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University of Rochester Collaboration

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."





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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®, 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