen for Ischemic Stroke


Study Seeks to Confirm Efficacy and Safety of Next-generation
Clot-dissolving Therapy Consisting of Low-dose tPA and HisproUK

Science, LLC
 (TSI) today announced initiation of a Phase 2 clinical
trial to confirm the efficacy and safety of its sequential
dual-treatment regimen of low-dose tissue plasminogen activator (tPA)
and HisproUK (TSI's mutant prourokinase [proUK]) in patients who have
experienced ischemic stroke. The study follows a recently completed
Phase 1 study that confirmed the safety and tolerability of TSI's
regimen in healthy volunteers (n=26).

The Phase 2 study will be led by Prof. Diederik Dippel, MD, PhD,
co-director of the Erasmus MC Stroke Center in Rotterdam, The
Netherlands, and will compare the TSI regimen against high-dose tPA
monotherapy – the current standard of care – following an ischemic
stroke in patients with distal blood clots (i.e., those not retrievable
with a surgical device). TSI also plans to initiate a Phase 2 study of a
pre-hospital dual-treatment regimen in heart attack patients, in 2019,
for which the company is currently fund raising.

"Initiation of our Phase 2 trial in ischemic stroke is an important
milestone for TSI, the medical community, and patients, as we take a
step closer to possibly treating ischemic stroke faster, safely, and
with greater confidence," said Alexis Wallace, MScENG, MBA, TSI
co-founder and CEO. "Having been greatly encouraged by the favorable
results from our Phase 1 trial of low-dose tPA and HisproUK, we are
confident that the Phase 2 study will further characterize the clinical
utility of this next-generation clot-dissolving regimen. We look forward
to exploring potential partnerships with pharmaceutical companies as we
continue to advance the clinical development program for this promising

TSI's flagship product, HisproUK, is a more stable and safer version of
proUK. Created by recombinant technology, HisproUK is designed to
modulate the high intrinsic activity of proUK, which led to bleeding in
previous studies. TSI's sequential dual-therapy regimen starts with
low-dose tPA, which initiates the natural process of thrombolysis. Low
dose tPA activates plasminogen into plasmin, which degrades the surface
of the clot. HisproUK then activates two additional plasminogen binding
sites on the degraded clot surface, a step that accelerates
thrombolysis. Together, these natural and synergistic mechanisms enable
the process of clot dissolution at low doses.

"Timely and rapid clot dissolution is key to treating ischemic stroke,
especially when the clots are distal, a situation that asks for medical
treatment with a next generation thrombolytic drug to minimize
complications and maximize chances of good outcome," explained Prof.
Dippel. "That makes this Phase 2 trial particularly important, as we
hope to show that sequential dual-therapy with low-dose tPA and HisproUK
can initiate thrombolysis safely and effectively."

About Stroke

The vast majority (roughly 85%) of stroke cases are ischemic, meaning
they are caused by an obstruction within a vessel supplying blood to the
brain. Stroke claims a life every 10 seconds, and kills more people each
year than AIDS, tuberculosis and malaria combined. In the U.S., it is
the leading cause of long-term disability and the fifth-leading cause of
death, costing the healthcare system in excess of $73 billion each year.
Currently, there is no effective or safe treatment to dissolve blood
clots, a factor that contributes to the low percentages of patients in
the U.S. (<5%) and Europe (<10%) who are treated for stroke.

About Thrombolytic Science

Thrombolytic Science, LLC (TSI) is a privately-held vascular health and
biotechnology company leading development of a next-generation,
life-saving therapy to transform traditional medical approaches for
treating blood clots caused by ischemic stroke and heart attacks –
interventions that have not changed in decades. The company's vision is
to bring clot-busting therapy directly to the patient quickly,
especially following an ischemic stroke, rather than having a patient
wait to get to a hospital. TSI's dual, sequential thrombolytic regimen
was established based upon research at Tufts University School of
Medicine and Harvard Medical School, where scientists designed HisproUK.
For more information, follow TSI on Twitter @ThrombolyticSci
and visit

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