Orbsen Therapeutics’ NEPHSTROM Clinical Trial Underway at
Four European Union Locations
Patients with diabetic kidney disease are being treated with a breakthrough stromal cell immunotherapy
(October 2, 2018) Galway, Ireland — Orbsen Therapeutics, a biotechnology company focused on the discovery, development and commercialization of first-in-class stromal cell immunotherapies, announced that ORBCEL-M™, a second generation stromal cell immunotherapy, currently is being administered to patients with type 2 diabetes and progressive diabetic kidney disease in a four-site, pan-European Phase I/II clinical trial.
“We are pleased the NEPHSTROM clinical trial has commenced and that randomized diabetic patients with kidney disease whose previous therapies failed now are receiving ORBCEL-M immunotherapy,” said Dr. Larry Couture, CEO of Orbsen Therapeutics. “The study may be a breakthrough moment for patients with end-stage renal disease caused by diabetes.”
Orbsen’s patented allogeneic ORBCEL-M yields nearly 100 percent pure stromal cells, a significant increase in purity when compared to first generation stromal cell therapies. The NEPHSTROM study aims to prove whether the purer stromal cells in ORBCEL-M will be more effective in the prevention and treatment of diabetic kidney disease. Up to 40 percent of people with diabetes will develop kidney disease. Many will require a kidney transplant or a lifetime of dialysis.
“It’s a privilege to have the first patients enrolled and receiving treatment at the Mario Negri Institute,” said Professor Giuseppe Remuzzi of the Mario Negri Institute in Bergamo, Italy, and the clinical trial’s lead investigator. “The complementary skills and expertise of the four participating European centers provides a critical network demonstrating the clinical feasibility of this innovative therapy and the opportunity for additional coordinated trials in diabetic patients with progressive kidney disease for whom new therapies are urgently needed.”
Noted Professor Timothy O’Brien, founding Director at Orbsen Therapeutics and coordinator of the NEPHSTROM study, “In my clinical practice, I see hundreds of patients with diabetic kidney disease who face the unpleasant possibility of dialysis or kidney transplantation. The outcome of this clinical trial may give patients another alternative and new hope.”
ORBCEL-M performed well in pre-clinical models as a therapy for diabetic kidney disease demonstrating significant improvements in kidney function.
“Encouraged by the promising results of the pre-clinical models, we are optimistic taking ORBCEL-M to the next stage to further investigate the immunotherapy as a solution to slow or stop progressive diabetic kidney disease,” said Steve Elliman, Chief Scientific Officer at Orbsen Therapeutics. “On behalf of Orbsen, we are privileged to be engaged with some of the European Union’s leading researchers and institutions through NEPHSTROM.”
Funded by the European Union Horizon 2020 program, the €80 billion research and innovation initiative, the NEPHSTROM study is designed to enroll up to 48 patients in a double-blind and placebo-controlled study. Patients who receive the ORBCEL-M therapy will be given three separate escalating doses.
NEPHSTROM’s four primary research locations are:
– The Mario Negri Institute, Bergamo, Italy
– National University of Ireland, Galway, Galway, Ireland
– University Hospitals Birmingham NHS Foundation Trust, Birmingham, UK
– Belfast Health and Social Care Trust, Belfast, Northern Ireland
Orbsen’s proprietary ORBCEL™ technology is pioneering potential stromal cell treatments to address a variety of diseases including diabetic foot ulcers, Acute Respiratory Distress Syndrome, Primary Sclerosing Cholangitis and other inflammatory and autoimmune disorders.
For more information about Orbsen Therapeutics, visit www.orbsentherapeutics.com.
About Orbsen Therapeutics
Orbsen Therapeutics, Ltd. is a leading company in the development of regenerative medicine therapies across a range of diseases and medical conditions. Founded in 2006, Orbsen Therapeutics Ltd., is a privately held company led by global leaders in the field of regenerative medicine. The company, which spun-out from Ireland’s Regenerative Medicine Institute at the National University or Ireland, Galway, has developed proprietary technologies that enables the isolation of pure and allogeneic stromal cells from human tissues which can be purified from a single donor, expanded and frozen to generate multiple doses of a high-margin, “off the shelf” therapeutic product.