Sapu Nano, part of the Sapu family of companies and a joint venture between Oncotelic Therapeutics, Inc. (OTCQB: OTLC) and Dragon Overseas Capital Limited, has initiated the first in-human clinical trial of Sapu-003. The trial was announced at the Australian Translational Breast Cancer Research Symposium (ATBCR). Sapu-003 is an injectable formulation of Everolimus (Afinitor(R)), a drug used to treat various cancers, and aims to offer higher bioavailability and better efficacy than oral versions of the drug.
The clinical trial is being conducted in collaboration with partners including the Southern Oncology Clinical Research Unit (SOCRU), Ingenū, and Medicilon. The announcement marks a significant step for Sapu Nano as it advances its pipeline of nano-formulated therapies. The injectable formulation could potentially address limitations of oral Everolimus, such as variable absorption and gastrointestinal side effects, by delivering the drug directly into the bloodstream.
Everolimus is an mTOR inhibitor approved for the treatment of advanced renal cell carcinoma, pancreatic neuroendocrine tumors, and other cancers. The oral formulation, marketed as Afinitor, has been widely used but is associated with challenges including low and variable bioavailability, food effects, and patient compliance issues. Sapu-003 aims to overcome these hurdles by leveraging nano-technology to create a stable, injectable formulation that could provide more consistent drug levels and potentially improved outcomes.
The first in-human trial will assess the safety, tolerability, and pharmacokinetics of Sapu-003 in patients. The results will inform further development and potential registration studies. The trial is being conducted at sites in Australia, with SOCRU providing clinical research services. Ingenū and Medicilon are contributing their expertise in nano-formulation and drug development.
This development is particularly relevant for breast cancer research, as Everolimus is used in combination with hormonal therapy for hormone receptor-positive, HER2-negative advanced breast cancer. The ATBCR symposium provided a platform for Sapu Nano to present the trial design and early data, highlighting the potential impact of improved drug delivery on patient care.
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