Verseon Corporation First participant dosed in Verseon clinical trial
2019年2月4日 - 4:00PM
RNSニュース (英語)
TIDMVSN
Verseon Corporation
04 February 2019
February 4, 2019
Verseon Corporation
("Verseon" or the "Company")
First participants receive Verseon PRrecision Oral AntiCoagulant
(PROAC) in phase I trial
Fremont, Calif.-Verseon, the clinical-stage pharmaceutical
company developing disruptive life-science technology to advance
global health, announces that dosing has started in the phase I
clinical trial of VE--1902, the Company's leading candidate for a
new class of PRecision Oral AntiCoagulants (PROACs). Preclinical
data suggest that PROACs could become the first anticoagulants
suitable for long-term co-administration with antiplatelet agents
for the prevention of stroke and heart attack in coronary artery
disease (CAD) patients.
Anticoagulants, commonly referred to as blood thinners, are used
to prevent stroke and venous thromboembolism. However, current
anticoagulants substantially increase major bleeding events, a
potentially fatal side effect, especially when they are
administered together with antiplatelet drugs (e.g., aspirin,
Plavix(TM) ). As a result, current treatment guidelines generally
do not recommend combined anticoagulant-antiplatelet treatment for
longer than twelve months.
In preclinical testing, PROACs have shown a unique combination
of efficacy with lower bleeding. In particular, PROACs have
demonstrated the ability to prevent the formation of blood clots
without disrupting platelet function. These results suggest that
VE--1902 and other PROACs in Verseon's pipeline may be safer
alternatives than currently available therapeutics when
administered in combination with one or more antiplatelet
agents.
The ongoing phase I trial, which is a single-center,
double-blinded, randomized, placebo-controlled study assessing the
safety, tolerability, and composite hemostatic profile of Verseon's
lead PROAC VE--1902, is expected to continue dosing through Q3 2019
with first results in Q4 2019.
"The start of subject dosing is an exciting milestone for
Verseon," said Dr. David Kita, Verseon's VP of R&D. "PROACs
have the potential to change the standard of care for millions of
CAD patients who would benefit from long-term combination therapy
with antiplatelet drugs. We look forward to the results of VE--1902
in this first-in-human trial."
About the phase I trial for VE--1902
"A Study of Safety, Pharmacokinetics, and Pharmacodynamics of
Single and Multiple Ascending Oral Doses of VE--01902 in Healthy
Volunteers"
The phase I trial for Verseon's first PROAC, VE--1902, (trial ID
ACTRN12618001509257) is a single-center, double-blinded,
randomized, placebo-controlled study of the safety, tolerability,
and composite hemostatic profile in 100-120 healthy volunteers.
Secondary endpoints will assess pharmacokinetic and pharmacodynamic
profiles of VE--1902. The study will include once-a-day oral dosing
in two stages: a single ascending dose stage with a food effect
cohort and a multiple ascending dose stage with 7-day repeat
dosing. The trial is being conducted at Nucleus Network in
Melbourne, Australia.
About Verseon's PROACs
Verseon's PRrecision Oral AntiCoagulants (PROACs) have shown
excellent efficacy in multiple preclinical studies without
disruption of platelet function. This unique feature could explain
the low bleeding of the PROACs observed in preclinical testing,
making PROACs excellent candidates for use in long-term combination
anticoagulant-antiplatelet therapy. Lead PROAC VE--1902, which is
currently in a phase I clinical trial, was well-tolerated in
regulatory toxicity studies and demonstrated low renal clearance, a
desirable property for patients with impaired kidney function. A
second PROAC is expected to enter the clinic in 2019.
About Verseon
Verseon Corporation (www.verseon.com, AIM: VSN) is developing
disruptive life-science technology to advance global health. The
clinical-stage company is using its proprietary, computational drug
discovery platform paired with a comprehensive in-house chemistry
and biology workflow to build a growing drug development pipeline.
The company is applying its platform to a growing drug pipeline and
currently has four active drug programs in the areas of
anticoagulation, diabetic macular edema, hereditary angioedema, and
oncology.
- Ends -
For further information, please contact
Verseon Corporation www.verseon.com
Sebastian Wykeham / Tina Schlafly +1 (510) 225 9000
Arden Partners (NOMAD and Joint Broker)
+44 (0) 20 7614
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Cantor Fitzgerald Europe (Joint Broker)
+44 (0) 20 7894
Phil Davies 7000
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Simon Vane Percy 890
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END
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