Oncotelic Therapeutics Announces Phase 1 Trial Enrollment for Novel Intravenous Everolimus Formulation in Australia

Oncotelic Therapeutics, through its joint venture GMP Biotechnology Ltd. with Dragon Overseas Capital Ltd., has initiated patient enrollment for a Phase 1 clinical trial of Sapu-003, a novel intravenous Deciparticle formulation of everolimus. The trial, now open at leading oncology centers across Australia, represents the first clinical evaluation of an intravenous Deciparticle formulation of everolimus, an established mTOR inhibitor used in breast cancer and other malignancies.

The clinical trial, registered under ACTRN12625001083482, is enrolling patients with advanced HR+/HER2– breast cancer or other mTOR-sensitive tumors. This development follows Sapu Nano's recent presentation at the 8th Australian Translational Breast Cancer Research Symposium, where researchers detailed the innovative formulation approach. The trial is being conducted through strategic collaborations with SOCRU, Ingenū, and Medicilon, leveraging their collective expertise in clinical research and drug development.

Dr. Vuong Trieu, CEO of Sapu Nano and Oncotelic, emphasized the significance of this advancement, stating that Sapu-003 represents a substantial improvement in the delivery of mTOR-targeted therapies. The intravenous Deciparticle technology could potentially overcome limitations associated with current oral formulations of everolimus, which may include variable absorption and bioavailability issues that can impact treatment efficacy and patient outcomes.

The implications of this clinical development extend beyond the immediate patient population in Australia. Successful development of an intravenous everolimus formulation could transform treatment paradigms for multiple cancer types where mTOR inhibition has demonstrated clinical benefit. The Deciparticle technology platform may enable more precise drug delivery, potentially reducing side effects while maintaining or enhancing therapeutic efficacy. This approach aligns with growing trends in oncology toward targeted delivery systems that maximize drug exposure to tumor tissues while minimizing systemic toxicity.

For the broader pharmaceutical industry, the advancement of Deciparticle technology represents another step forward in nanoparticle-based drug delivery systems. The successful clinical translation of this platform could open new possibilities for reformulating other challenging therapeutic compounds that currently face delivery limitations. The partnership model demonstrated through the collaboration between Oncotelic, GMP Biotechnology, and multiple research organizations highlights the increasing importance of strategic alliances in accelerating oncology drug development.

Additional information about Oncotelic Therapeutics is available through their corporate communications at https://ibn.fm/OTLC, while details about the broader biomedical communications platform supporting this announcement can be found at https://www.BioMedWire.com. The progression of Sapu-003 through clinical development will be closely monitored by the oncology community, as it may establish new standards for mTOR inhibitor delivery and potentially expand treatment options for patients with advanced cancers who have limited therapeutic alternatives.