Nutra Pharma Corporation is collaborating with the University of Maryland Bioprocess Scale-Up Facility to optimise manufacturing processes for the production of RPI-78M for the upcoming clinical trials in Paediatric Multiple Sclerosis.
“Pediatric Multiple Sclerosis is a pressing and unmet medical need,” said Rik J Deitsch, CEO of Nutra Pharma. “These children have no therapeutic options that have been proven to be safe and effective for their disease. They must rely on off-label use of adult MS drugs.
“We have been laying the groundwork to move into sanctioned trials ever since we received Orphan Designation for RPI-78M. Standardising and scaling up drug production with BSF is the next logical step.”
The company were previously granted an Orphan Designation from the US FDA for the treatment of Pediatric Multiple Sclerosis with RPI-78M.
The designation is designed to encourage the development of drugs which may provide significant benefit to patients suffering from rare diseases.
“Based on our pre-clinical and open-label clinical studies, we believe that RPI-78M has the ability to successfully navigate the FDA approval process,” said Dale Vander Putten, PhD, Nutra Pharma’s Chief Scientific Officer.
He added: “We believe that a recombinant product will ultimately provide these kids with the best possible drug. We are now working with the BSF to scale up drug manufacturing in preparation for the upcoming Phase II clinical trials.”