Oncotelic Therapeutics (OTCQB: OTLC) together with Sapu Nano, announced publication of a peer-reviewed study in Biomedicines detailing the preclinical data supporting Sapu003, its intravenous Deciparticle(TM) formulation of everolimus. The publication outlines the program’s absorption, distribution, metabolism, excretion (“ADME”), pharmacokinetics, tissue distribution, GLP toxicology and cGMP manufacturing data, supporting the ongoing Phase 1 clinical evaluation of Sapu003 in patients with advanced solid tumors. According to the company, the formulation is designed to overcome pharmacokinetic limitations associated with oral everolimus while preserving the drug’s metabolic profile.
The published findings also describe reduced gastrointestinal drug exposure compared with oral everolimus, no treatment-related gastric pathology in repeat-dose GLP toxicology studies and successful development of a reproducible cGMP manufacturing process suitable for clinical production. The company said the comprehensive preclinical package supports continued clinical development of Sapu003 and further validates its Deciparticle platform for transforming hydrophobic therapeutics into intravenous medicines.
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