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

Oncotelic Therapeutics, through its joint venture GMP Biotechnology Ltd. with Dragon Overseas Capital Ltd., has announced that enrollment is now open for the Phase 1 clinical trial of Sapu-003, a novel intravenous Deciparticle formulation of everolimus. The trial marks the first clinical investigation of an intravenous Deciparticle formulation of everolimus, an mTOR inhibitor commonly used in breast cancer and other malignancies. This development represents a significant step forward in cancer treatment delivery methods, potentially offering improved therapeutic options for patients with advanced cancers.

The clinical trial, registered under ACTRN12625001083482, is being conducted in collaboration with SOCRU, Ingenū, and Medicilon at leading oncology centers across Australia. The study will enroll patients with advanced HR+/HER2– breast cancer or other mTOR-sensitive tumors, targeting populations that could benefit from enhanced delivery of mTOR-targeted therapies. The international collaboration underscores the global interest in advancing cancer treatment technologies and the potential impact of improved drug delivery systems on patient outcomes.

Dr. Vuong Trieu, CEO of Sapu Nano and Oncotelic, emphasized the significance of this development, stating that Sapu-003 represents a substantial advance in the delivery of mTOR-targeted therapies. The partnerships established for this trial aim to accelerate development and bring this next-generation treatment to patients with advanced cancers more efficiently. The Deciparticle technology platform represents an innovative approach to drug formulation that could potentially improve the bioavailability and therapeutic efficacy of existing cancer treatments.

The announcement was made following Sapu Nano's presentation of their research poster titled "Sapu-003: Novel Intravenous Deciparticle Everolimus Entering Phase 1 Study in Australia" at the 8th Australian Translational Breast Cancer Research Symposium. This symposium serves as an important platform for sharing cutting-edge research in breast cancer treatment and highlights the significance of this clinical development within the oncology research community. The progression to clinical trials demonstrates the maturation of the Deciparticle technology from preclinical research to human studies.

The initiation of this Phase 1 trial represents an important milestone in the development of novel cancer therapeutics, particularly for patients with advanced HR+/HER2– breast cancer who may have limited treatment options. The intravenous formulation could potentially address limitations of existing oral everolimus formulations, including variable absorption and gastrointestinal side effects. As the trial progresses, it will provide critical data on the safety, tolerability, and preliminary efficacy of this innovative drug delivery approach, potentially paving the way for improved treatment paradigms in oncology.