Orgenesis Enters Into R&D Agreement With The Fraunhofer IGB
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Orgenesis Inc. (OTCBB:ORGS) (“Orgenesis” or the “Company”), a development-stage company with a novel therapeutic technology dedicated to converting a patient’s own liver cells into functioning insulin-producing cells as a treatment for diabetes, announced today that it has entered into a service agreement (the “Agreement”) with the Fraunhofer Institute for Interfacial Engineering and Biotechnology (“Fraunhofer IGB”), a leading German contract research and development center for regenerative medicine.
The commencement of clinical studies of Advanced Medicinal Therapy Products (“ATMPs”), such as Orgenesis’ autologous insulin-producing cell transplants, necessitates formal approval by the senior medical regulatory approval organizations. This approval requires manufacturing, processing and testing of ATMPs in accordance with current national regulations, including good manufacturing practice (“GMP”).
Pursuant to the Agreement, the Fraunhofer IGB will explore a pilot process to manufacture human autologous insulin-producing cell transplants based on the Orgenesis technology. It is anticipated that the subsequent establishment of a fully GMP-compliant production process will, in turn, enable Orgenesis to obtain authorization for the production of clinical grade material to be used in a first-in-man study of the Company’s diabetes treatment product candidate.
“The Fraunhofer IGB’s expertise in developing manufacturing processes for ATMPs, combined with its ability to manufacture cell-based therapeutics in a clinical scale at its own certified GMP manufacturing unit, makes it an ideal R&D collaboration partner for Orgenesis as we continue to work towards initiating advanced stage trials of our technology,” commented Jacob BenArie, CEO of Orgenesis.
“We are very excited to support Orgenesis in their development of a very promising new therapy for diabetes that overcomes the problem of donor shortage and removes the risk of transplant rejection. This project fits exactly into our strategy to support the translation of innovative tissue engineering technologies into the clinical application,” commented by Dr. Martin Funk, head of the GMP unit at the Fraunhofer IGB.
Orgenesis (OTCBB:ORGS) is a development stage company with a novel therapeutic technology that employs a molecular and cellular approach directed at converting a patient's own liver cells into functional insulin producing cells, as a treatment for diabetes. The Company believes that converting the diabetic patient's own tissue into insulin-producing cells overcomes the problem of donor shortage and removes the risk of transplant rejection. If successful, this could mean the end of diabetes, as we now know it. For more information visit: .
The Fraunhofer Institute for Interfacial Engineering and Biotechnology IGB offers R&D solutions in the fields of medicine, pharmacy, chemistry, the environment and energy. Our competences comprise Interfacial Engineering and Materials Science, Molecular Biotechnology, Physical Process Technology, Environmental Biotechnology and Bioprocess Engineering, as well as Tissue Engineering. We offer solutions from market analysis through research & development through the finished product. For more information visit:
On Behalf of the BoardOrgenesis Inc.
Vered Caplan, Chairperson