Oncotelic Therapeutics, Inc. (OTCQB: OTLC) and Sapu Nano announced the expansion of its Phase 1b clinical development program for Sapu003 (Everolimus for Injection) and the appointment of Global Clinical Trials (GCT) as the lead contract research organization for international execution of Study SP-03-B101. This move follows recent regulatory approvals supporting study expansion and marks the transition of the Sapu003 program from an Australia-based clinical effort toward a broader multinational development strategy, including planned expansion into Europe.
SP-03-B101 is an open-label Phase 1b dose-escalation study evaluating the safety, tolerability, pharmacokinetics, pharmacodynamics and preliminary anti-tumor activity of Sapu003 in patients with advanced mTOR-sensitive solid tumors. The company said GCT has already completed key regulatory submissions ahead of schedule and initiated clinical operations, site activation and study management activities. Sapu003 is an intravenous formulation of everolimus developed using Sapu Nano’s Deciparticle™ platform, which is designed to improve drug delivery and provide more predictable systemic exposure than oral administration while supporting future global registrational studies.
The expansion of this program is significant because it moves Sapu003 closer to potential registration and commercialization. By transitioning from a single-country study to a multinational effort, Oncotelic aims to accelerate patient enrollment and generate data that could support global regulatory approvals. The intravenous formulation addresses limitations of oral everolimus, such as variable absorption and food effects, potentially offering more consistent therapeutic levels and improved patient outcomes.
Oncotelic Therapeutics is a clinical-stage biopharmaceutical company focused on oncology and immunotherapy products addressing high-unmet-need cancers and rare pediatric indications. The company benefits from a robust portfolio of inventions created by its CEO, Dr. Vuong Trieu, who has filed over 500 patent applications and holds 75 issued patents. Oncotelic also leverages its proprietary AI-enabled PDAOAI platform for research, biomarker discovery, and regulatory processes.
Beyond internal programs, Oncotelic licenses and co-develops drug candidates through strategic partnerships and joint ventures, including a 45% interest in GMP Bio. For more information, visit the company’s newsroom at https://nnw.fm/OTLC.
The full press release is available at https://nnw.fm/olX92.
