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A Basque (Spain) biopharmaceutical SME is currently running clinical trials in phase I/II for two different clinical indications (Acute Spinal Cord Injury-SCI and Acute Respiratory Distress Syndrome-ARDS) using a proprietary innovative stem cell therapy technology platform. They are looking for pharma companies interested in licensing the technology and investors interested in financing the company for further development of the clinical phases. A technical collaboration is also envisaged.
The Basque biopharmaceutical company was founded in 2004 and focuses its activity on the development, manufacturing and commercialization of novel medical devices, active ingredients and cell therapy drugs for regenerative medicine.
The SME has developed an innovative cell therapy technology platform that can be applied to pathologies with a relevant oxidative and/or inflammatory component.
Inflammation is a protective response of a multicellular organism to injury in order to localize, eliminate, and remove harmful stimuli as well as to recover (or replace) damaged tissues. There recently has been increasing evidence that reactive oxygen species (ROS) are central factors in the initiation, progression, and persistence of the inflammatory response. At the same time, there is clear evidence that sustained inflammation dramatically interferes with natural tissue healing capacity.
The company’s new cell therapy technology is based on proprietary and patented allogenic adipose derived Mesenchymal stem cells (MSC) preconditioned in oxidative stress conditions, a process that increases the resistance and survival of the cells in adverse environments with the aim of protecting host’s damaged tissues and improving the natural healing process. MSCs are multipotent stem cells that can differentiate into a variety of cell types. They hold tremendous potential in cell-based therapies and regenerative medicine because of their potential use in autologous transplantation.
After seeing promising results in preclinical studies, the SME is already conducting clinical trials with this new cell therapy.
Safety and preliminary efficacy of a single intra-medullar injection of the cells in patients with acute traumatic spinal cord injury (SCI) is being evaluated in a Phase I/II, randomized, controlled and double-blind clinical trial. Results have demonstrated that the treatment carried out in patients of Phase I (sequential escalating doses) is safe; Phase II of this study is already running.
In addition, a new clinical trial has been recently submitted to evaluate safety and preliminary efficacy of the cells administered by intravenous infusion in patients with acute respiratory distress syndrome (ARDS); this is a Phase I/II, randomized, controlled and double-blind clinical trial. This study is expected to start in the last quarter of 2019.
The manufacture of the cellular products takes place in the own cleanrooms of the SME within a validated manufacturing that to meets GMP standards.
The Basque SME offers its cell platform for licence and is looking for investment agreements. It is also open to technical cooperation to further develop their platform.
The cell therapy technology platform is applied to pathologies with a relevant oxidative and/or inflammatory component. It is a last-generation adipose-derived mesenchymal stem cell technology that uses a fully quality controlled and proprietary process to increase the level efficacy of traditional mesenchymal stem cells. This process is based on a preconditioning under oxidative stress, which provides the stem cells with a higher ability to survive and migrate in highly oxidative inflammatory environments. These properties make them particularly suitable for pro-inflammatory diseases.
There are numerous advantages of using this new cell-based therapy as a therapeutic strategy for a diverse range of clinical applications aimed at repairing, preventing or reversing tissue injury. This distinctive therapeutic approach has the potential to survive under highly adverse conditions thanks to their enhanced resistance against the cytotoxic environments. For this reason, the cells show an increased survival rates following implant in the injury site. Moreover, the cells have significantly higher activity in terms of greater inflammatory modulation activity, greater pro-regenerative factors secretion and enhance host tissue protection (detoxifying molecules) comparing with traditional mesenchymal stem cells.
The cell therapy is a promising therapeutic approach because of its broad variety of treatment applications, capacity to easy expansion to prepare wide range of optimal doses and various delivery methods, both local and intravenous.
The cell therapy technology platform is ongoing clinical trials in Phase I/II in two different clinical indications. Patients with Acute Spinal Cord Injury (SCI) and patients with Acute Respiratory Distress Syndrome (ARDS).
The cell therapy technology patent has already been granted in the main markets: United States, Europe, Japan, China, Canada, Australia, Mexico, Korea and has been filed also in Brazil and India.
The company is looking for partners interested in licensing the cell therapy technology platform and investors interested in financing them for further development of the clinical phases in both pathologies: Acute Spinal Cord Injury (SCI) and Acute Respiratory Distress Syndrome (ARDS). Technical collaboration is as well envisaged.
The type of partner sought is international pharma companies.