Evgen Pharma PLC University of Rochester Collaboration (8375C)
13 February 2020 - 6:01PM
UK Regulatory
TIDMEVG
RNS Number : 8375C
Evgen Pharma PLC
13 February 2020
Evgen Pharma plc
("Evgen" or "the Company" or "the Group")
University of Rochester Collaboration
Evgen Pharma (Evgen) and The University of Rochester School of
Medicine and Dentistry have entered into a Memorandum of
Understanding to advance SFX-01 towards a clinical trial in chronic
kidney disease (CKD).
Evgen Pharma plc (AIM: EVG), the clinical stage drug development
company developing sulforaphane based medicines for the treatment
of multiple diseases, announces that it has entered into a
Memorandum of Understanding with The University of Rochester School
of Medicine and Dentistry to advance SFX-01 towards a clinical
trial in chronic kidney disease (CKD).
Evgen has agreed to supply SFX-01 to support a potential future
clinical trial led by Dr. Thu Le, Professor of Medicine and Chief
of the Division of Nephrology at the University of Rochester
Medical Center.
With the assistance of Evgen, Professor Le will lead the process
to secure appropriate grant funding and obtain clinical trial
regulatory approval. The intention is to investigate in a
randomised controlled trial whether treatment with SFX-01 can
decrease kidney disease progression rate and decrease markers of
oxidative stress and inflammation in CKD patients. In particular,
the study will test whether patients with the null allele of the
GSTM1 gene respond better than wild type or placebo-treated
patients. The GSTM 1 gene is part of the GST
(glutathione-S-transferase) family regulated by Nrf2, which SFX-01
is known to activate.
Clinical data arising from a successful trial would provide a
sound rationale to apply for funding for a large randomised trial
to test the efficacy of SFX-01 in slowing the rate of decline of
patients with later stage CKD. Furthermore, a positive result would
reinforce and establish further mechanistic evidence for future
research on the effects of regulation of the Nrf2-GSTM1 pathway on
kidney function.
In the United States the prevalence of CKD in adults is
estimated to be circa 14%, with 140 deaths per 1,000 patients. More
patients with CKD die of cardiovascular consequences than reach
end-stage kidney disease (ESKD). The mainstay of therapy for CKD
are angiotensin-converting enzyme inhibitors or angiotensin
receptor blockers, which were introduced more than 20 years ago,
but many CKD patients still progress to ESKD and require a kidney
transplant or regular dialysis to sustain life.
Professor Le and colleagues have previously published research
showing an association between CKD patients with the GSTM1 null
allele and more rapid CKD progression, and also that consumption of
cruciferous vegetables (a source of sulforaphane) is associated
with lower risks of kidney failure, with stronger effects in those
having the GSTM1 null allele. On this basis, Professor Le
approached Evgen, the developer of SFX-01, a stable form of
sulforaphane that has demonstrated excellent safety and
tolerability in previous clinical trials.
Thu Le, Professor of Medicine, and Chief of the Division of
Nephrology at the University of Rochester Medical Center said: "We
are pleased that Evgen will support our plans to undertake a
clinical trial on SFX-01 in patients with CKD. Increased oxidative
stress is a major molecular underpinning of CKD progression and our
research suggests that patients with the GSTM1 null allele may
particularly benefit from sulforaphane treatment via SFX-01
dosing."
Dr Stephen Franklin, CEO of Evgen Pharma, commented:
"We are delighted to be supporting the work of such a respected
team and prestigious university. We very much hope the proposed
trial will generate data demonstrating that SFX-01 could
potentially improve the lives of patients suffering from CKD."
Enquiries:
Evgen Pharma plc www.evgen.com via Walbrook
Dr Stephen Franklin, CEO
Richard Moulson, CFO
finnCap www.finncap.com +44 (0) 20 7220 0500
Geoff Nash / Teddy Whiley (Corporate
Finance)
Alice Lane, Manasa Patil (ECM)
WG Partners LLP +44 (0) 20 3705 9330
Nigel Barnes / Claes Spång
Walbrook PR +44 (0)20 7933 87870 or evgen@walbrookpr.com
+44 (0)7980 541 893 / +44 (0)7876 741
Paul McManus / Anna Dunphy 001
About Evgen Pharma plc
Evgen Pharma is a clinical stage company developing sulforaphane
based medicines for the treatment of multiple diseases The
Company's core technology is Sulforadex(R), 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.
The Company commenced operations in January 2008 and has its
headquarters at The Colony, Wilmslow, Cheshire, and its registered
office is at the Liverpool Science Park, Liverpool. Our lead
product, SFX-01, has demonstrated efficacy in a Phase II trial for
advanced metastatic breast cancer. It has been used to treat over
150 patients in clinical trials and is well-tolerated with
predominately mild side-effects.
Evgen shares are traded on the AIM market of the London Stock
under the ticker symbol EVG.
For further information, please visit: www.evgen.com
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END
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