Orbsen Therapeutics Cell Therapy Selected for Diabetic Wound Clinical Trial Led by NUI Galway and Steno Diabetes Centre

Pictured at the announcement of the EU FP7-funded REDDSTAR project from L-R: Professor Timothy O'Brien, Dean of Medicine and Director of REMEDI at NUI Galway, Brian Molloy and Steve Elliman, Orbsen Therapeutics. Photo: Aengus McMahon
May 12 2014 Posted: 11:21 IST

The European Union FP7-funded REDDSTAR consortium has selected Orbsen Therapeutics’ proprietary cell therapy (Cyndacel-M ™) to be tested in a phase 1b clinical trial in diabetic patients suffering with ulcerating (non-healing) wounds. The trial will be led by the Steno Diabetes Centre in Copenhagen in 2015.

Orbsen Therapeutics proprietary stromal cell therapy (Cyndacel-M ™) has been selected to be tested in a EU Framework 7 (FP7) funded safety trial for the treatment of non-healing, ulcerating wounds in patients with diabetes. The project known by the acronym “REDDSTAR” (Repair of Diabetic Damage by Stromal Cell Administration) is being co-ordinated by Professor Timothy O’Brien, Dean of Medicine and Director of Ireland’s Regenerative Medicine Institute (REMEDI) at NUI Galway.

Approximately 50 million diabetic EU citizens are using approved anti-diabetic agents to control their diabetes. However, diabetes still leads to 6 progressive complications, namely: nephropathy, retinopathy, cardiomyopathy, neuropathy and wound ulceration. In 2010, 11% of EU adult deaths (634,000) were caused by diabetic complications. The foot ulcer is a leading cause of hospital admissions for people with diabetes in the EU and is a major morbidity associated with diabetes. Diabetic foot ulcers (DFU) are estimated to occur in 15% of all patients with diabetes and precede 84% of all diabetes-related lower-leg amputations.

As part of the project, academic and clinical research teams in Galway, Berlin, Belfast, Munich and Porto have been testing the Orbsen Therapeutics proprietary cell product (called Cyndacel-M ™) against the current standard cell therapy. The results have been collated and analysed and an independent panel at the Steno Diabetes Centre in Copenhagen, decided to use Cyndacel-M ™ for a clinical trial in patients with diabetic ulcers, in preference to the current cell technology.

The clinical study will combine Orbsen’s Cyndacel-M ™ with an existing wound therapy called Excellagen, an FDA-cleared collagen treatment developed by US-based Cardium Therapeutics Inc. (Trading Symbol: CRXM). This transatlantic collaboration between Orsben and Cardium represents an exciting development that brings Cardium’s significant commercial expertise in the wound healing market to the REDDSTAR project.

Professor Timothy O’Brien, Dean of Medicine and Director of REMEDI at NUI Galway said, “I have been very impressed by the experimental rigour applied by all the project partners. It was important to obtain independent verification of the efficacy of the therapy and that is what the EU funding and design of REDDSTAR allowed.”

Orbsen CEO Brian Molloy said, “We are absolutely delighted with this decision. This is a very significant moment in the development of Orbsen Therapeutics. We have spent the past 3 years developing and validating our therapy. Advancing to a clinical trial is a major milestone for the company – particularly in a condition as prevalent as diabetic wound ulceration, which is so poorly served by existing treatment options at the moment.”

The REDDSTAR project was originally conceived by Dr Steve Elliman, Head of Research and Development at Orbsen Therapeutics, and it is co-ordinated by Professor Timothy O’Brien at NUI Galway. The first phase of the project studied the use of stromal cells as a treatment for six major complications of diabetes namely Nephropathy, Neuropathy, Ulcers, Retinopathy, Cardiomyopathy and impaired bone healing. Each of the research teams presented their results at a plenary meeting in Paris on April 22 and these results were reviewed by an independent panel from the Steno Diabetes centre in Copenhagen.

Dr. Steve Elliman, Orbsen Therapeutics commented, “The REDDSTAR teams presented very promising data from the six models of diabetic complications. In each case the teams compared the performance of our Cyndacel-M ™ therapy with the existing Plastic Adherent (PA) MSC product. We are delighted to see that Cyndacel was equivalent or better in all the complications. Our therapy represents a significant advance in terms of purity of the cell therapy and we expect this improved purity to correlate with improved clinical safety efficacy. Whilst diabetic wound ulceration has been selected for this trial, I expect that the Cyndacel will be advanced into other REDDSTAR-derived clinical trials over the coming years.”

Orbsen has become one of Ireland’s most successful companies at securing EU FP7 funding over recent years. REDDSTAR is one of 5 programmes that they have secured – the others being PURSTEM (completed), DeCIDE (ongoing) and the recently announced MERLIN and VISICORT projects which include clinical trials of Cyndacel in auto-immune disease of the liver and cornea transplant rejection respectively.

Brian Molloy added, “Our mission is to join Europe’s leading Cell Therapy companies in developing effective new medicines for disease with unmet need. In doing so we hope we can position Ireland and NUI Galway in particular as a European hub for cell therapy development. Developing new therapies is a slow process but we have made remarkable progress over the past three years.

Mr Molloy continued, “The symbiotic relationship that we have developed with NUI Galway (who are shareholders in Orbsen) has been a key factor in our development as a company. We are based on campus which enables us to gain access to world class researchers and facilities. In return, we have been able to employ NUI Galway graduates, supervise NUI Galway students and attract significant amounts of research funding into the University. The relationship works very well for both parties and as we move into the clinical phase of our development we expect that relationship to continue as a “win-win” for both parties.”

Orbsen Therapeutics Ltd. is a privately-held company founded in 2006 as a spin-out from Ireland’s Regenerative Medicine Institute (REMEDI) in NUI Galway. As part of the PurStem EU FP7 program, Orbsen developed proprietary technologies that enable the prospective purification of highly defined and therapeutic (stromal) cells from several human tissues, including bone marrow, adipose tissue and umbilical cord.

The company has developed a unique method of isolating therapeutic stromal cells from human tissue at class-leading levels of purity. The Orbsen Therapeutics cell therapy product is unique in that it has been designed to meet future EU regulations regarding cell-based medicines.

Orbsen’s proprietary Cyndacel-M ™ is being developed for several diseases, including inflammatory disease of the lungs and liver, diabetes, cardiovascular disorders, joint disease, kidney injury, organ graft rejection and wound repair.

The novel aspects of Orbsen’s technology place it at the leading edge of research, development and regulatory compliance of adult mesenchymal stromal cell therapies. Cyndacel-M ™ can be purified from a single human donor, expanded and frozen to generate many doses of high-margin, allogeneic (“off-the-shelf”) therapeutic products for conditions with unmet need.