Oncotelic Therapeutics Inc. has received clearance to begin Phase 1 clinical trials for Sapu003, an injectable form of Everolimus that represents a significant advancement in cancer treatment delivery. The development comes through Sapu Nano, part of Oncotelic's GMP Bio joint venture, and targets breast cancer patients who may benefit from improved drug delivery systems. The key innovation lies in the Deciparticles technology developed by Oncotelic, which creates sub-20nm nanoparticles that dramatically enhance drug bioavailability.
Preclinical studies have shown remarkable results, with Sapu003 potentially increasing the bioavailability of Everolimus from approximately 10% as an oral pill to anywhere from 80% to 100% as an injectable formulation. This substantial improvement could translate to better, faster, and more consistent efficacy for patients undergoing treatment. Dr. Vuong Trieu, Chairman and CEO of Oncotelic Therapeutics, emphasized the company's strategic approach in a recent interview on theBioMedWire podcast, highlighting their focus on de-risked, late-stage assets and accelerated development through efficient regulatory pathways.
The Deciparticles technology is being advanced by Sapu Nano, which operates as part of the Sapu family of companies established through GMP Biotechnology Limited. This joint venture between Oncotelic Therapeutics and Dragon Overseas Capital Limited represents a collaborative effort to push the boundaries of drug delivery systems. The enhanced bioavailability could mean that patients receive more consistent dosing with potentially reduced side effects and improved treatment outcomes. For breast cancer patients currently relying on oral Everolimus, the transition to an injectable form with significantly higher bioavailability could represent a major treatment advancement.
The increased bioavailability suggests that lower doses might achieve the same therapeutic effect, potentially reducing costs and minimizing adverse effects while maintaining or improving efficacy. The Phase 1 trial will be crucial in determining whether these preclinical benefits translate to human patients and establish safe dosing parameters for future clinical development. The company maintains its newsroom at ibn.fm/OTLC for investor updates, providing a centralized source for information about this promising development in cancer treatment technology.
