Oncotelic's Injectable Everolimus Formulation Cleared for Clinical Trials with Potential to Dramatically Increase Bioavailability

Oncotelic Therapeutics Inc. has achieved a significant milestone with the clearance to begin Phase 1 clinical trials for Sapu003, an injectable formulation of Everolimus marketed as Afinitor. This development represents a potential breakthrough in cancer treatment delivery, as the company's proprietary Deciparticles technology enables the creation of sub-20nm nanoparticles that dramatically improve drug bioavailability. The technology is being developed by Sapu Nano, part of Oncotelic's GMP Bio joint venture established with Dragon Overseas Capital Limited.

Preclinical studies have demonstrated remarkable results, showing that Sapu003 could increase the bioavailability of Everolimus from approximately 10% when administered orally to between 80% and 100% when delivered via injection. This substantial improvement in bioavailability could lead to dramatically better, faster, and more consistent efficacy for patients undergoing breast cancer treatment. The implications for cancer therapy are profound, as higher bioavailability typically translates to more predictable dosing, reduced side effects, and improved patient outcomes.

Oncotelic Therapeutics, trading as OTCQB: OTLC, operates as a clinical-stage biopharmaceutical company with a diversified pipeline spanning oncology, immunotherapy, neurodegeneration, and rare diseases. In a recent interview available through the BioMedWire podcast, Chairman and CEO Dr. Vuong Trieu emphasized the company's strategic focus on de-risked, late-stage assets and accelerating development through regulatory pathways designed for speed and efficiency. This approach positions the company to potentially bring improved treatments to market more rapidly than traditional development models.

The advancement of Sapu003 into clinical trials marks a critical step in validating the Deciparticles technology platform, which could have broader applications beyond Everolimus. The ability to transform poorly bioavailable oral medications into highly effective injectable formulations opens new possibilities for numerous existing drugs that suffer from absorption limitations. For breast cancer patients specifically, this development could mean more effective treatment with lower doses, reduced variability in drug response, and potentially better survival outcomes.