Oncotelic Therapeutics, Inc. (OTCQB: OTLC) and Sapu Nano have announced the expansion of the 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. The 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 the Sapu003 program is significant as it leverages a novel delivery technology that could enhance the therapeutic profile of everolimus, a drug used in various cancers. By transitioning to a multinational strategy, Oncotelic aims to accelerate patient recruitment and data collection, potentially expediting the path to regulatory approvals. The appointment of GCT, a global CRO with experience in international trials, underscores the company's commitment to rigorous study execution.
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 by its CEO, Dr. Vuong Trieu, and leverages its AI-enabled PDAOAI platform for research and regulatory processes. Oncotelic also holds a 45% interest in GMP Bio, a joint venture advancing complementary therapeutic candidates.
For more information, visit the company’s newsroom at https://nnw.fm/OTLC. The full press release is available at https://nnw.fm/olX92.
