Oncotelic's Sapu003 Trial Clears Safety Review, Expands to Europe

Oncotelic Therapeutics (OTCQB: OTLC) and its 45%-owned subsidiary, Sapu Nano (US) LLC, have achieved a significant clinical milestone. The independent Safety Review Committee completed its review of the initial three-patient safety cohort in the ongoing Phase 1b SP-03-B101 trial of Sapu003, a novel intravenous everolimus formulation. The committee found no dose-limiting toxicities and recommended advancing the trial to the next planned dose level. Additionally, Oncotelic announced plans to expand the study into Europe by adding clinical sites, aiming to broaden patient access and accelerate enrollment.

The clinical progress follows the publication of peer-reviewed research detailing the scientific foundation of the Deciparticle(TM) nanomedicine platform, which underpins Sapu003. This publication validates the platform’s scalable manufacturing capabilities, stability, and preclinical antitumor activity, reinforcing the ongoing clinical development program. Oncotelic Therapeutics is a clinical-stage biopharmaceutical company focused on oncology and immunotherapy, addressing high-unmet-need cancers and rare pediatric indications. The company also develops PDAOAI, a proprietary AI platform for drug discovery and manufacturing, in collaboration with TechForce Robotics.

The news release also highlights the role of BioMedWire as a communications platform distributing this update. BioMedWire, part of the Dynamic Brand Portfolio @ IBN, provides wire solutions, editorial syndication to 5,000+ outlets, and social media distribution. This ensures that investors and stakeholders receive timely information about Oncotelic’s progress. For more details, the full press release is available at https://ibn.fm/sBbID.