Evgen and Rochester University partner to advance SFX-01 trial

Evgen Pharma has signed a memorandum of understanding (MoU) with the University of Rochester School of Medicine & Dentistry to advance SFX-01 towards a clinical study for treating patients with chronic kidney disease (CKD).

The CKD disorder is caused by kidney dysfunction and is also known as chronic kidney failure.

Evgen’s SFX-01 product is a patented composition of synthetic sulforaphane and alpha-cyclodextrin.

Under the agreement, Evgen will supply SFX-01 to support a potential future clinical trial led by University of Rochester Nephrology division chief Thu Le.

According to the company, the intention of the study is to investigate SFX-01 in a randomised controlled trial to see if the treatment can decrease kidney disease progression rate.

The trial will also investigate whether SFX-01 can decrease markers of oxidative stress and inflammation in CKD patients.

Thu Le 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.’”

Evgen noted that the study will test whether patients with the null allele of the Glutathione S-Transferase M1 (GSTM1) gene respond better compared to that of placebo-administered patients.

The GSTM 1 gene is part of the glutathione-S-transferase (GST) family regulated by Nrf2, which SFX-01 is said to activate.

Evgen Pharma CEO Stephen Franklin said: “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.”

In March last year, Evgen Pharma announced positive headline results from the open-label Phase II STEM trial of SFX-01 to treat patients with estrogen-positive (ER+) metastatic breast cancer.