Evgen Pharma PLC - All approvals received for STAR trial to commence
Evgen Pharma plc
("Evgen" or the "Company")
All approvals received for STAR trial to commence
Evgen Pharma plc (AIM: EVG), a clinical stage drug development company, is pleased to announce that all necessary regulatory approvals have now been received for the STAR trial (SFX-01 treatment for Acute Respiratory Infections). Trial recruitment is expected to commence around the end of the month.
STAR is a Phase II/III trial to investigate whether the company's lead asset, SFX-01, can reduce the severity, or prevent the onset of, acute respiratory distress syndrome ("ARDS") in patients with suspected COVID-19. Patients may therefore be drawn from both hospital and community settings and may present with COVID-19 or other respiratory diseases. It is a randomised, placebo-controlled trial and is sponsored by the University of Dundee.
SFX-01 upregulates the Nrf2 pathway which is part of the natural human defence against inflammatory and oxidative stress, such as the inflammation that occurs during a severe viral infection. Preclinical studies have shown that up-regulating the Nrf2 pathway reduces the severity of ARDS, the progressive lung damage observed in COVID-19 and pneumonia patients, which can result in the need for invasive ventilation in an intensive care unit.
The clinical study is being supported by a grant from LifeArc, as previously announced in
Evgen will supply clinical centres with SFX-01 and a placebo as its contribution to the trial. No additional financing is required as the costs of providing SFX-01 for the trial are not material.
The information communicated in this announcement is inside information for the purposes of Article 7 of EU Regulation 596/2014.
Evgen Pharma plc www.evgen.com
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+44 (0)20 7220 0500
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+44 (0)20 7933 87870 or [email protected]
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+44 (0)7980 541 893 / +44 (0)7876 741 001
About Evgen Pharma plc
Evgen Pharma is a clinical stage drug development company developing sulforaphane based medicines for the treatment of multiple diseases. The Company's core technology is Sulforadex®, a method for synthesising and stabilising the naturally occurring compound sulforaphane and novel proprietary analogues based on sulforaphane. The lead product, SFX-01, is a patented composition of synthetic sulforaphane and alpha-cyclodextrin.
Clinical data from the Company's open-label Phase II STEM trial has shown that SFX-01 can halt the growth of progressing tumours in patients with oestrogen-positive (ER+) metastatic breast cancer, and in some cases significantly shrink the tumour, whilst causing very few side effects.
The Company commenced operations in
For further information, please visit: www.evgen.com
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