Nutra Pharma announces manufacturing alliance with Omnia Biologics to produce RPI-78M for clinical trials in pediatric multiple sclerosis.
Nutra Pharma Corporation, a biotechnology company marketing Nyloxin® and Pet Pain-Away in the over-the-counter (OTC) pain management market, and which is also developing treatments for multiple sclerosis (MS), human immunodeficiency virus (HIV), adrenomyeloneuropathy (AMN), and pain, announced a manufacturing alliance with Omnia Biologics to clone and produce alpha-cobratoxin for the production of RPI-78M for upcoming clinical trials in pediatric MS.
“Pediatric multiple sclerosis is a pressing and unmet medical need,” commented Rik J Deitsch, Chief Executive Officer of Nutra Pharma. “While it is distinct from the adult form of the disease, there are no drugs approved for the treatment of Pediatric MS. These children have no other option than to rely on off label use of adult MS drugs to control their disease.
“Based on our pre-clinical and open-label studies, we believe that RPI-78M has the ability to successfully navigate the approval process. We are now working with Omnia to scale up drug manufacturing in preparation for the upcoming clinical trials.”
The company previously announced that they had been granted Orphan Designation by the US-Food and Drug Administration (FDA) for the treatment of pediatric MS with RPI-78M. The designation is designed to encourage the development of drugs which may provide significant benefit to patients suffering from rare diseases.
Omnia Biologics will clone the alpha-cobratoxin gene as the raw material for the production of the drug, RPI-78M. They will also produce the purified clinical trial materials for the proposed studies in their cGMP manufacturing facilities located in Rockville, Maryland. Additionally, Omnia will provide process and assay development services that will be necessary as the drug moves through the FDA approval process.
RPI-78M was originally derived from an extract of cobra venom and is an antagonist of the nicotinic acetylcholine receptor. The drug has a remarkably low toxicity with a very large therapeutic window. Scientific publications have demonstrated that native and modified neurotoxins can protect nerve cells from early cell death. Furthermore, it is expected that RPI-78M may be beneficial in neuromuscular disorders where the activity of nicotinic acetylcholine receptor has been compromised. The proprietary technology is covered by patents describing the application and use of RPI-78M in the treatment of autoimmune diseases.
Filed Under: Drug Discovery